吡咯替尼联合化疗新辅助治疗HER2阳性早期或局部晚期乳腺癌的临床研究

Clinical study of Pyrotinib combined with chemotherapy in neoadjuvant treatment in HER2 positive early or locally advanced breast cancer

目的 研究吡咯替尼联合化疗新辅助治疗人类表皮生长因子受体2 (HER2)阳性早期或局部晚期乳腺癌的疗效与安全性。方法 回顾性分析兰州大学第一医院收治的22例初诊HER2阳性早期或局部晚期乳腺癌患者,吡咯替尼联合白蛋白紫杉醇4周期治疗后评价全面疗效,进行多学科会诊讨论,对于没有进展的患者行手术治疗,术后吡咯替尼联合表柔比星和环磷酰胺辅助治疗4周期,后序贯曲妥珠单抗和帕妥珠单抗1年。结果 22例患者均完成预先设定的治疗方案,总病理完全缓解率为54.5%,术前新辅助治疗客观缓解率为100%,术后中位随访时间为13.4个月(9~21个月),12个月的无事件生存期为100%,其中1例患者术后出现疾病进展,无事件生存率为12.5个月。其余患者至随访结束均未出现疾病进展。最常见的不良反应是白细胞减少、腹泻、周围神经综合征,发生3级不良反应最多的是腹泻(7例,31.8%),不良反应均经治疗后好转。结论 吡咯替尼联合化疗在HER2阳性早期或局部晚期乳腺癌中获益,且不良反应可耐受。

Objective To study the efficacy and safety of Pyrotinib combined with chemotherapy in the neoadjuvant treatment of human epidermal growth factor receptor 2(HER2) positive early or locally advanced breast cancer. Methods Retrospective analysis of 22 patients with early or locally advanced HER2 positive breast cancer admitted to the First Hospital of Lanzhou University. After 4 cycles of treatment with Pyrotinib combined with Albumin-binding paclitaxel, a comprehensive efficacy evaluation was carried out by multi-disciplinary treatment discussion. Patients who did not progress were treated with surgery. After surgery, Pyrotinib combined with Epirubicin and Cyclophosphamide were continued for 4 cycles, followed by Trastuzumab and Pertuzumab for 1 year. Results 22 patients completed the treatment protocol. The total pathologic complete response rate was 54.5%, Preoperative neoadjuvant therapy objective response rate was100%, the median follow-up time was 13.4 months(9~21 months), and the event-free survival(EFS) was100% at 12 months. One patient developed disease progression after operation, EFS was 12.5 months. No disease progression was found in other patients until the end of follow-up date. The most common adverse reactions were leucopenia, diarrhea, peripheral nerve syndrome, and diarrhea(7 cases, 31.8%) occurred the most grade 3 adverse reactions. The above adverse reactions were improved after treatment. Conclusion Pyrotinib combined with chemotherapy benefits from HER2 positive early or locally advanced breast cancer, and the adverse reactions are tolerable.