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Latest
Report Of 'Accent': Docetaxel And Calcitriol
(October 2006)
EXECUTIVE
SUMMARY of what was reported at the Prostate Cancer Update Conference,
Vail Colorado, February 2006: The Phase II ASCENT trial compared doxetaxel/placebo
(D+P) with docetaxel/calcitriol (D+C) in 250 men with progressive
metastatic AIPC. The D/C combination showed a significant survival benefit
compared to monotherapy. The recipe: catcitriol 45 mcg
orally day 1, followed on day 2 by 36 mg/m2 docetaxel, both repeated
weekly for a total of 3 consecutive weeks in a 4-week cycle. Oral Decadron,
4 mg, was given 1 hour before and 12 hours after chemotherapy. Results:
PSA response (> 50% reduction) for those men on study for 6 months - D+P,
49%, D+C, 58%.
Overall PSA
response for D+P vs. D+C: 52% vs 63%; median time in days to PSA response,
163 vs 87; measurable tumor response, 20% (n=56) vs. 28% (n=46),
respectively. The estimated median survival for D+P was 16.4 months vs.
24.5 months for D+C. For D+P vs. D+C: neutropenia - 8% vs. 10%; fatigue -
16% vs. 8%; infection - 13% vs. 8%; hyperglycemia - 12% vs 6%, and for
thromboembolic events 8.8% vs. 1.6%, respectively. Overall grade 3/4
toxicity was less in the D+C arm: 58% vs. 70%. A confirmatory ASCENT II is
ongoing comparing the weekly regimen of the first trial with docetaxel at
75 mg/m2 q 3 weeks + prednisone 5 mg bid.
Why calcitriol, the active and most potent form of Vitamin
D? As the ligand targeting the vitamin D receptor, calcitriol is potently
antiproliferative and proapoptotic and exhibits synergy with chemotherapy.
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