Incidence of Anaemia and Thrombocytopenia Following Breast Cancer Chemotherapeutic Regimens AC-T, AC-T+ Ca, and AC-T+Tr IN in a Tertiary Care Center

Incidence of Anaemia and Thrombocytopenia Following Breast Cancer Chemotherapeutic Regimens AC-T, AC-T+ Ca, and AC-T+Tr IN in a Tertiary Care Center | 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 Incidence of Anaemia and Thrombocytopenia Following Breast Cancer Chemotherapeutic Regimens AC-T, AC-T+ Ca, and AC-T+Tr IN in a Tertiary Care Center Dr Arun S, Dr Seema P. Mohamedali, Dr Ajay Kumar T, Dr Anuradha M This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4876309/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 BACKGROUND : In breast cancer, the most common regimen used for the neoadjuvant and adjuvant nonmetastatic setting is 4 cycles of adriamycin and cyclophosphamide followed by docetaxel, docetaxel + trastuzumab, docetaxel, and carboplatin. (1) Patients with breast cancer were treated with three different chemotherapeutic regimens, namely, AC-T (adriamycin and cyclophosphamide followed by docetaxel) regimen I, AC-T+Ca (adriamycin and cyclophosphamide followed by docetaxel and carboplatin) regimen II, and AC-T+Tr (adriamycin and cyclophosphamide followed by docetaxel and trastuzumab) regimen III, at a tertiary care hospital. Of these, myelosuppression was the major concern in treatment follow-ups. Here, I reviewed the incidence and management of anemia during the post-chemotherapy period. METHODS: A prospective open-label observational comparative study was performed to evaluate the incidence of anemia and thrombocytopenia among three regimens, namely, the chemotherapy regimen AC-T, Regimen II AC-T+Ca, and Regimen III AC-T+Tr. All enrolled patients received pegfilgrastim/filgrastim prophylactically or as a part of the case of myelosuppression. The regimen I enrolled and completed a study of 38 patients, regimen II 40 patients, and regimen III 46 patients. All patients were subjected to statistical analysis using SPSS. RESULTS: A total of 882 (88.9%) episodes of anemia (all grades) were observed among a total of 992 cycles of chemotherapy. Twenty-seven patients in Regimen I and II and 31 patients in Regimen III had at least one episode of anemia (grade 2 or above) during their chemotherapy cycles. Overall, 293 episodes were Grade 2, 21 episodes were Grade 3, and 3 episodes were Grade 4 anemia among the 3 study regimens. The mean incidence of anemia in regimen I in the initial 4 cycles was 3.4+/- 1.1, in the final 4 cycles, it was 3. 7± 0.6, and in the overall 8 cycles was 7. 1± 1.5. In regimen II, as in the initial 4 cycles:3.5 + 0.8, in the final 4 cycles: 3.9 + 0.4, and in the overall 8 cycles:7.4 + 1.1. In regimen III, as in the initial 4 cycles: 3.3 + 1; in the final 4 cycles: 3.7 + 0.6; and in the overall 8 cycles: 7.1 + 1.5. The mean incidence of all grades of anemia was comparable among the 3 study regimens, with a mean incidence of 7.1 in regimen I, 7.4 in regimen II, and 7.1 in regimen III over 8 cycles of chemotherapy. There was no statistically significant difference in the mean incidence of anemia among the 3 study groups. A total of 109 episodes of thrombocytopenia out of 992 cycles of chemotherapy (10.9%) were observed. In the initial 4 cycles of chemotherapy, 44 episodes occurred, and in the final 4 cycles, 65 episodes occurred . Grade 2 or above thrombocytopenia resulting from at least one episode during the treatment period was reported in 6 patients in regimen I, 5 patients in regimen II, and 1 patient in regimen III. Of the total thrombocytopenia grades 2 and above, only 6 episodes in regimen I, 5 episodes in regimen II, and 2 episodes in regimen III were noted. The mean incidence of thrombocytopenia in regimen I in the initial 4 cycles: 0.1 + 0.5; in the final 4 cycles: 0.2 + 0.6, and in the overall 8 cycles: 0.3 + 1. In regimen II, the initial 4 cycles, were 0.1 + 0.3; in the final 4 cycles0.3 + 0.6; and in the overall 8 cycles, 0.4 + 0.7. In regimen III, as in the initial 4 cycles:0 + 0; in the final 4 cycles: 0.1 + 0.4; and in the overall 8 cycles:0.1 + 0.4. The mean incidence of thrombocytopenia of all grades was comparable among the 3 study regimens, with 0.3 in regimen I, 0.4 in regimen II, and 0.1 in regimen III over 8 cycles of chemotherapy. There was no statistically significant difference in the mean incidence of thrombocytopenia among the 3 study regimens. CONCLUSION: There was no significant difference in the incidence of anemiaamong the 3 regimens in the initial 4 chemo cycles, final 4 chemo cycles, or overall 8 cycles of chemotherapy. There was a statistically significant difference in the mean incidence of thrombocytopenia during the initial 4 cycles of chemotherapy among the 3 regimens. However, among the overall 8 cycles of chemotherapy, there was no statistically significant difference in the mean incidence of thrombocytopenia among the three regimens. A trend towards a decrease in the mean Hb value was observed towards later cycles of chemotherapy in the overall study population due to the cumulative toxicity of chemotherapy regimens in the bone marrow. Oncology Clinical Pharmacology Anemia Thrombocytopenia Adriamycin Chemotherapy Breast Cancer Figures Figure 1 Figure 2 Figure 3 Figure 4 INTRODUCTION Breast cancer is a common cause of malignancy in the female population worldwide( 1 , 2 ). It is a heterogeneous disease resulting from many factors, such as the progressive accumulation of genetic aberrations, including point mutations, chromosomal amplifications, deletions, rearrangements, and translocations( 2 ). Treatment for breast cancer consists of multiple modalities, namely surgery, chemotherapy, radiation therapy, and biological therapy. Anthracycline-based chemotherapeutic regimens are commonly used( 1 , 2 ). Three common regimens used for therapeutic purposes in breast cancer treatment are Adriamycin chemotherapy regimen and cyclophosphamide(AC), followed by docetaxel(AC-T) (Regimen I); AC, followed by docetaxel and carboplatin (AC-T + Carboplatin)(Regimen II) ; and AC followed by docetaxel and trastuzumab (AC-T + Tr) (Regimen III), which are administered to patients with stage 0 to stage 3 disease. In a phase 11 trial of docetaxel and carboplatin-based neoadjuvant chemotherapy for stage II/111 breast cancer, a differential response was observed, with the highest pCR rate achieved in patients with TNBC( 3 ). The Hematological adverse drug reactions associated with anthracycline-based chemotherapy regimens include neutropenia, anemia, thrombocytopenia, and, rarely, leukemia( 5 , 6 , 7 , 8 ). Along with docetaxel and carboplatin regimens, more myelosuppression has been noted( 6 ). When docetaxel is given in combination with doxorubicin, an increased incidence of myelosuppression and gastrointestinal side effects has been reported( 6 ). Myelosuppression is a dose-limiting side effect. Myelosuppression is more severe and prolonged in patients with impaired renal function. Leukopenia, thrombocytopenia, and anemia occur in patients taking carboplatin( 6 ). According to a study involving 710 patients, myelosuppression was the dose-limiting toxicity of carboplatin, leukopenia occurred in 55% of patients, and leukopenia and thrombocytopenia resulted in symptomatic events such as infection and bleeding in a minority of patients. Anemia was frequent (59%) and required transfusion support in one-fifth of the patients( 6 , 12 ). There is an increased incidence of leucopenia, thrombocytopenia, anemia, and febrile neutropenia when trastuzumab is given with chemotherapy, but it infrequently causes myelosuppression when used alone( 6 ). In cyclophosphamide-containing chemotherapeutic regimens, the major dose-limiting side effect is myelosuppression. After a single dose, the white blood cell count may reach its nadir within approximately 1–2 weeks, and full recovery usually occurs within approximately 3–4 weeks. Thrombocytopenia and anemia may occur but tend to be less common and less severe( 6 ). METHODS This study aimed to analyze the incidence of anemia and thrombocytopenia among patients treated with three chemotherapeutic regimens for breast cancer in a tertiary care center. In Regimens I, II, and III, patients were treated with an initial 4 cycles of AC followed by the next 4 cycles of docetaxel, docetaxel + carboplatin, and docetaxel + trastuzumab respectively. All patients received prophylactic pegfilgrastim and filgrastim for treatment in the oncology department of a tertiary care center. The incidence of anemia and thrombocytopenia following chemotherapy was measured by recording hemoglobin and platelet count on the 7th day after chemotherapy as a routine procedure. The Case report form was entered regularly in a structured format throughout the study period. The present study included a prospective open-label comparative cohort. The study was initiated only after ethical committee approval was obtained from the institution. The duration of the study ranged from January 2016 to January 2017. A total of 41 patients were enrolled in each study arm. It is calculated by the formula N = 2 pq (Zcrit + Zpwr) 2/D Inclusion criteria Patients with normal cognition Patients with breast malignancies aged 18–65 years and with stage 1–3 disease G-CSF support was obtained (Pegfilgrastim/Filgrastim). Absolute neutrophil count > 1.5x109/l Platelet count > 100x109/l Serum creatinine < 2 Serum total bilirubin < 1.5 times the upper limit of normal Exclusion criteria Stage 4 metastatic patients Concurrent other malignancies Cardiac failure, and myocardial infarction in the past 1 year Pregnancy and Nursing population Prior bone marrow transplantation or stem cell therapy Written informed consent was obtained from all the study subjects before starting the study in the vernacular language. Study procedure After screening, patients who fulfilled the inclusion criteria were enrolled in the study. Patients were divided into three groups, patients who underwent chemotherapy regimen I, patients who received chemotherapy regimen II, and patients who received chemotherapy regimen III. AC was followed by docetaxel in regimen I. AC was followed by docetaxel and carboplatin in regimen II. AC followed by docetaxel and trastuzumab in regimen III. A total of 132 patients were screened for the study, and those who satisfied the inclusion criteria were