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Japanese Journal of Clinical Oncology Advance Access published online on April 15, 2008
Japanese Journal of Clinical Oncology, doi:10.1093/jjco/hyn029
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© The Author (2008). Published by Oxford University Press. All rights reserved

Docetaxel Plus Prednisolone for the Treatment of Metastatic Hormone-refractory Prostate Cancer: A Multicenter Phase II Trial in Japan

S. Naito1, T. Tsukamoto2, H. Koga1, T. Harabayashi3, Y. Sumiyoshi4, S. Hoshi5 and H. Akaza6

1 Department of Urology, Faculty of Medicine, Kyushu University, Fukuoka
2 Sapporo Medical University School of Medicine, Sapporo
3 Graduate School of Medicine Hokkaido University, Sapporo
4 Shikoku Cancer Center, Matsuyama
5 Yamagata Prefectural Central Hospital, Yamagata
6 University of Tsukuba, Tsukuba, Japan

For reprints and all correspondence: S. Naito, Department of Urology, Faculty of Medicine, Kyushu University 71, 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8585, Japan. E-mail: naito{at}uro.med.kyushu-u.ac.jp

Received February 1, 2008; accepted March 18, 2008

Background: Docetaxel-based chemotherapy has been shown to be effective and well tolerated by Western patients with metastatic hormone-refractory prostate cancer (HRPC). This study was undertaken to assess the feasibility of docetaxel in combination with prednisolone in Japanese patients with HRPC.

Methods: Patients aged 50–74 years with measurable metastatic HRPC were included in this non-comparative Phase II study. Treatment consisted of docetaxel 70 mg/m2 once every 3 weeks plus prednisolone 5 mg twice daily, for a maximum of 10 cycles. The primary endpoint was overall tumor response rate, assessed by Response Evaluation Criteria in Solid Tumors; secondary endpoints included prostate-specific antigen (PSA) response and toxicity.

Results: A total of 43 patients were evaluable for efficacy and toxicity. The response rate was 44.2% (90% CI, 31.2–57.8%), with partial responses in 19/43 patients. The median duration of response was 19.3 weeks. PSA responses were recorded in 44.4% of patients (95% CI, 27.9–61.9%). The most common non-hematological adverse events (of any grade) possibly related to treatment were alopecia (88.4%), anorexia (65.1%) and fatigue (53.5%). Grade 3/4 leukopenia and neutropenia occurred in 81.4 and 93.0% of patients, respectively; however, the grade 3/4 rates of febrile neutropenia (16.3%) and infection without fever (14.0%) were lower.

Conclusion: The combination of docetaxel and prednisolone was feasible and active in Japanese patients with HRPC, with a manageable adverse-event profile similar to that observed in Western patients.

Key Words: prostate cancer • docetaxel • prednisolone • phase II • chemotherapy


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