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Title: Thalidomide Combination Shows Activity in Androgen-Independent Prostate Cancer: Presented at CFS

"Thalidomide Combination Shows Activity in Androgen-Independent Prostate Cancer: Presented at CFS"

By Charlene Laino NEW YORK, NY -- November 21, 2003 -- A combination of paclitaxel, estramustine and thalidomide shows activity for the treatment of chemotherapy-refractory, androgen-independent prostate cancer, a Phase II study suggests. This finding was presented here on November 14th at Chemotherapy Foundation Symposium XXI, by Danai Daliani, MD, medical oncologist, University of Texas M.D. Anderson Cancer Center, Houston, United States. The study has enrolled 30 patients with androgen-independent prostate cancer progressing after 1 or 2 prior cytotoxic treatment(s). The median age was 66 years, and the median Zubrod performance status was 1. Twenty of the men had had 1 prior chemotherapy regimen and the rest had had 2 prior regimens. The men were given 100 mg/m2 of paclitaxel a week, for 2 of 3 weeks; 140 mg of oral estramustine every 8 hours, 5 days a week, for 2 of 3 weeks; and escalating doses of thalidomide, starting with 200 mg a day and titrated up to 600 mg a day. Seventy-two percent of the 25 evaluable patients achieved a sustained decline in prostate-specific antigen levels of 50% or more, Dr. Daliani reported. Twelve percent showed a drop of 80% or more. The men who experienced a drop in PSA also reported less bone pain, she added. Nearly 14% of the 29 men evaluable for toxicity developed Grade 3-4 deep-vein thrombosis, despite warfarin prophylaxis, requiring treatment discontinuation in 2 of the 4 patients. Also, 2 additional patients stopped treatment due to intercurrent infection, and 1 man died from sepsis. There were no cases of grade 2-4 neuropathy. Noting that a clinically significant indicator of anti-tumour activity is having 30% or more patients experience at least a 50% drop in PSA levels, Dr. Daliani concluded that the results justify further study of the combination therapy in patients with androgen-independent prostate cancer. [Study Title: A Tolerance and efficacy Study of Thalidomide, Paclitaxel, and Estramustine for Patients with Chemotherapy Refractory Androgen Independent Prostate cancer. Abstract 48]

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