Short-term Group Venetoclax Combined with Azacitidine for Treating Newly Diagnosed Elderly Acute Myeloid Leukemia: A Retrospective Study

Short-term Group Venetoclax Combined with Azacitidine for Treating Newly Diagnosed Elderly Acute Myeloid Leukemia: A Retrospective Study | 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 Research Article Short-term Group Venetoclax Combined with Azacitidine for Treating Newly Diagnosed Elderly Acute Myeloid Leukemia: A Retrospective Study Zhuruohan Yu, Shuangyue Li, Renzhi Pei, Ying Lu, Yuxiao Wang, and 1 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4569429/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 The induction regimen of venetoclax (VEN) in combination with demethylating agents has improved outcomes in elderly patients with acute myeloid leukemia (AML). However, the optimal course of VEN use during treatment needs further exploration. We conducted a retrospective study to determine the efficacy and safety of VEN in 90 newly diagnosed elderly patients with AML. This included 47 patients who used VEN for 14 days in combination with the azacitidine (AZA) regimen and 43 patients who used VEN for 28 days in combination with the AZA regimen. The rates of clinical remission were similar in the two groups, with a shorter time to neutropenia recovery in the shorter duration group. The short-term group also experienced reduced febrile neutropenia and a trend toward a lower incidence of other adverse events. With a median follow-up time of 494 days, there was a non-significant difference in median overall survival and Event-free survival observed between the two groups. This retrospective study demonstrated that VEN 14 days combined with AZA had similar efficacy to the VEN 28 days regimen combined with AZA. The short-term VEN combined with AZA regimen ensured efficacy with relatively less myelosuppressive effect, shortened blood recovery time, and reduced incidence of infection and fever during treatment. This regimen is suitable for elderly patients who are in poor physical condition and unable to tolerate low-dose chemotherapy and the long-term VEN combined with AZA regimen. It is easier to accept and more regarding the biopsychosocial medicine model. Short-term Venetoclax Elderly Acute myeloid leukemia Figures Figure 1 Figure 2 Introduction Acute myeloid leukemia (AML) is a highly heterogeneous hematologic malignancy. Its incidence gradually increases with age, with a median age of 68 years [ 1 , 2 ]. Elderly patients with AML have poorer physical status, more comorbidities, and higher rates of cytogenetic and molecular biological adverse events compared to younger patients, resulting in poorer clinical outcomes. Standard chemotherapeutic regimens are less effective in this population, with a 5-year overall survival (OS) rate of less than 20% in AML patients over 60 years of age [ 3 , 4 , 5 ]. Therefore, elderly patients with AML face many risks and challenges when choosing therapeutic agents and regimens. Venetoclax (VEN), a selective BCL-2 inhibitor, is recommended for elderly patients with AML who are unsuitable for intensive chemotherapy combined with azacitidine (AZA) [ 6 ]. Balancing efficacy and safety, national and international guidelines recommend an optimal dose of 400 mg/d (1–3 days ramp-up period) and a treatment cycle of 28 days [ 7 , 8 ]. However, the VEN can cause serious adverse events that require attention. In a phase Ib clinical trial conducted at the Anderson Cancer Center, 41% of patients discontinued VEN treatment due to neutropenia-induced fever, with a median time to discontinuation of 12.5 days; 60% of patients in the 400 mg dose group required discontinuation of treatment [ 9 ]. Our patients with AML are predominantly elderly and in poor physical condition, unable to tolerate the 28 days long-term of VEN. Consequently, it is crucial to mitigate treatment-related adverse events while ensuring efficacy. This study aimed to evaluate the efficacy and safety of the 14 days short-term VEN combined with AZA regimen for treating newly diagnosed elderly AML in China to identify the optimal duration of treatment for Chinese patients. Patients and Methods Patients The study population consisted of elderly AML (non-M3) patients aged ≥ 60 years admitted to the Department of Hematology of Ningbo University Affiliated People’s Hospital between January 2019 and December 2023. All patients underwent morphological, immunologic, cytogenetic, and molecular biologic typing testing and were diagnosed according to the 2022 World Health Organization (WHO) AML diagnostic criteria. They were risk-stratified according to the 2022 European Leukemia Net (ELN) criteria [ 10 , 11 ]. The study protocol was approved by the Institutional Review Board of Ningbo University Affiliated People’s Hospital and was conducted under the Declaration of Helsinki. Treatment plan The treatment plan was divided into a short-term group (14 days of taking VEN) and a long-term group (28 days of taking VEN) based on the duration of VEN administration. The dose of VEN was 100 mg on the first day, 200 mg on the second day, and 400 mg on the fourth day. The short-term group was administered continuously until day 14, and the long-term group was administered continuously until day 28. In both groups, AZA 75 mg/m 2 was administered subcutaneously or intravenously from day 1 to 7. If a CYP3A4 inhibitor such as voriconazole was used, or if intolerable adverse events occurred during chemotherapy, the dose could be reduced, and the interval between treatments could be temporarily discontinued or extended. During chemotherapy, supportive measures such as hydration, alkalinization, gastric protection, and antiemetics were provided, along with intensive oral and perianal care. During the period of myelosuppression, active transfusion of blood components and symptomatic supportive therapy are provided according to the patient’s clinical manifestations and blood routine results. After achieving remission with induction chemotherapy, the original chemotherapy regimen or hematopoietic stem cell transplantation could be used for consolidation. If the patient did not achieve remission after two courses of induction therapy, other treatment options were considered. Efficacy assessment Efficacy was assessed by repeat myelography between days 14 and 28 of induction therapy based on residual leukemia cells in the peripheral blood and bone marrow. The efficacy of AML was assessed concerning the diagnostic and efficacy criteria for hematological disorders [ 11 ], including complete remission (CR), complete morphological remission with incomplete hematological recovery (CRi), and partial remission (PR). CR: No signs or symptoms of leukemic cell infiltration; bone marrow primitive cells < 5%, normal erythrocyte, and megakaryocyte lineage; primitive cells without Auer bodies; no extramedullary leukemia; no primitive cells in the peripheral blood, absolute neutrophil value ≥ 1.0 × 10 9 /L; platelet count ≥ 100 × 10 9 /L; cessation of blood transfusion. CRi with incomplete recovery of blood cell counts: Meets other criteria for CR; absolute peripheral blood neutrophil value < 1.0 × 109/L or platelet count < 100 × 10 9 /L. PR: At least 50% reduction of primitive cells in the bone marrow, ranged 5%-20%; peripheral blood cell counts meet CR criteria. Combined complete remission rate (CRc): The sum of the patient’s CR rate and CRi rate. Overall remission rate (ORR): The sum of the patient’s CR, CRi, and PR rates. Minimal residual disease (MRD) negative rate: Immunophenotyping of bone marrow cells detected and analyzed using four-color immunolabeled flow cytometry; 0.1% was chosen as the threshold for MRD determination, with negative defined as 0.5 × 10 9 /L and platelet counts > 20 × 10 9 /L. Adverse events occurring during treatment were evaluated according to the National Cancer Institute’s Common Terminology Criteria for Adverse Events (version 4.0). overall survival (OS) was defined as the time from the date of patient diagnosis to death, last follow-up, or loss to follow-up. Event-free survival (EFS) was the time of recurrence, death, last follow-up, or loss of follow-up after the patient received treatment. Statistical methods Statistical Products and Services Solutions (version 26.0) software was used for data processing and related statistical analysis. The contingency table rank-square ( X 2 ) test was used to compare count data between groups. If the total sample size was less than 40 or the minimum theoretical frequency was less than 1, Fisher’s exact probability method was used. The independent samples t-test was used to compare quantitative data between groups. Survival curves were plotted using Kaplan Meier, and OS and EFS were compared using the log-rank test. p < 0.05 indicated a statistically significant difference. Study results Patient demographics A total of 90 newly diagnosed elderly patients with AML were enrolled, and their clinical characteristics, including age, gender, performance status, diagnostic blood count, bone marrow hematopoietic cell count, and prognostic stratification, were collected. The median age of all patients was 70 years (range: 60–87), the median Eastern Cooperative Oncology Group (ECOG) score was 2 (range 0–3), and the median bone marrow blast count was 45.5% (range: 20–92.5%). Seven patients (7.8%) had a good prognosis, 25 patients (27.8%) had an intermediate prognosis, and 58 patients (64.4%) had a poor prognosis. there were 47 patients in the short-term treatment group and 43 patients in the long-term treatment group. Details of patient demographic characteristics are summarized in Table 1 . Table 1 Patients characteristics in the Short-term Group and the Long-term Group Variable Short-term group Long-term group p value N = 47 N = 43 Age, year, median (range) 71(60–87) 