A Real-world cost-effectiveness study of autologous stem cell transplant plus CAR-T versus CAR-Ttherapy alone in Chinese patients with relapsed/refractory large B-cell lymphoma

A Real-world cost-effectiveness study of autologous stem cell transplant plus CAR-T versus CAR-Ttherapy alone in Chinese patients with relapsed/refractory large B-cell lymphoma | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Article A Real-world cost-effectiveness study of autologous stem cell transplant plus CAR-T versus CAR-Ttherapy alone in Chinese patients with relapsed/refractory large B-cell lymphoma Xiaojian Zhu, Zhengtao Zhou, Haitao Ruan, Ting Deng, Fankai Meng, and 4 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4372075/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract This study aimed to evaluate the cost-effectiveness of autologous stem cell transplant plus CAR-T (ASCT + CAR-T) therapy compared to CAR-T therapy among relapsed/refractory large B-cell lymphoma (r/r LBCL) patients based on real-world data.Complete response rate (CR), adverse events (AE), and total treatment cost were identified and compared between the two therapy groups. Using a decision analytic model based on standard clinical flow, incremental cost-effectiveness ratios (ICERs) for overall survival were calculated with stratification by disease stage and hormone-receptor status. A total of 76 patients received CAR-T therapy and 81 underwent ASCT + CAR-T therapy. The average total treatment cost was ¥242,265.44 for the CAR-T group and ¥321,649.84 for the ASCT + CAR-T group (p < 0.001), 44.70% and 58.02% patients achieved CR at 6-month respectively (p = 0.1). Grade III or higher cytokine release syndrome events occurred in 6.8% of the CAR-T group and 13.6% of the ASCT + CAR-T group (p < 0.001). The ICER was ¥5,974.21 per 1% CR rate increase. The use of ASCT + CAR-T for r/r LBCL patients may lead to better effectiveness but also higher treatment costs. Commercial CAR-T demonstrated a higher CR rate but higher treatment costs compared to in-hospital CAR-T formulations. Our research provides support for the cost-effectiveness of different treatment option for r/r LBCL patients. Health sciences/Diseases/Cancer/Haematological cancer/Lymphoma Health sciences/Diseases/Cancer/Haematological cancer/Lymphoma Health sciences/Medical research Health sciences/Medical research Figures Figure 1 Figure 2 Introduction Non-Hodgkin lymphoma (NHL) is the most common hematological malignancy with 97,788 estimated new cases in the China in 2022 [ 1 ] . Diffuse large B-cell lymphoma (DLBCL), the most frequent non-Hodgkin lymphoma (NHL) subtype, accounts for 30–40% of cases. DLBCL is an aggressive disease that patients typically present with rapidly enlarging lymphadenopathy and constitutional symptoms, necessitating immediate treatment. It is the most common lymphoma subtype, accounting for 30–58% of all non-Hodgkin lymphomas [ 2 ] . The most common up-front treatment is chemoimmunotherapy with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone), which leads to cure in approximately 50%-60% of patients. However, outcomes are particularly poor for those who are refractory to up-front treatment or relapse after achieving remission. High-dose chemotherapy and autologous stem cell transplant (ASCT) only achieve long-term remissions in a minority of patients in the era of rituximab [ 3 ] . Recently, anti-CD19 chimeric antigen receptor T-cells (CAR-T) have become available as third-line therapy for patients with relapsed/refractory (r/r) LBCL and are rapidly moving as second-line treatment for those who are refractory or early relapse after R-CHOP. Anti-CD19 CAR-T cells consist of autologous T lymphocytes redirected against CD19 antigen by the introduction of a chimeric anti-CD19 T cell receptor (CAR) with a replication-incompetent retroviral vector [ 4 ] . Three CAR-T therapies (axicabtagene ciloeucel; tisagenlecleucel; lisocabtagene maraleucel) have been approved in North America and European Union in the refractory and relapsed lymphoma setting. CAR-T has dramatically changed the therapeutic effectiveness in patients with r/r LBCL, offering substantial benefits for long-term survival [ 5 ] . In order to improve patients’ response and quality of life, the treatment of the combination of CAR-T plus ASCT was first reported in 2020 [ 6 – 9 ] . This treatment for patients with a low probability of long-term survival expected through simple autologous transplantation, or when poor post-transplant outcomes are anticipated based on certain risk factors, autologous transplantation combined with CAR-T therapy can be considered, such as: (1) patients with early relapse (r/r); (2) high International Prognostic Index (IPI) scores for lymphoma; (3) positive pre-transplant minimal residual disease (MRD) and PET/CT results; (4) presence of adverse genetics or molecular mutations; (5) lymphomas with immune-privileged organ involvement (PCNSL) [ 10 ] . A high remission rate of ASCT-CART therapy can be attributed to high dose conditioning chemotherapy that improved CART activity which help patients to achieve better response [ 11 ] . In terms of treatment efficacy evaluation, the overall response rate (ORR) for the ASCT plus CAR-T therapy group and the ASCT therapy group were 90% and 89% respectively, with complete response (CR) rates of 71% and 33% respectively. The 3-year progression-free survival (PFS) rates were 80% and 44% respectively, with median PFS of not reached and 26 months respectively. The 3-year overall survival (OS) rates were 80% and 69% respectively, with median OS not reached in both groups. The 3-year tumor recurrence or progression rates were 15% and 56% respectively [ 12 ] . Studies have shown the efficacy outcomes of ASCT plus CAR-T compared to CAR-T, but have not considered the affordability issue for patients due to the high cost of CAR-T [ 9 , 11 ] . Therefore, in this study, we explored the cost-effectiveness of CAR-T therapy compared to ASCT plus CAR-T (ASCT + CAR-T) therapy among Chinese patients in the real-world. Additionally, we investigated the cost-effectiveness of different types of CAR-T treatments, aiming to provide patients with better treatment selection criteria. Method Patients and Study Design We performed a cost-effectiveness analysis of ASCT + CAR-T versus CAR-T alone in patients with relapsed/refractory large B-cell lymphoma. The model input, both clinical outcomes and costs were derived from a retrospective, single-center cohort study in Tongji Hospital affiliated to Tongji Medical College of Hust, Wuhan, China. Patients who received CAR-T therapy or received ASCT with CAR-T (including both commercial CAR-T and in-hospital CAR-T preparations) were included in the study. All patients must meet the following inclusion criteria: ≥18 years old, diagnosed with r/r LBCL, and had already completed CAR-T cell infusion with or without ASCT before 31st September 2022. Patients who were not eligible for this analysis were excluded. All patients were followed up for 6 months. The study was performed in accordance with the principle of the Declaration of Helsinki. Study approval was granted by the Ethics Committee of Tongji Hospital affiliated to Tongji Medical College of Hust, Wuhan. Model Design A decision-tree model was designed to reflect patients’ treatment flow and clinical effectivenesss. The schematic diagrams of the model are presented in Fig. 1 . The starting point for the decision tree model was the initial choice of treatment strategy: CAR-T or ASCT + CAR-T. Based on the different type of CAR-T use, patients were divided into commercial CAR-T preparation group or in-hospital CAR-T preparation group. Cost and Effectiveness This study was conducted from the perspective of Chinese healthcare system. As such, only direct costs were considered, including both initial treatment costs and follow-up visit costs of patients. The costs for initial CAR-T therapy with or without ASCT were extracted from the electronic hospital records while the cost of patient follow-up at 6 months is based on self-estimated feedback from patients during telephone follow-up. Clinical effectiveness endpoints included: ORR, CR, PR and survival status. Safety endpoints were examined by presence of cytokine release syndrome [ 9 ] (CRS) and by the type and severity of individual signs and symptoms, treatment, and date of onset. Descriptive statistics were used to summarize characteristics and outcomes from the study population. Continuous variables were presented as means (SD) and medians (IQR), and categorical variables were described as frequencies (percentage). Comparisons between two groups with respect to continuous variables of interest, both before and after the analysis by propensity score matching, were evaluated using the t-student parametric test or the Mann–Whitney non-parametric test according to data distribution. The associations between the categorical variables were evaluated with the Chi-Square test or with the Fisher exact test when appropriate. To compare ORR and CR, in order to control potential confounders and selection bias, we performed a subgroup analysis using propensity score matching with the R package ‘MatchIt’ (method nearest neighbor). The patients were matched 1:1 by age, gender, ECOG, IPI, LDH, staging and the CAR-T product used. P values < 0.05 were considered statistically significant. Statistical analyses were performed with R Statistical Software 4.2.1 with default parameters. Cost-Effectiveness Analysis We calculated incremental cost-effectiveness ratios (ICERs) as the model output. The ICERs were defined as the ratio of change in costs between the 2 groups to the change in clinical outcomes. All ICERs were represented as Chinese Yuan (¥). Result Patient’s Characteristics A total of 157 patients met all inclusion and exclusion criteria and included in our study. The mean age of all the patients was 48.0 years (SD, ± 12.3 years); 48.4% of patients were males. 