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Oct. 4, 2002 |
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Browse Archives n Lung n Breast n General n Prostate n Leukemia n Lymphoma n Colon n News/Issues |
Help for prostate cancer that has spread to bone SEATTLE Oct. 4, 2002 -- A drug shown to benefit women with advanced breast cancer may also help men with advanced prostate cancer that has spread to bone, but not without side effects, according to a new study. The drug called zoledronic acid is a member of a new class of drug called bisphosphanates that have been shown to provide pain relief and decreased risk of fractures, bone surgery and high levels of calcium in the blood in women with advanced breast cancer. This study led by Dr. Fred Saad of the Hospital Notre-Dame in Montreal, Quebec showed that advanced prostate cancer patients treated with zoledronic acid had fewer fractures, pain and other bone-related events than patients on placebo. Men with advanced prostate cancer are particularly prone to cancer spreading to the bone. The study was published in the Oct. 2, 2002 issue of the Journal of the National Cancer Institute. "In this study, prostate cancer patients with bone metastases who received zoledronic acid, a new bisphosphonate, given as a 4-mg infusion, had fewer skeletal-related events than those who received the placebo." Saad and colleagues wrote. "Furthermore, the median time to the first skeletal-related event was statistically significantly longer and the skeletal morbidity rate was statistically significantly lower for patients who received zoledronic acid at 4 mg than for those who received the placebo." Zoledronic acid ( zo-le-DRO-nik) is used to treat high levels of calcium in the blood (hypercalcemia ) that may occur in patients with some types of cancer. In the study, the researchers randomly assigned 643 patients with advanced prostate cancer that had spread to bone and did not respond to hormone treatment to one of three groups. One group received a high dose of zoledronic acid (8 mg), the second group received half the dose (4 mg) of the first group, and the third group received a placebo. Each patient received their drug or placebo every 3 weeks, and was to continue that for up to 15 months. The high dose group was subsequently reduced to the 4 mg dose when one of the patients experienced kidney complications. The researchers found that 44 percent of men on placebo had "skeletal-related events" compared with 33 percent of men on 4 mg of zoledronic acid. Pain increased more in the men on placebo, but there were no differences between the drug and placebo groups in terms of quality of life or disease progression. The time to the first bone-related event an episode of pain, a fracture or compression of a vertebra -- was not reached for patients who received zoledronic acid at 4 mg and was, therefore, considered as at least 420 days. On average, patients in the placebo group experienced their first bone-related event after 321 days, and the 8/4 mg group went an average of 363 days before experiencing an event. Writing in an accompanying editorial Drs. Christina Canil and Ian Tannock of the Princess Margaret Hospital at the University of Toronto commented that "Thus, this study with zoledronic acid has not provided a clear demonstration of net therapeutic benefit," they wrote. "Zoledronic acid is a reasonable option for patients who do not respond to alternative therapies and who are at high risk for bone fractures or spinal cord compression, but currently zoledronic acid cannot be recommended as a standard therapy for men with prostate cancer and metastases to bone." The study was funded by Novartis, the maker of zoledronic acid, which is marketed under the name Zometa®. SOURCE: Journal of the National Cancer Institute, Vol. 94, No. 19, 1458-1468, Oct. 2, 2002 |
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