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Ramucirumab/Docetaxel Significantly Improves PFS, Not OS, in Urothelial Carcinoma

Urothelial carcinoma.

In previous studies, ramucirumab plus docetaxel has been shown to improve progression-free survival in platinum-refractory, advanced urothelial carcinoma. To add to this research, investigators conducted a study to determine overall survival results of ramucirumab/docetaxel after receiving platinum-based therapy.

In this randomized, double-blind, phase 3 trial, 530 patients with advanced or metastatic urothelial carcinoma who experienced disease progression during or after platinum-based chemotherapy were enrolled. In a 1:1 ratio, patients were administered either intravenous ramucirumab at a dose of 10 mg/kg or placebo. Both groups also received intravenous docetaxel at a dose of 75 mg/m2 on day 1 of a 21-day cycle.

After a median follow-up of 7.4 months, results revealed that median progression-free survival remained significantly improved with ramucirumab compared with placebo (4.1 months vs 2.8 months). In addition, median overall survival was 9.4 months in the ramucirumab group and 7.9 months in the placebo group. However, this improvement in overall survival did not reach statistical significance.

Among all of the grade 3 and greater adverse events, those that occurred in ≥5% of patients and had a 2% higher incidence in the ramucirumab group included febrile neutropenia and neutropenia. The incidence of grade 3 or higher febrile neutropenia was higher in the ramucirumab arm versus placebo (9% vs 6%). Neutropenia incidence was also higher in the ramucirumab arm compared with the placebo arm (7% vs 2%).

The study authors, led by Daniel Petrylak, MD, Professor of Medicine and Urology at Yale School of Medicine, conclude, "Additional follow-up supports that ramucirumab plus docetaxel significantly improves progression-free survival, without a significant improvement in overall survival, for patients with platinum-refractory advanced urothelial carcinoma. Clinically meaningful benefit might be restricted in an unselected population."

For More Information

Petrylak DP, Wit RD, Chi KN, et al (2019). Ramucirumab plus docetaxel versus placebo plus docetaxel in patients with locally advanced or metastatic urothelial carcinoma after platinum-based therapy (RANGE): overall survival and updated results of a randomized, double-blind, phase 3 trial. Lancet Oncol. [Epub ahead of print] DOI:10.1016/S1470-2045(19)30668-0

Image Courtesy of Wikimedia Commons. Licensed under CC BY-SA 3.0


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