Rutika Mehta, MB, BS, MD, MPH
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SUMMARY
This post hoc analysis of the Phase 3 RATIONALE‑305 trial evaluated quality‑of-life adjusted survival in patients with advanced gastric or gastroesophageal junction adenocarcinoma with peritoneal metastasis who received first‑line tislelizumab plus chemotherapy or placebo plus chemotherapy. The analysis used long‑term follow‑up data with a minimum follow‑up of 3.0 years and a data cutoff of February 28, 2024, applying the Quality‑adjusted Time Without Symptoms or Toxicity (Q‑TWiST) methodology. At a maximum follow‑up of 57 months in the overall randomized population, patients treated with tislelizumab plus chemotherapy (n=501) had longer mean quality‑of-life adjusted overall survival than those receiving placebo plus chemotherapy (n=496) (16.3 vs 13.1 months). Among patients with peritoneal metastasis, mean quality‑of-life adjusted overall survival was higher with tislelizumab plus chemotherapy (n=220) compared with placebo plus chemotherapy (n=214) (13.4 vs 10.8 months), corresponding to a 17.7% relative Q‑TWiST gain. Quality‑of-life adjusted survival benefit was also reported in patients who received tislelizumab plus chemotherapy with peritoneal metastasis with PD‑L1 TAP score ≥1% (16.8% gain) and ≥5% (33.0% gain) compared with placebo plus chemotherapy.
ClinicalTrials.gov ID: NCT03777657
Hugh Giovinazzo, PharmD, PhD
Elena Elimova, MD
Judith Raimbourg, MD, PhD
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