老年乳腺癌患者应用非蒽环类辅助化疗方案的安全性及耐受性临床研究

摘要

背景与目的：乳腺癌发病率随年龄增长而升高，老年患者占有较大的比例。但由于老年患者所接受的治疗不足、合并症多、身体一般状况差，预后往往较年轻患者差。本研究观察我国老年乳腺癌患者应用以紫杉类为主的非蒽环类辅助化疗方案的安全性和耐受性。方法：2008年11月—2012年1月共有56例接受手术治疗的老年乳腺癌患者，以2∶1比例(≥65岁)入TC组(4或6个周期的多西他赛75 mg/m2和环磷酰胺600 mg/m2，35例)和PC组(4或6个周期的紫杉醇175 mg/m2和环磷酰胺600 mg/m2，21例)。在化疗结束后，根据患者病情，继续进行局部放射治疗和(或)内分泌治疗。结果：本研究共有50例患者按计划完成化疗，2组完成计划化疗的比例均在90%以上。中位随访33个月，中位无复发生存和总生存时间均未达到。PC组和TC组2年无病生存率分别为89.5%(17/19)和90.3%(28/31)；2年生存率分别为100%和96.8%(30/31)。非蒽环类辅助化疗方案的主要不良反应为Ⅲ～Ⅳ度中性粒细胞减少、白细胞减少以及Ⅰ～Ⅳ度的脱发、胃肠道反应和周围神经毒性。2组相比，PC组更易出现Ⅲ～Ⅳ度中性粒细胞减少(76.2%vs 48.6%，P=0.044)和不同程度的周围神经毒性(9.5%vs 2.9%)。不能耐受化疗相关不良反应是患者提前终止化疗和减少化疗药物剂量的主要原因。结论：非蒽环类化疗方案的耐受性及安全性好，老年乳腺癌患者能较好地接受以紫杉类为主的化疗方案。PC方案在耐受性和安全性上与TC方案相当，为我国老年乳腺癌患者增加一个安全、低毒的化疗方案的选择。%Background and purpose: The incidence of breast cancer increases as patients age, elderly patients account for a large proportion. Due to the insufifcient systemic therapy, more complications and poorly physical condition, the prognosis of elderly patients is often worse than the younger. The aim of this study was to investigate the safety and tolerance with non-anthracyclin regimen as adjuvant chemotherapy in elderly breast cancer patients. Methods:From Nov. 2008 to Jan. 2012, 56 patients (≥65 years) after surgical excision were enrolled into this study. The patients were divided into two groups:TC and PC groups. Each patient received 4 or 6 cycles of chemotherapy of PC (175 and 600 mg/m2, respectively;n=21) or TC (75 and 600 mg/m2, respectively;n=35), administered intravenously every 3 weeks, as adjuvant chemotherapy. Radiation therapy (as indicated) and endocrine therapy, for patients with hormone receptor-positive disease, were administered after completion of chemotherapy. Results: In this study, 50 patients completed chemotherapy as plan, the proportion of two groups were above 90%. After a median follow-up of 33 months, the median disease-free survival(DFS) and overall survival(OS) were not reached. The relapse-free rate and survival rate were 89.5%and 100%in the PC regime group, which were 90.3%and 96.8%in the TC regime group. Major toxicities included:neutropenia, leucopenia, alopecia, nausea, vomiting and various degree of peripheral neuropathy. The incidence of gradeⅢ-Ⅳneutropenia was 76.2%in PC group vs 48.6%in TC group (P=0.044). The most common cause for withdrawing from treatment was to be unable to tolerate the adverse effects. Conclusion:Adjuvant chemotherapy with paclitaxel and cyclophosphamide is safe, tolerable and promising for elderly breast cancer patients.