76 patients received CAR-T therapy while 81 underwent ASCT + CAR-T therapy. 10 patients had a commercial CAR-T preparation for axi-cel or relma-cel (5 in CAR-T group and 5 in ASCT + CAR-T group). Patients were heavily pre-treated where 39.5% of CAR-T and 30.8% of ASCT + CAR-T patients underwent 3 or more previous lines of treatment. All patients were treated in an inpatient setting. Patients receiving CAR T-cell therapy had a mean hospital length of stay of 29.8 days (SD, ± 10.5 days) which was slightly shorter than that of the ASCT + CAR-T group (33.2 ± 6.8 days). 25% of CAR-T patients and 44.4% of ASCT + CAR-T patients had an IPI score of 3 or higher. Baseline characteristics of treated patients are listed in Table 1 . All patients’ 6-month follow-up data were collected. Table 1 Patient characteristics of all patients. Variable Overall N = 157 CART N = 76 ASCT + CART N = 81 p-value Age < 0.001 Mean (SD) 48.01 (12.34) 51.54 (11.62) 44.69 (12.14) Sex 0.5 Male 93.0 (59.2%) 47.0 (61.8%) 46.0 (56.8%) Female 64.0 (40.8%) 29.0 (38.2%) 35.0 (43.2%) Length of stay 0.001 Mean (SD) 31.55 (8.95) 29.79 (10.53) 33.20 (6.82) ECOG score, n (%) 0.03 0 6.0 (3.8%) 4.0 (5.3%) 2.0 (2.5%) 1 96.0 (61.1%) 53.0 (69.7%) 43.0 (53.1%) 2 55.0 (35.0%) 19.0 (25.0%) 36.0 (44.4%) IPI score, n (%) 0.6 0 2.0 (1.3%) 1.0 (1.3%) 1.0 (1.2%) 1 4.0 (2.5%) 3.0 (3.9%) 1.0 (1.2%) 2 56.0 (35.7%) 24.0 (31.6%) 32.0 (39.5%) 3 68.0 (43.3%) 37.0 (48.7%) 31.0 (38.3%) 4 25.0 (15.9%) 10.0 (13.2%) 15.0 (18.5%) 5 2.0 (1.3%) 1.0 (1.3%) 1.0 (1.2%) LDH, n (%) 0.6 Increased 153.0 (97.5%) 75.0 (98.7%) 78.0 (96.3%) Decreased 4.0 (2.5%) 1.0 (1.3%) 3.0 (3.7%) Staging, n (%) 0.012 I A 1.0 (0.6%) 0.0 (0.0%) 1.0 (1.2%) II A 11.0 (7.0%) 8.0 (10.5%) 3.0 (3.7%) II B 1.0 (0.6%) 0.0 (0.0%) 1.0 (1.2%) III A 20.0 (12.7%) 8.0 (10.5%) 12.0 (14.8%) III B 8.0 (5.1%) 6.0 (7.9%) 2.0 (2.5%) IV A 79.0 (50.3%) 30.0 (39.5%) 49.0 (60.5%) IV B 37.0 (23.6%) 24.0 (31.6%) 13.0 (16.0%) Previous lines of treatment, n (%) 0.2 1 17.0 (10.8%) 4.0 (5.3%) 13.0 (16.0%) 2 85.0 (54.1%) 42.0 (55.3%) 43.0 (53.1%) 3 45.0 (28.7%) 24.0 (31.6%) 21.0 (25.9%) 4 9.0 (5.7%) 5.0 (6.6%) 4.0 (4.9%) 5 1.0 (0.6%) 1.0 (1.3%) 0.0 (0.0%) (inserting Table 1 ) Effectiveness With 6-months of follow-up, 34 (44.74%) patients in the CAR-T group and 47 (58.02%) patients in the CAR-T + ASCT achieved CR, 46 (60.53%) patients in CAR-T and 65 (80.25%) patients in CAR-T + ASCT achieved ORR. 2 patients in CAR-T and 7 patients in ASCT-CAR-T patients died. Subgroup analysis Subgroup 1 For patients with in-hospital CAR-T preparations, 7 parameters were used to stringent PSM, absolute values of the p value were more than 0.5 for all matching covariates (Supplementary Table 1). In the 1:1 matched population (n = 70; 35patients treated with CAR-T and 35 patients treated with ASCT + CAR-T). For patients treated with in-hospital ASCT + CAR-T therapy, with the 6-month follow-up, the results demonstrate favorable outcomes in terms of CR rates (42.86% vs 54.29%) and ORR rates (57.14% vs 77.14%). The 6-month survival rate is same (94.29%). Subgroup 2 For patients with CAR-T, after stringent PSM on 5 parameters, absolute values of the p value were more than 0.5 for all matching covariates (Supplementary Table 2). In the 1:2 matched population (n = 10; 5 patients treated with commercial CAR-T and 5 patients treated with in-hospital CAR-T) (Supplementary Table 2). For patients treated with commercial CAR-T therapy, with the 6-month follow-up, the results demonstrate favorable outcomes in terms of CR rates (60.00% vs 40.00%) than treated with in-hospital CAR-T. The 6-month survival rate is lower (80.00% vs 100.00%). Subgroup 3 For patients with ASCT + CAR-T, after stringent PSM on 5 parameters, absolute values of the p value were more than 0.5 for all matching covariates (Supplementary Table 3). In the 1:2 matched population (n = 10; 5 patients treated with commercial CAR-T and 5 patients treated with in-hospital CAR-T). For patients treated with commercial CAR-T therapy, with the 6-month follow-up, the results demonstrate favorable outcomes in terms of CR rates (80.00% vs 28.57%) than treated with in-hospital CAR-T. The 6-month survival rate is lower (80.00% vs 85.71%). Safety Among the patients infused, 74 (97.4%) in the CAR-T group and 81 (100%) in the CAR-T + ASCT group developed a CRS (any grade). In most cases, CRS was grade ≤ 3; with only 5 out of 74 patients (6.8%) and 11 out of 81 patients (13.6%) experiencing CRS grade ≥ 3 in two groups, respectively (P < 0.001). Only 1 patient (1.3%) in CAR-T therapy reported death during the 6-month follow-up. Cost The average total treatment costs were ¥242,265 and ¥321,650 for the CAR-T group and the ASCT + CAR-T group, respectively. (p < 0.001). Excluding CAR-T costs, the treatment cost for CAR-T therapy was ¥113,054, while the cost for ASCT + CAR-T therapy was ¥198,439. Excluding the initial treatment cost, average follow-up costs were ¥45,457 and ¥61,466, for the CAR-T group and ASCT + CAR-T group, respectively. In order to compare the costs in detail, the cost breakdown of two treatment regimens for in-hospital patients was used to analyzed. The results showed that for in-hospital patients, the nursing and medication costs of ASCT + CAR-T were significantly higher than those of the CAR-T group (P < 0.001) (Fig. 2 ). The primary reason is that nursing costs are higher for ASCT + CAR-T due to the need for patient observation in the transplant ward. Cost-effectiveness analysis All population For all patients, compared to CAR-T therapy, each 1% increase in CR with ASCT + CAR-T therapy requires an additional expenditure of ¥5974.21. If ORR is considered as the clinical outcome, an extra ¥4025.46 is needed. From the results, it is observed that both treatment regimens offer clinical benefits to patients when assessed based on 6-month survival. However, with ASCT + CAR-T compared to CAR-T, every additional 1% increase in survival rate incurs an extra cost of ¥9,77,380.36. Table 2 shows all cost-effectiveness analysis result by different therapy and clinical outcomes among r/r LBCL patients. Subgroup analysis Subgroup 1 For 1:1 matched population treated with in-hospital CAR-T therapy (n = 70; 35patients treated with CAR-T and 35 patients treated with ASCT + CAR-T), the results demonstrate favorable outcomes in terms of CR rates, ORR rates, and 6-month survival rates, with minimal differences observed between the two treatment groups. Compared to CAR-T therapy alone, for patients receiving ASCT + CAR-T therapy, every additional 1% increase in CR requires an additional expenditure of ¥6,770.12. If ORR is considered as the clinical outcome, an additional expenditure of ¥3,868.64 is required for every 1% increase in ORR. If 6-month survival rate is considered as the clinical endpoint, an additional expenditure of ¥27,080.48 yuan is needed for every 1% increase in 6-month survival rate. The result was shown in Table 2 . Subgroup 2 For 1:2 matched population treated with CAR-T (n = 10; 5 patients treated with commercial CAR-T and 5 patients treated with in-hospital CAR-T), the results indicate that there are more patients achieving CR at 6 months when using commercial CAR-T compared to in-house CAR-T, with an additional expenditure of ¥62,178.24 for every 1% increase in CR. There is no difference in 6-month ORR and survival rate between the two groups. However, due to sample size limitations, the differences between the two groups are not statistically significant. Detailed result data can be found in Table 3 . Subgroup 3 For 1:2 matched population treated with ASCT + CAR-T, the results indicate that there are more patients achieving CR at 6 months when using commercial CAR-T compared to in-hospital CAR-T, with an additional expenditure of ¥24,083.96 for every 1% increase in CR. Regarding the 6-month survival rate, the results show that one patient died in each group, but due to sample size limitations, the differences between the two groups are not statistically significant. Detailed result data can be found in Table 3 . Table 2 Cost-effectiveness results of two therapies. Clinical Outcome Item No. of patients,n Percentage (%) Cost All Patients CAR-T 76 ¥242,265.45 ASCT + CAR-T 81 ¥321,649.84 CR CAR-T 34 44.74% ASCT + CAR-T 47 58.02% ICER ¥5,974.21 ORR CAR-T 46 60.53% ASCT + CAR-T 65 80.25% ICER ¥4,025.46 Survival CAR-T 74 97.37% ASCT + CAR-T 74 91.36% ICER ¥-13,207.85 In-hospital patients (PSM) CAR-T 35 ¥174,618.07 ASCT + CAR-T 35 ¥251,990.87 CR CAR-T 15 42.86% ASCT + CAR-T 19 54.29% ICER ¥6,770.12 ORR CAR-T 20 57.14% ASCT + CAR-T 27 77.14% ICER 3868.64 Survival CAR-T 33 94.29% ASCT + CAR-T 33 94.29% ICER / (inserting Table 2 ) Table 3 Cost-effectiveness results of two types of CAR-T. Clinical Outcome Item No. of patients,n Percentage (%) Cost CAR-T (PSM) commercial 5 ¥1,358,242.82 in-hospital 5 ¥114,678.08 CR commercial 3 60.00% in-hospital 2 40.00% ICER ¥62,178.24 ORR commercial 3 60.00% in-hospital 3 60.00% ICER / Survival commercial 4 80.00% in-hospital 5 100.00% ICER ¥-62,178.24 ASCT + CAR-T (PSM) commercial 5 ¥1,486,201.64 in-hospital 14 ¥247,597.83 CR commercial 4 80.00% in-hospital 4 28.57% ICER ¥24,083.96 ORR commercial 4 80.00% in-hospital 4 28.57% ICER ¥24,083.96 Survival commercial 4 80.00% in-hospital 12 85.71% ICER ¥-216,755.67 (inserting Table 3 ) Discussion With the clinical application of CAR-T in China, the combination of ASCT and CART therapy (ASCT-CART) has been explored to improve patients' response and long‐term survival [ 13 – 16 ] . Based on this, some articles have reported on the efficacy of ASCT + CAR-T compared to CAR-T in patients with r/r LBCL and central nervous system. Study results indicate that ASCT + CAR-T demonstrates longer PFS and OS compared to CAR-T [ 17 – 18 ] . Our study utilized real-world data to perform an economic evaluation of CAR-T therapy versus ASCT + CAR-T therapy. All parameters utilized in this investigation were derived from real-world data sources, thereby providing insights into the practical application of CAR-T and ASCT + CAR-T therapies among Chinese patients. This study represents the pioneering effort in China to present findings on patient expenditures alongside the clinical effectiveness of different CAR-T modalities. CAR-T therapy first entered the Chinese market in 2019, offering more treatment options for r/r LBCL patients. Currently, the commercially available CAR-T therapies approved by the China National Medical Products Administration were all based on single-arm clinical trials. Our study is the first study that includes all available CAR-T formulations (axi-cel, relma-cel, in-hospital) up to September 30, 2022, for r/r LBCL patients in real-world settings. The study results indicate that patients treated with ASCT + CAR-T achieved significantly higher clinical responses while incurred overall higher costs, notably in nursing and medication expenses compared to the CAR-T group. This is primarily due to the necessary expenditures associated with ASCT. It implies that to some extent, the use of ASCT + CAR-T therapy will increase the nursing burden within the healthcare system. From a clinical effectiveness perspective at 6 months post treatment, ASCT + CAR-T demonstrates superior CR (ASCT + CAR-T vs CAR-T: 58.02% vs 44.74%) and ORR (ASCT + CAR-T vs CAR-T: 80.25% vs 60.53%) outcomes irrespective of whether commercial CAR-T is utilized.ASCT + CAR-T therapy was comparatively more expensive (ASCT + CAR-T Vs CAR-T: ¥321,649.84 vs ¥242,265.45) but patients may be willing to pay a higher treatment cost to receive ASCT + CAR-T Therapy. Additionally, it's worth noting that our study findings indicate that the average cost associated with CAR-T therapy is not notably high. This is primarily because most included patients received in-hospital CAR-T therapy rather than commercial CAR-T, resulting in lower average costs. Based on our subgroup analysis results, commercial CAR-T yielded higher CR rates compared to in-hospital CAR-T with significant higher treatment cost. After balancing for patient baseline characteristics, we speculate that the difference in efficacy between the two groups may stem from variations in CAR-T manufacturing processes. Commercial CAR-T undergoes stringent production pathways and quality control standards, whereas in-hospital CAR-T formulations may lack standardized quality control, potentially resulting in lower product quality and instability. Despite the inferior manufacturing process and lack of strict quality control associated with in-hospital CAR-T, its lower cost makes it a viable treatment option for many patients. Our study data shows that there was a total of 157 patients treated with CAR-T, but only 10 received commercial CAR-T treatment. This indicates a high demand for CAR-T therapy among patients, but its accessibility is greatly limited due to the high cost. Therefore, in-hospital CAR-T formulations have become one of the treatment choices for patients. Apart from the high treatment costs, the number of patients using commercial CAR-T is extremely limited may also be attributed to the lack of reimbursement by medical insurance for CAR-T therapy. Although more and more commercial CAR-T products are currently available in China, the inability to be reimbursed by medical insurance results in poor accessibility for patients. The low accessibility of CAR-T therapy for Chinese patients due to excessively high treatment costs is currently an unmet need. Improving patient accessibility is a future direction that requires joint efforts from companies and Chinese healthcare insurance. Our study is limited by a small sample size, which tends to yield more false negative findings, i.e., no difference between the tested groups. However, our research was conducted at a tertiary hospital, aligning with the standards of hospitals in China providing CAR-T therapy. Thus, the favorable effectiveness of CAR-T treatment and its lower incidence of grade III or IV cytokine release syndrome observed in our study confirm CAR-T therapy in addressing urgent unmet medical needs for with relapsed/refractory large B-cell lymphoma. Furthermore, our research encompasses sequential therapy involving ASCT + CAR-T, aiming to support broader clinical options and their application. For future real-world CAR-T therapy studies in China, conducting multicenter research is recommended to acquire more comprehensive sample sizes. Additionally, considering the long-term clinical benefits associated with CAR-T therapy, longer-term observations are necessary to ascertain its extended-term value. Conclusion The study results indicate that, the use of ASCT + CAR-T may lead to better effectiveness and higher treatment costs for r/r LBCL patients. Commercial CAR-T -demonstrated a higher CR rate compared to in-house CAR-T formulations, but the treatment costs are significantly higher than those of in-hospital CAR-T formulations. Our research provides support for the cost-effectiveness of different treatment option for r/r LBCL patients. Declarations Competing Interests : The authors declare that they have no competing interests. Author Contributions: TD and HT R collected and analyzed the data and ZT Z drafted the manuscript, they contributed equally to this work and share first authorship; XJ Z and XX Z conceived and designed the study; all authors executed this clinical trial and approved the final version for submission. Acknowledgements: This work was supported by the National Natural Science Foundation of China (82270183), and Project of Hubei Province Medical Youth Top Talents. Data Availability Statement: The additional data collected in this study are available from the corresponding authors on reasonable request. 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Hematopoietic stem cell transplantation and chimeric antigen receptor T cell for relapsed or refractory diffuse large B-cell lymphoma. Immunotherapy. 2020;12(13):997‐1006. DOI: 10.2217/imt-2020-0075 . Song Z, Xu L, Tang G, Gao L, Wang L, Ni X, et al. Prognostic differences of refractory/relapsed nodal and extranodal diffuse large B-cell lymphoma in the chimeric antigen receptor T cell therapy era. Clin Chim Acta.2022; 532:72–78. DOI: 10.1016/j.cca.2022.05.018 . Xue F, Zheng P, Liu R, Feng S, Guo Y, Shi H, et al. The Autologous Hematopoietic Stem Cells Transplantation Combination-Based Chimeric Antigen Receptor T-Cell Therapy Improves Outcomes of Relapsed/Refractory Central Nervous System B-Cell Lymphoma. J Oncol. 2022;2022:2900310. DOI: 10.1155/2022/2900310 . Additional Declarations There is NO conflict of interest to disclose. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4372075","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Article","associatedPublications":[],"authors":[{"id":299906576,"identity":"ee98e353-d711-4fa4-b63a-5ca26156957d","order_by":0,"name":"Xiaojian Zhu","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA+0lEQVRIiWNgGAWjYDACCSBOYGBgZmNgYHwMFTMgWguzMZRPhBYoYJMmSov87B4ziQc1Nux87GePVRe21dUxsDdvk2CouYNTC+OcM8YGCcfSmNl48tJuz2w7LMHAc6xMguHYM5xamCVyDB8ksB0G+iXH7DZv2wEJBokcMwnGhsM4tbBJ5BgcSPgH1ML/xqyYt61OgkH+DX4tPCBbEtuAWoCGM/O2MQNt4cGvRUIirdggsQ/oF4k3xtI85w5LtvGkFVskHMOtRX5G8jbJH99skuX7cww/85TV8fOzH95440MNbi0wkIzwHYhIIKiBgcGOCDWjYBSMglEwUgEA6QpFAr+jOCIAAAAASUVORK5CYII=","orcid":"https://orcid.org/0000-0002-2782-0311","institution":"Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology","correspondingAuthor":true,"prefix":"","firstName":"Xiaojian","middleName":"","lastName":"Zhu","suffix":""},{"id":299906577,"identity":"ceaa414d-45e9-48cc-9ea7-4be6ab230327","order_by":1,"name":"Zhengtao Zhou","email":"","orcid":"","institution":"Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology","correspondingAuthor":false,"prefix":"","firstName":"Zhengtao","middleName":"","lastName":"Zhou","suffix":""},{"id":299906589,"identity":"3b98e272-724b-49f5-a0cd-a47a34fb9239","order_by":2,"name":"Haitao Ruan","email":"","orcid":"","institution":"ongji Hospital, Tongji Medical College, Huazhong University of Science and Technology","correspondingAuthor":false,"prefix":"","firstName":"Haitao","middleName":"","lastName":"Ruan","suffix":""},{"id":299906579,"identity":"317ca904-9565-4e7b-8773-af0d1127bc39","order_by":3,"name":"Ting Deng","email":"","orcid":"","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Ting","middleName":"","lastName":"Deng","suffix":""},{"id":299906580,"identity":"b668bc1c-51eb-4faf-b6d5-7ad885d8ab61","order_by":4,"name":"Fankai Meng","email":"","orcid":"","institution":"Tongji Hospital, Tongji Medical College","correspondingAuthor":false,"prefix":"","firstName":"Fankai","middleName":"","lastName":"Meng","suffix":""},{"id":299906581,"identity":"18483fcc-7bd6-4aeb-ac2e-7307eaea3f85","order_by":5,"name":"Yang Cao","email":"","orcid":"","institution":"Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology","correspondingAuthor":false,"prefix":"","firstName":"Yang","middleName":"","lastName":"Cao","suffix":""},{"id":299906582,"identity":"2c1c7988-2032-461b-9913-9086d8780f56","order_by":6,"name":"Liang Huang","email":"","orcid":"https://orcid.org/0000-0002-8370-3232","institution":"Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology","correspondingAuthor":false,"prefix":"","firstName":"Liang","middleName":"","lastName":"Huang","suffix":""},{"id":299906583,"identity":"d6cf1c1c-1b9e-41e7-aa21-2871386a3e53","order_by":7,"name":"Xiaoxi