included in the study. Forty-two patients received regimen I,42 patients received regimen II, and 48 patients in the third group received regimen III. In Regimen I, 4 patients were included, and in Regimen II and III, 2 patients each dropped out of the study; hence, Regimen I included 38 patients, Regimen II 40 patients, and Regimen III included 46 patients for final statistical analysis. Dosage and administration AC-docetaxel regimen The initial regimen consisted of 4 cycles of doxorubicin (60 mg/m2) and cyclophosphamide (600mg/m2) every 3 weeks, followed by a final of 4 cycles of docetaxel (100mg/m 2 ) every 3 weeks( 9 , 10 ). AC-docetaxel and carboplatin regimen The initial regimen consisted of 4 cycles of doxorubicin (60 mg/m2) and cyclophosphamide (600mg/m2) every 3 weeks, and the final regimen consisted of 4 cycles of chemotherapy combined with carboplatin and docetaxel. Carboplatin dose: AUC of 6 intravenously on day 1. Docetaxel: 75 mg/m2 intravenously on day 1. Each chemotherapy cycle was repeated every 21 days( 11 ). AC-docetaxel and trastuzumab regimen The initial 4-cycle AC regimen was followed by a final 4-cycle chemotherapy regimen comprising docetaxel and trastuzumab. The docetaxel dose was 75 mg/m2 intravenously on day 1, the trastuzumab dose was 4 mg/kg intravenously, and the dose was subsequently 2 mg/kg intravenously weekly. Chemotherapy was repeated every 21 days for a total of 8 cycles( 11 ). Dosage of Peg filgrastim/Filgrastim for neutropenia associated with myelosuppressive chemotherapy: Subcutaneous administration of 5 mcg/kg/day is preferred over the intravenous route until the absolute neutrophil count is 2–3 x 109/mcl or for up to 14 days. Pegylated filgrastim was administered (6 mg) subcutaneously once per chemotherapy cycle. OUTCOME ASSESSMENT Established number of patients with anemia and thrombocytopenia of all grades documented and recorded in the prescribed format for assessment during the 8 cycles of chemotherapy before and after chemotherapy for evaluating the different grades of chemotherapy-induced anemia and thrombocytopenia Statistical analysis Statistical analysis was performed using Statistical Package for Social Science (SPSS) software version 22. For quantitative data with non-normal distribution used Kruskal-Wallis test, and descriptive statistics with mean, and standard deviation were used for the representation of the baseline and demographic data. Wilcoxon signed-rank test for the paired comparison of the non-normally distributed quantitative data. RESULTS Baseline demographic features: The mean age of the patients was 49.06+/-8.6 years(standard deviation), the minimum age was 26 years, the maximum age was 65 years, the body surface area was 1.58 m 2 +/- 0.14(SD), the mean baseline hemoglobin level was 11.95 gm/dl +/- 1.36(SD), and the mean baseline platelet count was 3.21lak/dl+/-0.09 (SD) in the overall study population. Twenty- five percent of patients received neoadjuvant treatment and 75% received adjuvant treatment. Incidence of anemia in patients receiving different chemotherapy regimens: Table 1 The pattern of incidence of patient-wise anemia and the cycle of chemotherapy-wise anemia and thrombocytopenia of Grade 2 and above in three different regimens of breast cancer Pattern of distribution of anemia : 882 (88.9%) episodes of anemia(all grades) out of a total of 992 cycles of chemotherapy were observed. Twenty-seven patients groups I and II, and 31 patients in group III had at least one episode of anemia (grade 2 or above) during their chemotherapy cycles (Table 1 ). Overall, 293 episodes were Grade 2, 21 episodes were Grade 3, and 3 episodes were Grade 4 anemia among the 3 study groups ( Tables 1 , 4 ) . Adverse Drug Effects Regimens Patient Wise Incidence Cycle Of Chemotherapy Wise(Overall) Incidence Frequency- No Of Patients (Percentage-%) Frequency-No Of Episodes(Percentage %) Mean Incidence/8 Cycles Anemia(Grade 2 And Above) REG I 27(71) 114(37.5) 3.11 REG II 27(68) 91(28.4) 2.38 REG III 31(67) 112(30.4) 2.7 Thrombocytopenia(Grade 2 And Above) REG I 6( 16 ) 5(1.6) 0.16 REGII 5( 12 ) 4(1.25) 0.12 REGIII 1( 2 ) 2(0.005) 0.04 Table 2 Distribution of different grades of anemia in the 3 study groups according to the initial 4, final 4, and overall 8 cycles of chemotherapy. REG GRADE ANEMIA INITIAL 4 FINAL4 TOTAL8 AC-T Grade1 87 70 157 Grade2 38 69 107 Grade3 2 3 5 Grade4 2 0 2 AC-T + C Grade1 113 91 204 Grade2 24 59 83 Grade3 3 4 7 Grade4 0 1 1 AC-T + T Grade1 110 104 204 Grade2 42 61 103 Grade3 2 7 9 Grade4 0 0 0 The mean incidence of anemia in group I in the initial 4 cycles was 3.4+/-1.1; in the final 4 cycles, 3. 7+/- 0.6; and in the overall 8 cycles, 7.1+/- 1.5 . In group II, as in the initial 4 cycles: 3.5 ± 0.8; in the final 4 cycles:3.9 ± 0.4, and in the overall 8 cycles: 7.4 ± 1.1 . In group III, as in the initial 4 cycles: 3.3 ± 1; in the final 4 cycles: 3.7 ± 0.6; and in the overall 8 cycles: 7.1 ± 1.5 . (Table 2 , 4 & Fig. 1 ) The mean incidence of all grades of anemia was comparable among the 3 study groups, with a mean incidence of 7.1 in group I, 7.4 in group II, and 7.1 in group III after 8 cycles of chemotherapy. There was no statistically significant difference in the mean incidence of anemia among the 3 study groups. By reviewing the incidences and grades of anemia in these 124 patients, it can be clearly inferred that the incidence of anemia is greater during chemotherapy cycles. This can be attributed to the cumulative toxicity of the chemotherapy regimens to the patient's bone marrow. Figure 2 clearly shows the pattern of the decrease in Hb in the patients after each chemotherapy cycle. hemoglobin levels are presented as the mean values of hemoglobin prechemotherapy and post-chemotherapy. On analysis, there was a statistically significant difference in the prechemotherapy and post-chemotherapy hemoglobin levels, with a p-value of 0.000 for each chemotherapy cycle from cycle 1 to cycle 8. There were also significant differences in baseline hemoglobin levels and prechemotherapy 4th cycle hemoglobin levels; baseline hemoglobin levels and post-chemotherapy 4th cycle hemoglobin levels; baseline hemoglobin levels and prechemotherapy 8th cycle hemoglobin levels; and post-chemotherapy 8th cycle hemoglobin levels. The p-value of these comparisons was 0.000. The pattern of distribution of thrombocytopenia in patients receiving three regimens of chemotherapy A total of 109 episodes of thrombocytopenia out of 992 cycles of chemotherapy (10.9%) were observed. In the initial 4 cycles of chemotherapy, 44 episodes occurred, and in the final 4 cycles, 65 episodes occurred during the overall chemotherapy cycles. Grade 2 or above thrombocytopenia resulting from at least one episode during the treatment period was reported in 6 patients in group I, 5 patients in group II, and 1 patient in group III. Of the total thrombocytopenia grades 2 and above, only 6 episodes in group I, 5 episodes in group II, and 2 episodes in group III were noted. (Table 3 . In addition 4) Table 3 Distribution of Thrombocytopenia Grade among the 3 groups according to initial 4, final 4, and overall 8 cycles of chemotherapy Reg Grade THP Initial 4 Final4 Total8 AC-T Grade1 17 13 30 Grade2 3 1 4 Grade3 1 0 1 Grade4 0 0 0 AC-T + C Grade1 7 26 33 Grade2 3 1 4 Grade3 0 0 0 Grade4 0 0 0 AC-T + T Grade1 13 22 35 Grade2 0 2 2 Grade3 0 0 0 Grade4 0 0 0 The mean incidence of thrombocytopenia in group I in the initial 4 cycles was 0.1+/- 0.5; in the final 4 cycles, 0.2+/- 0.6; and in the overall 8 cycles, 0.3+/-0.1. In group II, as in the initial 4 cycles:0.1+/-0.3; in the final 4 cycles:0.3 ± 0.6; and in the overall 8 cycles: 0.4 ± 0.7. In group III, as in the initial 4 cycles, 0 + 0; in the final 4 cycles, 0.1 ± 0.4; and in the overall 8 cycles, 0.1 ± 0.4 was found.(Fig. 3 ) The mean incidence of thrombocytopenia of all grades was comparable among the 3 study groups, with 0.3 in group I,0.4 in group II, and 0.1 in group III for a total of 8 cycles of chemotherapy. There was no statistically significant difference in the mean incidence of thrombocytopenia among the 3 study groups. There was a statistically significant difference in the mean incidence of thrombocytopenia in the initial 4 cycles of chemotherapy among the 3 regimens. The pattern of the mean platelet count according to overall patient prechemotherapy and post-chemotherapy cycles is shown in Fig. 4 . The statistical analysis of the platelet count values was done using Wilcoxson signed rank test. There was a statistically significant difference between the pre-chemotherapy and post-chemotherapy platelet counts at 1–8 cycles(p value = 0.000). A comparison of the baseline platelet count before chemotherapy and after the fourth cycle of chemotherapy revealed that the post-8th cycle platelet count was significantly different, with a p-value of 0.000. Therefore, both the Adriamycin and cyclophosphamide regimens during the initial 4 cycles caused statistically significant changes in the PLT in the overall study population. In the final 4 cycles of chemotherapy, docetaxel or docetaxel + carboplatin and docetaxel + trastuzumab-based chemotherapy( i.e. docetaxel-based chemotherapy regimens) regimens caused changes in the platelet count in the overall study population. Among the three study groups, there was a statistically significant difference in the mean platelet count only during the initial 4 cycles of chemotherapy, but there was no statistically significant difference in the final 4 cycles or overall 8 cycles of chemotherapy. DISCUSSION Myelosuppression is a common adverse effect associated with breast cancer chemotherapy involving anthracyclines and taxanes( 4 ). A total of 124 breast cancer patients with an average mean age of 49 years and a mean body surface area of 1.6 m 2 were diagnosed with stage 1 to stage 3 disease and underwent 8 cycles of chemotherapy for a total of 992 cycles. GRADING OF ANAEMIA, THROMBOCYTOPENIA( 13 ): Definition Anemia: a disorder characterized by a reduction in the amount of hemoglobin in 100ml of blood. Symptoms of anemia may include pallor of the skin and mucous membrane, shortness of breath, palpitations of the heart, soft systolic murmurs, lethargy, and fatigue. Thrombocytopenia: A finding based on laboratory test results indicating a decrease in the number of platelets in blood specimens. Table 4 Grading Of