Department of General Surgery, The Affiliated Hospital of Inner Mongolia Medical University, Inner Mongolia, China.
The First Department of Breast Cancer, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Tianjin, China.
Cancer Biother Radiopharm. 2024 Aug;39(6):435-440. doi: 10.1089/cbr.2023.0175. Epub 2024 Mar 25.
Pyrotinib, a new irreversible dual pan-human epidermal growth factor receptor 2 (HER2) receptor tyrosine kinase inhibitor blocking EGFR and HER2, has achieved a promising efficacy for advanced HER2-positive (HER2) breast cancer. This study intended to further investigate the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus chemotherapy for HER2 breast cancer treatment. Thirty-eight HER2 breast cancer patients who received neoadjuvant pyrotinib and trastuzumab plus chemotherapy (docetaxel and carboplatin) were retrospectively reviewed. Clinical response by Response Evaluation Criteria in Solid Tumors (RECIST), pathological complete response (pCR), and adverse events data was retrieved. According to the RECIST, the complete response rate was 0.0%, 10.5%, and 15.8% after second-cycle, fourth-cycle, and sixth-cycle therapy, respectively; whereas the objective response rate was 76.3%, 92.1%, and 100.0%, accordingly. The total pCR (tpCR) rate was 52.6%, the pCR rate of the breast was also 52.6%, and the pCR rate of lymph nodes was 86.8%. The tpCR rate was lower in patients with HER2 immunohistochemistry (IHC)++ and amplification by fluorescent hybridization (FISH) than in those with HER2 IHC+++ (14.3% vs. 61.3%, = 0.024), which was also lower in patients with Ki-67 expression ≥30% than in those with Ki-67 expression <30% (40.0% vs. 76.9%, = 0.031). The common adverse events included diarrhea (84.2%), anemia (73.7%), nausea and vomiting (63.2%), fatigue (50.0%), hypomagnesemia (44.7%), leukopenia (42.1%), thrombocytopenia (39.5%), elevated transaminase (36.8%), and pruritus (31.6%). Pyrotinib and trastuzumab plus chemotherapy serve as an acceptable neoadjuvant regimen exhibiting good efficacy and tolerance in HER2 breast cancer patients, while further large-scale validation is warranted.
吡咯替尼是一种新型不可逆双靶点人表皮生长因子受体 2（HER2）受体酪氨酸激酶抑制剂，能同时阻断 EGFR 和 HER2，在治疗 HER2 阳性（HER2+）乳腺癌中显示出了令人鼓舞的疗效。本研究旨在进一步探讨吡咯替尼联合曲妥珠单抗加化疗新辅助治疗 HER2 乳腺癌的疗效和安全性。
回顾性分析了 38 例接受吡咯替尼联合曲妥珠单抗加化疗（多西他赛和卡铂）新辅助治疗的 HER2 乳腺癌患者。采用实体瘤疗效评价标准（RECIST）评估临床反应、病理完全缓解（pCR）和不良事件数据。
根据 RECIST，第 2 周期、第 4 周期和第 6 周期治疗后完全缓解率分别为 0.0%、10.5%和 15.8%；客观缓解率分别为 76.3%、92.1%和 100.0%。总 pCR（tpCR）率为 52.6%，乳腺 pCR 率为 52.6%，淋巴结 pCR 率为 86.8%。HER2 免疫组化（IHC）++和荧光原位杂交（FISH）扩增的患者 tpCR 率低于 HER2 IHC+++的患者（14.3%比 61.3%， = 0.024），Ki-67 表达≥30%的患者 tpCR 率低于 Ki-67 表达<30%的患者（40.0%比 76.9%， = 0.031）。常见的不良反应包括腹泻（84.2%）、贫血（73.7%）、恶心呕吐（63.2%）、乏力（50.0%）、低镁血症（44.7%）、白细胞减少症（42.1%）、血小板减少症（39.5%）、转氨酶升高（36.8%）和瘙痒（31.6%）。
吡咯替尼联合曲妥珠单抗加化疗作为一种新辅助方案，在 HER2 乳腺癌患者中显示出良好的疗效和耐受性，值得进一步进行大规模验证。
