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Randomized Controlled Trial
. 2006 Aug 7;95(3):266-71.
doi: 10.1038/sj.bjc.6603279. Epub 2006 Jul 25.

Adjuvant chemotherapy vs radiotherapy in high-risk endometrial carcinoma: results of a randomised trial

R Maggi  1 , A Lissoni, F Spina, M Melpignano, P Zola, G Favalli, A Colombo, R Fossati
Affiliations
Randomized Controlled Trial

Adjuvant chemotherapy vs radiotherapy in high-risk endometrial carcinoma: results of a randomised trial

R Maggi et al. Br J Cancer. .

Abstract

Patients with high-risk endometrial carcinoma (stage IcG3, IIG3 with myometrial invasion >50%, and III) receive adjuvant therapy after surgery but it is not clear whether radiotherapy (RT) or chemotherapy (CT) is better. We randomly assigned 345 patients with high-risk endometrial carcinoma to adjuvant CT (cisplatin (50 mg m(-2)), doxorubicin (45 mg m(-2)), cyclophosphamide (600 mg m(-2)) every 28 days for five cycles, or external RT (45-50 Gy on a 5 days week(-1) schedule). The primary end points were overall and progression-free survival. After a median follow-up of 95.5 months women in the CT group as compared with the RT group, had a no significant hazard ratio (HR) for death of 0.95 (95% confidence interval (CI), 0.66-1.36; P = 0.77) and a nonsignificant HR for event of 0.88 (95% CI, 0.63-1.23; P = 0.45). The 3, 5 and 7-year overall survivals were 78, 69 and 62% in the RT group and 76, 66 and 62% in the CT group. The 3, 5 and 7-year progression-free survivals were, respectively, 69, 63 and 56 and 68, 63 and 60%. Radiotherapy delayed local relapses and CT delayed metastases but these trends did not achieve statistical significance. Overall, both treatments were well tolerated. This trial failed to show any improvement in survival of patients treated with CT or the standard adjuvant radiation therapy. Randomised trials of pelvic RT combined with adjuvant cytotoxic therapy compared with RT alone are eagerly awaited.

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Figures

Figure 1
Figure 1
Flow chart of the progress of patients through the trial (Adapted from Begg C, Cho M, Eastwood S, et al. proving the quality of reporting of randomised controlled trials: the CONSORT statement. JAMA 1996;276;637–639). * Lower risk profile=FIGO stage IaG1-3, IbG1-3, IcG1-2, IIaG1-2, IIbG1-2.
Figure 2
Figure 2
Overall survival of patients with high-risk endometrial carcinoma (stage IcG3, IIG3 with myometrial invasion >50%, and III) receiving adjuvant radiotherapy (Radio) or chemotherapy (Chemio). Five-year overall survival was 69% and 66% respectively for adjuvant radiotherapy and chemotherapy.
Figure 3
Figure 3
Progression-free survival of patients with high-risk endometrial carcinoma (stage IcG3, IIG3 with myometrial invasion >50%, and III) receiving adjuvant radiotherapy (Radio) or chemotherapy (Chemio). Five-year progression-free survival was 63% and 63%.
Figure 4
Figure 4
Cumulative incidence of distant relapses for patients with high-risk endometrial carcinoma (stage IcG3, IIG3 with myometrial invasion >50%, and III) receiving adjuvant radiotherapy (Radio) or chemotherapy (Chemo).
Figure 5
Figure 5
Cumulative incidence of local (central pelvic, including vaginal cuff recurrence, lateral pelvic and vaginal) relapses for patients with high-risk endometrial carcinoma (stage IcG3, IIG3 with myometrial invasion >50%, and III) receiving adjuvant radiotherapy (Radio) or chemotherapy (Chemo).
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