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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 14^th 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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