Matei Daniela E, Enserro Danielle M, Randall Marcus E, Mutch David, Small William, DiSilvestro Paul A, Spirtos Nick M, O'Malley David M, Cantuaria Guilherme H, Michelin David, Waggoner Steven, Shahin Mark, Guntupalli Saketh, Lara Olivia, Ueland Frederick R, Warshal David, Bonebrake Albert, Tewari Krishnansu S, Tan Annie, Powell Matthew A, Walker Joan L, Santin Alessandro D, Kim Jong Hyeok, Miller David S
Northwestern University, Chicago, IL.
NRG Oncology Statistical and Data Center, Buffalo, NY.
J Clin Oncol. 2025 Mar 20;43(9):1055-1060. doi: 10.1200/JCO.24.01121. Epub 2024 Dec 19.
This randomized phase III trial aimed to determine whether treatment with cisplatin and volume-directed radiation followed by carboplatin and paclitaxel for four cycles (chemoradiotherapy [C-RT]) increased recurrence-free survival (RFS) and overall survival (OS) when compared with carboplatin and paclitaxel for six cycles (chemotherapy [CT]) in locally advanced endometrial cancer (UC). Previously reported results showed that C-RT did not improve RFS compared with CT. Here we report the final OS analysis. Patients with International Federation of Gynecology and Obstetrics (FIGO) 2009 stage III-IVA UC or stage I/II serous or clear cell UC and positive cytology were enrolled. The primary objective was RFS. Secondary objectives were OS, toxicity, and quality of life. Cumulative probabilities of OS were estimated using the Kaplan-Meier method. Subgroup analyses of treatment effect for FIGO stage, age, race, gross residual disease, histology, lymph-vascular space invasion, and body mass index were performed. In total, 813 patients were randomly assigned (407 C-RT and 406 CT). The median follow-up was 112 months. Median OS was not achieved in either arm. The stratified hazard ratio for death comparing C-RT versus CT was 1.05 (95% CI, 0.82 to 1.34, log-rank two-sided value = .72). None of the factors analyzed predicted OS benefit from C-RT. Although C-RT reduced the rate of local recurrence compared with CT, it did not increase OS or RFS in stage III/IVA UC.
这项随机III期试验旨在确定，对于局部晚期子宫内膜癌（UC）患者，与六个周期的卡铂和紫杉醇化疗（CT）相比，顺铂和容积引导放疗后再进行四个周期的卡铂和紫杉醇化疗（放化疗[C-RT]）是否能提高无复发生存期（RFS）和总生存期（OS）。先前报告的结果显示，与CT相比，C-RT并未改善RFS。在此我们报告最终的OS分析结果。入组患者为国际妇产科联盟（FIGO）2009分期III-IVA期UC或I/II期浆液性或透明细胞UC且细胞学检查阳性的患者。主要终点为RFS。次要终点为OS、毒性和生活质量。采用Kaplan-Meier方法估计OS的累积概率。对FIGO分期、年龄、种族、大体残留病灶、组织学类型、淋巴血管间隙侵犯和体重指数进行治疗效果的亚组分析。总共813例患者被随机分组（407例接受C-RT，406例接受CT）。中位随访时间为112个月。两组均未达到中位OS。比较C-RT与CT的死亡分层风险比为1.05（95%CI，0.82至1.34，对数秩检验双侧P值=.72）。所分析的因素均未预测C-RT对OS有获益。虽然与CT相比，C-RT降低了局部复发率，但在III/IVA期UC中，它并未提高OS或RFS。