Anemia, Thrombocytopenia-Common Terminology Criteria For Adverse Events- US, Department Of Health And Human Services Grade 0 Grade 1 Grade 2 Grade3 Grade4 Grade5 Hemoglobin Within normal <LLN-10 gm/dl 8.0-<10 gm/dl < 8 gm/dl, transfusion indicated Life-threatening complications and urgent intervention needed Death Platelet count <LLN-75,000/mm 3 < 75000 − 50000/mm 3 < 50000 − 25000/mm 3 < 25000/mm 3 - - The incidence of thrombocytopenia was as follows: Grade 1–4: 109 ( 10.9% ) episodes, 35 (3.5%) in Regimen I, and 37 (3.7%) in Regimen II and Regimen III. Among these, clinically relevant thrombocytopenia of grade 2 or grade 3 was identified as occurring in only 11 episodes overall, with Regimen I exhibiting 5 episodes, Regimen II exhibiting 4 episodes, and Regimen III exhibiting 2 episodes. Grade 3 thrombocytopenia with a count < 50000 cells/dl may be associated with complications and the chance of internal bleeding. Patients with Grade 3 thrombocytopenia may need platelet transfusion depending on the clinical scenario. The mean incidence was significantly greater for Regimen I. The incidence of thrombocytopenia in one study with an AC-T regimen was 1.6%, and that in another study with AC-T + Tr was 2.1%( 14 ). Overall 882 episodes (88.9%) of anemia (grade 1 or above) noticed in the study. Out of which 271 (27.4%) episodes in regimen I, 295(29.7%) episodes in regimen II, 316(31.8%)episodes in regimen III. Out of which clinically relevant episodes( grade 2 and above) anemia was noticed as described. In Regimen I the total incidence of grade 2 and above grade of anemia was 114 episodes(11.49%), similarly in Regimen II and III as 91 episodes(9.1%) and 112 episodes (11.29%) respectively. Regimens I, II, and III had 5,7,9 episodes of grade 3 anemia respectively. All these episodes are managed with blood transfusion. 2, 1 episode of grade 4 anemia occurred in regimens I and II respectively. These episodes were managed with blood transfusion and other supportive measures as may have serious life-threatening sequelae. In a study by Jeffrey et al., the overall incidence of anemia with an AC regimen was 40%( 15 ). In the initial 4 cycles, the incidence of anemia incidence was 424 episodes (42%), and the final 4 cycles as 469 episodes (47%). However, between the three regimens, there was no statistically significant difference in the mean incidence of anemia during the initial 4 cycles of chemotherapy, the final 4 cycles of chemotherapy or a total 8 cycles of chemotherapy. A systematic review of early triple-negative breast cancer patients receiving platinum-based chemotherapy by Manson SRE et al reported that more hematological toxicity occurred in the platinum group than in the control group, with a relative risk ratio of 8.2 and a 95% confidence interval of 5.66–11.86 out of 18 studies; additionally, 4757 patients and thrombocytopenia patients with a relative risk of 7.59 and 95% confidence interval of 5.10 to 11.29 were included in 18 studies with 4731 patients.( 16 ) A cross-sectional study reported by Leila Pourali et al. described the frequency of anemia induced by chemotherapy regimens in patients with breast cancer, in which the chance of developing anemia was greater in patients who received the 8-cycle AC + paclitaxel regimens than in those who received the 6 cycles of regimens or other chemotherapy regimens.( 17 ) CONCLUSION There was no statistically significant difference in the incidence of anemia among the 3 groups in the initial 4 chemotherapy cycles, final 4 chemotherapy cycles, or overall, 8 cycles of chemotherapy. There was a statistically significant difference in the mean incidence of thrombocytopenia during the initial 4 cycles of chemotherapy among the 3 regimens. However, after 8 cycles of chemotherapy, there was no statistically significant difference in the mean incidence of thrombocytopenia. There is a clear-cut pattern of decrease in Hb levels towards later cycles of chemotherapy due to the cumulative toxicity of chemotherapy regimens to the bone marrow. Abbreviations AC-T (adriamycin and cyclophosphamide followed by docetaxel) AC-T+C/Ca (adriamycin and cyclophosphamide followed by docetaxel and carboplatin) AC-T+Tr/T(adriamycin and cyclophosphamide followed by docetaxel and trastuzumab) HB PR RE1(mean value of hemoglobin pre-chemotherapy in Regimen 1 in 8 cycles) HB PO RE1(mean value of hemoglobin post-chemotherapy in Regimen 1 in 8 cycles) HB PR RE2(mean value of hemoglobin prechemotherapy in regimen 2 in 8 cycles) HB PO RE2(mean value of hemoglobin post-chemotherapy in Regimen 2 in 8 cycles) HB PR RE3(mean value of hemoglobin prechemotherapy in Regimen 3 in 8 cycles) HB P0 RE2(mean value of hemoglobin post-chemotherapy in Regimen 3 in 8 cycles) PLT PR RE1(mean value of platelet count prechemotherapy in Regimen 1 in 8 cycles) PLT PO RE1(mean platelet count post-chemotherapy in Regimen 1 in 8 cycles) PLT PRRE2(mean platelet count during prechemotherapy in Regimen 2 in 8 cycles) PLT PORE2(mean platelet count post- chemotherapy in Regimen 2 in 8 cycles) PLT PR RE3(mean value of platelet count prechemotherapy in Regimen 3 in 8 cycles) PLT PR RE3(mean platelet count post-chemotherapy in Regimen 3 in 8 cycles) TNBC- Triple-negative breast cancer Declarations Funding : No funding sources Conflict of interest : There are no conflicts of interest among the investigators. Data availability statement : The data that support the findings of this study are available from the corresponding author upon reasonable request. Ethical approval : The study was approved by the institutional ethics committee of the Government Medical College Kozhikode, and the patient was enrolled in the study after providing written informed consent. Authors' contributions : Prospective, open-label study patient enrollment, consent, and data documentation were provided by AS. The manuscript was prepared and written by AS, SM, and AT. Manuscript reviewed by AS, SM, AT, and AM. The final manuscript was approved by AS, SM, and AT. Acknowledgments: I would like to acknowledge Professor . Dr. Jeeja M Former Professor and head of the Department of Pharmacology, Government Medical College Idukki, presently Professor and Head of the Pharmacology department, MES Medical College Perinthalmanna, Dr. Jayakrishnan T Former Professor of Community Medicine Department Government Medical College Kozhikode To support the writing and suggestions for invaluable suggestions and unwavering support, which have greatly enriched the quality and depth of our study.We extend our heartfelt appreciation to Dr.Anoop Pratheesh P , Surgeon in Government Health Services, Kerala, and Dr. G. Krishnakumar , Physician and Intensivist at Dr. Govindans Hospital Thiruvananthapuram. Dr. Sneha Ambwani Professor and Head of the Pharmacology Department, AIIMS, Jodhpur, Dr. Shanthanu Munshi Professor and Head of Clinical Pharmacology School of Tropical Medicine Calcutta for constant support in preparing and publishing the manuscript. 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N Eng J Med 365:1273–1283 Kirshner J, Hatch M, Hennessy DD, Fridman M, Tannous RE (2004) Anemia in Stage II and Stage III Breast Cancer Patients Treated With Adjuvant Doxorubicin and Cyclophosphamide Chemotherapy. Oncologist 9:25–32 Mason SR, Willson ML, Egger SJ, Beith J, Dear RF, Goodwin A (2023) Platinum-based chemotherapy for early triple-negative breast cancer. Cochrane Database Syst Rev 9(9):CD014805 Pourali L, Taghizadeh A, Akhoundi MR, Varshoei F, Zarifian A, Sheikh Andalibi MS (2016) Frequency of Chemotherapy Induced Anemia in Breast Cancer Patients. Iran J Cancer Prev [Internet]. Sep 27 [cited 2024 Aug 4];In Press(In Press). https://brieflands.com/articles/ijcm-4672.html Additional Declarations The authors declare no competing interests. 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Mohamedali","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA7UlEQVRIiWNgGAWjYPCCAxDqAxCzsZOihXEGSAszKVqYecAkAbXy7c1HN/zccUfefNrhh59tfm2T52NmYPzwMQe3FoMzx9Ju9p55ZjjndpqxdG7fbcM2ZgZmyZnb8GiRyDG7wdt2mHGGdIIZc27PbUagFjZmXjxa5Oe//3bzb9th+xnS6d+YLXtu2xPUwnCDh+020JbEGdI5ZswMP24nEtRicCbN7LbsmcPJQC3Fkr0Nt5PbmBmb8fpFvv3ws5tvdxy2BTps44cff27bzm9vPvjhIz6HgQBjA4zRhsIlRgvDH8KKR8EoGAWjYOQBAH6IVl1OLlN+AAAAAElFTkSuQmCC","orcid":"","institution":"Government Medical college Kozhikode","correspondingAuthor":true,"prefix":"Dr","firstName":"Seema","middleName":"P.","lastName":"Mohamedali","suffix":""},{"id":337334422,"identity":"4fec5b2f-275e-4719-8e19-db638c97da87","order_by":2,"name":"Dr Ajay Kumar T","email":"","orcid":"","institution":"Government Medical college Kozhikode","correspondingAuthor":false,"prefix":"Dr","firstName":"Ajay","middleName":"Kumar","lastName":"T","suffix":""},{"id":337334423,"identity":"3d062821-71bf-4758-98c1-e93e1575ddae","order_by":3,"name":"Dr Anuradha M","email":"","orcid":"","institution":"Malabar Medical College, Ulliyeri, Kozhikode","correspondingAuthor":false,"prefix":"Dr","firstName":"Anuradha","middleName":"","lastName":"M","suffix":""}],"badges":[],"createdAt":"2024-08-07 17:07:11","currentVersionCode":1,"declarations":{"humanSubjects":true,"vertebrateSubjects":false,"conflictsOfInterestStatement":false,"humanSubjectEthicalGuidelines":true,"humanSubjectConsent":true,"humanSubjectClinicalTrial":false,"humanSubjectCaseReport":false,"vertebrateSubjectEthicalGuidelines":false},"doi":"10.21203/rs.3.rs-4876309/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4876309/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":62120952,"identity":"c817f25e-523e-4f96-ac27-54d3a0b8f497","added_by":"auto","created_at":"2024-08-09 13:55:43","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":15703,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eComparison of anemia in the initial 4th, final 4th and overall 8th cycles of chemotherapy among the 3 study groups\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-4876309/v1/6598e3a8b8bc902983e34751.png"},{"id":62121755,"identity":"d266df9a-94cc-40e7-8a97-45bde817722e","added_by":"auto","created_at":"2024-08-09 14:03:43","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":30526,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eComparison of the mean hemoglobin levels before and after chemotherapy among the 3 groups after all 8 cycles of chemotherapy.