Maintenance capecitabine after first-line platinum-based chemotherapy in advanced oesophagogastric adenocarcinoma: final analysis from the PLATFORM trial

TY - JOUR

T1 - Maintenance capecitabine after first-line platinum-based chemotherapy in advanced oesophagogastric adenocarcinoma

T2 - final analysis from the PLATFORM trial

AU - Gordon, Anderley

AU - Tran, Amina

AU - Fong, Caroline

AU - Cromarty, Susan

AU - Piadel, Katarzyna

AU - Zhitkov, Oleg

AU - Leamon, Becky

AU - Cafferkey, Catherine

AU - Davidson, Michael

AU - Das, Prantik

AU - Petty, Russell

AU - Roques, Tom

AU - Hewish, Madeleine

AU - Morgan, Carys

AU - Waddell, Tom

AU - Darby, Suzanne

AU - Bradshaw, Alexander

AU - Rao, Sheela

AU - Starling, Naureen

AU - Chau, Ian

AU - Cunningham, David

N1 - Publisher Copyright: © The Author(s) 2026.

PY - 2026/4/21

Y1 - 2026/4/21

N2 - Background: PLATFORM is an adaptive phase II trial assessing maintenance therapies in advanced oesophagogastric adenocarcinoma (OGA). We evaluated maintenance capecitabine in patients with disease control after first-line chemotherapy. Methods: HER2-negative patients with advanced OGA who had response or stable disease after 18 weeks of first-line chemotherapy were randomised (1:1) to surveillance or capecitabine. The primary endpoint was progression-free survival (PFS); secondary endpoints included overall survival (OS) and safety. Results: Between May 2015 and May 2024, 266 patients were randomised (129 surveillance, 137 capecitabine). Median follow up was 70.7 months. Capecitabine significantly improved PFS (HR 0.69; 95% CI 0.54–0.89; p = 0.002), with median PFS of 5.0 vs 2.8 months. One-year PFS rates were 19.9% vs 6.8%; and two-year rates 8.1% vs 4.3%. No OS difference was observed (median OS: 10.5 vs 10.0 months; HR 0.87; 95% CI 0.67–1.12; p = 0.143). One and two-year OS rates were similar (1-year: 44.1% vs 45.7%; 2-year: 18.8% vs 16.8%). Grade ≥3 adverse events were more frequent with capecitabine (46% vs 29%), with 21% experiencing grade 3 treatment related events. Discussion: Maintenance capecitabine significantly prolonged PFS compared to surveillance, meeting the primary endpoint and supporting its use to extend disease control in advanced OGA.

AB - Background: PLATFORM is an adaptive phase II trial assessing maintenance therapies in advanced oesophagogastric adenocarcinoma (OGA). We evaluated maintenance capecitabine in patients with disease control after first-line chemotherapy. Methods: HER2-negative patients with advanced OGA who had response or stable disease after 18 weeks of first-line chemotherapy were randomised (1:1) to surveillance or capecitabine. The primary endpoint was progression-free survival (PFS); secondary endpoints included overall survival (OS) and safety. Results: Between May 2015 and May 2024, 266 patients were randomised (129 surveillance, 137 capecitabine). Median follow up was 70.7 months. Capecitabine significantly improved PFS (HR 0.69; 95% CI 0.54–0.89; p = 0.002), with median PFS of 5.0 vs 2.8 months. One-year PFS rates were 19.9% vs 6.8%; and two-year rates 8.1% vs 4.3%. No OS difference was observed (median OS: 10.5 vs 10.0 months; HR 0.87; 95% CI 0.67–1.12; p = 0.143). One and two-year OS rates were similar (1-year: 44.1% vs 45.7%; 2-year: 18.8% vs 16.8%). Grade ≥3 adverse events were more frequent with capecitabine (46% vs 29%), with 21% experiencing grade 3 treatment related events. Discussion: Maintenance capecitabine significantly prolonged PFS compared to surveillance, meeting the primary endpoint and supporting its use to extend disease control in advanced OGA.

UR - https://www.scopus.com/pages/publications/105036181449

U2 - 10.1038/s41416-026-03448-4

DO - 10.1038/s41416-026-03448-4

M3 - Article

C2 - 42014556

AN - SCOPUS:105036181449

SN - 0007-0920

JO - British Journal of Cancer

JF - British Journal of Cancer

ER -