67(60–81) 0.533 ≤ 70 23(48.9) 25(58.1) > 70 24(51.1) 18(41.9) Gender, n (%) 0.291 Male 26(55.3) 19(44.2) Female 21(44.7) 24(55.8) Classification, n (%) 0.752 Primary 37(78.7) 35(81.4) Secondary 10(21.3) 8(18.6) ECOG score, n (%) 0.743 0–1 points 22(46.8) 25(58.2) 2–4 points 25(53.2) 18(41.8) Risk classification, n (%) 0.108 Favorable 3(6.4) 4(9.3) Intermediate 9(19.1) 16(37.2) Adverse 35(74.5) 23(53.5) Bone marrow blast cell rate, median (range) 40.5(16–88) 52(20-92.5) 0.345 Blood count during diagnosis, median (range) White blood cell count, ×10 9 /L 4.9(0.4-152.7) 4.4(0.5–257) 0.345 Neutrophils count, ×10 9 /L 1.1(0.08–132.9) 0.78(0.04–121.9) 0.303 Hemoglobin, g/L 78.5(44–132) 80(35–129) 0.365 Platelet count, ×10 9 /L 50(7-704) 55(4-402) 0.358 Abbreviations: ECOG, Eastern Cooperative Oncology Group Response to treatment In the short-term treatment group, the CRc rate, ORR, and MRD negative rates of one course of induction therapy were 55.3%, 82.9%, and 40.7%. In the long-term treatment group, the CRc rate, ORR, and MRD negativity rate of one course of induction therapy were 53.5%, 81.4%, and 56.0%. In the short-term group, the CRc, ORR, and MRD negative rates were 57.4%, 85.1%, and 61.5% for two or more courses of induction therapy, whereas in the long-term group, the CRc, ORR, and MRD negative rates were 58.1%, 86%, and 73%, for 2 or more courses of induction therapy. The overall CRc rates were 56.5% and 64.0% for patients under 70 years of age and 54.2% and 38.9% for patients over 70 years of age. The total CRc rates were 66.7% and 60.0% for patients with a good and intermediate prognosis and 51.4% and 47.8% for patients with a poor prognosis. The cumulative recurrence rates were 29.8% and 30.2% for patients in the two groups. The recent efficacy of patients are summarized in Table 2 . Table 2 Analysis of therapeutic effects in the Short-term Group and the Long-term Group Short-term group Long-term group p value N = 47 N = 43 CRc rate, n (%) 1 courses of treatment 26(55.3) 23(53.5) 0.862 2 or more courses of treatment 27(57.4) 25(58.1) 0.947 ORR rate, n (%) 1 courses of treatment 39(82.9) 35(81.4) 0.844 2 or more courses of treatment 40(85.1) 37(86.0) 0.899 MRD negative rate, n (%) 1 courses of treatment 11(40.7) 14(56.0) 0.357 2 or more courses of treatment 16(61.5) 17(73.9) 0.271 CRc rate based on age, n (%) ≤ 70 13(56.5) 16(64.0) 0.597 > 70 13(54.2) 7(38.9) 0.327 CRc rate based on risk classification, n (%) favorable and intermediate 8(66.7) 12(60) 0.659 adverse 18(51.4) 11(47.8) 0.778 VA regimen treatment duration, median (range) 2(1–10) 2(1–6) 0.789 CIR rate, n (%) 14(29.8) 13(30.2) 0.963 Abbreviations: CRc, Combined complete remission; ORR, Overall remission; MRD, Minimal residual disease; VA, VEN combined with AZA; CIR, Cumulative incidence of relapse; Safety analysis A total of 7 patients (21.21%) in the short-term treatment group and 9 patients (56.25%) in the long-term treatment group reduced the number of days on VEN due to toxicities, primarily neutropenia with fever. The main hematologic adverse event was myelosuppression of varying degrees. The incidence of grade III and higher leukopenia, neutropenia, and thrombocytopenia in the short-term treatment group was 80.9%, 78.7%, and 78.7%, which were lower than those in the long-term treatment group, and the difference was statistically significant ( p < 0.05). Non-hematological adverse events were primarily neutropenia with fever, with an incidence of 72.3% and 90.7% in the two groups. The incidence of neutropenia with fever was significantly higher in the long-term treatment group than in the short-term treatment group ( p = 0.026). There were no statistically significant differences in other non-hematological adverse events such as infection, bleeding, and organ dysfunction. Table 3 summarizes the adverse events of patients during the first course of chemotherapy. Table 3 Adverse events during the first course of chemotherapy in the Short-term Group and the Long-term Group Short-term group Long-term group p value N = 47 N = 43 Hematology adverse events Above level III, n (%) Leukopenia 38(80.9) 41(95.3) 0.036 Neutropenia 37(78.7) 42(97.7) 0.006 Hemoglobin reduction 34(72.3) 32(74.4) 0.824 Thrombocytopenia 37(78.7) 41(95.3) 0.020 Non hematology adverse events above level III, n (%) Febrile neutropenia 34(72.3) 39(90.7) 0.026 Infect 34(72.3) 36(83.7) 0.195 Hemorrhage 12(25.5) 16(37.2) 0.232 Cardiac insufficiency 6(12.8) 8(18.6) 0.445 Hepatic insufficiency 6(12.8) 8(18.6) 0.445 Renal insufficiency 7(14.9) 9(20.9) 0.454 Dizziness and fatigue 23(48.9) 20(60.6) 0.303 Nausea and vomiting 11(23.4) 11(25.6) 0.810 Tumor lysis syndrome 2(4.3) 3(7.0) 0.537 In the first course of induction chemotherapy regimen, the median recovery time of neutrophils in the short-term and long-term groups was 12.5 days and 36 days. In the short-term group, the recovery time of neutrophils was significantly shorter ( p = 0.001); the median recovery time of platelets was non-significantly different. Table 4 summarizes the recovery time of the patient’s blood count during the first course of chemotherapy. Table 4 Recovery time of blood count during the first course of chemotherapy in the Short-term Group and the Long-term Group Short-term group Long-term group p value Neutrophil recovery time, days, median (range) 12.5(1–31) 26(3–34) 0.001 Platelet recovery time, days, median (range) 8(2–24) 9(2–36) 0.653 Survival Analysis The median follow-up time for all patients was 697 (37–1170) days. The median OS was 494 days in the short-term group and 578 days in the long-term group. The median EFS was 416 days in the short-term and 454 days in the long-term groups. Notably, the median OS in the long-term treatment group indicated an upward trend compared to the short-term treatment group, but there was no statistically significant difference in OS and EFS between the two groups (Figs. 1 a-b). There was also no statistically significant difference in OS and EFS between the two groups of patients by age and risk-stratified (Figs. 2 a-d). Similarly, no significant differences were observed in OS and EFS between the two groups, regardless of the status of MRD (Figs. 2 e-f). Discussion AML is an aggressive malignant tumor with a poor prognosis and a high recurrence rate. Age is an independent prognostic risk factor for AML [ 12 ], with elderly patients having a worse prognosis than younger patients. As a result, treating elderly patients with AML involves many risks and challenges. VEN, a novel selective BCL-2 inhibitor, has shown therapeutic efficacy in AML in preclinical studies [ 13 ], but monotherapy is prone to drug resistance [ 14 ]. AZA enhances the antitumor effect of VEN by activating the transcription of the proapoptotic protein NOXA, and the combination of the two drugs induces deep and long-lasting antileukemic effects by blocking the energy metabolism of leukemic stem cells [ 15 ]. VEN combined with AZA induction regimen has been recommended by international guidelines for elderly AML patients who are unsuitable for intensive chemotherapy. In an efficacy exposure analysis study of VEN combined with hypomethylating agents (HMAs)for treating newly diagnosed elderly patients with AML, the remission rate increased with doses of VEN ≤ 400 mg/day. Beyond this dose, the remission rate non-significantly changed or decreased, and the incidence of adverse events increased with higher doses [ 16 ]. Considering efficacy and safety, international guidelines recommend an optimal dose of 400 mg/day when combining HMAs. However, there is an unclear indication of the specific duration of use. Aiba M et al. retrospectively studied 13 newly diagnosed patients with AML who received induction therapy with the VEN combined with AZA (VA) regimen. They found that the VEN14 and VEN28 groups had similar CRc and OS rates, with the VEN14 group having a significantly lower incidence of febrile neutropenia and shorter hospitalization time [ 17 ]. Analyzing near-term efficacy, this study found that the total CRc rate of induction therapy in the short-term and long-term groups was 57.4% and 58.1%, and the total ORR was 85.1% and 86%. The remission rate was similar in the two groups, with most patients achieving remission in the first course of therapy. The overall CRc rate was lower in this study compared to the VIALE-A trial, which had a CRc rate of 66.4% [ 18 ], which was considered to be possible because all elderly patients were included in this study. Age and risk stratification can affect the remission rate of induction therapy. The present study demonstrated that for elderly patients with AML aged ≥ 70 years, the ORR in the short-term group was up to 93.33%, significantly higher than the aforementioned studies and similar to the ORR in the long-term group. The CRc rate of elderly patients (age > 70 years) in the short-term group was 54.2%, which indicated an increasing trend compared to the 38.9% elderly patients in the long-term group and was similar to the data reported in different studies [ 19 ]. This was considered possibly because elderly patients with AML were more unable to tolerate the long-term regimen. The short-term regimen alleviates the adverse events associated with the treatment, especially the severity of myelosuppression, shortening the duration of neutrophil deficiency and reducing the incidence of severe infections. Clinical studies by DiNardo et al. have indicated CR/CRi rates of up to 60% for VA regimens in poor-prognosis elderly patients with AML [ 9 ]. In the present study, the CRc rates were similar in both groups of poor-prognosis patients (51.4% versus 47.8%), suggesting that in the real-world setting, even in elderly patients with a high number of high-risk patients, shortening the duration of VEN use can achieve the same near-term efficacy as 28 days. Regarding safety, during