吡咯替尼对携带HER-2突变的HER-2阴性晚期乳腺癌患者的疗效观察

目的：评估吡咯替尼对携带HER-2突变的HER-2阴性晚期乳腺癌患者的治疗疗效和安全性。方法：回顾性分析2018年1月至2019年6月于北京市朝阳区桓兴肿瘤医院收治的13例携带HER-2突变的HER-2阴性晚期乳腺癌患者的临床资料，均使用吡咯替尼单药行抗HER-2治疗，对患者的治疗疗效和不良反应进行综合评估。结果：13例患者中3例因不良反应难以耐受出组，未行疗效评价，其余10例患者中获得完全缓解（complete response,CR）1例、部分缓解（partial response,PR）3例、疾病稳定（stable disease,SD）3例、疾病进展（progressive disease,PD）3例。客观缓解（CR+PR）率为40%(4/10)，临床获益（CR+PR+SD≥6.0个月）率为60%(6/10)，疾病控制（CR+PR+SD）率为70%(7/10)。无进展生存时间最长者达15.5个月，中位无进展生存期（progression-free survival,PFS）为4.9个月（95%CI:3.8～6.0）。吡咯替尼最常见的不良反应为腹泻、占84.6%(11/13),3...

Evaluation of efficacy of pyrotinib in patients with HER-2 negative advanced breast cancer and HER-2 mutation

  Objective  To evaluate the efficacy and safety of pyrotinib in managing patients with HER-2 negative advanced breast cancer, with HER-2 mutation.   Methods  A retrospective analysis was performed using the clinical data of 13 patients with HER-2 negative advanced breast cancer, with HER-2 mutation, admitted to the Huan Xing Cancer Hospital, Chaoyang District, Beijing, from January 2018 to June 2019. All patients were managed with pyrotinib monotherapy against HER-2. The therapeutic efficacy and adverse events of the patients were comprehensively evaluated.   Results  Among the 13 patients, three were excluded from the study because of intolerant adverse events before the first tumor response evaluation. Among the ten remaining patients, one patient achieved a complete response (CR), three patients achieved partial response (PR), three patients achieved a best response of stable disease (SD), and three patients experienced progressive disease (PD). The objective response (CR+PR) rate was 40.0% (4/10), the clinical benefit (CR+PR+SD≥6.0 months) rate was 60% (6/10), and the disease control (CR+PR+SD) rate was 70% (7/10). The longest progression-free survival (PFS) time was 15.5 months, and the median PFS was 4.9 months (95% CI: 3.8-6.0). The main toxicity related to pyrotinib was diarrhea, accounting for 84.6% (11/13). Adverse events above grade 3 experienced by the patients included diarrhea (2/13, 15.4%), nausea (1/13, 7.7%), and vomiting (1/13, 7.7%).   Conclusions  Patients with HER-2 negative advanced breast cancer, with HER-2 mutation, may benefit from anti-HER-2 treatment with pyrotinib.