June 18, 1999
The addition of tamoxifen to a chemotherapy regimen of cisplatin, dacarbazine and carmustine does not appear to improve survival or reduce time to progression in patients with advanced malignant melanoma.
Dr. Edward T. Creagan, of the Mayo Clinic in Rochester, Minnesota, and colleagues at other centers conducted a phase III clinical trial comparing the two combination therapy with and without tamoxifen in 184 patients with advanced malignant melanoma.
In both groups, patients received 25 mg/meters squared IV cisplatin and 220 mg/meters squared IV dacarbazine on days 1 to 3 of the 3-week cycle and 150 mg/meters squared IV carmustine on day 1 every other cycle. In addition, patients randomized to tamoxifen took 20 mg of the drug orally every morning.
Median time to progression, median survival, progression-free survival and overall survival did not differ significantly between the two groups, according to a report in the June issue of the Journal of Clinical Oncology.
"Unfortunately," Dr. Creagan and others write, "...we cannot offer the prolongation of life with the addition of [tamoxifen]..." to the combination of cisplatin, dacarbazine and carmustine. However, they note that new drugs and genetic techniques "...may provide promise for patients with disseminated malignant melanoma."