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Gemcitabine and docetaxel in metastatic, castrate-resistant prostate cancer†
Results from a phase 2 trial
Article first published online: 4 OCT 2010
Copyright © 2010 American Cancer Society
Volume 117, Issue 4, pages 752–757, 15 February 2011
How to Cite
Garcia, J. A., Hutson, T. E., Shepard, D., Elson, P. and Dreicer, R. (2011), Gemcitabine and docetaxel in metastatic, castrate-resistant prostate cancer. Cancer, 117: 752–757. doi: 10.1002/cncr.25457
Presented at the 2006 American Society of Clinical Oncology Prostate Cancer Symposium; San Francisco, California; February 24-26, 2006.
- Issue published online: 3 FEB 2011
- Article first published online: 4 OCT 2010
- Manuscript Accepted: 3 MAY 2010
- Manuscript Revised: 29 APR 2010
- Manuscript Received: 2 MAR 2010
- castrate-resistant prostate cancer;
- prostate-specific antigen
Docetaxel is the standard of care for patients with metastatic, castrate-resistant prostate cancer (CRPC). Gemcitabine is a nucleoside analogue with broad antitumor activity. In a phase 2 study of combined docetaxel and gemcitabine, the authors assessed its safety and activity in patients with chemotherapy-naive, metastatic CRPC.
Eligible patients had untreated, metastatic CRPC with radiologic and/or biochemical evidence of progression after antiandrogen withdrawal with castrate testosterone levels, an Eastern Cooperative Oncology performance status (ECOG PS) of 0 to 2, and adequate organ function; no previous chemotherapy was permitted. Patients received gemcitabine (800 mg/m2) Days 1 and 8 and docetaxel (75 mg/m2) on Day 8 every 21 days for a maximum of 6 cycles. Response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) for measurable disease. A prostate-specific antigen (PSA) response was defined as a decline ≥50% in baseline PSA level.
Thirty-five patients with chemotherapy-naive, metastatic CRPC were enrolled. The median age was 67 years, and 60% of patients had an ECOG PS of 0. PSA responses were observed in 49% of patients. Among the patients who had measurable disease (n = 25), 3 patients (12%) had a confirmed, RECIST-defined partial response (PR); 4 patients (16%) had an unconfirmed PR; and 15 patients (60%) achieved stable disease. The most common adverse events included grade 1 and 2 fatigue (69%), alopecia (80%), and nausea/vomiting (54%). No treatment-related deaths were noted, but an unusually high incidence of grade 3 and 4 neutropenia was observed.
The efficacy of combined gemcitabine and docetaxel in metastatic CRPC was similar to that observed with single-agent docetaxel. In contrast to single-agent docetaxel, the combination was moderately toxic and had an impact primarily on bone marrow reserve. Cancer 2011. © 2010 American Cancer Society.