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High-dose Calcitrol Potentiates Docetaxel: Advanced Prostate Ca

High-dose calcitriol potentiates docetaxel in advanced prostate cancer

A unique high-dose formulation of calcitriol (DN-101) prolongs survival of patients treated with docetaxel for advanced prostate cancer while reducing toxic side effects, according to the results of a phase II study presented today at the 13th annual meeting of the European Cancer Conference in Paris.

"In in vitro studies, vitamin D receptor ligands, such as calcitriol, arrest proliferation of cancer cells and induce apoptosis," presenter Tomasz Beer, MD, from Oregon Health and Science University Cancer Institute in Portland, told Reuters Health.

250 subjects with androgen-independent prostate cancer were recruited to be randomized to treatment with 45 µg oral DN-101 or placebo 1 day prior to treatment with weekly docetaxel 36 mg/m2 for 3 weeks of a 4-week cycle.

33% reduction in the risk of death was found for those men on the treatment arm receiving DN 101.

Median survival in the placebo-treated patients was 16.4 months, while that for patients receiving DN-101 is estimated to be at least 24.5 months, but it may be longer since "fewer than half have died as of the last analysis."

Toxicity was also reduced, with grade 3/4 adverse events occurring in only 58% of DN-101-treated patients but 70% the men who received a placebo.

DN-101 was particularly associated with reduced gastrointestinal and thromboembolic toxicities, Beer said.

A Phase III trial will be conducted - they are looking to recruit 900 men.

Thanks to Reuters Health, November 2005

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