恩度联合TEC方案新辅助治疗Ⅲ期乳腺癌临床研究  

Trail of neoadjuvant endostar in combination with docetaxel,epirubicin and cyclophosphamide in patients with stage Ⅲ breast cancer

作　　者：张香梅[1] 曹淼[2] 刘北辰[3] 刘月平[4] 刘运江[2] ZHANG Xiang-mei;CAO Miao;LIU Bei-chen;LIU Yue-ping;LIU Yun-jiang(Fourth Hospital of Hebei Medical University, Shijiazhuang 050011, P. R. China)

机构地区：[1]河北医科大学第四医院科研中心,河北省肿瘤基因诊断,预防与治疗重点实验室,河北石家庄050011 [2]河北医科大学第四医院乳腺中心,河北石家庄050011 [3]河北医科大学第四医院血液科,河北石家庄050011 [4]河北医科大学第四医院病理科,河北石家庄050011

出　　处：《中华肿瘤防治杂志》2018年第4期258-262,共5页Chinese Journal of Cancer Prevention and Treatment

摘　　要：目的Ⅲ期乳腺癌患者属于局部晚期乳腺癌,治疗上以新辅助化疗为主。重组人血管内皮抑制素恩度(Endostar;recombinant human endostatin,EN)是我国学者自主研发的抗血管生成新药,单药或联合化疗后,在肺癌等治疗上效果显著。本研究探讨EN联合TEC方案新辅助化疗对Ⅲ期乳腺癌的有效性及安全性,为其个体化治疗提供参考。方法收集河北医科大学第四医院乳腺中心2011-05-01-2015-05-31收治的乳腺癌71例,遵循分层随机对照原则,将空心针穿刺确诊、需新辅助化疗的Ⅲ期乳腺癌分为TEC组(多西他赛75mg/m^2,静脉滴入,d1;表柔比星75mg/m^2,静脉推注,d1~d2;环磷酰胺600mg/m^2,静脉推注,d1)34例及EN联合TEC组(TEC同时接受EN15 mg,静脉滴入,d1~d14)37例,21d为1个周期,4个周期后手术。观察肿瘤客观缓解率(objective response rate,ORR)、病理完全缓解率(pathological complete response rate,pCR)、无复发生存(relapse-free survival,RFS)、总生存(overall survival,OS)和毒副作用。结果 EN联合TEC组和TEC的ORR分别为83.8%(31/37)和58.8%(20/34),差异有统计学意义,P=0.020。EN联合TEC组中位RFS为53.0个月(95%CI为49.45~56.56个月),较TEC组48.0个月(95%CI为39.65~56.35个月)延长,P=0.932。EN联合TEC组OS为67.8个月(95%CI为64.37~71.25个月),较TEC组57.7个月(95%CI为51.43~63.99个月)显著延长,差异有统计学意义,P=0.047。TEC联合EN后,提高了Ⅲ期乳腺癌患者的pCR率(13.5%,5/37),高于TEC组的8.8%(3/34),但差异无统计学意义,P=0.532。未出现不可控制的血液、神经及心血管系统等毒副作用,2组不良反应比较差异无统计学意义,无预期以外的不良反应发生。结论 EN联合TEC方案新辅助化疗有效提高乳腺癌ORR,延长患者OS,毒副作用可控,为Ⅲ期乳腺癌的治疗提供了新选择。OBJECTIVE Stage Ⅲ breast cancer belongs to the local advanced diseases and mainly depend on the neoadjuvant chemotherapy.Endostar（EN）,recombinant human endostatin,a new developed antiangiogenesis agent in China,is available to improve the prognosis of patients with lung cancer.In this study,we evaluated the efficiency and safety of EN combined with docetaxel,epirubicin and cyclophosphamide（EN＋TEC）as a neoadjuvant in treatment of stage Ⅲbreast cancer patients.METHODS Totally 71 cases of breast cancer patients confirmed by core biopsy randomly were treated at the Fourth Hospital of Hebei Medical University from 1 st May 2011 to 31 th May 2015 with a median age of 46,these patients received 4 cycles neoadjuvant therapy of TEC（docetaxel 75 mg/m^2 day 1;epirubicin 75 mg/m^2 day 1,2;cyclophosphamide 600 mg/m^2 day 1）or EN＋TEC（EN 15 mg day 1-14）.Cycles were repeated every 3 weeks.The objective response rate（ORR）,pathological complete response rate（pCR）,relapse-free survival（RFS）,overall survival（OS）and toxicity were analyzed.RESULTS Treatment with EN＋TEC significantly increased the ORR,83.8%（31/37）,compared to control group 58.8%（20/34,P=0.020）.Follow-up displayed a better OS,67.8 months（95%CI：64.37-71.25）in EN＋TEC treatment compared to TEC only 57.7 months（95%CI：51.43-63.99,P=0.047）.EN＋TEC treatment also displayed a prolonged RFS 53.0 months（95%CI：49.45-56.56）,compared to TEC only 48.0 months（95%CI：39.65-56.35,P=0.932）.Although no significant difference was found in pCR,the tendency of pCR was increased by EN treatment（13.5%vs 8.8%,P=0.532）.Meanwhile,the adverse events showed no difference between EN＋TEC and TEC therapy.CONCLUSION Our study display EN combined with TEC neoadjuvant can effectively improve the ORR and OS of stageⅢ breast cancer with controlled adverse events,suggesting a favorable way in breast cancer therapy.

关 键 词：恩度 重组人血管内皮抑制素 乳腺癌 新辅助治疗 肿瘤客观缓解率 总生存期 

分 类 号：R737.9[医药卫生—肿瘤]