Skip to main content
Top
Published in: International Journal of Clinical Oncology 1/2013

01-02-2013 | Original Article

Can docetaxel therapy improve overall survival from primary therapy compared with androgen-deprivation therapy alone in Japanese patients with castration-resistant prostate cancer? A multi-institutional cooperative study

Authors: Tomoyuki Shimabukuro, Shigeru Sakano, Kenji Matsuda, Yoriaki Kamiryo, Norio Yamamoto, Yoshitaka Kaneda, Takahito Nasu, Yoshikazu Baba, Akinobu Suga, Mitsutaka Yamamoto, Akihiko Aoki, Kimio Takai, Satoru Yoshihiro, Motohiko Konishi, Katsuhiko Imoto, Hideyasu Matsuyama

Published in: International Journal of Clinical Oncology | Issue 1/2013

Login to get access

Abstract

Background

To verify the actual clinical benefit of docetaxel (DOC) therapy and to explore the prognostic factors that may predict overall survival in Japanese patients with castration-resistant prostate cancer (CRPC).

Methods

Baseline characteristics-matched CRPC patients who received conventional androgen-deprivation therapy (ADT) or ADT plus DOC were compared retrospectively. The primary endpoint was overall survival (OS) from primary therapy. Secondary endpoints were response of tumor(s), prostate-specific antigen (PSA) levels, and toxicity.

Results

Median OS was significantly longer in the DOC group (n = 117) than the control group (n = 118) (94.0 vs. 70.0 months, P = 0.0077) and the corresponding hazard ratio (HR) for death in DOC group was 0.566 [95% confidence interval (95%CI) 0.370–0.867; P = 0.0088]. Effective DOC groups [medium dose (50–69 mg/m2) and high dose (≥70 mg/m2)] had significantly longer median OS than control even when survival times were calculated from the start of castration-resistant events (151 vs. 36 months; P = 0.0173) and the corresponding HR for death in the DOC group was 0.515 (95%CI 0.293–0.903; P = 0.0205). In multivariate analysis, statistically significant prognostic indicators were Gleason score, time to CRPC events, and receipt of DOC therapy. Response rate of both measurable lesion and PSA was not significantly different between each DOC dose group. Grade 3 or 4 adverse events associated with low- [30–49 mg/m2], medium-, and high-dose DOC were 21.9, 35.7, and 90.7%, respectively. No death due to DOC therapy was reported.