Zhou","email":"","orcid":"","institution":"Tongji Hospital Huazhong University of Science \u0026 Technology","correspondingAuthor":false,"prefix":"","firstName":"Xiaoxi","middleName":"","lastName":"Zhou","suffix":""},{"id":299906584,"identity":"73a56d72-f390-4c01-822d-03b805246e40","order_by":8,"name":"Jianfeng Zhou","email":"","orcid":"https://orcid.org/0000-0002-1332-9230","institution":"Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology","correspondingAuthor":false,"prefix":"","firstName":"Jianfeng","middleName":"","lastName":"Zhou","suffix":""}],"badges":[],"createdAt":"2024-05-05 14:35:17","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4372075/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4372075/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":56674684,"identity":"7dfb238a-b28f-4149-80c5-74fcd794fe64","added_by":"auto","created_at":"2024-05-17 15:44:06","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":558382,"visible":true,"origin":"","legend":"\u003cp\u003eDecision Tree Structure\u003c/p\u003e","description":"","filename":"Figure1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4372075/v1/47780a098a31eb19dd291762.jpg"},{"id":56674685,"identity":"4fa1d124-d7e0-493d-b6a7-c6e6c307ff7f","added_by":"auto","created_at":"2024-05-17 15:44:06","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":181189,"visible":true,"origin":"","legend":"\u003cp\u003eThe comparison of nursing and medication expenses between the two treatment regimens of in-hospital patients. (P\u0026lt;0.001)\u003c/p\u003e","description":"","filename":"Figure2.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4372075/v1/283fd5b6d6bd9a68f571fc93.jpg"},{"id":57913285,"identity":"1e59f977-84bd-46ce-a075-9be2474d796a","added_by":"auto","created_at":"2024-06-07 11:19:25","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1462295,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4372075/v1/dc408e6f-5c3f-4bb4-b3f6-d20d833b65b0.pdf"},{"id":56674682,"identity":"f1b4bb94-1010-4584-afb8-91c39b29fd94","added_by":"auto","created_at":"2024-05-17 15:44:06","extension":"pdf","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":74017,"visible":true,"origin":"","legend":"Supplementary file","description":"","filename":"Supplementaryfile.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4372075/v1/0704024428dd1041849c823f.pdf"}],"financialInterests":"There is \u003cb\u003eNO\u003c/b\u003e conflict of interest to disclose.","formattedTitle":"A Real-world cost-effectiveness study of autologous stem cell transplant plus CAR-T versus CAR-Ttherapy alone in Chinese patients with relapsed/refractory large B-cell lymphoma","fulltext":[{"header":"Introduction","content":"\u003cp\u003eNon-Hodgkin lymphoma (NHL) is the most common hematological malignancy with 97,788 estimated new cases in the China in 2022\u003csup\u003e[\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]\u003c/sup\u003e. Diffuse large B-cell lymphoma (DLBCL), the most frequent non-Hodgkin lymphoma (NHL) subtype, accounts for 30\u0026ndash;40% of cases. DLBCL is an aggressive disease that patients typically present with rapidly enlarging lymphadenopathy and constitutional symptoms, necessitating immediate treatment. It is the most common lymphoma subtype, accounting for 30\u0026ndash;58% of all non-Hodgkin lymphomas \u003csup\u003e[\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eThe most common up-front treatment is chemoimmunotherapy with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone), which leads to cure in approximately 50%-60% of patients. However, outcomes are particularly poor for those who are refractory to up-front treatment or relapse after achieving remission. High-dose chemotherapy and autologous stem cell transplant (ASCT) only achieve long-term remissions in a minority of patients in the era of rituximab \u003csup\u003e[\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]\u003c/sup\u003e. Recently, anti-CD19 chimeric antigen receptor T-cells (CAR-T) have become available as third-line therapy for patients with relapsed/refractory (r/r) LBCL and are rapidly moving as second-line treatment for those who are refractory or early relapse after R-CHOP.\u003c/p\u003e \u003cp\u003eAnti-CD19 CAR-T cells consist of autologous T lymphocytes redirected against CD19 antigen by the introduction of a chimeric anti-CD19 T cell receptor (CAR) with a replication-incompetent retroviral vector \u003csup\u003e[\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]\u003c/sup\u003e. Three CAR-T therapies (axicabtagene ciloeucel; tisagenlecleucel; lisocabtagene maraleucel) have been approved in North America and European Union in the refractory and relapsed lymphoma setting. CAR-T has dramatically changed the therapeutic effectiveness in patients with r/r LBCL, offering substantial benefits for long-term survival \u003csup\u003e[\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eIn order to improve patients\u0026rsquo; response and quality of life, the treatment of the combination of CAR-T plus ASCT was first reported in 2020\u003csup\u003e[\u003cspan additionalcitationids=\"CR7 CR8\" citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]\u003c/sup\u003e. This treatment for patients with a low probability of long-term survival expected through simple autologous transplantation, or when poor post-transplant outcomes are anticipated based on certain risk factors, autologous transplantation combined with CAR-T therapy can be considered, such as: (1) patients with early relapse (r/r); (2) high International Prognostic Index (IPI) scores for lymphoma; (3) positive pre-transplant minimal residual disease (MRD) and PET/CT results; (4) presence of adverse genetics or molecular mutations; (5) lymphomas with immune-privileged organ involvement (PCNSL)\u003csup\u003e[\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]\u003c/sup\u003e. A high remission rate of ASCT-CART therapy can be attributed to high dose conditioning chemotherapy that improved CART activity which help patients to achieve better response \u003csup\u003e[\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]\u003c/sup\u003e. In terms of treatment efficacy evaluation, the overall response rate (ORR) for the ASCT plus CAR-T therapy group and the ASCT therapy group were 90% and 89% respectively, with complete response (CR) rates of 71% and 33% respectively. The 3-year progression-free survival (PFS) rates were 80% and 44% respectively, with median PFS of not reached and 26 months respectively. The 3-year overall survival (OS) rates were 80% and 69% respectively, with median OS not reached in both groups. The 3-year tumor recurrence or progression rates were 15% and 56% respectively \u003csup\u003e[\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eStudies have shown the efficacy outcomes of ASCT plus CAR-T compared to CAR-T, but have not considered the affordability issue for patients due to the high cost of CAR-T \u003csup\u003e[\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]\u003c/sup\u003e. Therefore, in this study, we explored the cost-effectiveness of CAR-T therapy compared to ASCT plus CAR-T (ASCT\u0026thinsp;+\u0026thinsp;CAR-T) therapy among Chinese patients in the real-world. Additionally, we investigated the cost-effectiveness of different types of CAR-T treatments, aiming to provide patients with better treatment selection criteria.\u003c/p\u003e"},{"header":"Method","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003ePatients and Study Design\u003c/h2\u003e \u003cp\u003eWe performed a cost-effectiveness analysis of ASCT\u0026thinsp;+\u0026thinsp;CAR-T versus CAR-T alone in patients with relapsed/refractory large B-cell lymphoma. The model input, both clinical outcomes and costs were derived from a retrospective, single-center cohort study in Tongji Hospital affiliated to Tongji Medical College of Hust, Wuhan, China. Patients who received CAR-T therapy or received ASCT with CAR-T (including both commercial CAR-T and in-hospital CAR-T preparations) were included in the study. All patients must meet the following inclusion criteria: \u0026ge;18 years old, diagnosed with r/r LBCL, and had already completed CAR-T cell infusion with or without ASCT before 31st September 2022. Patients who were not eligible for this analysis were excluded. All patients were followed up for 6 months. The study was performed in accordance with the principle of the Declaration of Helsinki. Study approval was granted by the Ethics Committee of Tongji Hospital affiliated to Tongji Medical College of Hust, Wuhan.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eModel Design\u003c/h2\u003e \u003cp\u003eA decision-tree model was designed to reflect patients\u0026rsquo; treatment flow and clinical effectivenesss. The schematic diagrams of the model are presented in Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. The starting point for the decision tree model was the initial choice of treatment strategy: CAR-T or ASCT\u0026thinsp;+\u0026thinsp;CAR-T. Based on the different type of CAR-T use, patients were divided into commercial CAR-T preparation group or in-hospital CAR-T preparation group.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eCost and Effectiveness\u003c/h2\u003e \u003cp\u003eThis study was conducted from the perspective of Chinese healthcare system. As such, only direct costs were considered, including both initial treatment costs and follow-up visit costs of patients. The costs for initial CAR-T therapy with or without ASCT were extracted from the electronic hospital records while the cost of patient follow-up at 6 months is based on self-estimated feedback from patients during telephone follow-up.