哌柏西利联合内分泌药物治疗激素受体阳性人表皮生长因子受体2阴性晚期乳腺癌的真实世界研究  

Clinical outcomes and toxicity in patients with hormone receptor-positive and HER-2 negative metastatic breast cancer treated with palbociclib and endocrine therapy:a real-world study

作　　者：袁渊[1] 彭颖 胡赛男[1] 钱瑜 张莉莉[1] Yuan Yuan;Peng Ying;Hu Sainan;Qian Yu;Zhang Lili(Department of Medical Oncology,Jiangsu Cancer Hospital,Jiangsu Institute of Cancer Research,the Affiliated Cancer Hospital of Nanjing Medical University,Nanjing 210009,China;Department of Medical Oncology,the Affiliated Cancer Hospital of Nanjing Medical University,Nanjing 210009,China)

机构地区：[1]江苏省肿瘤医院,江苏省肿瘤防治研究所,南京医科大学附属肿瘤医院内科,南京210009 [2]南京医科大学附属肿瘤医院内科,南京210009

出　　处：《中华肿瘤杂志》2022年第8期882-887,共6页Chinese Journal of Oncology

基　　金：江苏省青年医学人才计划(QNRC2016647)。

摘　　要：目的探讨哌柏西利联合内分泌药物治疗激素受体(HR)阳性人表皮生长因子受体2(HER-2)阴性晚期乳腺癌的疗效及安全性。方法收集2018年10月至2020年11月在江苏省肿瘤医院接受哌柏西利治疗的HR阳性HER-2阴性晚期乳腺癌患者95例,总结其近期疗效、远期疗效及不良反应,主要观察指标为无进展时间(PFS),次要观察指标为客观缓解率(ORR)、疾病控制率(DCR)、临床获益率(CBR)。采用Log rank检验和Cox比例风险回归模型分析患者PFS的影响因素。结果95例患者的ORR为29.5%(28/95),DCR为88.4%(84/95),CBR为72.6%(69/95),中位PFS为10.4个月。单因素分析显示,是否内脏转移、哌柏西利治疗线数和内分泌治疗敏感性与接受哌柏西利联合内分泌治疗后患者的PFS有关(均P<0.05)。多因素Cox回归分析显示,是否内脏转移、内分泌治疗敏感性是接受哌柏西利联合内分泌治疗后患者PFS的独立影响因素。与无内脏转移的患者相比,合并内脏转移患者的HR为3.118(95%CI:1.405~7.236);与内分泌治疗敏感患者相比,内分泌治疗原发性耐药和继发性耐药患者的HR分别为4.455(95%CI:1.380~14.385)和1.4566(95%CI:0.488~4.346)。主要不良反应为血液学毒性,主要表现为白细胞、中性粒细胞及血小板减少,发生率分别为78.9%(75/95)、85.3%(81/95)和72.6%(69/95),3~4级发生率分别为27.4%(26/95)、51.6%(49/95)和20.0%(19/95)。结论哌柏西利联合内分泌药物治疗HR阳性HER-2阴性晚期乳腺癌取得了良好的疗效,不良反应可控。Objective To demonstrate the clinical efficiency and safety of palbociclib combined with endocrine therapy in the treatment of hormone receptor(HR)positive and human epidermal growth factor receptor 2(HER-2)negative advanced breast cancer patients.Methods A total of 95 breast cancer patients with HR-positive/HER-2 negative underwent palbociclib combined with endocrine in Jiangsu Cancer Hospital from Octorber,2018 to Novermber,2020 were retrospectively recruited.The short-term and long-term efficacy and adverse reactions were summarized.The primary end point was progressive free survival(PFS)and the second end points were disease control rate(DCR),objective response rate(ORR),clinical benefit rate(CBR).Log rank test and Cox proportional hazards regression model were used to analyze the influencing factors of PFS in patients.Results The ORR,DCR and CBR of 95 patients were 29.5%,88.4%and 72.6%,respectively.The total median PFS for palbociclib plus endocrine therapy was 10.4 months.The univariate analysis showed that visceral metastasis,the line number of palbociclib treatment and the sensitivity of endocrine therapy were associated with the PFS of patients who received palbociclib combined with endocrine(P<0.05).The multivariate Cox regression analysis showed that the sensitivity of endocrine therapy and visceral metastasis were the independent influencing factors of PFS in patients receiving palbociclib combined with endocrine therapy.Compared with patients with visceral metastasis,HR of patients with non-visceral metastases was 3.118(95%CI:1.405-7.236).Compared with endocrine therapy sensitive patients,the HR of patients with primary and secondary resistance to endocrine therapy were 4.455(95%CI:1.380-14.385)and 1.4566(95%CI:0.488-4.346),respectively.The main adverse reaction was hematological toxicity.The leukopenia,neutrophilsand thrombocytopenia were main manifestations,which incidence rates were 78.9%(75/95),85.3%(81/95)and 72.6%(69/95),respectively and the incidence rates of grade 3 to 4 of these manifestatio

关 键 词：乳腺肿瘤 哌柏西利 内分泌治疗 激素受体 人表皮生长因子受体2 疗效 不良反应 

分 类 号：R737.9[医药卫生—肿瘤]