Phase II study of low-dose docetaxel/estramustine in elderly patients or patients aged 18-74 years with hormone-refractory prostate cancer.
OBJECTIVE
Chemotherapy is often poorly tolerated in elderly patients or patients with poor performance status. This trial was designed to determine whether low-dose weekly docetaxel/estramustine was efficacious with acceptable toxicity.


METHODS
Dexamethasone was administered as premedication. Subjects received docetaxel 25 mg/m2 intravenously on days 2, 9, and 16 and estramustine 140 mg orally twice daily on days 1-3, 8-10, and 15-17. Cycles were 28 days. Participants received < or = 6 cycles unless progression or intolerable toxicity occurred.


RESULTS
Fifty-eight subjects were enrolled at 31 sites in the US Oncology Network. Median age was 78 years (range, 64-92 years); performance status scores (0, 1, 2, and 3) were 36%, 38%, 24%, and 2%, respectively; 55 subjects received > or = 1 cycle of treatment; and 4 participants were nonevaluable because they completed < 2 cycles. Among the 56 treated subjects, 38 (68%) had a decreased prostate-specific antigen level (> or = 50% compared with baseline level and maintained for 4 weeks). There were 40 subjects with measurable tumor(s). Responses, assessed using Response Evaluation Criteria in Solid Tumors, were 1 complete response (2.5%), 7 partial responses (17.5%), 26 stable diseases (65%), and 6 progressive diseases (15%). At 1 year, 17% of participants were progression free; median progression-free survival was 5.3 months (range, 1-14.5 months); estimated 1-year survival was 65%. There were no grade 4 treatment-related events. Grade 3 treatment-related events included fatigue/asthenia (11%) and arrhythmia, dehydration, cerebral ischemia, thrombocytopenia, and dyspnea (4% each). There was 1 treatment-related death (acute respiratory distress syndrome).


CONCLUSIONS
These findings suggest that elderly men with advanced-stage prostate cancer tolerate this regimen, with significant responses and prolonged progression-free survival. These patients should not be excluded from chemotherapeutic interventions based on age alone.
Chittoor
Sreeni
S
US Oncology Research, Inc, Houston, TX, USA. sreeni.chittoor@usoncology.com
Berry
William
W
Loesch
David
D
Logie
Keith
K
Fleagle
John
J
Mull
Stephanie
S
Boehm
Kristi A
KA
Zhan
Feng
F
Asmar
Lina
L
D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D000077143:Docetaxel; D004334:Drug Administration Schedule; D004961:Estramustine / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009376:Neoplasms, Hormone-Dependent / Q000188:drug therapy; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000188:drug therapy*; D011788:Quality of Life; D043823:Taxoids / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome
D043823:Taxoids; D000077143:Docetaxel; D004961:Estramustine; D017430:Prostate-Specific Antigen