\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-4876309/v1/e200e64045a1b6198c972314.png"},{"id":62120953,"identity":"4b9eeaf3-c01f-4175-9f9d-74ea84f250f8","added_by":"auto","created_at":"2024-08-09 13:55:43","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":15269,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eComparison of thrombocytopenia among patients receiving different chemotherapy regimens\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"3.png","url":"https://assets-eu.researchsquare.com/files/rs-4876309/v1/81a7c5922de9ba5768fbb958.png"},{"id":62120957,"identity":"b84b1439-2c56-4ce1-82ae-90b2a889c9fe","added_by":"auto","created_at":"2024-08-09 13:55:43","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":29033,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eComparison of the mean pre-and post-chemotherapy platelet counts among the 3 groups after all 8 cycles of chemotherapy.\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"4.png","url":"https://assets-eu.researchsquare.com/files/rs-4876309/v1/7550bd38cfc6a6ca4d0a57a5.png"},{"id":62122510,"identity":"90263d15-dfee-40f0-8624-3ce806b45a52","added_by":"auto","created_at":"2024-08-09 14:11:43","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":898758,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4876309/v1/3692d2ac-74c2-4f78-955b-9c1a886fc7c3.pdf"}],"financialInterests":"The authors declare no competing interests.","formattedTitle":"\u003cp\u003e\u003cstrong\u003eIncidence of Anaemia and Thrombocytopenia Following Breast Cancer Chemotherapeutic Regimens AC-T, AC-T+ Ca, and AC-T+Tr IN in a Tertiary Care Center\u003c/strong\u003e\u003c/p\u003e","fulltext":[{"header":"INTRODUCTION","content":"\u003cp\u003eBreast cancer is a common cause of malignancy in the female population worldwide(\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e). It is a heterogeneous disease resulting from many factors, such as the progressive accumulation of genetic aberrations, including point mutations, chromosomal amplifications, deletions, rearrangements, and translocations(\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e). Treatment for breast cancer consists of multiple modalities, namely surgery, chemotherapy, radiation therapy, and biological therapy. Anthracycline-based chemotherapeutic regimens are commonly used(\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThree common regimens used for therapeutic purposes in breast cancer treatment are Adriamycin chemotherapy regimen and cyclophosphamide(AC), followed by docetaxel(AC-T) (Regimen I); AC, followed by docetaxel and carboplatin (AC-T\u0026thinsp;+\u0026thinsp;Carboplatin)(Regimen II) ; and AC followed by docetaxel and trastuzumab (AC-T\u0026thinsp;+\u0026thinsp;Tr) (Regimen III), which are administered to patients with stage 0 to stage 3 disease.\u003c/p\u003e \u003cp\u003eIn a phase 11 trial of docetaxel and carboplatin-based neoadjuvant chemotherapy for stage II/111 breast cancer, a differential response was observed, with the highest pCR rate achieved in patients with TNBC(\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e). The Hematological adverse drug reactions associated with anthracycline-based chemotherapy regimens include neutropenia, anemia, thrombocytopenia, and, rarely, leukemia(\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e, \u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e). Along with docetaxel and carboplatin regimens, more myelosuppression has been noted(\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e). When docetaxel is given in combination with doxorubicin, an increased incidence of myelosuppression and gastrointestinal side effects has been reported(\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e). Myelosuppression is a dose-limiting side effect. Myelosuppression is more severe and prolonged in patients with impaired renal function. Leukopenia, thrombocytopenia, and anemia occur in patients taking carboplatin(\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eAccording to a study involving 710 patients, myelosuppression was the dose-limiting toxicity of carboplatin, leukopenia occurred in 55% of patients, and leukopenia and thrombocytopenia resulted in symptomatic events such as infection and bleeding in a minority of patients. Anemia was frequent (59%) and required transfusion support in one-fifth of the patients(\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e). There is an increased incidence of leucopenia, thrombocytopenia, anemia, and febrile neutropenia when trastuzumab is given with chemotherapy, but it infrequently causes myelosuppression when used alone(\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eIn cyclophosphamide-containing chemotherapeutic regimens, the major dose-limiting side effect is myelosuppression. After a single dose, the white blood cell count may reach its nadir within approximately 1\u0026ndash;2 weeks, and full recovery usually occurs within approximately 3\u0026ndash;4 weeks. Thrombocytopenia and anemia may occur but tend to be less common and less severe(\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e).\u003c/p\u003e"},{"header":"METHODS","content":"\u003cp\u003eThis study aimed to analyze the incidence of anemia and thrombocytopenia among patients treated with three chemotherapeutic regimens for breast cancer in a tertiary care center. In Regimens I, II, and III, patients were treated with an initial 4 cycles of AC followed by the next 4 cycles of docetaxel, docetaxel\u0026thinsp;+\u0026thinsp;carboplatin, and docetaxel\u0026thinsp;+\u0026thinsp;trastuzumab respectively. All patients received prophylactic pegfilgrastim and filgrastim for treatment in the oncology department of a tertiary care center. The incidence of anemia and thrombocytopenia following chemotherapy was measured by recording hemoglobin and platelet count on the 7th day after chemotherapy as a routine procedure. The Case report form was entered regularly in a structured format throughout the study period. The present study included a prospective open-label comparative cohort. The study was initiated only after ethical committee approval was obtained from the institution. The duration of the study ranged from January 2016 to January 2017. A total of 41 patients were enrolled in each study arm.\u003c/p\u003e \u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eIt is calculated by the formula\u003c/h2\u003e \u003cp\u003eN\u0026thinsp;=\u0026thinsp;2 pq (Zcrit\u0026thinsp;+\u0026thinsp;Zpwr) 2/D\u003c/p\u003e \u003cp\u003e \u003cb\u003eInclusion criteria\u003c/b\u003e \u003c/p\u003e \u003cp\u003e \u003col\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003ePatients with normal cognition\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003ePatients with breast malignancies aged 18\u0026ndash;65 years and with stage 1\u0026ndash;3 disease\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eG-CSF support was obtained (Pegfilgrastim/Filgrastim).\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eAbsolute neutrophil count\u0026thinsp;\u0026gt;\u0026thinsp;1.5x109/l\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003ePlatelet count\u0026thinsp;\u0026gt;\u0026thinsp;100x109/l\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eSerum creatinine\u0026thinsp;\u0026lt;\u0026thinsp;2\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eSerum total bilirubin\u0026thinsp;\u0026lt;\u0026thinsp;1.5 times the upper limit of normal\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003c/ol\u003e \u003c/p\u003e \u003cp\u003e \u003cb\u003eExclusion criteria\u003c/b\u003e \u003c/p\u003e \u003cp\u003e \u003col\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eStage 4 metastatic patients\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eConcurrent other malignancies\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eCardiac failure, and myocardial infarction in the past 1 year\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003e Pregnancy and Nursing population\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003ePrior bone marrow transplantation or stem cell therapy\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003c/ol\u003e \u003c/p\u003e \u003cp\u003e Written informed consent was obtained from all the study subjects before starting the study in the vernacular language.\u003c/p\u003e \u003cp\u003e \u003cstrong\u003eStudy procedure\u003c/strong\u003e \u003cp\u003eAfter screening, patients who fulfilled the inclusion criteria were enrolled in the study. Patients were divided into three groups, patients who underwent chemotherapy regimen I, patients who received chemotherapy regimen II, and patients who received chemotherapy regimen III. AC was followed by docetaxel in regimen I. AC was followed by docetaxel and carboplatin in regimen II. AC followed by docetaxel and trastuzumab in regimen III. A total of 132 patients were screened for the study, and those who satisfied the inclusion criteria were included in the study. Forty-two patients received regimen I,42 patients received regimen II, and 48 patients in the third group received regimen III. In Regimen I, 4 patients were included, and in Regimen II and III, 2 patients each dropped out of the study; hence, Regimen I included 38 patients, Regimen II 40 patients, and Regimen III included 46 patients for final statistical analysis.\u003c/p\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eDosage and administration\u003c/h2\u003e \u003cdiv id=\"Sec5\" class=\"Section3\"\u003e \u003ch2\u003eAC-docetaxel regimen\u003c/h2\u003e \u003cp\u003eThe initial regimen consisted of 4 cycles of doxorubicin (60 mg/m2) and cyclophosphamide (600mg/m2) every 3 weeks, followed by a final of 4 cycles of docetaxel (100mg/m\u003csup\u003e2\u003c/sup\u003e) every 3 weeks(\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e).