\u003c/p\u003e \u003cp\u003eClinical effectiveness endpoints included: ORR, CR, PR and survival status. Safety endpoints were examined by presence of cytokine release syndrome \u003csup\u003e[\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]\u003c/sup\u003e (CRS) and by the type and severity of individual signs and symptoms, treatment, and date of onset.\u003c/p\u003e \u003cp\u003eDescriptive statistics were used to summarize characteristics and outcomes from the study population. Continuous variables were presented as means (SD) and medians (IQR), and categorical variables were described as frequencies (percentage). Comparisons between two groups with respect to continuous variables of interest, both before and after the analysis by propensity score matching, were evaluated using the t-student parametric test or the Mann\u0026ndash;Whitney non-parametric test according to data distribution. The associations between the categorical variables were evaluated with the Chi-Square test or with the Fisher exact test when appropriate. To compare ORR and CR, in order to control potential confounders and selection bias, we performed a subgroup analysis using propensity score matching with the R package \u0026lsquo;MatchIt\u0026rsquo; (method nearest neighbor). The patients were matched 1:1 by age, gender, ECOG, IPI, LDH, staging and the CAR-T product used. P values\u0026thinsp;\u0026lt;\u0026thinsp;0.05 were considered statistically significant. Statistical analyses were performed with R Statistical Software 4.2.1 with default parameters.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eCost-Effectiveness Analysis\u003c/h2\u003e \u003cp\u003eWe calculated incremental cost-effectiveness ratios (ICERs) as the model output. The ICERs were defined as the ratio of change in costs between the 2 groups to the change in clinical outcomes. All ICERs were represented as Chinese Yuan (\u0026yen;).\u003c/p\u003e \u003c/div\u003e"},{"header":"Result","content":"\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003ePatient\u0026rsquo;s Characteristics\u003c/h2\u003e \u003cp\u003eA total of 157 patients met all inclusion and exclusion criteria and included in our study. The mean age of all the patients was 48.0 years (SD, \u0026plusmn;\u0026thinsp;12.3 years); 48.4% of patients were males. 76 patients received CAR-T therapy while 81 underwent ASCT\u0026thinsp;+\u0026thinsp;CAR-T therapy. 10 patients had a commercial CAR-T preparation for axi-cel or relma-cel (5 in CAR-T group and 5 in ASCT\u0026thinsp;+\u0026thinsp;CAR-T group). Patients were heavily pre-treated where 39.5% of CAR-T and 30.8% of ASCT\u0026thinsp;+\u0026thinsp;CAR-T patients underwent 3 or more previous lines of treatment. All patients were treated in an inpatient setting. Patients receiving CAR T-cell therapy had a mean hospital length of stay of 29.8 days (SD, \u0026plusmn;\u0026thinsp;10.5 days) which was slightly shorter than that of the ASCT\u0026thinsp;+\u0026thinsp;CAR-T group (33.2\u0026thinsp;\u0026plusmn;\u0026thinsp;6.8 days). 25% of CAR-T patients and 44.4% of ASCT\u0026thinsp;+\u0026thinsp;CAR-T patients had an IPI score of 3 or higher. Baseline characteristics of treated patients are listed in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. All patients\u0026rsquo; 6-month follow-up data were collected.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003ePatient characteristics of all patients.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"6\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVariable\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eOverall\u003c/p\u003e \u003cp\u003eN\u0026thinsp;=\u0026thinsp;157\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eCART\u003c/p\u003e \u003cp\u003eN\u0026thinsp;=\u0026thinsp;76\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eASCT\u0026thinsp;+\u0026thinsp;CART\u003c/p\u003e \u003cp\u003eN\u0026thinsp;=\u0026thinsp;81\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e \u003cp\u003ep-value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"4\" nameend=\"c4\" namest=\"c1\"\u003e \u003cp\u003eAge\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMean (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e48.01 (12.34)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e51.54 (11.62)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e44.69 (12.14)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"4\" nameend=\"c4\" namest=\"c1\"\u003e \u003cp\u003eSex\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e \u003cp\u003e0.5\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e93.0 (59.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e47.0 (61.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e46.0 (56.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFemale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e64.0 (40.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e29.0 (38.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e35.0 (43.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"4\" nameend=\"c4\" namest=\"c1\"\u003e \u003cp\u003eLength of stay\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e \u003cp\u003e0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMean (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e31.55 (8.95)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e29.79 (10.53)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e33.20 (6.82)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"4\" nameend=\"c4\" namest=\"c1\"\u003e \u003cp\u003eECOG score, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e \u003cp\u003e0.03\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e6.0 (3.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4.0 (5.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2.0 (2.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e96.0 (61.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e53.0 (69.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e43.0 (53.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e55.0 (35.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e19.0 (25.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e36.0 (44.4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"4\" nameend=\"c4\" namest=\"c1\"\u003e \u003cp\u003eIPI score, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e \u003cp\u003e0.6\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2.0 (1.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1.0 (1.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1.0 (1.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4.0 (2.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3.0 (3.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1.0 (1.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e56.0 (35.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e24.0 (31.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e32.0 (39.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e68.0 (43.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e37.0 (48.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e31.0 (38.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e25.0 (15.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e10.0 (13.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e15.0 (18.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2.0 (1.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1.0 (1.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1.0 (1.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"4\" nameend=\"c4\" namest=\"c1\"\u003e \u003cp\u003eLDH, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e \u003cp\u003e0.6\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIncreased\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e153.0 (97.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e75.0 (98.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e78.0 (96.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDecreased\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4.0 (2.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1.0 (1.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3.0 (3.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"4\" nameend=\"c4\" namest=\"c1\"\u003e \u003cp\u003eStaging, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e \u003cp\u003e0.012\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eI A\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1.0 (0.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.0 (0.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1.0 (1.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eII A\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e11.0 (7.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8.0 (10.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3.0 (3.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eII B\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1.0 (0.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.0 (0.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1.0 (1.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIII A\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e20.0 (12.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8.0 (10.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e12.0 (14.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIII B\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8.0 (5.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e6.0 (7.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2.0 (2.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIV A\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e79.0 (50.