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OA

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.