| Title: |
Adjuvant chemoradiotherapy versus radiotherapy alone in women with high-risk endometrial cancer (PORTEC-3): 10-year clinical outcomes and post-hoc analysis by molecular classification from a randomised phase 3 trial |
| Authors: |
Post, Cathalijne C B; de Boer, Stephanie M; Powell, Melanie E; Mileshkin, Linda; Katsaros, Dionyssios; Bessette, Paul; Leary, Alexandra; Ottevanger, Petronella B; McCormack, Mary; Khaw, Pearly; D'Amico, Romerai; Fyles, Anthony; Chargari, Cyrus; Kitchener, Henry C; Do, Viet; Lissoni, Andrea; Provencher, Diane; Genestie, Catherine; Nijman, Hans W; Whitmarsh, Karen; Jürgenliemk-Schulz, Ina M; Feeney, Amanda; Lutgens, Ludy C H W; Bouma, Jeanette; Leon-Castillo, Alicia; Nout, Remi A; Putter, Hein; Bosse, Tjalling; Creutzberg, Carien L |
| Contributors: |
Post, C; De Boer, S; Powell, M; Mileshkin, L; Katsaros, D; Bessette, P; Leary, A; Ottevanger, P; Mccormack, M; Khaw, P; D'Amico, R; Fyles, A; Chargari, C; Kitchener, H; Do, V; Lissoni, A; Provencher, D; Genestie, C; Nijman, H; Whitmarsh, K; Jürgenliemk-Schulz, I; Feeney, A; Lutgens, L; Bouma, J; Leon-Castillo, A; Nout, R; Putter, H; Bosse, T; Creutzberg, C |
| Publisher Information: |
GB; The Lancet Publishing Group |
| Publication Year: |
2025 |
| Collection: |
Università degli Studi di Milano-Bicocca: BOA (Bicocca Open Archive) |
| Subject Terms: |
High risk endometrial cancer; chemoradiotherapt; radiotherapy; molecular classification; Settore MEDS-21/A - Ginecologia e ostetricia; Settore MEDS-09/A - Oncologia medica; Settore MEDS-22/A - Diagnostica per immagini e radioterapia |
| Description: |
Background: The PORTEC-3 trial investigated the benefit of chemoradiotherapy versus pelvic radiotherapy alone for women with high-risk endometrial cancer. We present the preplanned long-term analysis of the randomised PORTEC-3 trial with a post-hoc analysis including molecular classification of the tumours. Methods: PORTEC-3 was an open-label, multicentre, randomised, international phase 3 trial. Women were eligible if they had high-risk endometrial cancer (either International Federation of Gynecology and Obstetrics 2009 stage I, grade 3, with deep myometrial invasion and/or lymphovascular space invasion; stage II–III; or stage I–III with serous or clear-cell histology), were aged 18 years or older, and had a WHO performance score of 0–2. Participants were randomly assigned (1:1) to receive pelvic radiotherapy (48·6 Gy in 1·8 Gy fractions) or chemoradiotherapy (radiotherapy combined with two cycles of cisplatin 50 mg/m2 intravenously in weeks one and four, followed by four cycles of carboplatin area-under-the-curve 5 and paclitaxel 175 mg/m2 intravenously at 3-week intervals). Randomisation was done by use of biased-coin minimisation with stratification for participating centre, lymphadenectomy, stage, and histological type. We report the primary outcomes of overall survival and recurrence-free survival at 10 years. We also report primary outcomes by molecular subgroup in a post-hoc analysis. Survival was analysed in the intention-to-treat population. The study is registered with ClinicalTrials.gov (NCT00411138) and is now complete. Findings: Between Nov 23, 2006, and Dec 20, 2013, 660 eligible and evaluable patients recruited at 103 centres in six clinical trial groups across seven countries were randomly assigned to chemoradiotherapy (n=330) or radiotherapy alone (n=330). Median follow-up was 10·1 years (IQR 9·8–11·0). Estimated 10-year overall survival was 74·4% (95% CI 69·8–79·4) in the chemoradiotherapy group and 67·3% (62·3–72·7) in the radiotherapy group (adjusted hazard ratio [HR] 0·73 [95% CI ... |
| Document Type: |
article in journal/newspaper |
| File Description: |
STAMPA |
| Language: |
English |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/40921169; info:eu-repo/semantics/altIdentifier/wos/WOS:001587922600021; volume:26; issue:10; firstpage:1370; lastpage:1381; numberofpages:12; journal:THE LANCET ONCOLOGY; https://hdl.handle.net/10281/566861 |
| DOI: |
10.1016/s1470-2045(25)00379-1 |
| Availability: |
https://hdl.handle.net/10281/566861; https://doi.org/10.1016/s1470-2045(25)00379-1 |
| Rights: |
info:eu-repo/semantics/openAccess ; license:Creative Commons ; license uri:http://creativecommons.org/licenses/by/4.0/ |
| Accession Number: |
edsbas.9D726F98 |
| Database: |
BASE |