Docetaxel, with or without estramustine phosphate, as first-line chemotherapy for hormone-refractory prostate cancer: Results of a multicentre, randomized phase II trial

Orazio Caffo, Teodoro Sava, Evi Comploj, Annamaria Fariello, Fable Zustovich, Romana Segati, Cosimo Sacco, Francesco Valduga, Gianluigi Cetto, Enzo Galligioni

Research output: Contribution to journalArticlepeer-review

Abstract

OBJECTIVE: To report the results of a randomized phase II trial of docetaxel with and without estramustine phosphate (EP) in patients with hormone-refractory prostate cancer (HRPC). PATIENTS AND METHODS: Patients with progressive HRPC were randomized to receive docetaxel 70 mg/m2 on day 1 (arm A), or docetaxel 70 mg/m2 on day 2 plus oral EP three times daily, at a total daily dose of 840 mg, on days 1-5 (arm B). The primary objective of the trial was to evaluate the activity of the treatments in terms of the response in prostate-specific antigen (PSA) level. RESULTS: Forty-five of the 49 patients centrally randomized to arm A and 44 of the 46 in arm B were evaluable for activity. The PSA level decreased by ≥50% in 40% of the patients in arm A and in 75% of those in arm B. The median time to PSA progression was 20 weeks in arm A and 30 weeks in arm B. The patients in arm B had an improvement in pain over time. CONCLUSION: These data support the existence of a possible advantage in combining docetaxel and EP, which should be verified in a specific randomized phase III study.

Original languageEnglish
Pages (from-to)1080-1085
Number of pages6
JournalBJU International
Volume102
Issue number9
DOIs
Publication statusPublished - Nov 2008

Keywords

  • Docetaxel
  • Estramustine phosphate
  • Prostate cancer
  • Randomized trial

ASJC Scopus subject areas

  • Urology

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