RECOURSE

NCT01607957 📎

Regimen

Experimental
Trifluridine/tipiracil (TAS-102) 35 mg/m² BID days 1–5 and 8–12 Q28D + BSC
Control
Placebo + BSC

Population

Metastatic CRC, 3L+, previously treated with fluoropyrimidine/oxaliplatin/irinotecan ± anti-VEGF ± anti-EGFR (RAS WT).

Key finding

3L+ mCRC (post-fluoropyrimidine+oxaliplatin+irinotecan±anti-VEGF±anti-EGFR): mOS 7.1 vs 5.3 mo (HR 0.68, 95% CI 0.58-0.81, p<0.001); mPFS 2.0 vs 1.7 mo (HR 0.48, p<0.001); ORR 1.6% vs 0.4%; DCR 44% vs 16% (p<0.001); key toxicities: neutropenia grade 3-4 38%, anemia 18%

Source: PMID 25970050

Timeline

    Guideline citations

    • NCCN Colon (p.46)
    • NCCN Rectal (p.63)