哌柏西利治疗激素受体阳性转移性乳腺癌的单中心真实世界研究

Role of palbociclib for hormone receptor-positive metastatic breast cancer:A single-center real-world study

目的分析哌柏西利治疗激素受体阳性转移性乳腺癌的单中心真实世界数据,探寻其疗效相关因素、获益人群和安全性。方法收集2019年1月至2021年6月浙江大学医学院附属第二医院接受哌柏西利治疗的激素受体阳性转移性乳腺癌患者65例的临床和随访数据,单因素和多因素生存分析探讨影响哌柏西利疗效的相关因素。结果65例转移性乳腺癌患者的客观缓解率(objective response rate,ORR)为38.6%(22/57)。中位随访时间10个月,中位无进展生存时间(progression-free survival,PFS)19个月(95%CI:14.2~23.8个月)。一线治疗中联合氟维斯群与联合芳香化酶抑制剂的患者的疗效比较,差异无统计学意义(P>0.05)。多因素分析显示,内脏转移和早期肿瘤退缩分别是PFS的危险因素(HR=5.75,95%CI:1.71~19.37,P=0.005)和保护因素(HR=0.31,95%CI:0.16~0.63,P=0.001)。结论哌柏西利在激素受体阳性转移性乳腺癌中疗效确切,在一线治疗中其联合氟维斯群或芳香化酶抑制剂疗效相当。内脏转移和早期肿瘤退缩是激素受体阳性转移性乳腺癌患者PFS的独立预后因素。

Objective To analyze the single-center real-world study of palbociclib in treating hormone receptor-positive metastatic breast cancer,and to explore the factors related to its efficacy,benefited population and safety.Methods The clinical and follow-up data of 65 patients with hormone receptor-positive metastatic breast cancer treated with palbociclib in the Second Affiliated Hospital,Zhejiang University School of Medicine,from January 2019 to June 2021,were collected.Univariate and multivariate survival analyses were utilized to explore the prognostic factors affecting the efficacy of palbociclib.Results The objective response rate(ORR)of 65 patients was 38.6%(22/57).The median follow-up time was 10 months and the median progression-free survival(PFS)time was 19 months(95%CI:14.2-23.8 months).The combination of palbociclib and fulvestrant was as effective as the combination of palbociclib and aromatase inhibitors in the first-line therapy subgroup(P>0.05).Multivariate analysis showed that visceral metastasis was a risk factor of PFS(HR=5.75,95%CI:1.71-19.37,P=0.005),and early tumor shrinkage(ETS)was a protective factor(HR=0.31;95%CI:0.16-0.63,P=0.001).Conclusions The efficacy of palbociclib in hormone receptor-positive metastatic breast cancer is confirmed.In the first-line therapy,the combination of palbociclib and fulvestrant possesses the same efficacy as palbociclib combined with aromotase inhibitors.Visceral metastasis and ETS are independent prognostic factors for PFS in patients with hormone receptor-positive metastatic breast cancer.