CDK4/6抑制剂剂量优化策略在HR+/HER2-晚期乳腺癌中疗效与安全性的Meta分析

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【中图分类号】R737.9；R956 【文献标识码】A

Efficacy and safety of dose-optimization strategies for CDK4/6 inhibitors in HR+1 HER2-advanced breast cancer：a Meta-analysis

ZHENG Yating1，LIU Songling²， ZHOU Liyan³

1.Departmentof Pharmacy， Qingdao Municipal Hospital， Qingdao 266o11，Shandong Province， China 2. Department of Breast Surgery， Qingdao Central Hospital， University of Health and Rehabilitation Sciences，Qingdao266ooo，ShandongProvince，China

3.Department of Obstetrical， Qingdao Eighth People's Hospital， Qingdao 266ooo，Shandong Province， China

Corresponding author： ZHOU Liyan， Email： liyanzhou1972@163.com

【Abstract】 Objective To systematically review the efficacy and safety of reduced versus standard dosesofCDK4/6 inhibitorsin patientswith HR .+ /HER2-advanced breastcancer.Methods PubMed， Web of Science， Cochrane Library， Embase， CNKI， WanFang Data， VIP， databases were electronically searched to collect randomized controlled trials （RCTs） on HR+/ HER2-advanced breast cancer patients treated with reduction of CDK4/6 inhibitor dose and standard dose from inception to April 1，2025. Two reviewers independentlyscreened the literature，extracteddata，andassessed the riskof biasof the included studies.Meta-analysis was performed using RevMan 5.1 software.Results A total of 14 RCTs involving 4，958 patients were included.The results ofMeta-analysis showed that there was no statistically signifcant diference in PFS[HR .=1.01 ， 95%CI （0.92，1.11）， P=0.81 ]and Os[HR =0.78 ！ 95%CI （0.52，1.18）， P=0.25 inthedose-reduced group and the standard dose group， while ORR [RR ， 95%CI （0.71， 0.96）， P=0.01 l and incidence of grade 3 and above neutropenia [RR .=0.42 ， 95%CI （0.21， 0.85）， P=0.02 ] in the dose-reduced group were significantly better than those in the standard dose group. Conclusions Currnt evidence shows that the dose reduction of CDK4/6 inhibitors can considerably reduce the incidence of grade 3 and above neutropenia without affecting PFS and OS.

【Keywords】CDK4/6 inhibitor; HR+， /HER2- breast cancer; Dose-optimization; Meta-analysis

激素受体阳性（hormone receptor + ， HR+ ） 1 人表皮生长因子受体2阴性（humanepidermalgrowth factor receptor 2- ，HER2-）乳腺癌是临床最常见的乳腺癌亚型，约占全部病例的60%～70%[1-2] 。（剩余16719字）