Phase II study of weekly docetaxel in symptomatic androgen-independent prostate cancer.
BACKGROUND
This study sought to define the activity and toxicity of weekly docetaxel in patients with androgen-independent prostate cancer and cancer-related pain.


METHODS
Twenty-five patients were treated with docetaxel 36 mg/m2 i.v. administered weekly for six consecutive weeks followed by two weeks without treatment. This eight-week treatment cycle was repeated until progression or unacceptable toxicity. Endpoints included palliative response (a 2-point reduction on the 6-point Present Pain Intensity scale without an increase in analgesic consumption or a 50% decrease in analgesic use without an increase in pain), PSA response (a 50% decrease maintained at least four weeks), measurable disease response, survival, and toxicity.


RESULTS
Twelve of 25 patients (48%, 95% confidence interval (95% CI): 28%-68%) had a palliative response. Eleven of the 24 patients who entered with an elevated PSA (46%, 95% CI: 25%-67%) had a PSA response. Two of five patients with measurable disease had a partial response. Toxicity of therapy was modest with no treatment-related mortality. Twenty-five percent of patients experienced a grade 3 or 4 hematologic toxicity and 36% of patients experienced a grade 3 non-hematologic toxicity.


CONCLUSIONS
Weekly docetaxel is well tolerated in patients with androgen-independent prostate cancer and has significant activity as measured by relief of pain, reduction in PSA, and reduction in measurable disease.
Beer
T M
TM
Department of Medicine, Oregon Health Sciences University, Portland 97201, USA. beert@ohsu.edu
Pierce
W C
WC
Lowe
B A
BA
Henner
W D
WD
D000368:Aged; D000369:Aged, 80 and over; D000700:Analgesics / Q000627:therapeutic use; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D018450:Disease Progression; D000077143:Docetaxel; D004334:Drug Administration Schedule; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology*; D010146:Pain / Q000188:drug therapy / Q000209:etiology; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D043823:Taxoids
D000700:Analgesics; D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D000077143:Docetaxel; D017430:Prostate-Specific Antigen; D017239:Paclitaxel