Hormone Therapy With Innovative Delivery System Available for Prostate Cancer

Sanofi-Synthelabo announced thecommercial availability of Eligard (leuprolide acetate, 7.5 mg) for thepalliative treatment of advanced prostate cancer at the 2002 annual meeting ofthe American Urological Association. Recommended in the prostate cancertreatment guidelines of the National Comprehensive Cancer Network (NCCN),leuprolide suppresses testosterone to beyond traditional castration levels. The1-month formulation, which was recently approved by the US Food and DrugAdministration, uses the Atrigel delivery system to provide continuous releaseof leuprolide over a 1-month period. When mixed with a drug and injected intothe body, Atrigel solidifies and forms a small implant that slowly dissolves,thereby releasing the drug into the body.

Study Confirms Efficacy

In an open-label, multicenter study, 120 patients withadvanced prostate cancer (89 had stage C disease, 31 had stage D) receivedmonthly injections of Eligard, 7.5 mg, for 6 months. The study evaluatedthe achievement and maintenance of serum testosterone suppression over 6 monthsof therapy. Serum testosterone was suppressed to below ≤ 50 ng/dL by day 28(week 4) in 112 of 119 (94.1%) patients. The remaining seven patients attainedserum testosterone suppression by day 42. At the conclusion of the study, all117 patients who completed the study had testosterone levels at or below 50 ng/dL.

The most common adverse effects reported in thisinvestigation were hot flashes/sweats; a total of 86 such events occurred in 70patients. Of these, 71 events (83%) were mild, and 14 (1%) were severe.

"Many advances have been made in the hormonal treatment of prostatecancer," said A. Oliver Sartor, MD, director of the Stanley S. Scott CancerCenter at Louisiana State University Medical School in New Orleans. "Inparticular, Eligard, 7.5 mg, utilizes a new delivery system for a proven drugthat has been used in prostate cancer for more than a decade. This deliverysystem has proven to deliver leuprolide acetate over a 30-day period in a mannerthat results in a consistently very low level of testosterone, thereby helpingto optimally manage this difficult disease."