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目的 比较多西他赛联合卡铂(TP)方案与表柔比星联合环磷酰胺序贯多西他赛(EC-T)方案辅助治疗三阴性乳腺癌(TNBC)的Ⅲ期临床研究的安全性.方法 2010年1月至2011年9月,经术后病理证实的95例Ⅰ～Ⅲ期TNBC患者随机分为EC-T组(47例)和TP组(48例)接受术后化疗.EC-T组:环磷酰胺600 mg/m2,表柔比星90 mg/m2,静脉滴注,第1天,每3周重复,共4个周期；序贯多西他赛80 mg/m2,第1天,每3周重复,共4个周期.TP组:多西他赛75mg/m2,卡铂曲线下面积(AUC)=5,静脉滴注,第1天,每3周重复,共6个周期.化疗后根据病情给予辅助放疗.以x2检验比较两组患者不良反应的发生率.结果 76例患者可评价不良反应,其中EC-T组37例,中位年龄47岁,绝经前21例(56.8％)；TP组39例,中位年龄46岁,绝经前22例( 56.4％).EC-T组患者均按计划完成化疗,TP组有2例(5.1％)患者因骨髓抑制未完成化疗.在化疗期间,EC-T组和TP组均有9例患者进行剂量调整.76例患者的不良反应以1～2级较常见.EC-T组和TP组患者3～4级脱发的发生率分别为29.7％和10.3％ (P=0.033),呕吐的发生率分别为21.6％和7.7％(P=0.085),白细胞减少的发生率分别为54.1％和25.6％(P=0.011),中性粒细胞减少的发生率分别为51.4％和35.9％(P=0.174).其他3～4级不良反应少见.除周围神经毒性和色素沉着外,其他不良反应均在化疗结束后1个月内恢复.结论EC-T和TP方案辅助治疗可手术TNBC患者的不良反应可以耐受,接受TP方案治疗的患者3～4级脱发和白细胞减少的发生率较低.

Objective Triple-negative [estrogen receptor (ER)-/progesterone receptor (PR)-/HER2-] breast cancer (TNBC) accounts for ～ 15％ of overall breast cancer and associated with a poor prognosis.There is a short of standard adjuvant chemotherapy regimens for TNBC.A number of studies have shown that TNBC might be sensitive to cisplatin and carboplatin on the basis that dysfunction of BRCA1 and its pathway is associated with a specific DNA-repair defect,but data of adjuvant setting about this is limited.Methods From January 2010 to September 2011,95 early triple-negative breast cancer patients confirmed by pathology were randomly assigned to receive TP ( docetaxel 75 mg/m2,carboplatin AUG =5,day 1,21 days a cycle for 6 cycles) or EC-T (epirubicin 90 mg/m2,cyclophosphamide 600 mg/m2,d1,21days a cycle for4 cycles,followed by docetaxel 80 mg/m2,d1,21 days a cycle for 4 cycles) chemotherapy.Adjuvant radiation therapy was given selectively after chemotherapy.Here we report a preliminary safety analysis with the chi-square test. Results Seventy-six out of the 95 patients had completed the chemotherapy and could be assessed for the safety profiles of the regimens.Thirty-seven of them were in the EC-T group with a median age of 47 years,and 21 out of these 37 patients were premenopausal (56.8％).Another 39 patients came from the TP group with a median age of 46 years,and 22 out of these 39 patients were premenopausal ( 56.4％ ).All of the 37 patients in EC-T group completed the planned treatment whereas 2 patients of the 39 cases in TP group did not because of bone marrow suppression.During the treatments,9 patients had dose adjustment in each group.Adverse events of grade 1/2 were common.Specific incidence of adverse events with grade 3/4 in each group was as follows:alopecia,29.7％ vs.10.3％ ( P =0.033),vomiting 21.6％ vs.7.7％ ( P =0.085 ),leukopenia 54.1％ vs.25.6％ ( P =0.011) and neutropenia 51.4％ vs.35.9％ ( P=0.174).Other grade 3/4 toxicities were rare.All the adverse events (except peripheral neuropathy and pigmentation ) recovered within 1 month after the chemotherapy.Conclusion Both EC-T and TP regimens as adjuvant chemotherapy are safe and tolerable for the treatment of triple-negative breast cancer patients,while the TP regimen has advantages with less grade Ⅲ/Ⅳ alopecia and leukopenia.