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Clinical Trial
. 2019 Jun 13;380(24):2317-2326.
doi: 10.1056/NEJMoa1813181.

Adjuvant Chemotherapy plus Radiation for Locally Advanced Endometrial Cancer

Daniela Matei  1 , Virginia Filiaci  1 , Marcus E Randall  1 , David Mutch  1 , Margaret M Steinhoff  1 , Paul A DiSilvestro  1 , Katherine M Moxley  1 , Yong M Kim  1 , Matthew A Powell  1 , David M O'Malley  1 , Nick M Spirtos  1 , William Small Jr  1 , Krishnansu S Tewari  1 , William E Richards  1 , John Nakayama  1 , Ursula A Matulonis  1 , Helen Q Huang  1 , David S Miller  1
Affiliations
Clinical Trial

Adjuvant Chemotherapy plus Radiation for Locally Advanced Endometrial Cancer

Daniela Matei et al. N Engl J Med. .

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. (Funded by the National Cancer Institute; ClinicalTrials.gov number, NCT00942357.).

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Figures

Figure 1.
Figure 1.. Relapse-free Survival.
Tick marks indicate censored data.
Figure 2.
Figure 2.. Subgroup Analysis According to Recognized Prognostic Factors.
Stages were assigned according to the International Federation of Gynecology and Obstetrics (FIGO) 2009 classification; stages range from I to IV, with higher stages indicating more advanced spread of cancer. BMI denotes body-mass index.
Figure 3 (facing page).
Figure 3 (facing page).. Cumulative Risk of Recurrence.
The insets show the same data on an enlarged y axis.
See this image and copyright information in PMC

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