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CALGB 90401: VEGF inhibitor did not improve outcomes for metastatic prostate cancer

Issue: May 25, 2012

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The addition of the VEGF inhibitor bevacizumab did not improve OS in patients with metastatic castration-resistant prostate cancer, despite an improvement in PFS and objective response, according to phase 3 results of the randomized placebo-controlled CALGB 90401 study.

“This study further illustrates that the success of future phase 3 programs in metastatic castration-resistant prostate cancer is dependent on identifying critical biomarkers that enrich the study population for the targeted therapy,” the researchers wrote.

In order to examine the effect of adding a VEGF inhibitor to prednisone/docetaxel, the researchers enrolled 1,050 patients who were randomly assigned to docetaxel 75 mg/m² plus prednisone 5 mg with or without bevacizumab (Avastin, Genentech) 15 mg/kg every 3 weeks. All patients were chemotherapy-naive and had progressive metastatic castration-resistant prostate cancer. The primary endpoint was OS.

The median OS for the bevacizumab arm was 22.6 months compared with 21.5 months for patients who received placebo (95% CI, 20-23), a difference that was not statistically significant. However, patients who received bevacizumab had a median PFS of 9.9 months compared with 7.5 months for those patients who received placebo (95% CI, 6.8-8.0).

In addition, more patients who received bevacizumab had at least 50% declines in PSA compared with patients who received placebo. The patients who received bevacizumab also had greater objective response (49.4% vs. 35.5%; P=.0013).

Subsequently, the researchers conducted subgroup analyses to try to determine whether certain patients were more likely to respond to bevacizumab.

“These analyses have generated the hypothesis that a targeted subpopulation of poor-risk patients with metastatic castration-resistant prostate cancer would experience greater clinical benefit form VEGF inhibition,” the researchers wrote.

References:

• Kelly WK. J Clin Oncol. 2012;30:1534-1540.