Adjuvant Chemotherapy plus Radiation for Locally Advanced Endometrial Cancer
Adjuvant Chemotherapy plus Radiation for Locally Advanced Endometrial Cancer
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DOI：
10.1056/nejmoa1813181
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发表时间：
2019-06-13
影响因子：
158.5
通讯作者：
Miller, David S.
中科院分区：
文献类型：
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作者：
Matei, Daniela;Filiaci, Virginia;Miller, David S.
背景III期或IVA期子宫内膜癌具有显著的全身性和区域性复发风险。方法在这项随机的3期试验中，我们测试了在III期或IVA期子宫内膜癌患者中，以铂为基础的化疗加放射治疗(放化疗)6个月的无复发生存期(主要终点)是否比单纯联合化疗6个周期更长。次要终点包括总存活率、急性和慢性毒性影响以及生活质量。结果813例患者中，736例进入无复发生存分析，707例患者接受了随机分配的干预(346例接受放化疗，361例仅接受化疗)。中位随访期47个月。在60个月时，Kaplan-Meier估计放化疗组患者存活和无复发的百分比为59%(95%可信区间，53至65)，而单纯化疗组为58%(95%可信区间，53对)(风险比，0.9；90%可信区间，0.74至1.10)。与单纯化疗相比，放化疗组5年内阴道复发率(2%比7%；风险比0.36；95%CI，0.16~0.82)和盆腔及腹主动脉旁淋巴结复发(11%比20%；风险比0.43；95%CI，0.28~0.66)更低，但远处复发更常见(27%比21%；风险比1.36；95%CI，1.00~1.86)。放化疗组202名患者(58%)和单纯化疗组227名患者(63%)报告了3级、4级或5级不良事件。结论在III期或IVA期子宫内膜癌患者中，化疗加放疗与单纯化疗相比并不能延长无复发生存期。(由国家癌症研究所资助；ClinicalTrials.gov编号，NCT00942357。)
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. (Funded by the National Cancer Institute; ClinicalTrials.gov number, NCT00942357.)