the first course of induction therapy, 21.2% and 56.2% of patients in the short-term and long-term groups needed to shorten the course of therapy, primarily due to neutropenia with fever. Shortening the course of VEN use reduced the incidence of shortening the course of therapy by more than half during the therapy. The results of this study indicated that prolonging the course of VEN use increased the severity of myelosuppression. The incidence of grade III-IV neutropenia was 97.7% in the long-term group, significantly higher than in the short-term group (78.7%, p = 0.006). Considering the therapeutic efficacy analysis, the possibility of the long course of the combination regimen increasing the severity of myelosuppression may affect the efficacy of therapy simultaneously. The incidence of other hematological adverse events, such as hemoglobin reduction and thrombocytopenia, was similar. Foreign phase III clinical studies demonstrated that the incidence of grade III or higher hematologic adverse events in the VA regimen for treating AML in the elderly was lower than the incidence of hematologic adverse events compared to this study [ 18 ]. This difference may be due to the small body surface area of the Chinese nationals, their poor physical status, more comorbidities, and poorer tolerance to the same course and dose of VEN, leading to a higher degree of myelosuppression. Further observation of blood recovery time during treatment revealed significantly shorter neutrophil recovery time in the short-term group, with a median recovery time of only 12.5 days, more than half of that in the long-term group. The long-term group had the highest incidence of invasive fungal infections (IFIs) before reaching CR due to the greater severity and duration of neutropenia. The severity and duration of neutropenia were related to the severity and duration of the hematological system of the malignant system, which was also related to the severity and duration of neutropenia. There is a correlation between the severity and duration of neutropenia and the incidence of IFIs in patients with hematologic malignancies [ 20 ]. The common non-hematologic adverse events were primarily neutropenia with fever, infection, dizziness, and fatigue, with a significantly lower incidence in the short-term group than in the long-term group (72.3% versus 90.7%, p = 0.026). The above analysis suggests that the short-term VA regimen may significantly shorten the duration of neutropenia, reduce infection incidence to some extent, and potentially reduce IFIs. Other non-hematological adverse events such as dizziness, fatigue, and vital organ insufficiency may also be reduced to some extent by the short-term VA regimen. Additionally, the high incidence of TLS is a major risk in VEN clinical use, and the incidence of TLS during AML treatment still needs to be further explored. According to this study, a non-significant difference was found in the incidence of TLS between the two groups of patients (4.3% versus 7.0%). Regarding survival analysis, several studies have demonstrated that VA regimens for treating elderly AML can significantly improve patient survival and prolong survival time. Bouligny et al. analyzed 176 patients with AML treated with VEN in combination with HMAs in the ERIS Project database. They found that compared to receiving VEN for 28 days, the reduced VEN regimen for 14 days resulted in significantly longer OS (8.9 months versus 2.1 months, p = 0.0002) and progression-free survival (8.2 months versus 1.5 months, p < 0.0001) [ 21 ]. Another retrospective analysis included 270 newly diagnosed patients with AML and analyzed the survival time of three groups with different courses of VEN (14 d, 21 d, and 28 d) in combination with HMAs, and the median OS of the three groups was 18.6, 21.3, and 13.2 months, with non-significant difference [ 22 ]. The OS and EFS of patients in the two groups in this study were similar to the results of foreign studies. On further analysis, a non-significant difference in OS and EFS was observed between the two groups in patients with advanced age, poor prognosis, and MRD-negative status. However, shortening the VEN regimen when combined with cytogenetic and molecular biological factors with poor prognosis may lead to their susceptibility to relapse, which needs confirmation by large, prospective studies. Elderly patients with AML are less tolerant of long-course regimens and have a high incidence of serious infections; therefore, a short-course VA regimen is considered more suitable for them. While MRD negativity is associated with better OS and EFS [ 23 ], the total MRD negativity rate was similar in the short-term and long-term groups in this study, and no significant difference in survival time was observed. In summary, shortening the course of VEN use may not affect near-term survival. This study explored the efficacy, advantages, and safety of a short-term VA regimen for treating elderly patients with AML in China. A short-term VEN combined with an AZA regimen for the treatment of newly diagnosed elderly AML achieved essentially the same clinical remission rate as the long-term VA regimen, especially for patients aged ≥ 70 years with poor prognosis. It also reduced myelosuppression during treatment, shortened neutrophil recovery time, attenuated granulocyte recovery time, and reduced the incidence of adverse events such as fever; recent follow-up suggests that shortening the course of VEN may not affect survival time in elderly patients with AML. However, this study did not analyze the impact of cytogenetics and molecular biology on the efficacy of the VA regimen in the treatment of elderly patients with AML. Besides, the study did not analyze the impact of allogeneic hematopoietic stem cell transplantation on long-term survival time. Due to the small sample size, retrospective analysis, and relatively short patient follow-up, there may be unclear statistical differences, and prospective studies with large sample sizes are needed. Declarations Authors’ contributions Z.R.H.Y. and S.Y.L. were the principal investigators who took primary responsibility for this study. Z.R.H.Y. wrote the manuscript. R.Z.P. and Y.L. participated in statistical analysis and commented on the manuscript. Z.R.H.Y., Y.X.W., and J.J.Y. collected data and interpreted results and participated in clinical data management. and both authors gave final approval for the manuscript. Funding This research was funded by the Medical Science and Technology Program (Clinical study of venetoclax combined with azacitidine in the treatment of newly diagnosed elderly AML, project number 2019Y51) led by the Ningbo Municipal Health Commission. 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Am J Hematol 99:e63–e66. https://doi.org/10.1002/ajh.27180 Pratz KW, Jonas BA, Pullarkat V et al (2022) Measurable Residual Disease Response and Prognosis in Treatment-Naïve Acute Myeloid Leukemia with Venetoclax and Azacitidine. J Clin oncology: official J Am Soc Clin Oncol 40:855–865. https://doi.org/10.1200/JCO.21.01546 Additional Declarations No competing interests reported. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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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-4569429","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":318458647,"identity":"870bbf8d-101b-4bd9-8dcb-f03a4343081a","order_by":0,"name":"Zhuruohan Yu","email":"","orcid":"","institution":"The Affiliated People’s Hospital of Ningbo University","correspondingAuthor":false,"prefix":"","firstName":"Zhuruohan","middleName":"","lastName":"Yu","suffix":""},{"id":318458648,"identity":"fe29f0e8-550e-4d94-bedb-2d1783367ca4","order_by":1,"name":"Shuangyue Li","email":"","orcid":"","institution":"The Affiliated People’s Hospital of Ningbo University","correspondingAuthor":false,"prefix":"","firstName":"Shuangyue","middleName":"","lastName":"Li","suffix":""},{"id":318458650,"identity":"dc7e63ee-02c1-4452-aaf1-fdcce7198d8c","order_by":2,"name":"Renzhi Pei","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAo0lEQVRIiWNgGAWjYFACxgYGhgoJOXkStZyxMDZsIM2itopEhgPEqjZnb277+HOeRAJjA/PDRzeI0WLZc7B5huQ2iTx2BjZj4xxitBjcSGxmMNwmUczYwMMmTZyW+w+bGRLnSCQ2HCBayw3GZoaDDaRosexJbGZsOCZhbNhMrF/M2Y8/ZvxRUycnz9788DFxDoOzmIlRjqplFIyCUTAKRgEuAACGyS1ox4FiwAAAAABJRU5ErkJggg==","orcid":"","institution":"The Affiliated People’s Hospital of Ningbo University","correspondingAuthor":true,"prefix":"","firstName":"Renzhi","middleName":"","lastName":"Pei","suffix":""},{"id":318458652,"identity":"9810a79a-2096-497c-9f15-b9e4b23b2928","order_by":3,"name":"Ying Lu","email":"","orcid":"","institution":"The Affiliated People’s Hospital of Ningbo University","correspondingAuthor":false,"prefix":"","firstName":"Ying","middleName":"","lastName":"Lu","suffix":""},{"id":318458653,"identity":"7e127cfd-3b35-40e5-9a1b-a9a819b3d9ce","order_by":4,"name":"Yuxiao Wang","email":"","orcid":"","institution":"The Affiliated People’s Hospital of Ningbo University","correspondingAuthor":false,"prefix":"","firstName":"Yuxiao","middleName":"","lastName":"Wang","suffix":""},{"id":318458654,"identity":"a4bb90fd-e7f6-4495-8460-f8c25ff9980f","order_by":5,"name":"Jiaojiao Yuan","email":"","orcid":"","institution":"The Affiliated People’s Hospital of Ningbo University","correspondingAuthor":false,"prefix":"","firstName":"Jiaojiao","middleName":"","lastName":"Yuan","suffix":""}],"badges":[],"createdAt":"2024-06-12 10:16:47","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4569429/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4569429/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":59872646,"identity":"ad99c762-74ec-4a39-a7ad-0bdb54b65fd2","added_by":"auto","created_at":"2024-07-08 17:14:02","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":44881,"visible":true,"origin":"","legend":"\u003cp\u003eSee image above for figure legend\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-4569429/v1/282d9de9084ad1e675bca9a6.png"},{"id":59872648,"identity":"2e28de01-0bd3-49ac-a863-38c6597549c9","added_by":"auto","created_at":"2024-07-08 17:14:02","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":559303,"visible":true,"origin":"","legend":"\u003cp\u003eSee image above for figure legend\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-4569429/v1/07352e940768e404b3fec2d3.png"},{"id":60006277,"identity":"2ebfaaba-7f82-408e-b857-c977b75160ea","added_by":"auto","created_at":"2024-07-10 11:57:24","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1236768,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4569429/v1/b42aa4f3-4240-41c4-ae48-a9f62489a680.