Phase II trial of estramustine phosphate and oral etoposide in patients with hormone-refractory prostate cancer

Gianluca Spitaleri, D. V. Matei, G. Curigliano, S. Detti, F. Verweij, S. Zambito, E. Scardino, B. Rocco, F. Nolè, L. Ariu, T. De Pas, F. de Braud, O. De Cobelli

Research output: Contribution to journalArticlepeer-review


Background: There is a need for active agents with a better safety profile than docetaxel, yet good activity, for patients with hormone-refractory prostate cancer (HRPC). We carried out a phase II trial to determine the activity and safety of estramustine plus oral etoposide in HRPC. Patients and methods: Patients were given estramustine (280 mg twice daily) and etoposide (100 mg/day, days 1-21) in 28-day cycles until disease progression or unacceptable toxicity. Primary end points were overall response rate and safety, as determined by prostrate-specific antigen (PSA) levels and lesion assessment. Results: From November 2001 to February 2007, 75 patients were enrolled. All patients were assessable for safety; 17 (22.6%) had grade 3/4 toxicity. PSA response was assessable in 69, 14 of whom had a >50% reduction in PSA. Of 10 patients with one or more measurable lesions, two (20%) had partial response and two (20%) disease stabilization. Overall, median time to progression was 4.4 months (range 1 week-43 months); median survival was 23 months (range 3 weeks-64+ months). Conclusions: Estramustine plus etoposide is active and has a manageable safety profile in patients with HRPC. In asymptomatic patients with nonaggressive disease this combination could be useful to delay the start of more demanding treatments.

Original languageEnglish
Pages (from-to)498-502
Number of pages5
JournalAnnals of Oncology
Issue number3
Publication statusPublished - 2009


  • Estramustine phosphate
  • Etoposide
  • Hormone-refractory prostate cancer

ASJC Scopus subject areas

  • Hematology
  • Oncology


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