哌柏西利治疗激素受体阳性人类表皮生长因子受体2阴性晚期乳腺癌的疗效和安全性  

Efficacy and safety of palbociclib in the treatment of hormone receptor-positive human epidermal receptor 2-negative advanced breast cancer

作　　者：张珍[1] 刘雅娟[1] 丁玲玉 ZHANG Zhen;LIU Ya-juan;DING Ling-yu(Department of Oncology,Hangzhou Cancer Hospital,Hangzhou 310002,Zhejiang Province,China)

机构地区：[1]杭州市肿瘤医院肿瘤内科,浙江杭州310002

出　　处：《中国临床药理学杂志》2022年第21期2545-2549,共5页The Chinese Journal of Clinical Pharmacology

基　　金：国家自然基金青年科学基金资助项目(81903645);浙江省医药卫生科技计划基金资助项目(2020KY455)。

摘　　要：目的回顾性研究哌柏西利治疗激素受体阳性人类表皮生长因子受体2阴性(HR+/HER2-)晚期乳腺癌(BC)的疗效和安全性。方法将本院收治的135例HR+/HER2-晚期乳腺癌女性患者资料按照用药差异分为试验组(n=67)和对照组(n=68)。2组患者均接受常规内分泌治疗(氟维司群250 mg,qm),对照组在常规治疗的基础上口服来曲唑2.5 mg,qd;试验组在对照组的用药基础上增加哌柏西利125 mg,qd,口服。2组患者均以4周为1个疗程(哌柏西利治疗21 d后停药7 d;来曲唑持续治疗28 d),治疗6个疗程。比较2组患者的疗效、无进展生存期(PFS)、总生存期(OS);以Cox比例风险模型计算风险比,评估相关因素对患者生存期的影响;分析2组患者的药物不良反应发生情况。结果治疗后,对照组和试验组病情稳定患者分别为40例(58.82%)和54例(80.60%),疾病进展患者分别为28例(41.18%)和10例(14.93%),部分缓解患者分别为0例和3例(4.48%)。对照组和试验组的客观缓解率(ORR)分别为4.48%和0,临床受益率(CBR)分别为58.82%和85.08%,2组患者的CBR比较,差异有统计学意义(P<0.05)。根据截至2021年12月的随访数据分析,对照组和试验组的PFS中位数分别为11.00月(95%CI 8.40~13.61)和19.00月(95%CI 16.36~22.64);对照组和试验组的OS中位数分别为17.00月(95%CI 13.22~20.78)和25.00月(95%CI 22.18~27.81),2组患者PFS和OS比较,差异均有统计学意义(均P<0.05)。Cox分析显示,影响哌柏西利疗效的关键因素是患者的年龄,美国东部肿瘤协作组(ECOG)评分、肿瘤分级和复发情况。对照组和试验组的药物不良反应发生率分别为10.29%和20.90%,差异无统计学意义(P>0.05)。结论哌柏西利联合来曲唑是HR+/HER2-晚期乳腺癌内分泌治疗有效、安全、耐受性好的治疗方案,治疗可以显著提升患者的PFS和OS。Objective To retrospectively study the efficacy and safety of palbociclib in the treatment of hormone receptor-positive human epidermal receptor 2-negative(HR+/HER2-)advanced breast cancer(BC).Methods Totally 135 female patients with HR+/HER2-advanced BC admitted to our hospital were divided into the treatment group(n=67)and the control group(n=68)according to the difference in medication.Both groups received conventional endocrine therapy(fulvestrant 250 mg,qm).The control group received oral letrozole 2.5 mg,qd,based on standard treatment;the treatment group received oral palbociclib 125 mg,qd,based onthe control group.Patients in both groups were treated with a 4-week course(piperacillin was administered for 21 dand then discontinued for 7 d;letrozole was administered for 28 d)for 6 courses.The efficacy,progression-freesurvival(PFS),and overall survival(OS)of the two groups were compared;Cox proportional hazards modelcalculated the hazard ratio,and the influence of related factors on the survival of the patients was evaluated;theincidence of adverse reactions in the two groups was analyzed.Results After treatment,there were 40 cases(58.82%)and 54 cases(80.60%)patients with stable disease in the control group and treatment group,28 cases(41.18%)and 10 cases(14.93%)patients with progressive disease.There were 0 and 3 cases(4.48%)patientswith partial remission,respectively.The objective response rate(ORR)of the control and treatment groups were4.48%and 0,respectively;the clinical benefit rate(CBR)were 58.82%and 85.08%,respectively.There werestatistically significant difference in CBR between the two groups(P<0.05).According to the analysis of follow-updata up to December 2021,the median PFS of the control and treatment groups were 11.00 months(95%CI 8.40-13.61)and 19.00 months(95%CI 16.36-22.64),respectively;the median OS of patients were 17.00 months(95%CI 13.22-20.78)and 25.00 months(95%CI 22.18-27.81),respectively.The two groups had significantdifferences in PFS and OS(P<0.05).Cox analysis showed that the key

关 键 词：乳腺癌 激素受体阳性人类表皮生长因子受体2阴性 哌柏西利 无进展生存期 总生存期 

分 类 号：R979.1[医药卫生—药品]