Clnical Study Of Adjuvant Chemotherapy With Nonanthracyclin Regimens For Eldely And Postmenopausal Breast Cancer With Low Risk Or Intermediate Risk

Objective The aim of this clinical study was to evaluate the safety, tolerance and efficacy with non-anthracyclin regimens as adjuvant chemotherapy in elderly and postmenopausal breast cancer with low risk or intermediate risk.Methods Patients were eligible if they had stage Ⅰ to Ⅲ operable invasive breast cancer with complete surgical excision of the primary tumor. Between November2008and January2012,203patients were randomly assigned to four or six cycles of either standard-dose PC (175and600mg/m2, respectively; n=64) or TC (75and600mg/m2, respectively; n=139), administered intravenously every3weeks, as adjuvant chemotherapy. Radiation therapy (as indicated) and tamoxifen, for patients with hormone receptor-positive disease, were administered after completion of chemotherapy.Results Both treatment groups (PC and TC) were well balanced with respect to major prognostic factors. Patients were observed through2012for a median of32.5months. At2years, DFS rates were no significant differences between PC and TC regimens groups (92.8%vs.90.6%, respectively; hazard ratio [HR]=1.189;95%CI,0.42-3.36; P=0.745). The median OS were not reached. The survival rate in PC regimen group was100%versus97.8%in the TC regimen group. Cases with lymph node positive, histological grade3and vascular invasion had worse DFS, P value had significance (P=0.006,0.003and0.034, respectively). Multivariate analysis revealed that cases with histological grade3was an independent prognostic factor for decreased risk of recurrence (HR0.268,95%CI0.103-0.701, P=0.007). However, lynph node status or vascular invasion wasnot associated with other clinical characteristics or survival parameters. The toxicity could be evaluated in all patients. Major grade Ⅲ-Ⅳ toxicities included:neutropenia, leucopenia and alopecia. The incidence of grade Ⅲ-Ⅳ neutropenia was65.6%in PC group versus45.3%in TC group (P=0.007), especially in the elderly subgroup. More grade Ⅲ-Ⅳ alopecia and various degree of peripheral neuropathy occurred on the PC arm. PC is not known to be cardiotoxic. The median numbers of completed treatment cycles were5and6. Relative dose intensity of paclitaxel was96.1%and docetaxel was97.7%. The most common cause for withdrawing from treatment was to be unable to tolerate the adverse effects (AEs).Conclusion:Adjuvant chemotherapy with paclitaxel or docetaxel and cyclophosphamide is safe, tolerable and promising for elderly and postmenopausal breast cancer with low risk and intermediate risk.