- Trifluridine/tipiracil chemotherapy offered better OS and PFS than placebo in patients with heavily pretreated metastatic gastric adenocarcinoma (including adenocarcinoma of the gastroesophageal junction).
Why this matters
- Few treatment options exist for patients with metastatic gastric cancer that has progressed despite multiple rounds of treatment.
- Randomized, double-blind, multinational, placebo-controlled, phase 3 trial.
- 507 patients with advanced gastric cancer with disease progression after ≥2 rounds of chemotherapy received supportive care and trifluridine/tipiracil (n=337) or placebo (n=170).
- Median follow-up, 10.7 (interquartile range, 7.4-15.4) months.
- Funding: Taiho Oncology and Taiho Pharmaceutical.
- Median OS was 5.7 months in the trifluridine/tipiracil group vs 3.6 months in the placebo group (HR, 0.69; 95% CI, 0.56-0.85).
- Median PFS was 2.0 months in the trifluridine/tipiracil group vs 1.8 months with the placebo group (HR, 0.57; 95% CI, 0.47-0.70).
- Objective response was 4% in the treatment group vs 2% with placebo (P=.28).
- 44% of the treatment group achieved disease control vs 14% of the placebo group (P<.0001>
- Grade ≥3 adverse events (AEs) were seen in 80% of the treatment group vs 58% with placebo.
- Serious AEs of any cause reported in 43% of treatment group vs 42% with placebo.
- 1 treatment-related death in each group.
- Some patients with HER2-positive tumors had not received prior anti-HER2 therapy.