May 17, 1999 A combination regimen using docetaxel, estramustine and low-dose hydrocortisone yields "impressive results" in advanced, hormonal refractory prostate cancer, according to a paper presented at the annual meeting of the American Society of Clinical Oncology (ASCO).
This Phase II study indicates that Docetaxel (trade name Taxotere®) combined with the nitrogen mustard estramustine phosphate (Emcyt®) and low dose hydrocortisone appears to be a "promising treatment" for men with advanced prostate cancer.
The study, paid for by the National Cancer Institute (NCI), found that the treatment was effective and well-tolerated in hormone-refractory prostate cancer. Hormone-refractory prostate cancer refers to advanced disease in which the patient no longer responds to conventional hormonal treatment with antiandrogens. (Prostate cancer is fueled by the male hormone testosterone; antiandrogens block production of testosterone or prevent it from docking in the body's receptors).
Almost all men whose cancers are initially sensitive or responsive to hormone therapy will eventually develop hormone resistance and tumor growth. "When hormone therapy is no longer successful in men with prostate cancer, chemotherapy may be tried," Diane Savarese, MD, of the University of Massachusetts, said. "However, current drug therapy, particularly single-agent therapy, confers limited benefit, and the development of new agents and combinations of agents may ultimately prove to be the most effective treatment once hormone resistance has emerged." " Indeed our data suggest," Dr. Savarese said, "that the docetaxel/estramustine combination may represent an encouraging approach."
The study included 47 men with an ECOG (Eastern Cooperative Oncology Group) performance status of 0 to 2 whose prostate cancer had progressed after initial hormone therapy. Patients who had had chemotherapy before or who had a history of blood clots (thrombotic events) or "severe" heart disease were not allowed to join enroll in the study.
Patients received intravenous docetaxel, 70 mg/m2, given on the second day of every three-week cycle; oral estramustine, 10 mg/kg/d, administered in divided doses for five days; and oral low dose hydrocortisone (40 mg), given daily.
Overall, 40 patients remained in the study long enough to be measured for response and/or toxicity. (These are what are Phase II trials normally are testing for -- "response" = impact of the drug on the disease; "toxicity" = side effects).
Of the 39 men with initially elevated PSA (prostate-specific antigen) levels, 27 (69%) had a greater than 50 percent decline in PSA. Of these 27 men, 21 had a greater than 75 percent decline. Twenty-one of 40 patients who received at least two cycles of therapy have measurable soft tissue disease. Of these patients, one had a complete response after six cycles, and three patients had a partial response in soft tissue. A complete response was defined as a complete disappearance of all clinical and X-ray signs of cancer, while a partial response refers to a 50 percent or greater decrease in measurable tumor size.
Side effects of the treatment included "modest hematologic (blood) toxicity." Other types of toxicity and gastrointestinal disturbances were infrequent.
Based on the favorable results reported in this study, Dr. Savarese said. "phase III studies should be undertaken to compare the combination regimen with other drugs that have been shown to be active in hormone-refractory prostate cancer including mitoxantrone and hydrocortisone."
The trial was conducted by the Cancer and Leukemia Group B (CALGB).
 |
 |
|
 |
 |
| Cover |
May 16, 1999
To
contact us or report problems with pages E-mailto top
PSA
Rising
prostate cancer survivor news
http://www.psa-rising.com ©2000
prostate cancer survivor news
http://www.psa-rising.com ©2000