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Short-term Group Venetoclax Combined with Azacitidine for Treating Newly Diagnosed Elderly Acute Myeloid Leukemia: A Retrospective Study","fulltext":[{"header":"Introduction","content":"\u003cp\u003eAcute myeloid leukemia (AML) is a highly heterogeneous hematologic malignancy. Its incidence gradually increases with age, with a median age of 68 years [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. Elderly patients with AML have poorer physical status, more comorbidities, and higher rates of cytogenetic and molecular biological adverse events compared to younger patients, resulting in poorer clinical outcomes. Standard chemotherapeutic regimens are less effective in this population, with a 5-year overall survival (OS) rate of less than 20% in AML patients over 60 years of age [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. Therefore, elderly patients with AML face many risks and challenges when choosing therapeutic agents and regimens.\u003c/p\u003e \u003cp\u003eVenetoclax (VEN), a selective BCL-2 inhibitor, is recommended for elderly patients with AML who are unsuitable for intensive chemotherapy combined with azacitidine (AZA) [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. Balancing efficacy and safety, national and international guidelines recommend an optimal dose of 400 mg/d (1\u0026ndash;3 days ramp-up period) and a treatment cycle of 28 days [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. However, the VEN can cause serious adverse events that require attention. In a phase Ib clinical trial conducted at the Anderson Cancer Center, 41% of patients discontinued VEN treatment due to neutropenia-induced fever, with a median time to discontinuation of 12.5 days; 60% of patients in the 400 mg dose group required discontinuation of treatment [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. Our patients with AML are predominantly elderly and in poor physical condition, unable to tolerate the 28 days long-term of VEN. Consequently, it is crucial to mitigate treatment-related adverse events while ensuring efficacy. This study aimed to evaluate the efficacy and safety of the 14 days short-term VEN combined with AZA regimen for treating newly diagnosed elderly AML in China to identify the optimal duration of treatment for Chinese patients.\u003c/p\u003e"},{"header":"Patients and Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003ePatients\u003c/h2\u003e \u003cp\u003eThe study population consisted of elderly AML (non-M3) patients aged ≥ 60 years admitted to the Department of Hematology of Ningbo University Affiliated People’s Hospital between January 2019 and December 2023. All patients underwent morphological, immunologic, cytogenetic, and molecular biologic typing testing and were diagnosed according to the 2022 World Health Organization (WHO) AML diagnostic criteria. They were risk-stratified according to the 2022 European Leukemia Net (ELN) criteria [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. The study protocol was approved by the Institutional Review Board of Ningbo University Affiliated People’s Hospital and was conducted under the Declaration of Helsinki.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eTreatment plan\u003c/h2\u003e \u003cp\u003eThe treatment plan was divided into a short-term group (14 days of taking VEN) and a long-term group (28 days of taking VEN) based on the duration of VEN administration. The dose of VEN was 100 mg on the first day, 200 mg on the second day, and 400 mg on the fourth day. The short-term group was administered continuously until day 14, and the long-term group was administered continuously until day 28. In both groups, AZA 75 mg/m\u003csup\u003e2\u003c/sup\u003e was administered subcutaneously or intravenously from day 1 to 7. If a CYP3A4 inhibitor such as voriconazole was used, or if intolerable adverse events occurred during chemotherapy, the dose could be reduced, and the interval between treatments could be temporarily discontinued or extended. During chemotherapy, supportive measures such as hydration, alkalinization, gastric protection, and antiemetics were provided, along with intensive oral and perianal care. During the period of myelosuppression, active transfusion of blood components and symptomatic supportive therapy are provided according to the patient’s clinical manifestations and blood routine results. After achieving remission with induction chemotherapy, the original chemotherapy regimen or hematopoietic stem cell transplantation could be used for consolidation. If the patient did not achieve remission after two courses of induction therapy, other treatment options were considered.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eEfficacy assessment\u003c/h2\u003e \u003cp\u003eEfficacy was assessed by repeat myelography between days 14 and 28 of induction therapy based on residual leukemia cells in the peripheral blood and bone marrow. The efficacy of AML was assessed concerning the diagnostic and efficacy criteria for hematological disorders [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e], including complete remission (CR), complete morphological remission with incomplete hematological recovery (CRi), and partial remission (PR). CR: No signs or symptoms of leukemic cell infiltration; bone marrow primitive cells \u0026lt; 5%, normal erythrocyte, and megakaryocyte lineage; primitive cells without Auer bodies; no extramedullary leukemia; no primitive cells in the peripheral blood, absolute neutrophil value ≥ 1.0 × 10\u003csup\u003e9\u003c/sup\u003e/L; platelet count ≥ 100 × 10\u003csup\u003e9\u003c/sup\u003e/L; cessation of blood transfusion. CRi with incomplete recovery of blood cell counts: Meets other criteria for CR; absolute peripheral blood neutrophil value \u0026lt; 1.0 × 109/L or platelet count \u0026lt; 100 × 10\u003csup\u003e9\u003c/sup\u003e/L. PR: At least 50% reduction of primitive cells in the bone marrow, ranged 5%-20%; peripheral blood cell counts meet CR criteria. Combined complete remission rate (CRc): The sum of the patient’s CR rate and CRi rate. Overall remission rate (ORR): The sum of the patient’s CR, CRi, and PR rates. Minimal residual disease (MRD) negative rate: Immunophenotyping of bone marrow cells detected and analyzed using four-color immunolabeled flow cytometry; 0.1% was chosen as the threshold for MRD determination, with negative defined as \u0026lt; 0.1%. Neutrophil deficiency and platelet recovery times were defined as post-transfusion neutrophil counts \u0026gt; 0.5 × 10\u003csup\u003e9\u003c/sup\u003e/L and platelet counts \u0026gt; 20 × 10\u003csup\u003e9\u003c/sup\u003e/L. Adverse events occurring during treatment were evaluated according to the National Cancer Institute’s Common Terminology Criteria for Adverse Events (version 4.0). overall survival (OS) was defined as the time from the date of patient diagnosis to death, last follow-up, or loss to follow-up. Event-free survival (EFS) was the time of recurrence, death, last follow-up, or loss of follow-up after the patient received treatment.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eStatistical methods\u003c/h2\u003e \u003cp\u003eStatistical Products and Services Solutions (version 26.0) software was used for data processing and related statistical analysis. The contingency table rank-square (\u003cem\u003eX\u003c/em\u003e\u003csup\u003e2\u003c/sup\u003e) test was used to compare count data between groups. If the total sample size was less than 40 or the minimum theoretical frequency was less than 1, Fisher’s exact probability method was used. The independent samples t-test was used to compare quantitative data between groups. Survival curves were plotted using Kaplan Meier, and OS and EFS were compared using the log-rank test. \u003cem\u003ep\u003c/em\u003e \u0026lt; 0.05 indicated a statistically significant difference.