阿帕替尼联合紫杉醇和卡铂密集方案新辅助治疗三阴性乳腺癌的近期疗效及安全性

Efficacy and safety of neoadjuvant apatinib in combination with dose-dense paclitaxel and carboplatin in locally advanced triple negative breast cancer patients

目的观察阿帕替尼联合紫杉醇和卡铀密集方案新辅助治疗三阴性乳腺癌(TNBC)的近期疗效及安全性。方法采用单中心、单臂、前瞻性n期临床研究,纳入Ⅱ〜Ⅲ期TNBC患者17例新辅助治疗方法:阿帕替尼250mg,1次/山紫杉醇175mg/m^2第1天;卡拍给药剂量按曲线下面积=4计算,第2天;每14d为1个周期结果16例患者纳人统计分析。16例患者完成阿帕替尼治疗的中位周期数为5个,化疗的中位周期数为6个。完全缓解2例,部分缓解12例,疾病稳定2例,客观缓解率为87.5%,疾病控制为100%12例患者完成手术治疗,其中8例(66.7%)达病理完全缓解。Ⅲ〜Ⅳ级不良反应为粒细胞下降和血小板下降各3例,贫血、疲乏、心律失常和丙氨酸氨基转移酶增高各1例阿帕替尼中断治疗5例,永久停药3例,化疗减量1例结论阿帕替尼联合紫杉醇、卡钼密集方案新辅助化疗TNIC近期疗效较好,不良反应可控,未发生严重不良反应。

Objective To observe the short-term efficacy and safety of apatinib in combination withdose-dense paclitaxel and carboplatin in locally advanced triple-negative breast cancer(TNBC)patients.Methods From September 2018 to Septembver 2019,17 stageⅡ-ⅢTNBC patients were enrolled in thissingle arm,single center prospective phase ll studly.They received neoadjuvant trealment of apatinib 250 mgper day,paclitaxel 175 mg/m^2 on 1^st day and a dose of carboplatin according to the area under curve(AUC)=4 on 2^nd day,every 14 days as a cycle.Results By January 2020,16 cases completed 4-7 cyclesof apatinib treatment and 4-8 cycles of chemotherapy.The median cycles of apatinib treatment andchemotherapy were 5 cycles and 6 eycles,respectively.Two cases achieved complete responses(CR),12achieved partial responses(PR),2 achieved stable diseases(SD)and no progressive disease was observed.The objective response rale(ORR)was 87.5%,dlisease control rate(DCR)was 100%.By January 2020,among 12 patients who received surgery,8 achieved pathologic complete response(pCR,66.7%).The gradeⅢ/Ⅳadverse events included:neutropenia,thrombocytopenia in 3 cases(18.8%)each,anemia,fatigue,arrhythmia and alanine aminotransferase(ALT)elevation in 1 case each.Apatinib was interrupted in 5 cases,and was discontinued in 3 cases;chemotherapy dosage was reduced in 1 case.Conclusion Apatinib in combination with dose-dense paclitaxel and carboplatin neoadjuvant therapy are effective and well tolerated in locally advanced TNBC patients.