Multicenter phase 2 trial of later-line trifluridine/tipiracil plus ramucirumab for advanced gastric cancer

Trifluridine/tipiracil (FTD/TPI) plus ramucirucimab may improve survival as later-line therapy for advanced gastric cancer; however, prospective evidence is limited. A multicenter phase 2 trial in Japan evaluated this combination in patients with unresectable or recurrent gastric or gastroesophageal junction adenocarcinoma who had received at least two previous systemic regimens for advanced disease, including a ramucirumab-containing regimen.The primary endpoint was time to treatment failure. Among 32 enrolled patients (median age 72.5 years; 53% male), median time to treatment failure was 4.0 months (95% CI 2.8-5.0), meeting the primary endpoint. Median progression-free survival and overall survival were 4.8 months (95% CI 2.8-8.3) and 12.2 months (7.8-17.2). Among 26 patients with measurable disease, objective response rate was 11.5% and disease control rate was 76.9%. Mean relative dose intensity was 78.6% for FTD/TPI and 93.1% for ramucirumab, supporting feasibility in this cohort. Grade ≥ 3 neutropenia occurred in 53.1% and febrile neutropenia in 9.4%. Frequent nonhematologic events were anorexia and fatigue, mostly grade 1 or 2. The authors conclude that FTD/TPI plus ramucirumab met its primary endpoint and was feasible with manageable safety in heavily pretreated advanced gastri cancer.