- 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.
- 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.
- 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%).
- The study did not include patients treated with a taxane.