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CALGB 90601: Combination Gemcitabine and Cisplatin With Bevacizumab in Urothelial Carcinoma

By: Noelle Cutter, PhD
Posted: Monday, June 14, 2021

The standard treatment for patients with metastatic urothelial cancer is the combination of gemcitabine and cisplatin. Jonathan E. Rosenberg, MD, and colleagues from Memorial Sloan Kettering Cancer Center, New York, evaluated the impact of adding bevacizumab to the combination treatment and determined that it did not improve overall survival. Their results from the phase III CALGB 90601 trial were published in the Journal of Clinical Oncology.

“Although there was a modest improvement in progression-free survival, these results do not change the standard of care, which remains initiation of first-line therapy with cisplatin-based combination chemotherapy for medically eligible patients,” noted the authors.

The randomized clinical trial included a total of 506 patients with metastatic urothelial carcinoma assigned to receive either gemcitabine/cisplatin placebo or gemcitabine/cisplatin bevacizumab. Patients had to have had no prior chemotherapy and no neoadjuvant or adjuvant chemotherapy within 12 months.

The results of the study indicated that the addition of bevacizumab did not improve overall survival. Patients in the bevacizumab arm had a median overall survival of 14.5 months (95% confidence interval [CI] = 13.5–16.2 months) versus 14.3 months (95% CI = 12.2–16.2 months) for those given the placebo (hazard ratio [HR] = 0.87; 95% CI = 0.72–1.05, P = .15). progression-free survival for those given bevacizumab was 8 months (95% CI = 7.1–8.5 months) compared with 6.7 months for those who received placebo (95% CI = 6.3–7.4 months; HR = 0.77; 95% CI = 0.63–0.95; P = .015). Patients in the bevacizumab arm had an overall response rate of 40.4% (95% CI = 33.8%–47.0%), compared with 36.4% (95% CI = 29.8%–42.9%; P = .56) in the placebo group.

“Improved understanding of the association of molecular biomarkers and response to chemotherapy may allow for optimal patient selection for treatment,” noted the authors.

Disclosure: For full disclosures of the study authors, visit ascopubs.org.



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