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Gemcitabine and docetaxel in metastatic, castrate‐resistant prostate cancer
Author(s) -
Garcia Jorge A.,
Hutson Thomas E.,
Shepard Dale,
Elson Paul,
Dreicer Robert
Publication year - 2010
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.25457
Subject(s) - docetaxel , medicine , gemcitabine , prostate cancer , oncology , chemotherapy , neutropenia , adverse effect , cancer , response evaluation criteria in solid tumors , common terminology criteria for adverse events , prostate specific antigen , progressive disease
BACKGROUND: 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. METHODS: 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/m 2 ) Days 1 and 8 and docetaxel (75 mg/m 2 ) 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. RESULTS: 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. CONCLUSIONS: 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.