To Evaluate Efficacy And Safety Of Vinorelbine In Combination With Capecitabine Or Docetaxel In Subjects With Triple-negative Metastatic Breast Cancer

Objective：Breast cancer is one of the most common malignant tumor.Because of The lackof treatment, triple-negative breast cancer can easily develop into metastatic breastcancer. Anthracycline drugs is the cornerstone of first-line chemotherapy for breastcancer. When anthracycline resistance, selecting the appropriate chemotherapy isthe main treatment for improving survival in patients with triple-negative breastcancer. vinorelbine and capecitabine is common antitumor drugs after the failure offirst-line therapy. vinorelbine (NVB) which comes from France is the third generationsemi-synthetic Changchun alkaloid. Capecitabine can inhibit cell division and disturbthe synthesis of RNA and protein.Through clinical trials, vinorelbine (NVB) plusCapecitabine(XLD) program (NX) is used in the first-line or second-line treatment oftriple-negative metastatic breast cancer (MBC), and the efficiency and toxicity werestatisticsed and compared with the vinorelbine (NVB) plus Docetaxel(T) program(NT) program to explore the efficacy and Safety of the NX program and NT program.Methods：This study is from October1,2010to April1,2013.73patients who come fromthe first affiliated hospital of Zhengzhou University entered the study. They who areall female patients with advanced breast cancer have been treated with anthracyclines.They have been all already diagnosed as MBC, with the estrogen receptor andprogesterone receptor negative,the human epidermal growth factor receptor-2(HER-2) negative measured in immunohistochemistry or positive for HER-2gene inFISH, and performance status(PS)<2.According to their will, patients entered intothe NX group and the NT group respectively. At last, there are34patients in the NXgroup and39patients in the NT group. The NX group were given Vinorelbine andCapecitabine. Capecitabine2500mg/m2/day,1-14days, bid, po. Vinorelbine25mg/㎡,1,8day, qd, ivgtt. The NT group were given Vinorelbine and Docetaxel. Docetaxel75mg/m2/day,2day, qd, ivgtt. Vinorelbine25mg/㎡,1,8day, qd, ivgtt. After2treatment cycles, the patients will take comprehensive review. In accordance with RECIST and NCI-CTCAEv3.0，we comprehensively assessment the response rate,toxicity of two groups. To the test terminal, the data will be used for statisticalanalysis to get the curative effect and the TTP.Results:Intention-to-treat analysis is used for Curative effect analysis。There are34patients in group NX and39patients in group NT. In group NX, there are0cases CR,13cases PR,8cases SD,13cases PD, and overall response rates(ORR) is38.2%(13/34). In group NT, there are1cases CR,24cases PR,6cases SD,8cases PD,and overall response rates(ORR) is64.1%(25/39). In recent efficacy, the ORR ofthe group NT is significantly higher than the group NX, and the difference isstatistically significant （χ2=4.870，P=0.027）. In group NX，the median TTP is3.8months. In group NT, the median TTP is6.4months and the median overall survivalis14.9months. We draw survival curves in Kaplan-Meier method. Compared inLog-rank method, the TTP in group NT is significantly higher than that of group NX,the difference was statistically significant（χ2=31.541，P＜0.01）.The most common adverse reactions in both group NX and group NT are decline ofneutrophils（76.3%VS90.7%，P=0.101），decline of Platelet（56.4%VS11.8%，P＜0.01）and decline of hemoglobin （84.6%VS35.3%，P＜0.05）.The most commonnon-hematologic Adverse reactions are vomiting （79.5%vs47.0%，P=0.004）anddiarrhea （15.4%vs5.9%， P=0.195）.besides,there are hand-foot syndrome（43.6%vs34.2%，P=0.325）,Abnormal liver function（56.4%vs2.9%，P＜0.01）and Oral mucositis （25.6%vs11.8%，P=0.133）.The most common Ⅲ, Ⅳ-leveladverse reaction in both group NX and group NT is decline of neutrophils（23.1%，22.6%,P=0.798), there is no significant difference by medical statistics. Besides,thereis no significant difference by medical statistics on leukopenia, diarrhea, hand footsyndrome and oral mucositis. the group NT is significantly higher than the group NXon the decrease of platelet, hemoglobin decreased, vomiting and abnormal liverfunction, and the difference is statistically significant.Conclusion：1. NT program is better than NX program in the treatment of triple-negativeMBC. 2. The uppermost adverse reaction in both group NX and group NT is decline ofneutrophils, but group NX is better than group NT on tolerance.