Journal of Clinical Oncology, Vol 21, Issue 1
(January), 2003: 123-128
© 2003 American Society for Clinical Oncology
Weekly High-Dose Calcitriol and Docetaxel in Metastatic Androgen-Independent Prostate Cancer
Tomasz M. Beer,
Kristine M. Eilers,
Mark Garzotto,
Merrill J. Egorin,
Bruce A. Lowe,
W. David Henner
From the Oregon Health & Science University and Portland VA Medical Center, Portland, OR; and University of Pittsburgh Cancer Institute, Pittsburgh, PA.
Address reprint requests to Tomasz M. Beer, MD, Department of Medicine, Oregon Health & Science University, Mail Code L586, 3181 SW Sam Jackson Park Road, Portland, OR 97239; email: beert{at}ohsu.edu.
Purpose: To determine the safety and efficacy of weekly high-dose oral calcitriol (Rocaltrol, Roche Pharmaceuticals, Basel, Switzerland) and docetaxel (Taxotere, Aventis Pharmaceuticals, Bridgewater, NJ) in patients with metastatic androgen-independent prostate cancer (AIPC).
Patients and Methods: Thirty-seven patients were treated with oral calcitriol (0.5 µg/kg) on day 1 followed by docetaxel (36 mg/m2) on day 2, repeated weekly for 6 weeks of an 8-week cycle. Patients maintained a reduced calcium diet and increased oral hydration. Prostate-specific antigen (PSA) response was the primary end point, which was defined as a 50% reduction in PSA level confirmed 4 weeks later.
Results: Thirty of 37 patients (81%; 95% confidence interval [CI], 68% to 94%) achieved a PSA response. Twenty-two patients (59%; 95% CI, 43% to 75%) had a confirmed > 75% reduction in PSA. Eight of the 15 patients with measurable disease (53%; 95% CI, 27% to 79%) had a confirmed partial response. Median time to progression was 11.4 months (95% CI, 8.7 to 14 months), and median survival was 19.5 months (95% CI, 15.3 months to incalculable). Overall survival at 1 year was 89% (95% CI, 74% to 95%). Treatment-related toxicity was generally similar to that expected with single-agent docetaxel. Pharmacokinetics of either calcitriol or docetaxel were not affected by the presence of its companion drug in an exploratory substudy.
Conclusion: The combination of weekly oral high-dose calcitriol and weekly docetaxel is a well-tolerated regimen for AIPC. PSA and measurable disease response rates as well as time to progression and survival are promising when compared with contemporary phase II studies of single-agent docetaxel in AIPC. Further study of this regimen is warranted.
Supported in part by grant GIA US 16,066 from Aventis Pharmaceuticals and grant 3M01RR00334 to 33S2 from the National Institutes of Health.
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