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BEAM: Carboplatin/paclitaxel plus bevacizumab failed to improve PFS

Issue: February 25, 2012

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The addition of the VEGF inhibitor bevacizumab to carboplatin failed to improve PFS in patients with metastatic melanoma, according to phase 2 data from the BEAM study.

Although bevacizumab (Avastin, Genentech) resulted in a numerical increase in PFS, the difference between the addition of bevacizumab and placebo was not statistically significant.

In the study, 214 patients were assigned 2:1 to carboplatin plus paclitaxel with or without bevacizumab. PFS was the primary endpoint, and OS analyses were conducted as a secondary endpoint.

At the 14-month follow-up, the PFS for patients who received bevacizumab was 5.6 months vs. 4.2 months for those who received placebo (P=.1414). The OS analyses found that the addition of bevacizumab resulted in a 33% reduction in the risk for death compared with placebo (HR=0.67; 95% CI, 0.46-0.98). At the 13-month follow-up, OS was 12.3 months in the bevacizumab arm vs. 8.6 months in the placebo arm.

A sub-analysis identified patients with elevated serum lactate dehydrogenase as having longer OS and PFS when given bevacizumab as compared with those given placebo.

In an accompanying editorial, Adil I. Daud, MD, director of melanoma clinical research at the UCSF Helen Diller Family Comprehensive Cancer Center, called this subset analysis “interesting.”

“The greatest magnitude of benefit seems to be for those with elevated lactate dehydrogenase, which may correlate with tumor hypoxia,” Daud wrote. “This may represent a group of patients to be targeted for antiangiogenic therapy trials.”

However, Daud said the overall results of the trial were negative.

“A more nuanced understanding of antiangiogenic agents in cancer therapy is emerging,” he wrote. “These agents are clearly effective in some tumor types, but they are certainly not universally effective and, even within a sensitive tumor, not additive with many common regimens.”

For more information:

• Kim KB. J Clin Oncol. 2011;30:34-41.