Journal
BJU INTERNATIONAL
Volume 102, Issue 11, Pages 1601-1606Publisher
WILEY
DOI: 10.1111/j.1464-410X.2008.08017.x
Keywords
DN-101; calcitriol; mitoxantrone; prostate cancer
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Funding
- Novacea, Inc.
- OSI Pharmaceuticals
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To evaluate the preliminary efficacy, safety, and impact on quality of life (QoL) of high-dose calcitriol (DN-101) combined with mitoxantrone and glucocorticoids in androgen-independent prostate cancer (AIPC). Nineteen patients with metastatic AIPC and no previous chemotherapy received DN-101 180 mu g orally on day 1 and mitoxantrone 12 mg/m(2) intravenously on day 2 every 21 days with continuous daily prednisone 10 mg orally for a maximum of 12 cycles. A confirmed decline in prostate-specific antigen (PSA) levels by half was the primary endpoint. QoL was evaluated using the European Organization for Research and Treatment of Cancer QLQ-C30 questionnaire, and pain and analgesic use were evaluated. Five of 19 patients (26%; 95% confidence interval, CI, 9-51) achieved a >= 50% decline in PSA level. The median (95% CI) time to PSA progression was 16 (6-26) weeks. The overall median (95% CI) survival was 16 (6-26) months; 47 (21-73)% of patients achieved an analgesic response. Toxicity was similar to that expected with mitoxantrone and prednisone alone. The QoL analysis suggested a decrease in physical functioning and increase in fatigue, insomnia, and diarrhoea. DN-101 given every 3 weeks does not add significant activity to mitoxantrone and prednisone in AIPC, as measured by the PSA decline. The high rate of analgesic response is encouraging. The addition of DN-101 does not appear to increase the toxicity of mitoxantrone.
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