\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eAC-docetaxel and carboplatin regimen\u003c/h2\u003e \u003cp\u003eThe initial regimen consisted of 4 cycles of doxorubicin (60 mg/m2) and cyclophosphamide (600mg/m2) every 3 weeks, and the final regimen consisted of 4 cycles of chemotherapy combined with carboplatin and docetaxel. Carboplatin dose: AUC of 6 intravenously on day 1. Docetaxel: 75 mg/m2 intravenously on day 1. Each chemotherapy cycle was repeated every 21 days(\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003eAC-docetaxel and trastuzumab regimen\u003c/h2\u003e \u003cp\u003eThe initial 4-cycle AC regimen was followed by a final 4-cycle chemotherapy regimen comprising docetaxel and trastuzumab. The docetaxel dose was 75 mg/m2 intravenously on day 1, the trastuzumab dose was 4 mg/kg intravenously, and the dose was subsequently 2 mg/kg intravenously weekly. Chemotherapy was repeated every 21 days for a total of 8 cycles(\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eDosage of Peg filgrastim/Filgrastim for neutropenia associated with myelosuppressive chemotherapy:\u003c/h2\u003e \u003cp\u003eSubcutaneous administration of 5 mcg/kg/day is preferred over the intravenous route until the absolute neutrophil count is 2\u0026ndash;3 x 109/mcl or for up to 14 days. Pegylated filgrastim was administered (6 mg) subcutaneously once per chemotherapy cycle.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003eOUTCOME ASSESSMENT\u003c/h2\u003e \u003cp\u003eEstablished number of patients with anemia and thrombocytopenia of all grades documented and recorded in the prescribed format for assessment during the 8 cycles of chemotherapy before and after chemotherapy for evaluating the different grades of chemotherapy-induced anemia and thrombocytopenia\u003c/p\u003e \u003cp\u003e \u003cstrong\u003eStatistical analysis\u003c/strong\u003e \u003cp\u003eStatistical analysis was performed using Statistical Package for Social Science (SPSS) software version 22. For quantitative data with non-normal distribution used Kruskal-Wallis test, and descriptive statistics with mean, and standard deviation were used for the representation of the baseline and demographic data. Wilcoxon signed-rank test for the paired comparison of the non-normally distributed quantitative data.\u003c/p\u003e \u003c/p\u003e \u003c/div\u003e"},{"header":"RESULTS","content":"\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eBaseline demographic features:\u003c/h2\u003e \u003cp\u003eThe mean age of the patients was 49.06+/-8.6 years(standard deviation), the minimum age was 26 years, the maximum age was 65 years, the body surface area was 1.58 m\u003csup\u003e2\u003c/sup\u003e +/- 0.14(SD), the mean baseline hemoglobin level was 11.95 gm/dl +/- 1.36(SD), and the mean baseline platelet count was 3.21lak/dl+/-0.09 (SD) in the overall study population. Twenty- five percent of patients received neoadjuvant treatment and 75% received adjuvant treatment.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eIncidence of anemia in patients receiving different chemotherapy regimens:\u003c/h2\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003e\u003cb\u003eThe pattern of incidence of patient-wise anemia and the cycle of chemotherapy-wise anemia and thrombocytopenia of Grade 2 and above in three different regimens of breast cancer\u003c/b\u003e \u003cspan type=\"BoldItalicUnderline\" class=\"BoldItalicUnderline\" name=\"Emphasis\"\u003ePattern of distribution of anemia\u003c/span\u003e: \u003cb\u003e882\u003c/b\u003e (88.9%) episodes of anemia(all grades) out of a total of 992 cycles of chemotherapy were observed. Twenty-seven patients groups I and II, and 31 patients in group III had at least one episode of anemia (grade 2 or above) during their chemotherapy cycles (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). Overall, 293 episodes were Grade 2, 21 episodes were Grade 3, and 3 episodes were Grade 4 anemia among the 3 study groups \u003cb\u003e(\u003c/b\u003eTables\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e, \u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e\u003cb\u003e)\u003c/b\u003e.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eAdverse Drug Effects\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eRegimens\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003ePatient Wise Incidence\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003eCycle Of Chemotherapy Wise(Overall) Incidence\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eFrequency- No Of Patients (Percentage-%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eFrequency-No Of Episodes(Percentage %)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eMean Incidence/8 Cycles\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003e\u003cb\u003eAnemia(Grade 2 And Above)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eREG I\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e27(71)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e114(37.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cem\u003e3.11\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eREG II\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e27(68)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e91(28.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cem\u003e2.38\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eREG III\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e31(67)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e112(30.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cem\u003e2.7\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003e\u003cb\u003eThrombocytopenia(Grade 2 And Above)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eREG I\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e6(\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e5(1.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cem\u003e0.16\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eREGII\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5(\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e4(1.25)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cem\u003e0.12\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eREGIII\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1(\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2(0.005)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cem\u003e0.04\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eDistribution of different grades of anemia in the 3 study groups according to the initial 4, final 4, and overall 8 cycles of chemotherapy.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eREG\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eGRADE ANEMIA\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eINITIAL 4\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eFINAL4\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eTOTAL8\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"3\" rowspan=\"4\"\u003e \u003cp\u003eAC-T\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eGrade1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e87\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e70\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e157\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eGrade2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e38\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e69\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e107\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eGrade3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e2\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e3\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e\u003cb\u003e5\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eGrade4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e2\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e0\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e\u003cb\u003e2\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"3\" rowspan=\"4\"\u003e \u003cp\u003eAC-T\u0026thinsp;+\u0026thinsp;C\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eGrade1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e113\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e91\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e204\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eGrade2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e24\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e59\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e83\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eGrade3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e3\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e4\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e\u003cb\u003e7\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eGrade4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e0\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e1\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e\u003cb\u003e1\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"3\" rowspan=\"4\"\u003e \u003cp\u003eAC-T\u0026thinsp;+\u0026thinsp;T\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eGrade1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e110\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e104\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e204\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eGrade2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e42\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e61\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e103\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eGrade3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e2\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e7\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e\u003cb\u003e9\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eGrade4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e0\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e0\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e\u003cb\u003e0\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eThe mean incidence of anemia in group I in the initial 4 cycles was 3.4+/-1.1; in the final 4 cycles, 3.\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e7+/-\u003c/span\u003e 0.6; and in the overall 8 cycles, \u003cb\u003e7.1+/- 1.5\u003c/b\u003e. In group II, as in the initial 4 cycles: 3.5\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;0.8; in the final 4 cycles:3.9\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;0.4, and in the overall 8 cycles:\u003cb\u003e7.4\u003c/b\u003e\u0026thinsp;\u003cspan type=\"BoldUnderline\" class=\"BoldUnderline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;\u003cb\u003e1.1\u003c/b\u003e. In group III, as in the initial 4 cycles: 3.3\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;1; in the final 4 cycles: 3.7\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;0.6; and in the overall 8 cycles:\u003cb\u003e7.1\u003c/b\u003e\u0026thinsp;\u003cspan type=\"BoldUnderline\" class=\"BoldUnderline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;\u003cb\u003e1.5\u003c/b\u003e. (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e,\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e \u003cb\u003e\u0026amp;\u003c/b\u003e Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e)\u003c/p\u003e \u003cp\u003eThe mean incidence of all grades of anemia was comparable among the 3 study groups, with a mean incidence of 7.1 in group I, 7.4 in group II, and 7.1 in group III after 8 cycles of chemotherapy. There was no statistically significant difference in the mean incidence of anemia among the 3 study groups.