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Annals of Oncology Advance Access published online on January 24, 2005
Annals of Oncology, doi:10.1093/annonc/mdi096
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© 2005 European Society for Medical Oncology
Received August 31, 2004
Revised November 4, 2004
Accepted November 10, 2004

Original article

Sequential mitoxantrone/prednisone followed by docetaxel/estramustine in patients with hormone refractory metastatic prostate cancer: results of a phase II study

A. Font 1*, A. Murias 2, F. R. García Arroyo 3, C. Martin 4, J. Areal 5, J. J. Sanchez 6, J. A. Santiago 2, M. Constenla 3, J. M. Saladie 5, and R. Rosell 1

1 Medical Oncology Service, Institut Català d'Oncologia, Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain
2 Medical Oncology Service, Hospital Universitario Insular de Gran Canaria, Las Palmas, Spain
3 Medical Oncology Service, Complexo Hospitalario de Pontevedra, Pontevedra, Spain
4 Hospital del Espiritu Santo, Santa Coloma de Grament, Barcelona, Spain
5 Urology Department, Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain
6 Autonomous University of Madrid, Red de Centros de Epidemiologia y Salod Publica (RCESP), Madrid, Spain

* To whom correspondence should be addressed.
A. Font, E-mail: afont{at}ns.hugtip.scs.es


  Abstract

Background: Mitoxantrone/prednisone ameliorates symptoms in hormone refractory prostate cancer (HRPC) but has no effect on survival. Docetaxel (Taxotere)/estramustine improves response but with significant toxicity. We reasoned that a sequential administration of the two regimens could be a viable alternative for delivering full doses of chemotherapy, avoiding overlapping toxicity and preserving dose intensity.

Patients and methods: Thirty HRPC patients were treated with mitoxantrone 10 mg/m2, day 1, every 3 weeks, plus prednisone 5 mg twice daily, for three cycles, followed by estramustine phosphate, 280 mg three times daily, days 1 to 5, plus docetaxel 75 mg/m2, day 2, every 3 weeks for a maximum of 10 cycles.

Results: All patients were assessable for response and toxicity. After mitoxantrone/prednisone treatment, the prostate-specific antigen (PSA) response rate was 23%, which increased to 63% after completion of sequential mitoxantrone/prednisone and docetaxel/estramustine treatment (12 partial and 7 complete responses). With a median follow-up of 18 months, median survival for all patients was 18 months, and median progression-free survival was 10 months. The mitoxantrone/prednisone regimen was well tolerated, and the only grade 3-4 toxicity was grade 3 neutropenia in four (13%) patients. Twenty-nine patients received a total of 173 cycles of docetaxel/estramustine (median, 6 cycles/patient). Six (20%) patients had grade 3-4 neutropenia and two (6%) patients had febrile neutropenia episodes. The most frequent non-hematological toxic effects were asthenia, nausea and vomiting, edemas and onycholysis. Two (6%) patients had deep venous thrombosis.

Conclusions: Mitoxantrone/prednisone followed by docetaxel/estramustine is a well-tolerated and active regimen in HRPC. Sequential therapy is feasible and can be used to integrate novel, more active regimens.

Keywords: docetaxel; mitoxantrone; prostate cancer; sequential; efficacy.
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