\u003c/p\u003e "},{"header":"Study results","content":"\u003ch2\u003ePatient demographics\u003c/h2\u003e\u003cp\u003eA total of 90 newly diagnosed elderly patients with AML were enrolled, and their clinical characteristics, including age, gender, performance status, diagnostic blood count, bone marrow hematopoietic cell count, and prognostic stratification, were collected. The median age of all patients was 70 years (range: 60–87), the median Eastern Cooperative Oncology Group (ECOG) score was 2 (range 0–3), and the median bone marrow blast count was 45.5% (range: 20–92.5%). Seven patients (7.8%) had a good prognosis, 25 patients (27.8%) had an intermediate prognosis, and 58 patients (64.4%) had a poor prognosis. there were 47 patients in the short-term treatment group and 43 patients in the long-term treatment group. Details of patient demographic characteristics are summarized in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e\u003cdiv class=\"gridtable\"\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=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\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\u003ePatients characteristics in the Short-term Group and the Long-term Group\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e\u003ccolgroup cols=\"4\"\u003e\u003c/colgroup\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eVariable\u003c/p\u003e \u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eShort-term group\u003c/p\u003e \u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eLong-term group\u003c/p\u003e \u003c/th\u003e\u003cth align=\"left\" colname=\"c4\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cem\u003ep\u003c/em\u003e value\u003c/p\u003e \u003c/th\u003e\u003c/tr\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eN = 47\u003c/p\u003e \u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eN = 43\u003c/p\u003e \u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eAge, year, median (range)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e71(60–87)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e67(60–81)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.533\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e≤ 70\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e23(48.9)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e25(58.1)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026gt; 70\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e24(51.1)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e18(41.9)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eGender, n (%)\u003c/b\u003e\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=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.291\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\u003e26(55.3)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e19(44.2)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\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\u003e21(44.7)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e24(55.8)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eClassification, n (%)\u003c/b\u003e\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=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.752\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePrimary\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e37(78.7)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e35(81.4)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSecondary\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10(21.3)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8(18.6)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eECOG score, n (%)\u003c/b\u003e\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=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.743\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e0–1 points\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e22(46.8)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e25(58.2)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e2–4 points\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e25(53.2)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e18(41.8)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eRisk classification, n (%)\u003c/b\u003e\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=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.108\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFavorable\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3(6.4)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4(9.3)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIntermediate\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e9(19.1)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e16(37.2)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAdverse\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e35(74.5)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e23(53.5)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eBone marrow blast cell rate, median (range)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e40.5(16–88)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e52(20-92.5)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.345\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eBlood count during diagnosis, median (range)\u003c/b\u003e\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\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWhite blood cell count, ×10\u003csup\u003e9\u003c/sup\u003e/L\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4.9(0.4-152.7)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4.4(0.5–257)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.345\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNeutrophils count, ×10\u003csup\u003e9\u003c/sup\u003e/L\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1.1(0.08–132.9)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.78(0.04–121.9)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.303\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHemoglobin, g/L\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e78.5(44–132)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e80(35–129)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.365\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePlatelet count, ×10\u003csup\u003e9\u003c/sup\u003e/L\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e50(7-704)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e55(4-402)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.358\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"4\"\u003eAbbreviations:\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"4\"\u003eECOG, Eastern Cooperative Oncology Group\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003ch2\u003eResponse to treatment\u003c/h2\u003e\u003cp\u003eIn the short-term treatment group, the CRc rate, ORR, and MRD negative rates of one course of induction therapy were 55.3%, 82.9%, and 40.7%. In the long-term treatment group, the CRc rate, ORR, and MRD negativity rate of one course of induction therapy were 53.5%, 81.4%, and 56.0%. In the short-term group, the CRc, ORR, and MRD negative rates were 57.4%, 85.1%, and 61.5% for two or more courses of induction therapy, whereas in the long-term group, the CRc, ORR, and MRD negative rates were 58.1%, 86%, and 73%, for 2 or more courses of induction therapy. The overall CRc rates were 56.5% and 64.0% for patients under 70 years of age and 54.2% and 38.9% for patients over 70 years of age. The total CRc rates were 66.7% and 60.0% for patients with a good and intermediate prognosis and 51.4% and 47.8% for patients with a poor prognosis. The cumulative recurrence rates were 29.8% and 30.2% for patients in the two groups. The recent efficacy of patients are summarized in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e.\u003c/p\u003e\u003cdiv class=\"gridtable\"\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=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\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\u003eAnalysis of therapeutic effects in the Short-term Group and the Long-term Group\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e\u003ccolgroup cols=\"4\"\u003e\u003c/colgroup\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eShort-term group\u003c/p\u003e \u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eLong-term group\u003c/p\u003e \u003c/th\u003e\u003cth align=\"left\" colname=\"c4\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cem\u003ep\u003c/em\u003e value\u003c/p\u003e \u003c/th\u003e\u003c/tr\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eN = 47\u003c/p\u003e \u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eN = 43\u003c/p\u003e \u003c/th\u003e\u003c/tr\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCRc rate, n (%)\u003c/p\u003e \u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1 courses of treatment\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e26(55.3)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e23(53.5)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.862\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e2 or more courses of treatment\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e27(57.4)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e25(58.1)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.947\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eORR rate, n (%)\u003c/b\u003e\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\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1 courses of treatment\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e39(82.9)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e35(81.4)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.844\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e2 or more courses of treatment\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e40(85.1)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e37(86.0)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.899\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eMRD negative rate, n (%)\u003c/b\u003e\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\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1 courses of treatment\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e11(40.7)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e14(56.0)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.357\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e2 or more courses of treatment\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e16(61.5)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e17(73.9)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.271\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eCRc rate based on age, n (%)\u003c/b\u003e\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\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e≤ 