Metastatic gastric cancer: trifluridine/tipiracil does well in phase 3 trial

  • Lancet Oncol

  • curated by Kelli Whitlock Burton
  • Univadis Clinical Summaries
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Takeaway

  • 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.

Study design

  • 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.

Key results

  • 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.

Limitations

  • Some patients with HER2-positive tumors had not received prior anti-HER2 therapy.

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