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e30.0 (39.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e49.0 (60.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIV B\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e37.0 (23.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e24.0 (31.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e13.0 (16.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"5\" nameend=\"c5\" namest=\"c1\"\u003e \u003cp\u003ePrevious lines of treatment, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.2\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e17.0 (10.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4.0 (5.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e13.0 (16.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e85.0 (54.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e42.0 (55.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e43.0 (53.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e45.0 (28.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e24.0 (31.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e21.0 (25.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e9.0 (5.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5.0 (6.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e4.0 (4.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1.0 (0.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1.0 (1.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.0 (0.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e(inserting Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e)\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003eEffectiveness\u003c/h2\u003e \u003cp\u003eWith 6-months of follow-up, 34 (44.74%) patients in the CAR-T group and 47 (58.02%) patients in the CAR-T\u0026thinsp;+\u0026thinsp;ASCT achieved CR, 46 (60.53%) patients in CAR-T and 65 (80.25%) patients in CAR-T\u0026thinsp;+\u0026thinsp;ASCT achieved ORR. 2 patients in CAR-T and 7 patients in ASCT-CAR-T patients died.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec10\" class=\"Section2\"\u003e \u003ch2\u003eSubgroup analysis\u003c/h2\u003e \u003cdiv id=\"Sec11\" class=\"Section3\"\u003e \u003ch2\u003eSubgroup 1\u003c/h2\u003e \u003cp\u003eFor patients with in-hospital CAR-T preparations, 7 parameters were used to stringent PSM, absolute values of the p value were more than 0.5 for all matching covariates (Supplementary Table\u0026nbsp;1). In the 1:1 matched population (n\u0026thinsp;=\u0026thinsp;70; 35patients treated with CAR-T and 35 patients treated with ASCT\u0026thinsp;+\u0026thinsp;CAR-T). For patients treated with in-hospital ASCT\u0026thinsp;+\u0026thinsp;CAR-T therapy, with the 6-month follow-up, the results demonstrate favorable outcomes in terms of CR rates (42.86% vs 54.29%) and ORR rates (57.14% vs 77.14%). The 6-month survival rate is same (94.29%).\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eSubgroup 2\u003c/h2\u003e \u003cp\u003eFor patients with CAR-T, after stringent PSM on 5 parameters, absolute values of the p value were more than 0.5 for all matching covariates (Supplementary Table\u0026nbsp;2). In the 1:2 matched population (n\u0026thinsp;=\u0026thinsp;10; 5 patients treated with commercial CAR-T and 5 patients treated with in-hospital CAR-T) (Supplementary Table\u0026nbsp;2). For patients treated with commercial CAR-T therapy, with the 6-month follow-up, the results demonstrate favorable outcomes in terms of CR rates (60.00% vs 40.00%) than treated with in-hospital CAR-T. The 6-month survival rate is lower (80.00% vs 100.00%).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eSubgroup 3\u003c/h2\u003e \u003cp\u003eFor patients with ASCT\u0026thinsp;+\u0026thinsp;CAR-T, after stringent PSM on 5 parameters, absolute values of the p value were more than 0.5 for all matching covariates (Supplementary Table\u0026nbsp;3). In the 1:2 matched population (n\u0026thinsp;=\u0026thinsp;10; 5 patients treated with commercial CAR-T and 5 patients treated with in-hospital CAR-T). For patients treated with commercial CAR-T therapy, with the 6-month follow-up, the results demonstrate favorable outcomes in terms of CR rates (80.00% vs 28.57%) than treated with in-hospital CAR-T. The 6-month survival rate is lower (80.00% vs 85.71%).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eSafety\u003c/h2\u003e \u003cp\u003eAmong the patients infused, 74 (97.4%) in the CAR-T group and 81 (100%) in the CAR-T\u0026thinsp;+\u0026thinsp;ASCT group developed a CRS (any grade). In most cases, CRS was grade\u0026thinsp;\u0026le;\u0026thinsp;3; with only 5 out of 74 patients (6.8%) and 11 out of 81 patients (13.6%) experiencing CRS grade\u0026thinsp;\u0026ge;\u0026thinsp;3 in two groups, respectively (P\u0026thinsp;\u0026lt;\u0026thinsp;0.001). Only 1 patient (1.3%) in CAR-T therapy reported death during the 6-month follow-up.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003eCost\u003c/h2\u003e \u003cp\u003eThe average total treatment costs were \u0026yen;242,265 and \u0026yen;321,650 for the CAR-T group and the ASCT\u0026thinsp;+\u0026thinsp;CAR-T group, respectively. (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001). Excluding CAR-T costs, the treatment cost for CAR-T therapy was \u0026yen;113,054, while the cost for ASCT\u0026thinsp;+\u0026thinsp;CAR-T therapy was \u0026yen;198,439. Excluding the initial treatment cost, average follow-up costs were \u0026yen;45,457 and \u0026yen;61,466, for the CAR-T group and ASCT\u0026thinsp;+\u0026thinsp;CAR-T group, respectively. In order to compare the costs in detail, the cost breakdown of two treatment regimens for in-hospital patients was used to analyzed. The results showed that for in-hospital patients, the nursing and medication costs of ASCT\u0026thinsp;+\u0026thinsp;CAR-T were significantly higher than those of the CAR-T group (P\u0026thinsp;\u0026lt;\u0026thinsp;0.001) (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). The primary reason is that nursing costs are higher for ASCT\u0026thinsp;+\u0026thinsp;CAR-T due to the need for patient observation in the transplant ward.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003eCost-effectiveness analysis\u003c/h2\u003e \u003cdiv id=\"Sec17\" class=\"Section3\"\u003e \u003ch2\u003eAll population\u003c/h2\u003e \u003cp\u003eFor all patients, compared to CAR-T therapy, each 1% increase in CR with ASCT\u0026thinsp;+\u0026thinsp;CAR-T therapy requires an additional expenditure of \u0026yen;5974.21. If ORR is considered as the clinical outcome, an extra \u0026yen;4025.46 is needed. From the results, it is observed that both treatment regimens offer clinical benefits to patients when assessed based on 6-month survival. However, with ASCT\u0026thinsp;+\u0026thinsp;CAR-T compared to CAR-T, every additional 1% increase in survival rate incurs an extra cost of \u0026yen;9,77,380.36. Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e shows all cost-effectiveness analysis result by different therapy and clinical outcomes among r/r LBCL patients.\u003c/p\u003e\u003cdiv id=\"Sec18\" class=\"Section2\"\u003e \u003ch2\u003eSubgroup analysis\u003c/h2\u003e \u003cdiv id=\"Sec19\" class=\"Section3\"\u003e \u003ch2\u003eSubgroup 1\u003c/h2\u003e \u003cp\u003eFor 1:1 matched population treated with in-hospital CAR-T therapy (n\u0026thinsp;=\u0026thinsp;70; 35patients treated with CAR-T and 35 patients treated with ASCT\u0026thinsp;+\u0026thinsp;CAR-T), the results demonstrate favorable outcomes in terms of CR rates, ORR rates, and 6-month survival rates, with minimal differences observed between the two treatment groups. Compared to CAR-T therapy alone, for patients receiving ASCT\u0026thinsp;+\u0026thinsp;CAR-T therapy, every additional 1% increase in CR requires an additional expenditure of \u0026yen;6,770.12. If ORR is considered as the clinical outcome, an additional expenditure of \u0026yen;3,868.64 is required for every 1% increase in ORR. If 6-month survival rate is considered as the clinical endpoint, an additional expenditure of \u0026yen;27,080.48 yuan is needed for every 1% increase in 6-month survival rate. The result was shown in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec20\" class=\"Section2\"\u003e \u003ch2\u003eSubgroup 2\u003c/h2\u003e \u003cp\u003eFor 1:2 matched population treated with CAR-T (n\u0026thinsp;=\u0026thinsp;10; 5 patients treated with commercial CAR-T and 5 patients treated with in-hospital CAR-T), the results indicate that there are more patients achieving CR at 6 months when using commercial CAR-T compared to in-house CAR-T, with an additional expenditure of \u0026yen;62,178.24 for every 1% increase in CR. There is no difference in 6-month ORR and survival rate between the two groups. However, due to sample size limitations, the differences between the two groups are not statistically significant. Detailed result data can be found in Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e.\u003c/p\u003e \u003cdiv id=\"Sec21\" class=\"Section2\"\u003e \u003ch2\u003eSubgroup 3\u003c/h2\u003e \u003cp\u003eFor 1:2 matched population treated with ASCT\u0026thinsp;+\u0026thinsp;CAR-T, the results indicate that there are more patients achieving CR at 6 months when using commercial CAR-T compared to in-hospital CAR-T, with an additional expenditure of \u0026yen;24,083.96 for every 1% increase in CR. Regarding the 6-month survival rate, the results show that one patient died in each group, but due to sample size limitations, the differences between the two groups are not statistically significant. Detailed result data can be found in Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eCost-effectiveness results of two therapies.