A phase II study of higher dose docetaxel in androgen-independent prostate cancer.
OBJECTIVE
To assess the efficacy and toxicity profile of single agent docetaxel at a higher dose than previously evaluated in patients with androgen-independent prostate cancer (AIPC).


METHODS
Patients with metastatic and progressive AIPC were treated with docetaxel 100 mg/m on day 1 of a 3-week cycle.


RESULTS
Twenty-five patients with overt and rapid symptomatic deterioration from AIPC were entered into this study. Nine men achieved a reduction in PSA of >50% and 4 >80% for an overall PSA response of 52% (95% confidence interval [CI], 31-73%). Sixty percent of men experienced pain relief. Of 16 subjects with measurable disease, 25% achieved partial response (95% CI, 0-48 months), 44% stable disease, and 31% progressed. Median time to progression was 4.5 months (95% CI, 2.9-6.1 month) and median survival was 9.3 months (95% CI, 5.7-12.9 months). Toxicity was significant and included grade 3 or greater neutropenia (76%), dehydration (16%), thrombosis (8%), confusion (4%), and death (4%).


CONCLUSIONS
Docetaxel is an active agent against AIPC and should be used judiciously. The side effect profile of the 100 mg/m dose was significant and cannot be recommended for everyday clinical practice.
Laber
Damian A
DA
J.G. Brown Cancer Center, University of Louisville, Louisville, Kentucky 40202, USA. damianla@ulh.org
Glisson
Shawn D
SD
Hargis
Jeffery B
JB
Kosfeld
Rodney E
RE
Goldsmith
George
G
Cervera
Alfonso
A
La Rocca
Renato V
RV
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000077143:Docetaxel; D006801:Humans; D008297:Male; D008875:Middle Aged; D011471:Prostatic Neoplasms / Q000188:drug therapy*; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage* / Q000009:adverse effects
D000970:Antineoplastic Agents; D043823:Taxoids; D000077143:Docetaxel