Conclusion

Treatment with DOC improves OS from primary therapy compared with conventional ADT alone in Japanese patients with CRPC.
Literature
1.
go back to reference Cancer Registration Committee of the Japanese Urological Association (2005) Clinicopathological statistics on registered prostate cancer patients in Japan: 2000 report from the Japanese Urological Association. Int J Urol 12:46–61CrossRef Cancer Registration Committee of the Japanese Urological Association (2005) Clinicopathological statistics on registered prostate cancer patients in Japan: 2000 report from the Japanese Urological Association. Int J Urol 12:46–61CrossRef
2.
go back to reference Hinotsu S, Akaza H, Usami M et al (2007) Current status of endocrine therapy for prostate cancer in Japan—analysis of primary androgen deprivation therapy on the basis of data collected by J-CaP. Jpn J Clin Oncol 37:775–781PubMedCrossRef Hinotsu S, Akaza H, Usami M et al (2007) Current status of endocrine therapy for prostate cancer in Japan—analysis of primary androgen deprivation therapy on the basis of data collected by J-CaP. Jpn J Clin Oncol 37:775–781PubMedCrossRef
3.
go back to reference Cooperberg MR, Hinotsu S, Namiki M et al (2009) Risk assessment among prostate cancer patients receiving primary androgen deprivation therapy. J Clin Oncol 27:4306–4313PubMedCrossRef Cooperberg MR, Hinotsu S, Namiki M et al (2009) Risk assessment among prostate cancer patients receiving primary androgen deprivation therapy. J Clin Oncol 27:4306–4313PubMedCrossRef
4.
go back to reference Tannock IF, Wit R, Berry WR et al (2004) Docetaxel plus predonisone or mitoxantrone plus predonisone for advanced prostate cancer. N Engl J Med 351:1502–1512PubMedCrossRef Tannock IF, Wit R, Berry WR et al (2004) Docetaxel plus predonisone or mitoxantrone plus predonisone for advanced prostate cancer. N Engl J Med 351:1502–1512PubMedCrossRef
5.
go back to reference Petrylak DP, Tangen CM, Hussain MHA et al (2004) Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med 351:1513–1520PubMedCrossRef Petrylak DP, Tangen CM, Hussain MHA et al (2004) Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med 351:1513–1520PubMedCrossRef
6.
go back to reference Japanese Urological Association and the Japanese Pathological Society (2001). General Rule for Clinical and Pathological Studies on Prostate Cancer, 3rd edn. Kanehara Syuppan, Tokyo Japanese Urological Association and the Japanese Pathological Society (2001). General Rule for Clinical and Pathological Studies on Prostate Cancer, 3rd edn. Kanehara Syuppan, Tokyo
7.
go back to reference Scher HI, Halabi S, Tannock I et al (2008) Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol 26:1148–1159PubMedCrossRef Scher HI, Halabi S, Tannock I et al (2008) Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol 26:1148–1159PubMedCrossRef
8.
go back to reference Berthold DR, Pond GR, Soban F et al (2008) Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer: update survival in the TAX327 study. J Clin Oncol 26:242–245PubMedCrossRef Berthold DR, Pond GR, Soban F et al (2008) Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer: update survival in the TAX327 study. J Clin Oncol 26:242–245PubMedCrossRef
9.
go back to reference Armstrong AJ, Tannock IF, Wit RD et al (2010) The development of risk groups in men with metastatic castration-resistant prostate cancer based on risk factors for PSA decline and survival. Eur J Cancer 46:517–525PubMedCrossRef Armstrong AJ, Tannock IF, Wit RD et al (2010) The development of risk groups in men with metastatic castration-resistant prostate cancer based on risk factors for PSA decline and survival. Eur J Cancer 46:517–525PubMedCrossRef
10.
go back to reference Savarese DM, Halabi S, Hars V et al (2001) Phase II study of docetaxel, vestramustine, and low-dose hydrocortisone in men with hormone-refractory prostate cancer: a final report of CALGB 9780. J Clin Oncol 19:2509–2516PubMed Savarese DM, Halabi S, Hars V et al (2001) Phase II study of docetaxel, vestramustine, and low-dose hydrocortisone in men with hormone-refractory prostate cancer: a final report of CALGB 9780. J Clin Oncol 19:2509–2516PubMed
11.