70\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e13(56.5)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e16(64.0)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.597\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026gt; 70\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e13(54.2)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7(38.9)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.327\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eCRc rate based on risk classification, n (%)\u003c/b\u003e\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\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003efavorable and intermediate\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8(66.7)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e12(60)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.659\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eadverse\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e18(51.4)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e11(47.8)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.778\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eVA regimen treatment duration, median (range)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2(1–10)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2(1–6)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.789\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eCIR rate, n (%)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e14(29.8)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e13(30.2)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.963\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/table\u003e\u003c/div\u003e\u003cp\u003e\u003cstrong\u003eAbbreviations:\u003c/strong\u003e CRc, Combined complete remission; ORR, Overall remission; MRD, Minimal residual disease; VA, VEN combined with AZA; CIR, Cumulative incidence of relapse;\u003c/p\u003e\u003ch2\u003eSafety analysis\u003c/h2\u003e\u003cp\u003eA total of 7 patients (21.21%) in the short-term treatment group and 9 patients (56.25%) in the long-term treatment group reduced the number of days on VEN due to toxicities, primarily neutropenia with fever.\u003c/p\u003e\u003cp\u003eThe main hematologic adverse event was myelosuppression of varying degrees. The incidence of grade III and higher leukopenia, neutropenia, and thrombocytopenia in the short-term treatment group was 80.9%, 78.7%, and 78.7%, which were lower than those in the long-term treatment group, and the difference was statistically significant (\u003cem\u003ep\u003c/em\u003e \u0026lt; 0.05). Non-hematological adverse events were primarily neutropenia with fever, with an incidence of 72.3% and 90.7% in the two groups. The incidence of neutropenia with fever was significantly higher in the long-term treatment group than in the short-term treatment group (\u003cem\u003ep\u003c/em\u003e = 0.026). There were no statistically significant differences in other non-hematological adverse events such as infection, bleeding, and organ dysfunction. Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e summarizes the adverse events of patients during the first course of chemotherapy.\u003c/p\u003e\u003ctable id=\"Tab3\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cp\u003eAdverse events during the first course of chemotherapy in the Short-term Group and the Long-term Group\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\u003ccolgroup cols=\"5\"\u003e\u003c/colgroup\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" rowspan=\"2\" style=\"width: 55.2553%;\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" style=\"width: 18.6186%;\"\u003e\n \u003cp\u003eShort-term group\u003c/p\u003e\n \u003c/th\u003e\u003cth align=\"left\" style=\"width: 18.3183%;\"\u003e\n \u003cp\u003eLong-term group\u003c/p\u003e\n \u003c/th\u003e\u003cth align=\"left\" rowspan=\"2\" style=\"width: 7.8078%;\"\u003e\n \u003cp\u003e\u003cem\u003ep\u003c/em\u003e value\u003c/p\u003e\n \u003c/th\u003e\u003c/tr\u003e\u003ctr\u003e\u003cth align=\"left\" style=\"width: 18.6186%;\"\u003e\n \u003cp\u003eN = 47\u003c/p\u003e\n \u003c/th\u003e\u003cth align=\"left\" style=\"width: 18.3183%;\"\u003e\n \u003cp\u003eN = 43\u003c/p\u003e\n \u003c/th\u003e\u003c/tr\u003e\u003ctr\u003e\u003cth align=\"left\" style=\"width: 55.2553%;\"\u003e\n \u003cp\u003eHematology adverse events Above level III, n (%)\u003c/p\u003e\n \u003c/th\u003e\u003cth align=\"left\" style=\"width: 18.6186%;\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" style=\"width: 18.3183%;\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" style=\"width: 7.8078%;\"\u003e\u0026nbsp;\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" style=\"width: 55.2553%;\"\u003e\n \u003cp\u003eLeukopenia\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"char\" style=\"width: 18.6186%;\"\u003e\n \u003cp\u003e38(80.9)\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"char\" style=\"width: 18.3183%;\"\u003e\n \u003cp\u003e41(95.3)\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"char\" style=\"width: 7.8078%;\"\u003e\n \u003cp\u003e0.036\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" style=\"width: 55.2553%;\"\u003e\n \u003cp\u003eNeutropenia\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"char\" style=\"width: 18.6186%;\"\u003e\n \u003cp\u003e37(78.7)\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"char\" style=\"width: 18.3183%;\"\u003e\n \u003cp\u003e42(97.7)\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"char\" style=\"width: 7.8078%;\"\u003e\n \u003cp\u003e0.006\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" style=\"width: 55.2553%;\"\u003e\n \u003cp\u003eHemoglobin reduction\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"char\" style=\"width: 18.6186%;\"\u003e\n \u003cp\u003e34(72.3)\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"char\" style=\"width: 18.3183%;\"\u003e\n \u003cp\u003e32(74.4)\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"char\" style=\"width: 7.8078%;\"\u003e\n \u003cp\u003e0.824\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" style=\"width: 55.2553%;\"\u003e\n \u003cp\u003eThrombocytopenia\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"char\" style=\"width: 18.6186%;\"\u003e\n \u003cp\u003e37(78.7)\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"char\" style=\"width: 18.3183%;\"\u003e\n \u003cp\u003e41(95.3)\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"char\" style=\"width: 7.8078%;\"\u003e\n \u003cp\u003e0.020\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" style=\"width: 55.2553%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eNon hematology adverse events above level III, n (%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"left\" style=\"width: 18.6186%;\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" style=\"width: 18.3183%;\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" style=\"width: 7.8078%;\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" style=\"width: 55.2553%;\"\u003e\n \u003cp\u003eFebrile neutropenia\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"char\" style=\"width: 18.6186%;\"\u003e\n \u003cp\u003e34(72.3)\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"char\" style=\"width: 18.3183%;\"\u003e\n \u003cp\u003e39(90.7)\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"char\" style=\"width: 7.8078%;\"\u003e\n \u003cp\u003e0.026\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" style=\"width: 55.2553%;\"\u003e\n \u003cp\u003eInfect\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"char\" style=\"width: 18.6186%;\"\u003e\n \u003cp\u003e34(72.3)\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"char\" style=\"width: 18.3183%;\"\u003e\n \u003cp\u003e36(83.7)\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"char\" style=\"width: 7.8078%;\"\u003e\n \u003cp\u003e0.195\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" style=\"width: 55.2553%;\"\u003e\n \u003cp\u003eHemorrhage\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"char\" style=\"width: 18.6186%;\"\u003e\n \u003cp\u003e12(25.5)\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"char\" style=\"width: 18.3183%;\"\u003e\n \u003cp\u003e16(37.2)\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"char\" style=\"width: 7.8078%;\"\u003e\n \u003cp\u003e0.232\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" style=\"width: 55.2553%;\"\u003e\n \u003cp\u003eCardiac insufficiency\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"char\" style=\"width: 18.6186%;\"\u003e\n \u003cp\u003e6(12.8)\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"char\" style=\"width: 18.3183%;\"\u003e\n \u003cp\u003e8(18.6)\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"char\" style=\"width: 7.8078%;\"\u003e\n \u003cp\u003e0.445\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" style=\"width: 55.2553%;\"\u003e\n \u003cp\u003eHepatic insufficiency\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"char\" style=\"width: 18.6186%;\"\u003e\n \u003cp\u003e6(12.8)\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"char\" style=\"width: 18.3183%;\"\u003e\n \u003cp\u003e8(18.6)\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"char\" style=\"width: 7.8078%;\"\u003e\n \u003cp\u003e0.445\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" style=\"width: 55.2553%;\"\u003e\n \u003cp\u003eRenal insufficiency\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"char\" style=\"width: 18.6186%;\"\u003e\n \u003cp\u003e7(14.9)\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"char\" style=\"width: 18.3183%;\"\u003e\n \u003cp\u003e9(20.9)\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"char\" style=\"width: 7.8078%;\"\u003e\n \u003cp\u003e0.454\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" style=\"width: 55.2553%;\"\u003e\n \u003cp\u003eDizziness and fatigue\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"char\" style=\"width: 18.6186%;\"\u003e\n \u003cp\u003e23(48.9)\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"char\" style=\"width: 18.3183%;\"\u003e\n \u003cp\u003e20(60.6)\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"char\" style=\"width: 7.8078%;\"\u003e\n \u003cp\u003e0.303\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" style=\"width: 55.2553%;\"\u003e\n \u003cp\u003eNausea and vomiting\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"char\" style=\"width: 18.6186%;\"\u003e\n \u003cp\u003e11(23.4)\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"char\" style=\"width: 18.3183%;\"\u003e\n \u003cp\u003e11(25.6)\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"char\" style=\"width: 7.8078%;\"\u003e\n \u003cp\u003e0.810\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" style=\"width: 55.2553%;\"\u003e\n \u003cp\u003eTumor lysis syndrome\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"char\" style=\"width: 18.6186%;\"\u003e\n \u003cp\u003e2(4.3)\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"char\" style=\"width: 18.3183%;\"\u003e\n \u003cp\u003e3(7.0)\u003c/p\u003e\n \u003c/td\u003e\u003ctd align=\"char\" style=\"width: 7.8078%;\"\u003e\n \u003cp\u003e0.537\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/table\u003e\u003cp\u003eIn the first course of induction chemotherapy regimen, the median recovery time of neutrophils in the short-term and long-term groups was 12.5 days and 36 days. In the short-term group, the recovery time of neutrophils was significantly shorter (\u003cem\u003ep\u003c/em\u003e = 0.001); the median recovery time of platelets was non-significantly different. Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e summarizes the recovery time of the patient’s blood count during the first course of chemotherapy.\u003c/p\u003e\u003cdiv class=\"gridtable\"\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=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eRecovery time of blood count during the first course of chemotherapy in the Short-term Group and the Long-term Group\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e\u003ccolgroup cols=\"4\"\u003e\u003c/colgroup\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eShort-term group\u003c/p\u003e \u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eLong-term group\u003c/p\u003e \u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cem\u003ep\u003c/em\u003e value\u003c/p\u003e \u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eNeutrophil recovery time, days, median (range)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e12.5(1–31)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e26(3–34)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.001\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003ePlatelet recovery time, days, median (range)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8(2–24)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9(2–36)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.653\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/table\u003e\u003c/div\u003e\u003ch2\u003eSurvival Analysis\u003c/h2\u003e\u003cp\u003eThe median follow-up time for all patients was 697 (37–1170) days. The median OS was 494 days in the short-term group and 578 days in the long-term group. The median EFS was 416 days in the short-term and 454 days in the long-term groups. Notably, the median OS in the long-term treatment group indicated an upward trend compared to the short-term treatment group, but there was no statistically significant difference in OS and EFS between the two groups (Figs.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e1\u003c/span\u003ea-b). There was also no statistically significant difference in OS and EFS between the two groups of patients by age and risk-stratified (Figs.\u0026nbsp;\u003cspan refid=\"Fig8\" class=\"InternalRef\"\u003e2\u003c/span\u003ea-d). Similarly, no significant differences were observed in OS and EFS between the two groups, regardless of the status of MRD (Figs.\u0026nbsp;\u003cspan refid=\"Fig8\" class=\"InternalRef\"\u003e2\u003c/span\u003ee-f).\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eAML is an aggressive malignant tumor with a poor prognosis and a high recurrence rate. Age is an independent prognostic risk factor for AML [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e], with elderly patients having a worse prognosis than younger patients. As a result, treating elderly patients with AML involves many risks and challenges. VEN, a novel selective BCL-2 inhibitor, has shown therapeutic efficacy in AML in preclinical studies [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e], but monotherapy is prone to drug resistance [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. AZA enhances the antitumor effect of VEN by activating the transcription of the proapoptotic protein NOXA, and the combination of the two drugs induces deep and long-lasting antileukemic effects by blocking the energy metabolism of leukemic stem cells [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. VEN combined with AZA induction regimen has been recommended by international guidelines for elderly AML patients who are unsuitable for intensive chemotherapy. In an efficacy exposure analysis study of VEN combined with hypomethylating agents (HMAs)for treating newly diagnosed elderly patients with AML, the remission rate increased with doses of VEN\u0026thinsp;\u0026le;\u0026thinsp;400 mg/day. Beyond this dose, the remission rate non-significantly changed or decreased, and the incidence of adverse events increased with higher doses [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]. Considering efficacy and safety, international guidelines recommend an optimal dose of 400 mg/day when combining HMAs. However, there is an unclear indication of the specific duration of use.\u003c/p\u003e \u003cp\u003eAiba M et al. retrospectively studied 13 newly diagnosed patients with AML who received induction therapy with the VEN combined with AZA (VA) regimen. They found that the VEN14 and VEN28 groups had similar CRc and OS rates, with the VEN14 group having a significantly lower incidence of febrile neutropenia and shorter hospitalization time [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. Analyzing near-term efficacy, this study found that the total CRc rate of induction therapy in the short-term and long-term groups was 57.4% and 58.1%, and the total ORR was 85.1% and 86%. The remission rate was similar in the two groups, with most patients achieving remission in the first course of therapy. The overall CRc rate was lower in this study compared to the VIALE-A trial, which had a CRc rate of 66.4% [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e], which was considered to be possible because all elderly patients were included in this study. Age and risk stratification can affect the remission rate of induction therapy. The present study demonstrated that for elderly patients with AML aged\u0026thinsp;\u0026ge;\u0026thinsp;70 years, the ORR in the short-term group was up to 93.33%, significantly higher than the aforementioned studies and similar to the ORR in the long-term group. The CRc rate of elderly patients (age\u0026thinsp;\u0026gt;\u0026thinsp;70 years) in the short-term group was 54.2%, which indicated an increasing trend compared to the 38.9% elderly patients in the long-term group and was similar to the data reported in different studies [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. This was considered possibly because elderly patients with AML were more unable to tolerate the long-term regimen. The short-term regimen alleviates the adverse events associated with the treatment, especially the severity of myelosuppression, shortening the duration of neutrophil deficiency and reducing the incidence of severe infections. Clinical studies by DiNardo et al. have indicated CR/CRi rates of up to 60% for VA regimens in poor-prognosis elderly patients with AML [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. In the present study, the CRc rates were similar in both groups of poor-prognosis patients (51.4% versus 47.8%), suggesting that in the real-world setting, even in elderly patients with a high number of high-risk patients, shortening the duration of VEN use can achieve the same near-term efficacy as 28 days.\u003c/p\u003e \u003cp\u003eRegarding safety, during the first course of induction therapy, 21.2% and 56.2% of patients in the short-term and long-term groups needed to shorten the course of therapy, primarily due to neutropenia with fever. Shortening the course of VEN use reduced the incidence of shortening the course of therapy by more than half during the therapy. The results of this study indicated that prolonging the course of VEN use increased the severity of myelosuppression. The incidence of grade III-IV neutropenia was 97.7% in the long-term group, significantly higher than in the short-term group (78.7%, \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.006). Considering the therapeutic efficacy analysis, the possibility of the long course of the combination regimen increasing the severity of myelosuppression may affect the efficacy of therapy simultaneously. The incidence of other hematological adverse events, such as hemoglobin reduction and thrombocytopenia, was similar. Foreign phase III clinical studies demonstrated that the incidence of grade III or higher hematologic adverse events in the VA regimen for treating AML in the elderly was lower than the incidence of hematologic adverse events compared to this study [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. This difference may be due to the small body surface area of the Chinese nationals, their poor physical status, more comorbidities, and poorer tolerance to the same course and dose of VEN, leading to a higher