哌柏西利在激素受体阳性晚期乳腺癌的疗效及安全性评价  

Efficacy and safety of palbociclib for hormone receptor-positive advanced breast cancer

作　　者：朱志敏 朱琼妮 ZHU Zhi-min;ZHU Qiong-ni(Department of Pharmaceutics,Shanghai Eighth People’s Hospital,SHANGHAI 200235,China;Department of Pharmacy,Ruijin Hospital,Shanghai Jiao Tong University School of Medicine,SHANGHAI 200025,China)

机构地区：[1]上海市第八人民医院药剂科,上海200235 [2]上海交通大学医学院附属瑞金医院药学部,上海200025

出　　处：《中国新药与临床杂志》2025年第3期195-199,共5页Chinese Journal of New Drugs and Clinical Remedies

基　　金：上海市青年科技英才扬帆计划项目(20YF1427000);中华医学会临床药学分会临床药学科研基金课题(Z-2021-46-2101-2023)。

摘　　要：目的评价真实世界哌柏西利治疗激素受体阳性(HR^(+))晚期乳腺癌的疗效和安全性,分析影响哌柏西利全疗程用药的因素。方法回顾性分析2021年1月1日至2021年12月31日接受哌柏西利治疗的HR^(+)晚期乳腺癌患者病历资料,收集其HR表达情况、患者用药及安全性信息,根据实体瘤的疗效评价标准进行疗效评估,参照美国国立癌症研究所不良事件通用标准进行不良反应分级,应用Log-rank检验进行组间分析评估影响哌柏西利疗效的因素。结果晚期乳腺癌患者接受哌柏西利治疗前行化疗较未行化疗的中位无进展生存期缩短(6个月vs.32个月,Log-rank P=0.047)。哌柏西利治疗相关不良反应的初次发生多集中在第一个治疗周期(34/49,69%),其中86%(42/49)的患者发生了Ⅲ级以上不良反应。29%的患者在用药过程中因耐受性不佳降低用药剂量,9例(14%)患者因经济原因停药。结论哌柏西利治疗HR^(+)晚期乳腺癌的临床疗效肯定,不良反应、药物经济性及患者依从性等是影响患者完成全疗程用药的主要因素。AIM To evaluate the efficacy and safety of palbociclib in the treatment of hormone receptor-positive(HR^(+))advanced breast cancer in the real world,and to analyze the factors influencing the full-course administration of palbociclib.METHODS A retrospective analysis was conducted on cases of advanced breast cancer patients treated with palbociclib at our hospital from January 1,2021 to December 31,2021.Data including HR expression status,medication adherence,and safety information were collected.Therapeutic efficacy was evaluated according to the Response Evaluation Criteria in Solid Tumors,and adverse reactions were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events.The Log-rank test was applied for intergroup analysis to assess factors affecting the efficacy of palbociclib.RESULTS The results showed that before palbociclib treatment,the median progression-free survival(mPFS)of patients who received chemotherapy due to metastasis was shorter than patients who did not receive chemotherapy(6 months vs.32 months,Log-rank P=0.047).The initial incidence of significant adverse reactions predominantly manifested during the first treatment cycle,accounting for 69%(34 out of 49)of cases.Among these,86%(42 out of 49)of patients experienced adverse reactions of gradeⅢor higher severity.Furthermore,29%of patients required a reduction in drug dosage due to inadequate tolerance,while 9 cases(14%)discontinued the drug for financial reasons.CONCLUSION Palbociclib combined with endocrine therapy in the treatment of HR^(+)advanced breast cancer has a positive clinical effect and good safety.Adverse reactions,patients’medication compliance and drug economy are the factors that affect the patients’full course medication.

关 键 词：乳腺癌 哌柏西利 疗效 安全性 真实世界研究 

分 类 号：R979.1[医药卫生—药品]