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ZD4054 demonstrates improved overall survival in prostate cancer

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SAN FRANCISCO – Treatment with an investigational endothelin receptor antagonist improved survival in patients with metastatic hormone-resistant prostate cancer.

Nancy Dawson, MD, director of clinical research at the Prostate Center of Lombardi Comprehensive Cancer Center at Georgetown University, presented data from a phase-2 trial at the 2008 Genitourinary Cancers Symposium. Dawson and colleagues analyzed the efficacy of ZD4054 (AstraZeneca) when used to treat patients with bone metastases who had minimal, if any, pain.

"ZD4054 was generally well-tolerated and demonstrated a promising survival in these men," Dawson said during her presentation. "If confirmed in phase-3 trials, these results may represent a significant advance in hormone-resistant prostate cancer."

The 312 patients were randomly assigned to 10 mg of ZD4054, 15 mg of ZD4054 or placebo. At the first analysis in April 2006, researchers found no improvement in progression-free survival, but there was a signal for improved overall survival.

The researchers amended the protocol to collect survival data after two years of treatment. At this second analysis, the improvement in overall survival continued, but, again, researchers found no difference in progression-free survival. The median overall survival was 23.5 months in the 15-mg arm, 24.5 months in the 10-mg arm and 17.3 months in the placebo arm. Researchers found no significant effect on development of new bone metastases. – by Emily Shafer

For more information:

• Dawson N, Phung D, Morris T et al. #7. Presented at: 2008 Genitourinary Cancers Symposium; Feb. 14-16, 2008; San Francisco.

Phase-2 studies are hypothesis generating, and at times form a foundation of evidence to pursue new drugs in a potentially definitive randomized trial. ZD4054 is a novel compound in an interesting class of agents that may have important implications in prostate cancer. One of the challenges for this compound is that in this study, there was no evidence of an improvement in either progression-free survival or PSA response. There was a suggestion of an improvement in overall survival, which was not a primary endpoint. The underlying mechanism of how that occurs is not well-characterized. Clearly, phase-3 confirmation of these findings is required, and to my knowledge, those studies are actively being planned.

– Robert Dreicer, MD

Chair of Solid Tumor Oncology, Taussig Cancer Center, Cleveland Clinic Foundation