肿瘤预防与治疗2026，Vol.39Issue(2)：97-106,10.DOI:10.3969/j.issn.1674-0904.2026.02.003
伊立替康联合替莫唑胺在初治MGMT启动子未甲基化胶质母细胞瘤术后患者治疗中的疗效与安全性评估
Irinotecan plus Temozolomide in Newly Diagnosed Postoperative Glioblas-toma with Unmethylated MGMT Promoter:An Efficacy and Safety Study
摘要
Abstract
Objective:This study aims to retrospectively analyze and evaluate the impact of adding irinotecan(CPT-11)during concurrent chemoradiotherapy and adjuvant therapy phases on efficacy enhancement and safety in postoperative pa-tients with unmethylated O6-methylguanine-DNA methyltransferase(MGMT)promoter glioblastoma(GBM),thereby provi-ding evidence for optimizing treatment strategies for this patient population.Methods:This retrospective analysis included 46 patients with newly diagnosed,MGMT promoter-unmethylated GBM who underwent surgery at Sichuan Cancer Hospital be-tween January 2018 and November 2023.Patients were assigned to two groups according to the postoperative adjuvant regi-men:Group A(n=24)received the standard STUPP protocol(temozolomide-based concurrent chemoradiotherapy followed by adjuvant temozolomide),and Group B(n=22)received the STUPP protocol with the addition of irinotecan(CPT-11).The primary endpoint was overall survival(OS).Secondary endpoints included progression-free survival(PFS)and the inci-dence of grade 3/4 adverse events.Results:With a median follow-up of 35.13 months(95%CI:24.28～45.99)until December 31,2024,the median OS(mOS)and median PFS(mPFS)were 18.27 months(95%CI:15.56～20.97)and 8.50 months(95%CI:6.99～10.01),respectively.Significant improvements in both mOS(22.60 vs 14.00 months;P=0.004)and mPFS(10.20 vs 6.50 months;P=0.005)were observed in Group B compared to Group A.Multivariate Cox regression identified the temozolomide-CPT-11 regimen as an independent protective factor for improved OS(HR=0.426,P=0.022)and PFS(HR=0.391,P=0.013).No significant grade 3 or 4 adverse events were reported in ei-ther group,including delayed diarrhea,neutropenia,or emesis.Conclusion:The combination of CPT-11 with the STUPP regimen represents a safe and effective therapeutic strategy for postoperative GBM patients harboring an unmethylated MGMT promoter.This approach is associated with extended PFS and OS,without a marked elevation in severe adverse events.This demonstrates that the combination therapy is a safe and effective treatment option for this patient population.关键词
胶质母细胞瘤/MGMT启动子未甲基化/伊立替康/疗效/安全性/放射治疗Key words
Glioblastoma/Unmethylated MGMT Promoter/Irinotecan/Efficacy/Safety/Radiotherapy分类
医药卫生引用本文复制引用
梁春梅,李益民,何思敏,范铭,徐珂,周行,郎锦义,阴骏..伊立替康联合替莫唑胺在初治MGMT启动子未甲基化胶质母细胞瘤术后患者治疗中的疗效与安全性评估[J].肿瘤预防与治疗,2026,39(2):97-106,10.基金项目
希思科-再鼎肿瘤治疗研究基金项目(2021年度)(编号:Y-zai2021/qn-0005) This study was supported by Beijing CSCO Clinical Oncology Research Foundation(No.Y-zai2021/qn-0005). （2021年度）