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eBy reviewing the incidences and grades of anemia in these 124 patients, it can be clearly inferred that the incidence of anemia is greater during chemotherapy cycles. This can be attributed to the cumulative toxicity of the chemotherapy regimens to the patient's bone marrow. Figure\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e clearly shows the pattern of the decrease in Hb in the patients after each chemotherapy cycle. hemoglobin levels are presented as the mean values of hemoglobin prechemotherapy and post-chemotherapy. On analysis, there was a statistically significant difference in the prechemotherapy and post-chemotherapy hemoglobin levels, with a p-value of 0.000 for each chemotherapy cycle from cycle 1 to cycle 8. There were also significant differences in baseline hemoglobin levels and prechemotherapy 4th cycle hemoglobin levels; baseline hemoglobin levels and post-chemotherapy 4th cycle hemoglobin levels; baseline hemoglobin levels and prechemotherapy 8th cycle hemoglobin levels; and post-chemotherapy 8th cycle hemoglobin levels. The p-value of these comparisons was 0.000.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eThe pattern of distribution of thrombocytopenia in patients receiving three regimens of chemotherapy\u003c/h2\u003e \u003cp\u003eA total of 109 episodes of thrombocytopenia out of 992 cycles of chemotherapy (10.9%) were observed. In the initial 4 cycles of chemotherapy, 44 episodes occurred, and in the final 4 cycles, 65 episodes occurred during the overall chemotherapy cycles. Grade 2 or above thrombocytopenia resulting from at least one episode during the treatment period was reported in 6 patients in group I, 5 patients in group II, and 1 patient in group III. Of the total thrombocytopenia grades 2 and above, only 6 episodes in group I, 5 episodes in group II, and 2 episodes in group III were noted. (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e. \u003cb\u003eIn addition 4)\u003c/b\u003e\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eDistribution of Thrombocytopenia Grade among the 3 groups according to initial 4, final 4, and overall 8 cycles of chemotherapy\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eReg\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eGrade THP\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eInitial 4\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eFinal4\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eTotal8\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"3\" rowspan=\"4\"\u003e \u003cp\u003eAC-T\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eGrade1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e17\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e13\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e30\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eGrade2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eGrade3\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e1\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e0\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e\u003cb\u003e1\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eGrade4\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e0\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e0\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e\u003cb\u003e0\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"3\" rowspan=\"4\"\u003e \u003cp\u003eAC-T\u0026thinsp;+\u0026thinsp;C\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eGrade1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e26\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e33\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eGrade2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eGrade3\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e0\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e0\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e\u003cb\u003e0\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eGrade4\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e0\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e0\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e\u003cb\u003e0\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"3\" rowspan=\"4\"\u003e \u003cp\u003eAC-T\u0026thinsp;+\u0026thinsp;T\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eGrade1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e13\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e22\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e35\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eGrade2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eGrade3\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e0\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e0\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e\u003cb\u003e0\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eGrade4\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e0\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e0\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e\u003cb\u003e0\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eThe mean incidence of thrombocytopenia in group I in the initial 4 cycles was 0.1+/- 0.5; in the final 4 cycles, 0.2+/- 0.6; and in the overall 8 cycles, 0.3+/-0.1. In group II, as in the initial 4 cycles:0.1+/-0.3; in the final 4 cycles:0.3\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;0.6; and in the overall 8 cycles: 0.4\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;0.7. In group III, as in the initial 4 cycles, 0\u0026thinsp;+\u0026thinsp;0; in the final 4 cycles, 0.1\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;0.4; and in the overall 8 cycles, 0.1\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;0.4 was found.(Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003e)\u003c/p\u003e \u003cp\u003eThe mean incidence of thrombocytopenia of all grades was comparable among the 3 study groups, with 0.3 in group I,0.4 in group II, and 0.1 in group III for a total of 8 cycles of chemotherapy. There was no statistically significant difference in the mean incidence of thrombocytopenia among the 3 study groups. There was a statistically significant difference in the mean incidence of thrombocytopenia in the \u003cb\u003einitial 4 cycles\u003c/b\u003e of chemotherapy among the 3 regimens.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eThe pattern of the mean platelet count according to overall patient prechemotherapy and post-chemotherapy cycles is shown in Fig.\u0026nbsp;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e4\u003c/span\u003e. The statistical analysis of the platelet count values was done using Wilcoxson signed rank test. There was a statistically significant difference between the pre-chemotherapy and post-chemotherapy platelet counts at 1\u0026ndash;8 cycles(p value\u0026thinsp;=\u0026thinsp;0.000). A comparison of the baseline platelet count before chemotherapy and after the fourth cycle of chemotherapy revealed that the post-8th cycle platelet count was significantly different, with a p-value of 0.000. Therefore, both the Adriamycin and cyclophosphamide regimens during the initial 4 cycles caused statistically significant changes in the PLT in the overall study population. In the final 4 cycles of chemotherapy, docetaxel or docetaxel\u0026thinsp;+\u0026thinsp;carboplatin and docetaxel\u0026thinsp;+\u0026thinsp;trastuzumab-based chemotherapy( i.e. docetaxel-based chemotherapy regimens) regimens caused changes in the platelet count in the overall study population.\u003c/p\u003e \u003cp\u003eAmong the three study groups, there was a statistically significant difference in the mean platelet count only during the initial 4 cycles of chemotherapy, but there was no statistically significant difference in the final 4 cycles or overall 8 cycles of chemotherapy.\u003c/p\u003e \u003c/div\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eMyelosuppression is a common adverse effect associated with breast cancer chemotherapy involving anthracyclines and taxanes(\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e). A total of 124 breast cancer patients with an average mean age of 49 years and a mean body surface area of 1.6 m\u003csup\u003e2\u003c/sup\u003e were diagnosed with stage 1 to stage 3 disease and underwent 8 cycles of chemotherapy for a total of 992 cycles.\u003c/p\u003e \u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003eGRADING OF ANAEMIA, THROMBOCYTOPENIA(\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e):\u003c/h2\u003e \u003cp\u003e \u003cstrong\u003eDefinition\u003c/strong\u003e \u003cp\u003eAnemia: a disorder characterized by a reduction in the amount of hemoglobin in 100ml of blood. Symptoms of anemia may include pallor of the skin and mucous membrane, shortness of breath, palpitations of the heart, soft systolic murmurs, lethargy, and fatigue.\u003c/p\u003e \u003c/p\u003e \u003cp\u003eThrombocytopenia: A finding based on laboratory test results indicating a decrease in the number of platelets in blood specimens.