Ramucirumab Improves Survival in Gastric Cancer

The prior REGARD trial (NEJM JW Oncol Hematol Oct 28 2013) showed that ramucirumab — a vascular endothelial growth factor receptor-2 (VEGFR-2)-blocking antibody — improved overall survival (OS), progression-free survival (PFS), and disease control compared with best supportive care in patients with gastric cancer progressing on first-line chemotherapy.

Now, investigators report results of the industry-sponsored, international, randomized, double-blind, placebo-controlled, phase III RAINBOW trial of second-line paclitaxel with or without ramucirumab in 665 patients with metastatic gastric or gastro-esophageal junction adenocarcinoma. Eligible patients had experienced disease progression after fluorinated pyrimidine/platinum chemotherapy. A majority of patients had gastric cancer (79%–80%), were younger than 65 (62%–63%), and had disease progression within 6 months after first-line chemotherapy (76%); a minority had prior gastrectomy (38%–40%).

At a median follow-up of 7.9 months, OS (the primary endpoint) was improved with the addition of ramucirumab to paclitaxel (9.6 vs. 7.4 months; hazard ratio, 0.81; P=0.017). PFS was also improved (4.4 vs. 2.9 months; HR, 0.64; P<0.0001), as were objective response rate (28 vs. 16%; P=0.0001) and disease control (80% vs. 64%; P<0.0001). Ramucirumab resulted in more grade 3/4 fatigue (12% vs. 5%), neutropenia (41% vs. 19%), and hypertension (14% vs. 2%).