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Public Forum Participants Cautiously Optimistic on New Finasteride Data: Presented at AACR

By Brian Reid

WASHINGTON, DC -- July 14, 2003 -- The results of an 18,000-patient trial showing that finasteride reduces the incidence of prostate cancer in older men is a positive sign, experts say.

Experts participating in the first public forum on the drug expressed cautious optimism, despite findings that the cancers that did develop in the treatment area were significantly more likely to be aggressive. Finasteride is now used to treat benign prostate hyperplasia and hair loss.

The forum was held at the 94^th Annual Meeting of the American Association for Cancer Research and was led by Christopher Logothetis, MD, professor and chairman of the department of genitourinary medical oncology at M.D. Anderson Cancer Center, in Houston, Texas, United States. Dr. Logothetis said the forum was added to the agenda earlier this month to "frame the challenges" posed by the trial.

"This trial…was a landmark study. They proved, at least in part, that prostate cancer is preventable," said Peter Greenwald, MD, director of the division of cancer research at the National Cancer Institute, Bethesda, Maryland, United States, and a participant in the trial. Mirroring the overall findings, Dr. Greenwald learned after unblinding that had been in the drug arm and that he was free of prostate cancer. "There is more to learn, but it's a big step forward."

The study findings, published online by the New England Journal of Medicine on June 24^th, reported data from 9,060 men who completed the study and were biopsied. Of 2,692 patients in the placebo arm, 1,147 (24.4%) had biopsy-confirmed prostate cancer, compared with 803 (18.4%) of 4,368 taking finasteride.

More troubling, however, was that the incidence of tumors with a Gleason grade of 7, 8, 9, or 10 were more common in patients in the finasteride group.

That finding prompted concern from the panelists, who cautioned that it was too early to change clinical practice according to the study results, noting that additional research is needed to determine whether the proportion of more aggressive cancers was an artifact of the study design and treatment or a real risk associated with finasteride treatment.

"It's going to take us quite a bit of time before we can sort through the relative impact of these sort of problems," said Peter Gann, MD, ScD an assistant professor at Northwestern University Feinberg School of Medicine in Chicago, Illinois, United States.

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