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\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\u003eGrading Of Anemia, Thrombocytopenia-Common Terminology Criteria For Adverse Events- US, Department Of Health And Human Services\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"7\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eGrade 0\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eGrade 1\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eGrade 2\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eGrade3\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eGrade4\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003eGrade5\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHemoglobin\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eWithin normal\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u0026lt;LLN-10 gm/dl\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e8.0-\u0026lt;10 gm/dl\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;8 gm/dl, transfusion indicated\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eLife-threatening complications and urgent intervention needed\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eDeath\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePlatelet count\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026lt;LLN-75,000/mm\u003csup\u003e3\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;75000\u0026thinsp;\u0026minus;\u0026thinsp;50000/mm\u003csup\u003e3\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;50000\u0026thinsp;\u0026minus;\u0026thinsp;25000/mm\u003csup\u003e3\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;25000/mm\u003csup\u003e3\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eThe incidence of thrombocytopenia was as follows: Grade 1\u0026ndash;4: 109 (\u003cb\u003e10.9%\u003c/b\u003e) episodes, 35 (3.5%) in Regimen I, and 37 (3.7%) in Regimen II and Regimen III. Among these, clinically relevant thrombocytopenia of grade 2 or grade 3 was identified as occurring in only 11 episodes overall, with Regimen I exhibiting 5 episodes, Regimen II exhibiting 4 episodes, and Regimen III exhibiting 2 episodes. Grade 3 thrombocytopenia with a count\u0026thinsp;\u0026lt;\u0026thinsp;50000 cells/dl may be associated with complications and the chance of internal bleeding. Patients with Grade 3 thrombocytopenia may need platelet transfusion depending on the clinical scenario. The mean incidence was significantly greater for Regimen I. The incidence of thrombocytopenia in one study with an AC-T regimen was 1.6%, and that in another study with AC-T\u0026thinsp;+\u0026thinsp;Tr was 2.1%(\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eOverall 882 episodes (88.9%) of anemia (grade 1 or above) noticed in the study. Out of which 271 (27.4%) episodes in regimen I, 295(29.7%) episodes in regimen II, 316(31.8%)episodes in regimen III.\u003c/p\u003e \u003cp\u003eOut of which clinically relevant episodes( grade 2 and above) anemia was noticed as described. In Regimen I the total incidence of grade 2 and above grade of anemia was 114 episodes(11.49%), similarly in Regimen II and III as 91 episodes(9.1%) and 112 episodes (11.29%) respectively.\u003c/p\u003e \u003cp\u003eRegimens I, II, and III had 5,7,9 episodes of grade 3 anemia respectively. All these episodes are managed with blood transfusion. 2, 1 episode of grade 4 anemia occurred in regimens I and II respectively. These episodes were managed with blood transfusion and other supportive measures as may have serious life-threatening sequelae.\u003c/p\u003e \u003cp\u003eIn a study by Jeffrey et al., the overall incidence of anemia with an AC regimen was 40%(\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e). In the initial 4 cycles, the incidence of anemia incidence was 424 episodes (42%), and the final 4 cycles as 469 episodes (47%). However, between the three regimens, there was no statistically significant difference in the mean incidence of anemia during the initial 4 cycles of chemotherapy, the final 4 cycles of chemotherapy or a total 8 cycles of chemotherapy.\u003c/p\u003e \u003cp\u003eA systematic review of early triple-negative breast cancer patients receiving platinum-based chemotherapy by Manson SRE et al reported that more hematological toxicity occurred in the platinum group than in the control group, with a relative risk ratio of 8.2 and a 95% confidence interval of 5.66\u0026ndash;11.86 out of 18 studies; additionally, 4757 patients and thrombocytopenia patients with a relative risk of 7.59 and 95% confidence interval of 5.10 to 11.29 were included in 18 studies with 4731 patients.(\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e) A cross-sectional study reported by Leila Pourali et al. described the frequency of anemia induced by chemotherapy regimens in patients with breast cancer, in which the chance of developing anemia was greater in patients who received the 8-cycle AC\u0026thinsp;+\u0026thinsp;paclitaxel regimens than in those who received the 6 cycles of regimens or other chemotherapy regimens.(\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e)\u003c/p\u003e \u003c/div\u003e"},{"header":"CONCLUSION","content":"\u003cp\u003eThere was no statistically significant difference in the incidence of anemia among the 3 groups in the initial 4 chemotherapy cycles, final 4 chemotherapy cycles, or overall, 8 cycles of chemotherapy. There was a statistically significant difference in the mean incidence of thrombocytopenia during the initial 4 cycles of chemotherapy among the 3 regimens. However, after 8 cycles of chemotherapy, there was no statistically significant difference in the mean incidence of thrombocytopenia. There is a clear-cut pattern of decrease in Hb levels towards later cycles of chemotherapy due to the cumulative toxicity of chemotherapy regimens to the bone marrow.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003col\u003e\n \u003cli\u003eAC-T (adriamycin and cyclophosphamide followed by docetaxel)\u003c/li\u003e\n \u003cli\u003eAC-T+C/Ca (adriamycin and cyclophosphamide followed by docetaxel and carboplatin)\u003c/li\u003e\n \u003cli\u003eAC-T+Tr/T(adriamycin and cyclophosphamide followed by docetaxel and trastuzumab)\u003c/li\u003e\n \u003cli\u003eHB PR RE1(mean value of hemoglobin pre-chemotherapy in Regimen 1 in 8 cycles)\u003c/li\u003e\n \u003cli\u003eHB PO RE1(mean value of hemoglobin post-chemotherapy in Regimen 1 in 8 cycles)\u003c/li\u003e\n \u003cli\u003eHB PR RE2(mean value of hemoglobin prechemotherapy in regimen 2 in 8 cycles)\u003c/li\u003e\n \u003cli\u003eHB PO RE2(mean value of hemoglobin post-chemotherapy in Regimen 2 in 8 cycles)\u003c/li\u003e\n \u003cli\u003eHB PR RE3(mean value of hemoglobin prechemotherapy in Regimen 3 in 8 cycles)\u003c/li\u003e\n \u003cli\u003eHB P0 RE2(mean value of hemoglobin post-chemotherapy in Regimen 3 in 8 cycles)\u003c/li\u003e\n \u003cli\u003ePLT PR RE1(mean value of platelet count prechemotherapy in Regimen 1 in 8 cycles)\u003c/li\u003e\n \u003cli\u003ePLT PO RE1(mean platelet count post-chemotherapy in Regimen 1 in 8 cycles)\u003c/li\u003e\n \u003cli\u003ePLT PRRE2(mean platelet count during prechemotherapy in Regimen 2 in 8 cycles)\u003c/li\u003e\n \u003cli\u003ePLT PORE2(mean platelet count post- chemotherapy in Regimen 2 in 8 cycles)\u003c/li\u003e\n \u003cli\u003ePLT PR RE3(mean value of platelet count prechemotherapy in Regimen 3 in 8 cycles)\u003c/li\u003e\n \u003cli\u003ePLT PR RE3(mean platelet count post-chemotherapy in Regimen 3 in 8 cycles)\u003c/li\u003e\n \u003cli\u003e\u003cstrong\u003eTNBC-\u0026nbsp;\u003c/strong\u003eTriple-negative breast cancer\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003e\u003cem\u003eFunding\u003c/em\u003e\u003c/strong\u003e\u003cem\u003e: No funding sources\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConflict of interest\u003c/strong\u003e: There are no conflicts of interest among the investigators.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData availability statement\u003c/strong\u003e:\u0026nbsp;The data that support the findings of this study are available from the corresponding author upon reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthical approval\u003c/strong\u003e: The study was approved by the institutional ethics committee of the Government Medical College Kozhikode, and the patient was enrolled in the study after providing written informed consent.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026apos; contributions\u003c/strong\u003e\u003cstrong\u003e:\u0026nbsp;\u003c/strong\u003eProspective, open-label study patient enrollment, consent, and data documentation were provided by AS. The manuscript was prepared and written by AS, SM, and \u0026nbsp;AT. Manuscript reviewed by AS, SM, AT, and AM. The final manuscript was approved by AS, SM, and AT.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgments:\u0026nbsp;\u003c/strong\u003eI would like to acknowledge Professor\u003cstrong\u003e. Dr. Jeeja M\u003c/strong\u003e Former Professor and head of the Department of Pharmacology, Government Medical College Idukki, presently Professor and Head of the Pharmacology department, \u0026nbsp;MES Medical College Perinthalmanna, \u003cstrong\u003eDr. Jayakrishnan T\u003c/strong\u003e Former Professor of Community Medicine Department Government Medical College Kozhikode To support the writing and suggestions for invaluable suggestions and unwavering support, which have greatly enriched the quality and depth of our study.We extend our heartfelt appreciation to \u003cstrong\u003eDr.Anoop Pratheesh P\u003c/strong\u003e, Surgeon in Government Health Services, Kerala, and \u003cstrong\u003eDr. G. Krishnakumar\u003c/strong\u003e, Physician and Intensivist at Dr. Govindans Hospital Thiruvananthapuram. \u003cstrong\u003eDr. Sneha Ambwani\u003c/strong\u003e Professor and Head of the Pharmacology Department, AIIMS, Jodhpur, \u003cstrong\u003eDr. Shanthanu Munshi\u003c/strong\u003e Professor and Head of Clinical Pharmacology School of Tropical Medicine Calcutta for constant support in preparing and publishing the manuscript.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eBurstein HJ, Harris JR (2011) Morrow Monica.Malignant tumors of the breast. In: Vincent T.Devitha, Hellman, Steven A Rosenberg; Cancer principles and practice of oncology, 9th edition, Philadelphia, Wolters kluwer/Lippincott and Wilkins 106:1401-44\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHofstatter EW, Chung GG, Harris LN (2011) Molecular biology of breast cancer. In:Vincent T.Devitha, Hellman, Steven A Rosenberg; Cancer principles and practice of oncology, 9th edition, Philadelphia, Wolters kluwer/Lippincott and Wilkins. 