美国西北大学Daniela Matei团队，研究了辅助化疗联合放射治疗局部晚期子宫内膜癌是否可以取得新突破。这一研究成果于2019年6月13日发表在国际顶尖学术期刊《新英格兰医学杂志》上。

在这项随机3期临床试验中，研究团队测试了在III期或IVA子宫内膜癌患者中，6个月的铂类化疗联合放疗（化学放射治疗）与6个周期的单纯联合化疗相比，患者是否取得更长的无复发生存期（主要终点）。次要终点包括总体存活率，急慢性毒副作用以及患者生活质量。在招募的813例患者中，736例符合入选条件并纳入无复发生存分析，其中707例接受随机分配的干预治疗（346例接受化学放射治疗，361例仅接受化疗）。中位随访期为47个月。在60个月时，Kaplan-Meier评估患者存活及无复发比例，化学放射治疗组为59% (95%置信区间 [CI], 53 ~ 65)，单纯化疗组为58% (95%置信区间, 53 ~64) (风险比0.90; 90% CI, 0.74 ~ 1.10)。化学放射治疗与5年阴道复发率 (2% vs. 7%; 风险比, 0.36; 95% CI, 0.16 ~ 0.82)，盆腔及主动脉旁淋巴结复发率 (11% vs. 20%, 风险比,0.43; 95% CI, 0.28 ~ 0.66) 较低相关，但远端复发在化学放射治疗中更为常见 (27% vs. 21%; 风险比,1.36; 95% CI, 1.00 ~ 1.86)。化学放射治疗组发生3、4、5级不良反应事件202例 (58%)，单纯化疗组发生不良反应事件227例 (63%)。因此，在III期或IVA子宫内膜癌患者中，化疗联合放疗与单独化疗相比未取得更长的无复发生存期。

据悉，III期或IVA期子宫内膜癌有明显的局部复发和系统性转移风险。

附：英文原文

Title: Adjuvant Chemotherapy plus Radiation for Locally Advanced Endometrial Cancer

Author:Daniela Matei, M.D., Virginia Filiaci, Ph.D., Marcus E. Randall, M.D., David Mutch, M.D., Margaret M. Steinhoff, M.D., Paul A. DiSilvestro, M.D., Katherine M. Moxley, M.D., Yong M. Kim, M.D., Ph.D., Matthew A. Powell, M.D., David M. O’Malley, M.D., Nick M. Spirtos, M.D., William Small, Jr., M.D., Krishnansu S. Tewari, M.D., William E. Richards, M.D., John Nakayama, M.D., Ursula A. Matulonis, M.D., Helen Q. Huang, M.S., and David S. Miller, M.D.

Issue&Volume: VOL. 380 NO. 24, 2019

Abstract:

BACKGROUND
Stage III or IVA endometrial cancer carries a significant risk of systemic and locoregional recurrence.
METHODS
In this randomized phase 3 trial, we tested whether 6 months of platinum-based chemotherapy plus radiation therapy (chemoradiotherapy) is associated with longer relapse-free survival (primary end point) than six cycles of combination chemotherapy alone in patients with stage III or IVA endometrial carcinoma. Secondary end points included overall survival, acute and chronic toxic effects, and quality of life.
RESULTS
Of the 813 patients enrolled, 736 were eligible and were included in the analysis of relapse-free survival; of those patients, 707 received the randomly assigned intervention (346 received chemoradiotherapy and 361 received chemotherapy only). The median follow-up period was 47 months. At 60 months, the Kaplan–Meier estimate of the percentage of patients alive and relapse-free was 59% (95% confidence interval [CI], 53 to 65) in the chemoradiotherapy group and 58% (95% CI, 53 to 64) in the chemotherapy-only group (hazard ratio, 0.90; 90% CI, 0.74 to 1.10). Chemoradiotherapy was associated with a lower 5-year incidence of vaginal recurrence (2% vs. 7%; hazard ratio, 0.36; 95% CI, 0.16 to 0.82) and pelvic and paraaortic lymph-node recurrence (11% vs. 20%; hazard ratio, 0.43; 95% CI, 0.28 to 0.66) than chemotherapy alone, but distant recurrence was more common in association with chemoradiotherapy (27% vs. 21%; hazard ratio, 1.36; 95% CI, 1.00 to 1.86). Grade 3, 4, or 5 adverse events were reported in 202 patients (58%) in the chemoradiotherapy group and 227 patients (63%) in the chemotherapy-only group.
CONCLUSIONS
Chemotherapy plus radiation was not associated with longer relapse-free survival than chemotherapy alone in patients with stage III or IVA endometrial carcinoma.

DOI: 10.1056/NEJMoa1813181

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1813181