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eClinical Outcome\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eItem\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eNo. of patients,n\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003ePercentage (%)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eCost\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"5\" nameend=\"c5\" namest=\"c1\"\u003e \u003cp\u003eAll Patients\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eCAR-T\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e76\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026yen;242,265.45\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eASCT\u0026thinsp;+\u0026thinsp;CAR-T\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e81\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026yen;321,649.84\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eCAR-T\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e34\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e44.74%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eASCT\u0026thinsp;+\u0026thinsp;CAR-T\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e47\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e58.02%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eICER\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026yen;5,974.21\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eORR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eCAR-T\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e46\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e60.53%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eASCT\u0026thinsp;+\u0026thinsp;CAR-T\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e65\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e80.25%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eICER\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026yen;4,025.46\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSurvival\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eCAR-T\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e74\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e97.37%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eASCT\u0026thinsp;+\u0026thinsp;CAR-T\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e74\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e91.36%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eICER\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026yen;-13,207.85\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"5\" nameend=\"c5\" namest=\"c1\"\u003e \u003cp\u003eIn-hospital patients (PSM)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eCAR-T\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e35\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026yen;174,618.07\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eASCT\u0026thinsp;+\u0026thinsp;CAR-T\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e35\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026yen;251,990.87\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eCAR-T\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e15\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e42.86%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eASCT\u0026thinsp;+\u0026thinsp;CAR-T\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e19\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e54.29%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eICER\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026yen;6,770.12\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eORR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eCAR-T\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e20\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e57.14%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eASCT\u0026thinsp;+\u0026thinsp;CAR-T\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e27\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e77.14%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eICER\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3868.64\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSurvival\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eCAR-T\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e33\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e94.29%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eASCT\u0026thinsp;+\u0026thinsp;CAR-T\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e33\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e94.29%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eICER\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e/\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cp\u003e(inserting Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e)\u003c/p\u003e\u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eCost-effectiveness results of two types of CAR-T.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eClinical Outcome\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eItem\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eNo. of patients,n\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003ePercentage (%)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eCost\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"5\" nameend=\"c5\" namest=\"c1\"\u003e \u003cp\u003eCAR-T (PSM)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ecommercial\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026yen;1,358,242.82\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ein-hospital\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026yen;114,678.08\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ecommercial\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e60.00%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ein-hospital\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e40.00%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eICER\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026yen;62,178.24\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eORR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ecommercial\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e60.00%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ein-hospital\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e60.00%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eICER\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e/\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSurvival\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ecommercial\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e80.00%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ein-hospital\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e100.00%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eICER\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026yen;-62,178.24\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"5\" nameend=\"c5\" namest=\"c1\"\u003e \u003cp\u003eASCT\u0026thinsp;+\u0026thinsp;CAR-T (PSM)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ecommercial\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026yen;1,486,201.64\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ein-hospital\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e14\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026yen;247,597.83\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ecommercial\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e80.00%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ein-hospital\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e28.57%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eICER\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026yen;24,083.96\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eORR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ecommercial\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e80.00%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ein-hospital\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e28.57%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eICER\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026yen;24,083.96\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSurvival\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ecommercial\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e80.00%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ein-hospital\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e12\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e85.71%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eICER\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026yen;-216,755.67\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cp\u003e(inserting Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e)\u003c/p\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eWith the clinical application of CAR-T in China, the combination of ASCT and CART therapy (ASCT-CART) has been explored to improve patients' response and long‐term survival \u003csup\u003e[\u003cspan additionalcitationids=\"CR14 CR15\" citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]\u003c/sup\u003e. Based on this, some articles have reported on the efficacy of ASCT\u0026thinsp;+\u0026thinsp;CAR-T compared to CAR-T in patients with r/r LBCL and central nervous system. Study results indicate that ASCT\u0026thinsp;+\u0026thinsp;CAR-T demonstrates longer PFS and OS compared to CAR-T \u003csup\u003e[\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]\u003c/sup\u003e. Our study utilized real-world data to perform an economic evaluation of CAR-T therapy versus ASCT\u0026thinsp;+\u0026thinsp;CAR-T therapy. All parameters utilized in this investigation were derived from real-world data sources, thereby providing insights into the practical application of CAR-T and ASCT\u0026thinsp;+\u0026thinsp;CAR-T therapies among Chinese patients. This study represents the pioneering effort in China to present findings on patient expenditures alongside the clinical effectiveness of different CAR-T modalities. CAR-T therapy first entered the Chinese market in 2019, offering more treatment options for r/r LBCL patients. Currently, the commercially available CAR-T therapies approved by the China National Medical Products Administration were all based on single-arm clinical trials.