哌柏西利联合内分泌治疗对HR+/HER2-晚期乳腺癌患者的疗效观察

Clinical observation of palbociclib combined with endocrine therapy in hormone receptor positive and HER2 negative advanced breast cancer

目的回顾性分析在真实世界中,哌柏西利联合内分泌治疗在激素受体阳性(HR+)/人表皮生长因子受体2阴性(HER2-)晚期乳腺癌的临床应用、疗效及不良反应。方法收集2018年9月至2020年9月在河南省肿瘤医院接受哌柏西利治疗的晚期乳腺癌患者(HR+/HER2-)信息,共55例,均为女性,中位年龄57(34~79)岁。汇总一般病史资料、疾病特征。分析客观缓解率(ORR)、疾病控制率(DCR)、无进展生存期(PFS)、至治疗失败时间(TTF)、安全性及相关预后因素分析。结果收集接受含哌柏西利治疗方案的HR+/HER2-患者共55例,ORR为48.8%,DCR为88.4%;中位PFS和TTF分别为12.0个月(95%CI,11.1~13.0个月)和8.50个月(95%CI,2.5~14.5个月);其中哌柏西利在一线中优于多线治疗(P=0.0001);非肝转移患者预后较佳(P=0.01)。血液学毒性为重点观察不良事件,包括白细胞减少、中性粒细胞减少及血小板减少,其发生率为分别为78.2%、85.5%和34.5%;未发现其他3~4级非血液学毒性。结论哌柏西利联合内分泌治疗在HR+/HER2-晚期乳腺癌患者的疗效可,且不良反应可控,可以作为HR+/HER2-晚期乳腺癌一线或多线治疗选择。

Objective To analyze the application,efficacy,and safety of palbociclib in hormone receptor positive(HR+)and HER2 negative(HER2-)advanced breast cancer in the real world.Methods The information of patients who received palbociclib treatment from September 2018 to September 2020 was collected,and the general medical history data and disease characteristics were summarized.The objective response rate(ORR),disease control rate(DCR),progression-free survival(PFS),time to treatment failure(TTF),and safety were analyzed.Results A total of 55 patients with HR+/HER2-advanced breast cancer who received a treatment regimen containing palbociclib were enrolled.The ORR was 48.8%,and DCR was 88.4%.The median PFS was 12.0 months(95%CI,11.1-13.0 months),and the median TTF was 8.50 months(95%CI,2.5-14.5 months).Among them,palbociclib was superior to multi-line therapy in the first line(P=0.0001).The prognosis of patients with non-liver metastases was better(P=0.01).Hematological toxicity was the focus of observation of adverse events,including leukopenia,neutropenia,and thrombocytopenia.The incidence rates of them were 78.2%,85.5%,and 34.5%,respectively.No other grade 3-4 nonhematological toxicity was found.Conclusions Palbociclib combined with endocrine therapy in patients with HR+/HER2-advanced breast cancer has good efficacy and controllable adverse reactions.It can be used as a first-line or multi-line treatment option for HR+/HER2-advanced breast cancer.