THE VIRGINIAN-PILOT
Copyright (c) 1995, Landmark Communications, Inc.
DATE: Friday, October 13, 1995 TAG: 9510130522
SECTION: LOCAL PAGE: B3 EDITION: FINAL
SOURCE: BY MARIE JOYCE, STAFF WRITER
LENGTH: Medium: 56 lines
The Food and Drug Administration has approved use of a new medicine to fight prostate cancer, basing the decision on trials conducted in part in Hampton Roads.
The decision means that doctors can begin prescribing Casodex, a drug that slows the cancer by blocking hormones that help it grow.
The FDA gave accelerated approval, which allows the drug to be used before the manufacturer finishes tests to see exactly how much it improves survival in prostate cancer patients. The FDA sometimes takes this action to speed up the release of promising drugs that fight deadly illnesses.
The study of Casodex for advanced cancer cases included men at 60 sites around the United States. Fifty-eight Hampton Roads men participated. Now that group is being tracked to see whether the Casodex improves long-term survival.
Casodex is considered an improvement over a similar drug now on the market because it doesn't suppress a patient's sex drive.
Dr. Paul F. Schellhammer, a Hampton Roads physician who participated in the study, said he doesn't know yet how much he'll be using the drug. ``In terms of efficacy and advantages,'' the drug is impressive, he said. But a lot will depend on how much it costs and whether insurance companies will pay for it.
``I hope the company prices it competitively with what's in the marketplace now,'' said Schellhammer, who is program director of the Virginia Prostate Center, a joint program of Eastern Virginia Medical School and the Sentara Cancer Institute.
The prostate is a chestnut-sized gland in men that surrounds part of the urethra, the tube through which urine flows. It helps produce the fluid in semen.
Prostate cancer relies on the male hormone testosterone to help it grow. Casodex mimics testosterone, attaching itself to receptors on cancer cells so the hormone can't latch on.
Casodex is not a cure for prostate cancer. However, it can slow the growth of the disease enough that a patient might die of other causes before the cancer has a chance to kill him.
The drug is produced by the England-based Zeneca drug company and is being used in that country.
Casodex has far fewer side effects than other testosterone blockers, which cause diarrhea and loss of appetite in addition to the diminished sex drive. The other drugs also must be taken several times a day, while Casodex requires just one pill a day.
The side effects and the inconvenience often cause patients to drop the regimen, said Schellhammer.
Although the FDA is recommending the drug only for use in advanced cases of prostate cancer, the agency can't prevent doctors from prescribing it for early-stage cancer, or even as a preventive for men in high-risk groups. by CNB