【摘要】 目的:分析哌柏西利联合内分泌治疗的激素受体(hormone receptor,HR)阳性、HER-2阴性晚期乳腺癌临床疗效。方法:回顾性分析2018年9月至2019年12月78例于天津医科大学肿瘤医院行哌柏西利联合内分泌治疗HR阳性、HER-2阴性晚期乳腺癌患者的临床资料,并对其疗效与安全性进行分析。结果:78例患者的中位年龄为58岁,中位无进展生存期(progression-free survival,PFS)为7个月,总体客观缓解率(objective response rate,ORR)为36.7%(22/60),临床获益率(clinical benefit rate,CBR)为73.3%(44/60)。既往使用解救治疗<2线和≥2线的ORR分别为71.4%(20/28)和6.3%(2/32),两者比较差异具有统计学意义(P<0.001)。采用Cox比例风险回归模型多因素分析显示,转移部位数目、既往解救治疗线数和是否行解救化疗是哌柏西利联合内分泌治疗疗效的独立影响因素。不良事件中的中性粒细胞减少为96.2%(75/78)最常见,3～4级占62.8%(49/78),14.1%(11/78)患者因3～4级的白细胞减少/中性粒细胞减少而调整用药剂量。最常见的非血液学不良事件是乏力,占23.1%(18/78)。不良事件引起的停药发生率为7.7%(6/78)。结论:哌柏西利联合内分泌治疗更适合既往解救治疗线数少、未行解救化疗的患者,较后线使用有更好的疗效,且不良事件可控。更多还原

【Abstract】 Objective: To investigate the efficacy and safety of palbociclib in combination with endocrine therapy in the treatment of hormone receptor(HR)-positive HER-2 negative advanced breast cancer. Methods: We retrospectively analyzed the clinical data of 78 patients with HR positive HER-2 negative advanced breast cancer who underwent palbociclib and endocrine combination therapy at Tianjin Medical University Cancer Institute and Hospital from September 2018 to December 2019. The efficacy and safety of this combination therapy was analyzed. Results: Median age of patients was 58 years, median progression-free survival(PFS) was 7 months,and overall objective response rate(ORR) was 36.7%(22/60). The clinical benefit rate(CBR) was 73.3%(44/60), and the ORR of previous palliative treatment,<2 lines or ≥2 lines, was 71.4%(20/28) and 6.3%(2/32)(P<0.001), respectively. Analysis showed that the number of metastatic sites and previous palliative treatment lines, and whether palliative chemotherapy was performed were independent factors influencing the efficacy of palbociclib and endocrine therapy. Neutropenia was the most common adverse event, affecting96.2% of patients(75/78), with grade 3-4 neutropenia accounting for 62.8%(49/78) of all cases. Grade 3-4 leukopenia/neutropenia was evident in 14.1%(11/78) of patients, all of whom underwent dose adjustments. The most common non-hematological adverse event was fatigue, occurring in 23.1%(18/78) of cases. The rate of discontinuation due to adverse events was 7.7%(6/78). Conclusions: Palbociclib combined with endocrine therapy is more suitable for patients who have not received palliative chemotherapy. Adverse events can be controlled, and it may have a better curative effect than palliative chemotherapy.更多还原