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Annals of Oncology Advance Access originally published online on January 12, 2009
Annals of Oncology 2009 20(3):498-502; doi:10.1093/annonc/mdn650
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© The Author 2009. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

urogenital tumors

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

G. Spitaleri1,*,{dagger}, D. V. Matei2,{dagger}, G. Curigliano1, S. Detti2, F. Verweij2, S. Zambito2, E. Scardino2, B. Rocco2, F. Nolè1, L. Ariu1, T. De Pas1, F. de Braud1 and O. De Cobelli2

1 Division of Medical Oncology
2 Division of Urology, European Institute of Oncology, Milan, Italy

* Correspondence to: Dr G. Spitaleri, Division of Medical Oncology, European Institute of Oncology, Ripamonti 435, 20141 Milan, Italy. Tel: +39-02-57489 482; Fax: +39-02-57489-581; E-mail: gianluca.spitaleri{at}ieo.it

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.

Key words: estramustine phosphate, etoposide, hormone-refractory prostate cancer


{dagger} Both authors contributed equally to this work.

Received for publication May 15, 2008. Revision received September 1, 2008. Accepted for publication September 2, 2008.


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