\u003c/p\u003e \u003cp\u003eOur study is the first study that includes all available CAR-T formulations (axi-cel, relma-cel, in-hospital) up to September 30, 2022, for r/r LBCL patients in real-world settings. The study results indicate that patients treated with ASCT\u0026thinsp;+\u0026thinsp;CAR-T achieved significantly higher clinical responses while incurred overall higher costs, notably in nursing and medication expenses compared to the CAR-T group. This is primarily due to the necessary expenditures associated with ASCT. It implies that to some extent, the use of ASCT\u0026thinsp;+\u0026thinsp;CAR-T therapy will increase the nursing burden within the healthcare system. From a clinical effectiveness perspective at 6 months post treatment, ASCT\u0026thinsp;+\u0026thinsp;CAR-T demonstrates superior CR (ASCT\u0026thinsp;+\u0026thinsp;CAR-T vs CAR-T: 58.02% vs 44.74%) and ORR (ASCT\u0026thinsp;+\u0026thinsp;CAR-T vs CAR-T: 80.25% vs 60.53%) outcomes irrespective of whether commercial CAR-T is utilized.ASCT\u0026thinsp;+\u0026thinsp;CAR-T therapy was comparatively more expensive (ASCT\u0026thinsp;+\u0026thinsp;CAR-T Vs CAR-T: \u0026yen;321,649.84 vs \u0026yen;242,265.45) but patients may be willing to pay a higher treatment cost to receive ASCT\u0026thinsp;+\u0026thinsp;CAR-T Therapy.\u003c/p\u003e \u003cp\u003eAdditionally, it's worth noting that our study findings indicate that the average cost associated with CAR-T therapy is not notably high. This is primarily because most included patients received in-hospital CAR-T therapy rather than commercial CAR-T, resulting in lower average costs.\u003c/p\u003e \u003cp\u003eBased on our subgroup analysis results, commercial CAR-T yielded higher CR rates compared to in-hospital CAR-T with significant higher treatment cost. After balancing for patient baseline characteristics, we speculate that the difference in efficacy between the two groups may stem from variations in CAR-T manufacturing processes. Commercial CAR-T undergoes stringent production pathways and quality control standards, whereas in-hospital CAR-T formulations may lack standardized quality control, potentially resulting in lower product quality and instability. Despite the inferior manufacturing process and lack of strict quality control associated with in-hospital CAR-T, its lower cost makes it a viable treatment option for many patients. Our study data shows that there was a total of 157 patients treated with CAR-T, but only 10 received commercial CAR-T treatment. This indicates a high demand for CAR-T therapy among patients, but its accessibility is greatly limited due to the high cost. Therefore, in-hospital CAR-T formulations have become one of the treatment choices for patients. Apart from the high treatment costs, the number of patients using commercial CAR-T is extremely limited may also be attributed to the lack of reimbursement by medical insurance for CAR-T therapy. Although more and more commercial CAR-T products are currently available in China, the inability to be reimbursed by medical insurance results in poor accessibility for patients. The low accessibility of CAR-T therapy for Chinese patients due to excessively high treatment costs is currently an unmet need. Improving patient accessibility is a future direction that requires joint efforts from companies and Chinese healthcare insurance.\u003c/p\u003e \u003cp\u003eOur study is limited by a small sample size, which tends to yield more false negative findings, i.e., no difference between the tested groups. However, our research was conducted at a tertiary hospital, aligning with the standards of hospitals in China providing CAR-T therapy. Thus, the favorable effectiveness of CAR-T treatment and its lower incidence of grade III or IV cytokine release syndrome observed in our study confirm CAR-T therapy in addressing urgent unmet medical needs for with relapsed/refractory large B-cell lymphoma. Furthermore, our research encompasses sequential therapy involving ASCT\u0026thinsp;+\u0026thinsp;CAR-T, aiming to support broader clinical options and their application. For future real-world CAR-T therapy studies in China, conducting multicenter research is recommended to acquire more comprehensive sample sizes. Additionally, considering the long-term clinical benefits associated with CAR-T therapy, longer-term observations are necessary to ascertain its extended-term value.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThe study results indicate that, the use of ASCT\u0026thinsp;+\u0026thinsp;CAR-T may lead to better effectiveness and higher treatment costs for r/r LBCL patients. Commercial CAR-T -demonstrated a higher CR rate compared to in-house CAR-T formulations, but the treatment costs are significantly higher than those of in-hospital CAR-T formulations. Our research provides support for the cost-effectiveness of different treatment option for r/r LBCL patients.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e \u003ch2\u003eCompeting Interests\u003c/b\u003e:\u003c/h2\u003e \u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e \u003c/p\u003e\u003ch2\u003eAuthor Contributions:\u003c/h2\u003e \u003cp\u003eTD and HT R collected and analyzed the data and ZT Z drafted the manuscript, they contributed equally to this work and share first authorship; XJ Z and XX Z conceived and designed the study; all authors executed this clinical trial and approved the final version for submission.\u003c/p\u003e\u003ch2\u003eAcknowledgements:\u003c/h2\u003e \u003cp\u003eThis work was supported by the National Natural Science Foundation of China (82270183), and Project of Hubei Province Medical Youth Top Talents.\u003c/p\u003e\u003ch2\u003eData Availability Statement:\u003c/h2\u003e \u003cp\u003eThe additional data collected in this study are available from the corresponding authors on reasonable request.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eXia C, Dong X, Li H, Cao M, Sun D, He S, et al. 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DOI: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1155/2022/2900310\u003c/span\u003e\u003cspan address=\"10.1155/2022/2900310\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"","lastPublishedDoi":"10.21203/rs.3.rs-4372075/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4372075/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eThis study aimed to evaluate the cost-effectiveness of autologous stem cell transplant plus CAR-T (ASCT\u0026thinsp;+\u0026thinsp;CAR-T) therapy compared to CAR-T therapy among relapsed/refractory large B-cell lymphoma (r/r LBCL) patients based on real-world data.Complete response rate (CR), adverse events (AE), and total treatment cost were identified and compared between the two therapy groups. Using a decision analytic model based on standard clinical flow, incremental cost-effectiveness ratios (ICERs) for overall survival were calculated with stratification by disease stage and hormone-receptor status. A total of 76 patients received CAR-T therapy and 81 underwent ASCT\u0026thinsp;+\u0026thinsp;CAR-T therapy. The average total treatment cost was \u0026yen;242,265.44 for the CAR-T group and \u0026yen;321,649.84 for the ASCT\u0026thinsp;+\u0026thinsp;CAR-T group (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001), 44.70% and 58.02% patients achieved CR at 6-month respectively (p\u0026thinsp;=\u0026thinsp;0.1). Grade III or higher cytokine release syndrome events occurred in 6.8% of the CAR-T group and 13.6% of the ASCT\u0026thinsp;+\u0026thinsp;CAR-T group (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001). The ICER was \u0026yen;5,974.21 per 1% CR rate increase. The use of ASCT\u0026thinsp;+\u0026thinsp;CAR-T for r/r LBCL patients may lead to better effectiveness but also higher treatment costs. Commercial CAR-T demonstrated a higher CR rate but higher treatment costs compared to in-hospital CAR-T formulations. Our research provides support for the cost-effectiveness of different treatment option for r/r LBCL patients.\u003c/p\u003e","manuscriptTitle":"A Real-world cost-effectiveness study of autologous stem cell transplant plus CAR-T versus CAR-Ttherapy alone in Chinese patients with relapsed/refractory large B-cell lymphoma","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-05-17 15:44:01","doi":"10.21203/rs.3.rs-4372075/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"41372c13-e62e-42a7-8f66-0bf153b66f48","owner":[],"postedDate":"May 17th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[{"id":31644096,"name":"Health sciences/Diseases/Cancer/Haematological cancer/Lymphoma"},{"id":31644097,"name":"Health sciences/Diseases/Cancer/Haematological cancer/Lymphoma"},{"id":31644098,"name":"Health sciences/Medical research"},{"id":31644099,"name":"Health sciences/Medical research"}],"tags":[],"updatedAt":"2024-06-07T11:11:18+00:00","versionOfRecord":[],"versionCreatedAt":"2024-05-17 15:44:01","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-4372075","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4372075","identity":"rs-4372075","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}