Trifluridine/tipiracil (FTD/TPI) is a combination drug used as a third- or fourth-line treatment of metastatic colorectal cancer (gastric cancer [mGC]) or gastroesophageal junction cancer (GEJC). Patients who have undergone gastrectomy comprise a substantial proportion of patients with mGC or GEJC. This study aims to examine the safety and efficacy of FTD/TPI in patients with previously treated mGC or GEJC.
This preplanned subgroup analysis of a randomized, phase-3 trial included a total of 507 patients with mGC/GEJC who had received at least 2 previous chemotherapy regimens. The patients were randomly assigned in a 1:1 ratio to receive oral FTD/TPI or placebo twice daily. The primary outcome of the study was overall survival.
Of 507 patients, 221 (43.6%) had undergone gastrectomy, and 286 (56.4%) had not undergone gastrectomy. In the gastrectomy, the hazard ratio for overall survival in FTD/TPI group versus the placebo group was 0.57, and the progression-free survival was 0.48. For those who did not undergo gastrectomy, the HR for overall survival in the FTD/TPI versus placebo group was 0.80, and the HR for progression-free survival was 0.65.
The research concluded that FTD/TPI treatment in patients with mGC/GEJC was effective and well-tolerated regardless of the previous gastrectomy.