105:1392\u0026ndash;1400\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChang HR, Glaspy J, Allison MA, Kass FC, Elashoff R, Chung DU et al (2010) Differential response of triple negative breast cancer to a Docetaxel and Carboplatin based neoadjuvant treatment. Cancer 116:4227\u0026ndash;4237\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCrawford J, Ozer H, Stoller R, Johnson D, Lyman G, Tabbara I et al (1991) Reduction by granulocyte colony-stimulating factor of fever and neutropenia induced by chemotherapy in patients with small cell lung cancer N. Eng J Med 325:164\u0026ndash;170\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTew KD, Reed E, Saif WM, Chu E, Abu-Khalaf MM, Harris LN. Pharmacology of Cancer therapeutics/chemotherapeutic agents In: Vincent T.Devitha, Hellman, Steven A (2011) Rosenberg; Cancer principles and practice of oncology, 9th edition, Philadelphia, Wolters kluwer/Lippincott and Wilkins 4(1):375\u0026ndash;420\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSean l Sweetman Pauls Blake Martindale: The complete drug reference,thirty sixth edition,Lambeth high street, London SEI 75 N 100 South Atkinson road, suite 200 Grays lake, USA, 2009.1: 661\u0026thinsp;\u0026ndash;\u0026thinsp;62,693\u0026thinsp;\u0026ndash;\u0026thinsp;94,702\u0026thinsp;\u0026ndash;\u0026thinsp;15.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSlamon D, Eiermann W, Robert N, Pienkowski T, Martin M, Press M et al (2011) Adjuvant Trastuzumab in HER2-Positive Breast cancer. N Eng J Med 365:1273\u0026ndash;1283\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNiederhuber JE, Armitage JO, Joel E, Tepper et al (eds) Abeloff\u0026rsquo;s clinical oncology,fifth edition, Philadelphia, PA, Elsevier Saunders,2014.29: 434\u0026ndash;484,91:1630\u0026ndash;1691\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKardinal GC, Bobba RK, Cole JT (2012) Breast Cancer. In: Michael CP, Donald C.Doll, Carl E.Freter (ed) Perry\u0026rsquo;s The Chemotherapy source book, fifth edition, vol 32. Wolters Kluwer/Lippincott Williams \u0026amp;Wilkins, Philadelphia, pp 401\u0026ndash;435\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCarl MCPDCD E.Freter (ed) (2012) 32:669\u0026ndash;735,758\u0026thinsp;\u0026ndash;\u0026thinsp;62\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eEdward Chu VTD, .Jr Physicians cancer chemotherapy drug manual, 1st Indian edition, Wall Street Burlington, Jones and Bartett learning 2013.442-49\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCanetta R, Rozencweig M, Carter SK (1985) Carboplatin: The clinical spectrum to date. Cancer Treat Rev 12(suppl A):125\u0026ndash;136\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCommon terminology criteria for adverse drug event (CTCAE) version 4.0, published on May 28 2009, US department of health and human services, National institute of health, national institute of cancer\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSlamon D, Eiermann W, Robert N, Pienkowski T, Martin M, Press M et al (2011) Adjuvant Trastuzumab in HER2-Positive Breast cancer. N Eng J Med 365:1273\u0026ndash;1283\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKirshner J, Hatch M, Hennessy DD, Fridman M, Tannous RE (2004) Anemia in Stage II and Stage III Breast Cancer Patients Treated With Adjuvant Doxorubicin and Cyclophosphamide Chemotherapy. Oncologist 9:25\u0026ndash;32\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMason SR, Willson ML, Egger SJ, Beith J, Dear RF, Goodwin A (2023) Platinum-based chemotherapy for early triple-negative breast cancer. Cochrane Database Syst Rev 9(9):CD014805\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePourali L, Taghizadeh A, Akhoundi MR, Varshoei F, Zarifian A, Sheikh Andalibi MS (2016) Frequency of Chemotherapy Induced Anemia in Breast Cancer Patients. Iran J Cancer Prev [Internet]. Sep 27 [cited 2024 Aug 4];In Press(In Press). \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://brieflands.com/articles/ijcm-4672.html\u003c/span\u003e\u003cspan address=\"https://brieflands.com/articles/ijcm-4672.html\" targettype=\"URL\" 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":true,"hideJournal":true,"highlight":"","institution":"Government medical college , Kozhikode, kerala","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":"Anemia, Thrombocytopenia, Adriamycin, Chemotherapy, Breast Cancer","lastPublishedDoi":"10.21203/rs.3.rs-4876309/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4876309/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBACKGROUND\u003c/strong\u003e: In breast cancer, the most common regimen used for the neoadjuvant and adjuvant nonmetastatic setting is 4 cycles of adriamycin and cyclophosphamide followed by docetaxel, docetaxel + trastuzumab, docetaxel, and carboplatin. (1)\u003c/p\u003e\n\u003cp\u003ePatients with breast cancer were treated with three different chemotherapeutic regimens, namely, AC-T (adriamycin and cyclophosphamide followed by docetaxel) regimen I, AC-T+Ca (adriamycin and cyclophosphamide followed by docetaxel and carboplatin) regimen II, and AC-T+Tr (adriamycin and cyclophosphamide followed by docetaxel and trastuzumab) regimen III, at a tertiary care hospital. Of these, myelosuppression was the major concern in treatment follow-ups. Here, I reviewed the incidence and management of anemia during the post-chemotherapy period.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMETHODS: \u003c/strong\u003eA prospective open-label observational comparative study was performed to evaluate the incidence of anemia and thrombocytopenia among three regimens, namely, the chemotherapy regimen AC-T, Regimen II AC-T+Ca, and Regimen III AC-T+Tr. All enrolled patients received pegfilgrastim/filgrastim prophylactically or as a part of the case of myelosuppression. The regimen I enrolled and completed a study of 38 patients, regimen II 40 patients, and regimen III 46 patients. All patients were subjected to statistical analysis using SPSS.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRESULTS: A total of \u003c/strong\u003e882 (88.9%) episodes of anemia (all grades) were observed among a total of 992 cycles of chemotherapy. Twenty-seven patients in Regimen I and II and 31 patients in Regimen III had at least one episode of anemia (grade 2 or above) during their chemotherapy cycles. Overall, 293 episodes were Grade 2, 21 episodes were Grade 3, and 3 episodes were Grade 4 anemia among the 3 study regimens. The mean incidence of anemia in regimen I in the initial 4 cycles was 3.4+/- 1.1, in the final 4 cycles, it was 3.\u003cu\u003e7± \u003c/u\u003e0.6, and in the overall 8 cycles was 7.\u003cu\u003e1±\u003c/u\u003e 1.5. In regimen II, as in the initial 4 cycles:3.5\u003cu\u003e+\u003c/u\u003e0.8, in the final 4 cycles: 3.9\u003cu\u003e+\u003c/u\u003e0.4, and in the overall 8 cycles:7.4\u003cu\u003e+\u003c/u\u003e1.1. In regimen III, as in the initial 4 cycles: 3.3\u003cu\u003e+\u003c/u\u003e1; in the final 4 cycles: 3.7\u003cu\u003e+ \u003c/u\u003e0.6; and in the overall 8 cycles: 7.1\u003cu\u003e+\u003c/u\u003e1.5. The mean incidence of all grades of anemia was comparable among the 3 study regimens, with a mean incidence of 7.1 in regimen I, 7.4 in regimen II, and 7.1 in regimen III over 8 cycles of chemotherapy. There was no statistically significant difference in the mean incidence of anemia among the 3 study groups.\u003c/p\u003e\n\u003cp\u003eA total of 109 episodes of thrombocytopenia out of 992 cycles of chemotherapy (10.9%) were observed. In the initial 4 cycles of chemotherapy, 44 episodes occurred, and in the final 4 cycles, 65 episodes occurred\u003cstrong\u003e. \u003c/strong\u003eGrade 2 or above thrombocytopenia resulting from at least one episode during the treatment period was reported in 6 patients in regimen I, 5 patients in regimen II, and 1 patient in regimen III. Of the total thrombocytopenia grades 2 and above, only 6 episodes in regimen I, 5 episodes in regimen II, and 2 episodes in regimen III were noted. The mean incidence of thrombocytopenia in regimen I in the initial 4 cycles: 0.1\u003cu\u003e+\u003c/u\u003e 0.5; in the final 4 cycles: 0.2\u003cu\u003e+ \u003c/u\u003e0.6, and in the overall 8 cycles: 0.3\u003cu\u003e+\u003c/u\u003e 1. In regimen II, the initial 4 cycles, were 0.1\u003cu\u003e+ \u003c/u\u003e0.3; in the final 4 cycles0.3\u003cu\u003e+\u003c/u\u003e0.6; and in the overall 8 cycles, 0.4\u003cu\u003e+\u003c/u\u003e0.7. In regimen III, as in the initial 4 cycles:0\u003cu\u003e+\u003c/u\u003e0; in the final 4 cycles: 0.1\u003cu\u003e+ \u003c/u\u003e0.4; and in the overall 8 cycles:0.1\u003cu\u003e+\u003c/u\u003e0.4. The mean incidence of thrombocytopenia of all grades was comparable among the 3 study regimens, with 0.3 in regimen I, 0.4 in regimen II, and 0.1 in regimen III over 8 cycles of chemotherapy. There was no statistically significant difference in the mean incidence of thrombocytopenia among the 3 study regimens.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONCLUSION:\u003c/strong\u003e There was no significant difference in the incidence of anemiaamong the 3 regimens in the initial 4 chemo cycles, final 4 chemo cycles, or overall 8 cycles of chemotherapy. There was a statistically significant difference in the mean incidence of thrombocytopenia during the initial 4 cycles of chemotherapy among the 3 regimens. However, among the overall 8 cycles of chemotherapy, there was no statistically significant difference in the mean incidence of thrombocytopenia among the three regimens. A trend towards a decrease in the mean Hb value was observed towards later cycles of chemotherapy in the overall study population due to the cumulative toxicity of chemotherapy regimens in the bone marrow.\u003c/p\u003e","manuscriptTitle":"Incidence of Anaemia and Thrombocytopenia Following Breast Cancer Chemotherapeutic Regimens AC-T, AC-T+ Ca, and AC-T+Tr IN in a Tertiary Care Center","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-08-09 13:55:38","doi":"10.21203/rs.3.rs-4876309/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":"1ab529c8-75b8-4a54-88ab-f26cab741184","owner":[],"postedDate":"August 9th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[{"id":35746097,"name":"Oncology"},{"id":35746098,"name":"Clinical Pharmacology"}],"tags":[],"updatedAt":"2024-08-09T13:55:38+00:00","versionOfRecord":[],"versionCreatedAt":"2024-08-09 13:55:38","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-4876309","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4876309","identity":"rs-4876309","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}