Petrylak DP et al. -Threatments available for patients with platinum-refractory advanced or metastatic urothelial carcinoma are limited. The efficacy and safety of treatment with docetaxel plus either ramucirumab or placebo was determined in the current study, and shown to yield superior progression-free survival over chemotherapy.

Methods

• A randomised, double-blind, phase 3 trial was conducted in patients with advanced or metastatic urothelial carcinoma who progressed during or after platinum-based chemotherapy.
• Patients were enrolled from 124 sites in 23 countries.
• Patients were randomised to receive intravenous docetaxel (75 mg/m2) plus either intravenous ramucirumab (10 mg/kg) or matching placebo on day 1 of repeating 21-day cycles until disease progression.

Results

• 530 patients were randomly allocated to ramucirumab plus docetaxel (n=263) or placebo plus docetaxel (n=267).
• Progression-free survival was significantly longer in patients who received ramucirumab plus docetaxel versus placebo plus docetaxel (median, 4.07 months vs. 2·76 months; HR, 0.757).
• An objective response was achieved by 53 of 216 patients who received ramucirumab and 31 of 221 assigned placebo.