| Title: |
Adjuvant chemoradiotherapy versus radiotherapy alone in women with high-risk endometrial cancer (PORTEC-3): patterns of recurrence and post-hoc survival analysis of a randomised phase 3 trial |
| Authors: |
de Boer, SM; Powell, ME; Mileshkin, L; Katsaros, D; Bessette, P; Haie-Meder, C; Ottevanger, PB; Ledermann, JA; Khaw, P; D'Amico, R; Fyles, A; Baron, MH; Jürgenliemk-Schulz, IM; Kitchener, HC; Nijman, HW; Wilson, G; Brooks, S; Gribaudo, S; Provencher, D; Hanzen, C; Kruitwagen, RF; Smit, VTHBM; Singh, N; Do, V; Lissoni, A; Nout, RA; Feeney, A; Verhoeven-Adema, KW; Putter, H; Creutzberg, CL; McCormack, M; Whitmarsh, K; Allerton, R; Gregory, D; Symonds, P; Hoskin, PJ; Adusumalli, M; Anand, A; Wade, R; Stewart, A; Taylor, W; Lutgens, LCHW; Hollema, H; Pras, E; Snyers, A; Westerveld, GH; Jobsen, JJ; Slot, A; Mens, JM; Stam, TC; Van Triest, B; Van der Steen-Banasik, EM; De Winter, KAJ; Quinn, MA; Kolodziej, I; Pyman, J; Johnson, C; Capp, A; Fossati, R; Colombo, A; Carinelli, S; Ferrero, A; Artioli, G; Davidson, C; McLachlin, CM; Ghatage, P; Rittenberg, PVC; Souhami, L; Thomas, G; Duvillard, P; Berton-Rigaud, D; Tubiana-Mathieu, N |
| Publisher Information: |
ELSEVIER SCIENCE INC |
| Publication Year: |
2019 |
| Collection: |
The University of Melbourne: Digital Repository |
| Description: |
BACKGROUND: The PORTEC-3 trial investigated the benefit of combined adjuvant chemotherapy and radiotherapy versus pelvic radiotherapy alone for women with high-risk endometrial cancer. We updated the analysis to investigate patterns of recurrence and did a post-hoc survival analysis. METHODS: In the multicentre randomised phase 3 PORTEC-3 trial, women with high-risk endometrial cancer were eligible if they had International Federation of Gynaecology and Obstetrics (FIGO) 2009 stage I, endometrioid grade 3 cancer with deep myometrial invasion or lymphovascular space invasion, or both; stage II or III disease; or stage I-III disease with serous or clear cell histology; were aged 18 years and older; and had a WHO performance status of 0-2. Participants were randomly assigned (1:1) to receive radiotherapy alone (48·6 Gy in 1·8 Gy fractions given on 5 days per week) or chemoradiotherapy (two cycles of cisplatin 50 mg/m2 given intravenously during radiotherapy, followed by four cycles of carboplatin AUC5 and paclitaxel 175 mg/m2 given intravenously), by use of a biased coin minimisation procedure with stratification for participating centre, lymphadenectomy, stage, and histological type. The co-primary endpoints were overall survival and failure-free survival. Secondary endpoints of vaginal, pelvic, and distant recurrence were analysed according to the first site of recurrence. Survival endpoints were analysed by intention-to-treat, and adjusted for stratification factors. Competing risk methods were used for failure-free survival and recurrence. We did a post-hoc analysis to analyse patterns of recurrence with 1 additional year of follow-up. The study was closed on Dec 20, 2013; follow-up is ongoing. This study is registered with ISRCTN, number ISRCTN14387080, and ClinicalTrials.gov, number NCT00411138. FINDINGS: Between Nov 23, 2006, and Dec 20, 2013, 686 women were enrolled, of whom 660 were eligible and evaluable (330 in the chemoradiotherapy group, and 330 in the radiotherapy-alone group). At a median follow-up ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| ISSN: |
1470-2045 |
| Relation: |
https://hdl.handle.net/11343/250027 |
| Availability: |
https://hdl.handle.net/11343/250027 |
| Rights: |
https://creativecommons.org/licenses/by/4.0 ; CC BY |
| Accession Number: |
edsbas.AD27F18 |
| Database: |
BASE |