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Aug. 9, 2001 |
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New approach to prostate cancer, slow it down SEATTLE -- Aug. 9, 2001 (Cancer Digest) -- A drug that slows the progression of prostate cancer may allow men to lead more normal lives longer even if the drug cannot cure the cancer, according to a study published in the Sept. 2001 Journal of Urology. According to Dr. Erik T. Goluboff and colleagues at Columbia University College of Physicians & Surgeons, this is the first study to show that a drug can stabilize cancer in patients with advanced disease. "These results suggest that exisulind may delay disease progression in men with recurrent prostate cancer and thus prolong the time period between initial post-surgical PSA rise and the need for androgen (hormone) deprivation therapies," Goluboff said in a prepared statement. "Hormonal therapy produces high response rates in metastatic (spreading) prostate cancer, but patients develop resistance over time. The side effects of hormonal treatment can significantly impact the patient's quality of life. New treatment options that might delay the need for such side effect prone therapies could provide great benefit in the management of prostate cancer," said Goluboff, assistant professor of urology and director of urology at the Allen Pavilion of NewYork-Presbyterian Hospital. The drug, exisulind, is a member of a new class of compounds that selectively cause apoptosis, or programmed cell death, in precancerous or cancerous cells. While most chemotherapy drugs are toxic to all fast-growing cells, exisulind acts only on abnormally growing cells. Thus, patients on the drug may avoid some side effects (such as hair loss) that often result when normal cells are killed. The results of the study, involving 96 patients at six centers throughout the United States, demonstrated that exisulind inhibited the rise in PSA (prostate specific antigen) levels in treated men overall and significantly prolonged PSA doubling time in high-risk patients compared with non-active pill, or placebo. In the high risk men, over an average of 12 months, the PSA rose an average of 3.1 ng/ml for those on the placebo, compared to 1.15 ng/ml for those on exisulind. Among the intermediate risk men, the PSA rose an average of 2.23 ng/ml for the men on placebo, versus 1.47 ng/ml for the men on exisulind. The low-risk patients, whose pre-study PSA doubling times exceeded 20 months, did not show a significant change in the doubling time during the 12-month treatment period. Dr. Goluboff thinks the lack of a difference may be because it will take longer to so detect a difference in men whose PSAs are rising so slowly. "Due to the slower disease progression in low-risk men, there was no significant difference in the PSA rise in the placebo-group compared to exisulind-treated men. However, it is possible that a significant difference between treated and placebo groups might be seen in these low-risk men after longer-term exisulind therapy." The study was supported by a grant from Cell Pathways, which owns the rights to the drug. The early results were initially reported by Goluboff at the 95th annual meeting of the American Urological Association in May 2000. The experimental drug has not yet been approved by the US Food and Drug Administration, and more research will be needed to confirm its safety and effectiveness. |
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