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

    Research output: Contribution to journalArticle

    222 Citations (Scopus)

    Abstract

    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 (0.5μg/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. Twentytwo 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.

    Original languageEnglish (US)
    Pages (from-to)123-128
    Number of pages6
    JournalJournal of Clinical Oncology
    Volume21
    Issue number1
    DOIs
    StatePublished - Jan 1 2003

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    docetaxel
    Calcitriol
    Androgens
    Prostatic Neoplasms
    Prostate-Specific Antigen
    Confidence Intervals
    Survival
    Pharmaceutical Preparations
    Switzerland
    Pharmacokinetics

    ASJC Scopus subject areas

    • Cancer Research
    • Oncology

    Cite this

    Weekly high-dose calcitriol and docetaxel in metastatic androgen-independent prostate cancer. / Beer, Tomasz M.; Eilers, Kristine M.; Garzotto, Mark; Egorin, Merrill J.; Lowe, Bruce A.; Henner, W. David.

    In: Journal of Clinical Oncology, Vol. 21, No. 1, 01.01.2003, p. 123-128.

    Research output: Contribution to journalArticle

    Beer, Tomasz M. ; Eilers, Kristine M. ; Garzotto, Mark ; Egorin, Merrill J. ; Lowe, Bruce A. ; Henner, W. David. / Weekly high-dose calcitriol and docetaxel in metastatic androgen-independent prostate cancer. In: Journal of Clinical Oncology. 2003 ; Vol. 21, No. 1. pp. 123-128.
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    abstract = "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 (0.5μg/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. Twentytwo 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.",
    author = "Beer, {Tomasz M.} and Eilers, {Kristine M.} and Mark Garzotto and Egorin, {Merrill J.} and Lowe, {Bruce A.} and Henner, {W. David}",
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    AU - Beer, Tomasz M.

    AU - Eilers, Kristine M.

    AU - Garzotto, Mark

    AU - Egorin, Merrill J.

    AU - Lowe, Bruce A.

    AU - Henner, W. David

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    AB - 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 (0.5μg/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. Twentytwo 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.

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