吡咯替尼联合多西他赛/脂质体多柔比星/环磷酰胺新辅助治疗 HER2 阳性乳腺癌的疗效和安全性。
Efficacy and safety of neoadjuvant pyrotinib plus docetaxel/liposomal doxorubicin/cyclophosphamide for HER2-positive breast cancer.
机构信息
Department of Breast Surgery, Affiliated Hospital of Chengde Medical University, No.36 Nanyingzi Street, Shuangqiao District, Chengde, 067000, China.
School of Nursing, Chengde Medical University, Chengde, China.
出版信息
Ir J Med Sci. 2023 Jun;192(3):1041-1049. doi: 10.1007/s11845-022-03093-9. Epub 2022 Jul 13.
OBJECTIVE
Pyrotinib is a novel EGFR/HER2 dual tyrosine kinase inhibitor developed in China, while its role in neoadjuvant therapy of HER2-positive (HER2) breast cancer lacks evidence. The current study aimed to explore the efficacy and safety of neoadjuvant pyrotinib plus docetaxel/liposomal doxorubicin/cyclophosphamide (TAC) for HER2 breast cancer.
METHODS
A total of 27 HER2 breast cancer patients received neoadjuvant pyrotinib plus TAC for 6 cycles, then surgery was performed. The clinical and pathological responses, and adverse events were evaluated.
RESULTS
Complete response rate, objective response rate, and disease control rate were 0.0%, 44.4% and 100.0% after 2 treatment cycles; 0.0%, 37.0%, and 100.0% after 4 treatment cycles; 37.0%, 37.0%, and 96.3% after 6 treatment cycles; as well as 37.0%, 44.4%, and 100.0% based on the best clinical response. Regarding pathological response, there were 1 (2.7%), 3 (11.1%), 8 (29.6%), 5 (18.5%), and 10 (37.0%) patients realizing Miller-Payne grade (G) 1, G2, G3, G4, and G5, respectively; besides, 10 (37.0%) patients achieved total pathological complete response (pCR), 10 (37.0%) patients realized pCR in breast, and 23 (85.2%) patients achieved pCR in lymph node. Additionally, adverse events included diarrhea (81.5%), dental ulcer (7.4%), and hand-foot syndrome (3.7%); meanwhile, grade 3-4 adverse event consisted of only diarrhea (11.1%).
CONCLUSION
Neoadjuvant pyrotinib plus TAC treatment is efficient and safe in HER2 breast cancer patients, while further validation is needed.
目的
吡咯替尼是中国自主研发的一种新型 EGFR/HER2 双靶点酪氨酸激酶抑制剂，但其在 HER2 阳性（HER2）乳腺癌新辅助治疗中的作用尚缺乏证据。本研究旨在探讨吡咯替尼联合多西他赛/脂质体阿霉素/环磷酰胺（TAC）新辅助治疗 HER2 乳腺癌的疗效和安全性。
方法
共 27 例 HER2 乳腺癌患者接受吡咯替尼联合 TAC 治疗 6 个周期，然后行手术治疗。评估临床和病理反应以及不良反应。
结果
治疗 2 个周期后完全缓解率、客观缓解率和疾病控制率分别为 0.0%、44.4%和 100.0%；治疗 4 个周期后分别为 0.0%、37.0%和 100.0%；治疗 6 个周期后分别为 37.0%、37.0%和 96.3%；根据最佳临床反应，分别为 37.0%、44.4%和 100.0%。在病理反应方面，1 例（2.7%）、3 例（11.1%）、8 例（29.6%）、5 例（18.5%）和 10 例（37.0%）患者分别实现 Miller-Payne 分级（G）1、G2、G3、G4 和 G5；此外，10 例（37.0%）患者达到完全病理缓解（pCR），10 例（37.0%）患者在乳腺实现 pCR，23 例（85.2%）患者在淋巴结实现 pCR。此外，不良反应包括腹泻（81.5%）、口腔黏膜炎（7.4%）和手足综合征（3.7%）；同时，仅腹泻（11.1%）为 3-4 级不良反应。
结论
吡咯替尼联合 TAC 治疗 HER2 乳腺癌患者有效且安全，但需要进一步验证。
Zotero 插件