消癌平注射液联合化疗治疗转移性三阴型乳腺癌临床疗效观察

目的：观察消癌平注射液联合化疗治疗转移性三阴型乳腺癌（ triple-negative breast cancer，TNBC）的疗效及安全性。方法选择2012年12月—2014年12月共101例患者纳入此项研究，均经病理诊断为转移性 TNBC，转移部位主要包括肺、肝、骨、肾上腺、淋巴结等。所有患者需接受消癌平注射液联合化疗4~6周期。应用 RECIST 1.1实体瘤评价标准对患者进行疗效判定。并检测疗效与临床病理因素之间的相关性。应用 NCI-CTCAE 3.0毒性评价标准评估药物相关性不良反应。结果患者中位随访时间为22个月，疗效评估显示：完全缓解4例，部分缓解33例，疾病稳定45例和疾病进展19例。全组患者的客观有效率和疾病控制率分别为36.6%和81.2%。转移部位、转移灶数量和美国东部肿瘤协作组评分与 TNBC 患者的疗效有显著相关性（ P ﹤0.01）。1年总生存率（ overall survival，OS）为81.2%，中位 OS 未达到。常见不良反应多为轻中度，经对症治疗后均有效缓解，患者均可耐受。结论消癌平注射液联合化疗治疗转移性 TNBC 具有较好的疗效和安全性。

Clinical Efficacy of Xiaoaiping Injection Combined with Chemotherapy in Treatment of Patients with Metastatic and Triple Negative Breast Cancer

Objective To observe the clinical efficacy and safety of Xiaoaiping injection combined with chemo-therapy in treatment of patients with metastatic and triple negative breast cancer(TNBC). Methods A total of 101 pa-tients admitted during December 2012 and December 2014 were recruited in this study. All patients were diagnosed as having metastatic TNBC,and metastatic locations were lung,liver,bone,adrenal gland,lymph nodes and so on. All pa-tients received Xiaoaiping injection combined with chemotherapy for 4-6 cycles. RECIST 1. 1 solid tumor evaluation crite-rion was used to evaluate the curative effect,and the relationship between curative efficacy and clinicopathological factors was detected. Adverse reactions related drugs were evaluated using NCI-CTCAE 3. 0 toxicity evaluation criterion. Results The median follow-up period was 22 months. Curative effect assessment showed that there were 4 patients with com-plete remission(CR),33 patients with part remission(PR),45 patients with stable disease(SD)and 19 patients with progression disease(PD). The objective efficient and disease control rates were 36. 6% and 81. 2% respectively. Meta-static locations,number of metastatic lesions and eastern cooperative oncology group( ECOG)score were significantly correlated with efficacy of TNBC patients(P ﹤ 0. 01). One-year overall survival(OS)rate was 81. 2% ,and the median OS was not achieved. Common adverse reactions were form mild to moderate,and symptoms were relieved after symptom-atic treatment. All patients were able to tolerate. Conclusion Xiaoaiping injection combined with chemotherapy has good efficacy and safety in treatment of patients with metastatic TNBC.