Gastric/GEJ cancer: first-line ramucirumab fails in phase 3 RAINFALL

  • Lancet Oncol

  • curated by Jim Kling
  • Univadis Clinical Summaries
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Takeaway

  • Adding ramucirumab to front-line cisplatin plus fluoropyrimidine does not improve PFS or OS in gastric or gastroesophageal junction (GEJ) cancer, according to data from the phase 3 RAINFALL trial.

Why this matters

  • Ramucirumab efficacy as a second-line therapy suggests a change in the balance between proangiogenic and antiangiogenic factors after front-line therapy, or the potential evolution of tumors toward increased sensitivity to ramucirumab.

Study design

  • Double-blind trial of 645 patients at 126 centers in 20 countries, randomly assigned to receive cisplatin plus capecitabine in combination with ramucirumab or placebo.
  • Funding: Eli Lilly.

Key results

  • Ramucirumab was associated with better investigator-assessed PFS (adjusted HR, 0.756; P=.0022), but the benefit failed to achieve statistical significance in independent review.
  • Ramucirumab did not improve OS vs placebo (HR, 0.962; P=.68).
  • Frequency of neutropenia, anemia, and serious adverse events were similar between the 2 groups, but hypertension was more common in the ramucirumab group (10% vs 2%).

Limitations

  • The study did not include patients treated with a taxane.

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