哌柏西利治疗激素受体阳性/人表皮生长因子受体2阴性晚期/转移性乳腺癌的临床研究分析

Clinical trial analysis of palbociclib in the treatment of hormone receptor positive/human epidermal growth factor receptor 2 negative advanced/metastatic breast cancer

目的 评价哌柏西利治疗激素受体阳性(HR+)/人表皮生长因子受体2阴性(HER2-)晚期/转移性乳腺癌的有效性、安全性和经济性。方法 系统检索PubMed、EmBase、Cochrane Library、知网、万方、维普等数据库和卫生技术评估相关网站,根据入选和排除标准筛选文献,通过分类、比较并定性描述入选文献研究结果的方法对哌柏西利治疗HR+/HER2-晚期或转移性乳腺癌的有效性、安全性和经济性进行分析。结果 共入选17篇文献,包括9篇系统评价/Meta分析、7篇经济学研究和1篇卫生技术评估报告。在有效性方面,在HR+/HER2-晚期/转移性乳腺癌的治疗中,哌柏西利+内分泌治疗(ET)与单纯ET或单药化疗相比,可以延长无进展生存期[风险比(HR)=0.52,95%置信区间(CI)=0.44~0.60],提高肿瘤客观缓解率。在安全性方面,哌柏西利增加了造血系统相关不良事件和恶心、腹泻、脱发等的发生风险。在经济性方面,哌柏西利联合来曲唑与单纯来曲唑治疗或瑞博西利联合来曲唑相比,不具有成本效果优势。结论 哌柏西利治疗HR+/HER2-晚期或转移性乳腺癌的有效性和安全性良好,但无明显经济学优势。

Objective To access the efficacy,safety and economy of palbociclib for the treatment of hormone receptor positive(HR+)/human epidermal growth factor receptor 2 negative(HER2-) advanced breast cancer.Methods PubMed,EmBase,Cochrane Library,China national knowledge infrastructure,VIP and WanFang,and health technology assessment(HTA) related websites were systematically searched,and literature was screened according to the inclusion and exclusion criteria.The efficacy,safety and economy of palbociclib for the treatment of HR+/HER2-advanced breast cancer were analyzed by the methods of classification,comparison and qualitative description of the research results.Results A total of 17 literature was included,9 systematic review/meta-analysis,7 pharmacoeconomic studies and 1 HTA report.In the part of effectiveness,compared to endocrine therapy(ET) or chemotherapy alone,palbociclib plus ET significantly improved progression-free survival [harzard ratio(HR)=0.52,95% confidence interval(CI)=0.44-0.60]and objective response rate in the treatment of HR +/HER2-advanced breast cancer.In the part of safety,the addition of palbociclib increased the incidences of the adverse events of hematopoietic system and nausea,diarrhea,alopecia.In the part of economy,compared to LET or RIB + LET,palbociclib + LET cannot be considered cost-effective for the treatment of patients with metastatic breast cancer.Conclusion Palbociclib has good effectiveness and safety in the treatment of HR +/HER2-advanced breast cancer,however,there is no obvious cost-effectiveness advantage of palbociclib.