Injectable prostate Ca agent shows continued benefits beyond 1 year

June 10, 2010

Prostate cancer patients on leuprolide (Lupron Depot) who were offered to continue on degarelix (Firmagon) after 1 year of treatment reduced PSA recurrence, according to results of a phase III extension study presented at the AUA annual meeting in San Francisco.

Prostate cancer patients on leuprolide (Lupron Depot) who were offered to continue on degarelix (Firmagon) after 1 year of treatment reduced PSA recurrence, according to results of a phase III extension study presented at the AUA annual meeting in San Francisco.

Patients with all stages of prostate cancer were randomized to a degarelix starting dose of 240 mg, then monthly maintenance doses of 80 mg (207 patients) or 160 mg (202 patients), or leuprolide, 7.5 mg/month (201 patients). Bicalutamide (Casodex) could be given as flare protection to those being treated with leuprolide.

After 1 year, all patients taking leuprolide were re-randomized to degarelix, 240/80 mg, or 240/160 mg. PSA progression-free survival was defined as time to first PSA recurrence.Up to 1 year, patients receiving degarelix had a statistically lower risk of PSA recurrence compared with those receiving leuprolide (p=.05; log-rank). Adjusting for baseline disease state and PSA resulted in a hazard ratio of 0.664 (95% CI, 0.385 - 1.146). Beyond 1 year, the PSA recurrence rate decreased in patients previously on leuprolide. As of October 2009, there was a significant PSA progression-free survival hazard change, from 0.20 events/year in the first year to .09 in the same group of patients (p=.006).

"These preliminary data are very encouraging to clinicians who treat patients with locally advanced and advanced prostate cancer; however, further studies are required to confirm these findings," said lead author E. David Crawford, MD, of the University of Colorado Health Sciences Center, Denver. "This study provides additional evidence that Firmagon is an effective initial and continuous option for advanced prostate cancer patients."

Dr. Crawford is a meeting participant/lecturer for Endo Pharmaceuticals, Ferring Pharmaceuticals, GlaxoSmithKline, sanofi-aventis, and Watson.