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Randomized phase III trial of gemcitabine and cisplatin with bevacizumab or placebo in patients with advanced urothelial carcinoma: Results of CALGB 90601 (Alliance)

Journal of Clinical Oncology May 28, 2021

Rosenberg JE, Ballman KA, Halabi S, et al. - A randomized placebo-controlled trial was designed to evaluate if individuals treated with GC and bevacizumab (GCB) have superior overall survival (OS) than patients treated with GC and placebo (GCP). Researchers recruited a total of 506 patients. Individuals with metastatic urothelial carcinoma without prior chemotherapy for metastatic disease and no neoadjuvant or adjuvant chemotherapy within 12 months were allocated randomly to receive either GCB or GCP between July 2009 and December 2014. The primary outcome included OS. Points of progression-free survival, objective response, and toxicity were considered as secondary outcomes. It was shown that the addition of bevacizumab to GC did not result in improved OS. The results showed that observed median OS of about 14 months is consistent with prior phase III trials of cisplatin-based chemotherapy.

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