吡咯替尼联合曲妥珠单抗和帕妥珠单抗新辅助治疗HER-2阳性乳腺癌的回顾性研究  

A retrospective clinical study of pyrotinib in combination with trastuzumab and pertuzumab in neoadjuvant therapy for HER-2 positive breast cancer

作　　者：傅成斌[1] 韩晖[1] 林舜国[1] 许春森[1] Chengbin Fu;Hui Han;Shunguo Lin;Chunsen Xu(Department of Breast Surgery,Fujian Medical University Union Hospital,Fuzhou 350001,China)

机构地区：[1]福建医科大学附属协和医院乳腺外科,福州市350001

出　　处：《中国肿瘤临床》2023年第17期882-887,共6页Chinese Journal of Clinical Oncology

摘　　要：目的:比较曲妥珠单抗(trastuzumab,H)联合化疗与吡咯替尼(pyrotinib,Py)或帕妥珠单抗(pertuzumab,P)联合化疗的疗效和安全性,并探讨影响患者总体病理完全缓解(total pathologic complete response,tpCR)率的因素。方法:回顾性分析2021年1月至2022年12月于福建医科大学附属协和医院行新辅助治疗的330例HER-2阳性乳腺癌患者的临床病理资料,比较H+Py组(47例)、H+P组(268例)和H组(15例)分别联合化疗的疗效和安全性,并采用统计学方法分析影响患者tpCR率的因素。结果:所有患者的平均tpCR率为56.7%(187/330),H+P组和H+Py组的tpCR率分别为60.4%(162/268)和44.7%(21/47),H+Py组3级不良反应最高达21.3%(10/47),药物减量和3级不良反应影响H+Py组的tpCR率。影响所有患者tpCR率的独立影响因素是激素受体(hormone receptor,HR)和HER-2状态,HR阴性患者的tpCR率是HR阳性的3.217倍,而HER-2(+++)患者的tpCR率是HER-2(++)的3.710倍。结论:H+Py组的疗效劣于H+P组而优于H组,3级不良反应及药物减量影响H+Py组的疗效。应加强药物不良反应的管控,保证足剂量用药,H+Py联合化疗仍是HER-2阳性乳腺癌患者新辅助治疗的可选方案之一。HR和HER-2状态是患者tpCR率的预测因子。Objective:We compared the efficacy and safety of trastuzumab(H)chemotherapy alone or in combination with pertuzumab(P)or pyrrolitinib(Py),and explored factors that affect patient total pathologic complete response(tpCR)rate.Methods:We performed a retrospective analysis of the clinicopathological data of 330 patients with HER-2 positive breast cancer who received neoadjuvant treatment in Fujian Medical University Union Hospital from January 2021 to December 2022.We compared the efficacy and safety of H+Py combined chemotherapy(47 cases),H+P chemotherapy(268 cases),and H chemotherapy alone(15 cases),and analyzed factors influencing patient tp-CR rates using statistical methods.Results:The average tpCR rate for all patients was 56.7%(187/330),with 60.4%(162/268)and 44.7%(21/47)for the H+P group and H+Py group,respectively.The highest rate of grade 3 adverse reactions 21.3%(10/47)was observed in the H+Py group.Drug reduction and grade 3 adverse reactions affected the tpCR rate in the H+Py group.Independent factors influencing the tpCR rate among all patients include hormone receptor(HR)and HER-2 status.The tpCR rate of HR negative patients is 3.217 times higher than that of HR positive patients,while the tpCR rate of HER-2(+++)patients is 3.710 times higher than that of HER-2(++)patients.Conclusions:The therapeutic efficacy of H+Py chemotherapy is inferior to that of H+P treatment,but superior to treatment with H alone.Level 3 adverse reactions and drug reduction negatively impact the therapeutic efficacy of H+Py chemotherapy.The management and control of adverse drug reactions should be strengthened to ensure sufficient dosage of drugs.H+Py combined chemotherapy is still a viable option for neoadjuvant treatment of HER-2 positive breast cancer patients.HR and HER-2 status are predictive factors for patient tpCR rate.

关 键 词：乳腺癌 吡咯替尼 新辅助治疗 HER-2阳性 

分 类 号：R737.9[医药卫生—肿瘤]