go back to reference Sinibaldi VJ, Carducci MA, Moore-Cooper S et al (2002) Phase II evaluation of docetaxel plus one-day oral estramustine phosphate in the treatment of patients with androgen independent prostate cancer. Cancer 94:1457–1465PubMedCrossRef Sinibaldi VJ, Carducci MA, Moore-Cooper S et al (2002) Phase II evaluation of docetaxel plus one-day oral estramustine phosphate in the treatment of patients with androgen independent prostate cancer. Cancer 94:1457–1465PubMedCrossRef
12.
go back to reference Picus J, Schultz M (1999) Docetaxel (Taxotere) as monotherapy in the treatment of hormone-refractory prostate cancer: preliminary results. Semin Oncol 26:14–18PubMed Picus J, Schultz M (1999) Docetaxel (Taxotere) as monotherapy in the treatment of hormone-refractory prostate cancer: preliminary results. Semin Oncol 26:14–18PubMed
13.
go back to reference Berry W, Dakhil S, Gregurich MA et al (2001) Phase II trial of single-agent weekly docetaxel in hormone-refractory, symptomatic, metastatic carcinoma of prostate. Semin Oncol 28:8–15PubMedCrossRef Berry W, Dakhil S, Gregurich MA et al (2001) Phase II trial of single-agent weekly docetaxel in hormone-refractory, symptomatic, metastatic carcinoma of prostate. Semin Oncol 28:8–15PubMedCrossRef
14.
go back to reference Beer TM, Pierce WC, Lowe BA et al (2001) Phase II study of weekly docetaxel in symptomatic androgen-independent prostate cancer. Ann Oncol 12:1273–1279PubMedCrossRef Beer TM, Pierce WC, Lowe BA et al (2001) Phase II study of weekly docetaxel in symptomatic androgen-independent prostate cancer. Ann Oncol 12:1273–1279PubMedCrossRef
15.
go back to reference Naito S, Tsukamoto T, Koga H et al (2008) Docetaxel plus predonisolone for the treatment of metastatic hormone-refractory prostate cancer: a multicenter phase II trial in Japan. Jpn J Clin Oncol 38:365–372PubMedCrossRef Naito S, Tsukamoto T, Koga H et al (2008) Docetaxel plus predonisolone for the treatment of metastatic hormone-refractory prostate cancer: a multicenter phase II trial in Japan. Jpn J Clin Oncol 38:365–372PubMedCrossRef
16.
go back to reference Shimazui T, Kawai K, Miyanaga N et al (2007) Three-weekly docetaxel with prednisone is feasible for Japanese patients with hormone-refractory prostate cancer: a retrospective comparative study with weekly docetaxel alone. Jpn J Clin Oncol 37:603–608PubMedCrossRef Shimazui T, Kawai K, Miyanaga N et al (2007) Three-weekly docetaxel with prednisone is feasible for Japanese patients with hormone-refractory prostate cancer: a retrospective comparative study with weekly docetaxel alone. Jpn J Clin Oncol 37:603–608PubMedCrossRef
17.
go back to reference Kojima T, Shimazui T, Onozawa M et al (2004) Weekly administration of docetaxel in patients with hormone-refractory prostate cancer: a pilot study on Japanese patients. Jpn J Clin Oncol 34:137–141PubMedCrossRef Kojima T, Shimazui T, Onozawa M et al (2004) Weekly administration of docetaxel in patients with hormone-refractory prostate cancer: a pilot study on Japanese patients. Jpn J Clin Oncol 34:137–141PubMedCrossRef
18.
go back to reference Debes JD, Tindall Dj (2004) Mechanisms of androgen-refractory prostate cancer. N Engl J Med 351:1488–1490PubMedCrossRef Debes JD, Tindall Dj (2004) Mechanisms of androgen-refractory prostate cancer. N Engl J Med 351:1488–1490PubMedCrossRef
Metadata
Title
Can docetaxel therapy improve overall survival from primary therapy compared with androgen-deprivation therapy alone in Japanese patients with castration-resistant prostate cancer? A multi-institutional cooperative study
Authors
Tomoyuki Shimabukuro
Shigeru Sakano
Kenji Matsuda
Yoriaki Kamiryo
Norio Yamamoto
Yoshitaka Kaneda
Takahito Nasu
Yoshikazu Baba
Akinobu Suga
Mitsutaka Yamamoto
Akihiko Aoki
Kimio Takai
Satoru Yoshihiro
Motohiko Konishi
Katsuhiko Imoto
Hideyasu Matsuyama
Publication date
01-02-2013
Publisher
Springer Japan
Published in
International Journal of Clinical Oncology / Issue 1/2013
Print ISSN: 1341-9625
Electronic ISSN: 1437-7772
DOI
https://doi.org/10.1007/s10147-011-0344-x

Other articles of this Issue 1/2013

International Journal of Clinical Oncology 1/2013 Go to the issue
Webinar | 19-02-2024 | 17:30 (CET)

Keynote webinar | Spotlight on antibody–drug conjugates in cancer

Antibody–drug conjugates (ADCs) are novel agents that have shown promise across multiple tumor types. Explore the current landscape of ADCs in breast and lung cancer with our experts, and gain insights into the mechanism of action, key clinical trials data, existing challenges, and future directions.

Dr. Véronique Diéras
Prof. Fabrice Barlesi
Developed by: Springer Medicine