Results
toxicities
ADVERSE EVENTS
Baseline characteristics and prior therapy patterns were generally well balanced between trifluridine/tipiracil and placebo arms across subgroups. Trifluridine/tipiracil was associated with survival benefits versus placebo regardless of prior treatment: across subgroups, median overall survival was 4.6–6.1 versus 3.0–3.8 months (hazard ratios, 0.47–0.88), median progression-free survival was 1.9–2.3 versus 1.7–1.8 months (hazard ratios, 0.49–0.67), and median time to ECOG PS ≥ 2 was 4.0–4.7 versus 1.9–2.5 months (hazard ratios, 0.56–0.88). Among trifluridine/tipiracil-randomized patients, median overall and progression-free survival trended longer in those who had not received ramucirumab, paclitaxel and ramucirumab, or irinotecan (6.0–6.1 and 2.1–2.3 months, respectively) than in those who previously received these agents (4.6–5.7 and 1.9 months). The trifluridine/tipiracil safety profile was consistent across subgroups, with similar overall incidences of grade ≥ 3 adverse events. Minor variations in hematologic toxicities were noted.