degree of myelosuppression. Further observation of blood recovery time during treatment revealed significantly shorter neutrophil recovery time in the short-term group, with a median recovery time of only 12.5 days, more than half of that in the long-term group. The long-term group had the highest incidence of invasive fungal infections (IFIs) before reaching CR due to the greater severity and duration of neutropenia. The severity and duration of neutropenia were related to the severity and duration of the hematological system of the malignant system, which was also related to the severity and duration of neutropenia. There is a correlation between the severity and duration of neutropenia and the incidence of IFIs in patients with hematologic malignancies [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]. The common non-hematologic adverse events were primarily neutropenia with fever, infection, dizziness, and fatigue, with a significantly lower incidence in the short-term group than in the long-term group (72.3% versus 90.7%, \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.026). The above analysis suggests that the short-term VA regimen may significantly shorten the duration of neutropenia, reduce infection incidence to some extent, and potentially reduce IFIs. Other non-hematological adverse events such as dizziness, fatigue, and vital organ insufficiency may also be reduced to some extent by the short-term VA regimen. Additionally, the high incidence of TLS is a major risk in VEN clinical use, and the incidence of TLS during AML treatment still needs to be further explored. According to this study, a non-significant difference was found in the incidence of TLS between the two groups of patients (4.3% versus 7.0%).\u003c/p\u003e \u003cp\u003eRegarding survival analysis, several studies have demonstrated that VA regimens for treating elderly AML can significantly improve patient survival and prolong survival time. Bouligny et al. analyzed 176 patients with AML treated with VEN in combination with HMAs in the ERIS Project database. They found that compared to receiving VEN for 28 days, the reduced VEN regimen for 14 days resulted in significantly longer OS (8.9 months versus 2.1 months, \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.0002) and progression-free survival (8.2 months versus 1.5 months, \u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.0001) [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]. Another retrospective analysis included 270 newly diagnosed patients with AML and analyzed the survival time of three groups with different courses of VEN (14 d, 21 d, and 28 d) in combination with HMAs, and the median OS of the three groups was 18.6, 21.3, and 13.2 months, with non-significant difference [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]. The OS and EFS of patients in the two groups in this study were similar to the results of foreign studies. On further analysis, a non-significant difference in OS and EFS was observed between the two groups in patients with advanced age, poor prognosis, and MRD-negative status. However, shortening the VEN regimen when combined with cytogenetic and molecular biological factors with poor prognosis may lead to their susceptibility to relapse, which needs confirmation by large, prospective studies. Elderly patients with AML are less tolerant of long-course regimens and have a high incidence of serious infections; therefore, a short-course VA regimen is considered more suitable for them. While MRD negativity is associated with better OS and EFS [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e], the total MRD negativity rate was similar in the short-term and long-term groups in this study, and no significant difference in survival time was observed. In summary, shortening the course of VEN use may not affect near-term survival.\u003c/p\u003e \u003cp\u003eThis study explored the efficacy, advantages, and safety of a short-term VA regimen for treating elderly patients with AML in China. A short-term VEN combined with an AZA regimen for the treatment of newly diagnosed elderly AML achieved essentially the same clinical remission rate as the long-term VA regimen, especially for patients aged\u0026thinsp;\u0026ge;\u0026thinsp;70 years with poor prognosis. It also reduced myelosuppression during treatment, shortened neutrophil recovery time, attenuated granulocyte recovery time, and reduced the incidence of adverse events such as fever; recent follow-up suggests that shortening the course of VEN may not affect survival time in elderly patients with AML. However, this study did not analyze the impact of cytogenetics and molecular biology on the efficacy of the VA regimen in the treatment of elderly patients with AML. Besides, the study did not analyze the impact of allogeneic hematopoietic stem cell transplantation on long-term survival time. Due to the small sample size, retrospective analysis, and relatively short patient follow-up, there may be unclear statistical differences, and prospective studies with large sample sizes are needed.\u003c/p\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e "},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAuthors\u0026rsquo; contributions \u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eZ.R.H.Y. and S.Y.L. were the principal investigators who took primary responsibility for this study. Z.R.H.Y. wrote the manuscript. R.Z.P. and Y.L. participated in statistical analysis and commented on the manuscript. Z.R.H.Y., Y.X.W., and J.J.Y. collected data and interpreted results and participated in clinical data management. and both authors gave final approval for the manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThis research was funded by the Medical Science and Technology Program (Clinical study of venetoclax combined with azacitidine in the treatment of newly diagnosed elderly AML, project number 2019Y51) led by the Ningbo Municipal Health Commission.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics approval\u003c/strong\u003e \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThis study was conducted in accordance with the principles of the Declaration of Helsinki and approved by the ethics committee of the institution.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConflict of interest\u0026nbsp;\u003c/strong\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no conflict of interest.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eKantarjian HM, Kadia TM, DiNardo CD et al (2021) Acute myeloid leukemia: Treatment and research outlook for 2021 and the MD Anderson approach. 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Am J Hematol 99:e63\u0026ndash;e66. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1002/ajh.27180\u003c/span\u003e\u003cspan address=\"10.1002/ajh.27180\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePratz KW, Jonas BA, Pullarkat V et al (2022) Measurable Residual Disease Response and Prognosis in Treatment-Na\u0026iuml;ve Acute Myeloid Leukemia with Venetoclax and Azacitidine. J Clin oncology: official J Am Soc Clin Oncol 40:855\u0026ndash;865. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1200/JCO.21.01546\u003c/span\u003e\u003cspan address=\"10.1200/JCO.21.01546\" 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":"Short-term, Venetoclax, Elderly, Acute myeloid leukemia","lastPublishedDoi":"10.21203/rs.3.rs-4569429/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4569429/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eThe induction regimen of venetoclax (VEN) in combination with demethylating agents has improved outcomes in elderly patients with acute myeloid leukemia (AML). However, the optimal course of VEN use during treatment needs further exploration. We conducted a retrospective study to determine the efficacy and safety of VEN in 90 newly diagnosed elderly patients with AML. This included 47 patients who used VEN for 14 days in combination with the azacitidine (AZA) regimen and 43 patients who used VEN for 28 days in combination with the AZA regimen. The rates of clinical remission were similar in the two groups, with a shorter time to neutropenia recovery in the shorter duration group. The short-term group also experienced reduced febrile neutropenia and a trend toward a lower incidence of other adverse events. With a median follow-up time of 494 days, there was a non-significant difference in median overall survival and Event-free survival observed between the two groups. This retrospective study demonstrated that VEN 14 days combined with AZA had similar efficacy to the VEN 28 days regimen combined with AZA. The short-term VEN combined with AZA regimen ensured efficacy with relatively less myelosuppressive effect, shortened blood recovery time, and reduced incidence of infection and fever during treatment. This regimen is suitable for elderly patients who are in poor physical condition and unable to tolerate low-dose chemotherapy and the long-term VEN combined with AZA regimen. It is easier to accept and more regarding the biopsychosocial medicine model.\u003c/p\u003e","manuscriptTitle":"Short-term Group Venetoclax Combined with Azacitidine for Treating Newly Diagnosed Elderly Acute Myeloid Leukemia: A Retrospective Study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-07-08 17:13:57","doi":"10.21203/rs.3.rs-4569429/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":"64a3dee9-2e62-412c-ac6b-fddb9ccfaa35","owner":[],"postedDate":"July 8th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2024-07-10T11:49:16+00:00","versionOfRecord":[],"versionCreatedAt":"2024-07-08 17:13:57","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-4569429","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4569429","identity":"rs-4569429","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}