Long-term outcome of a phase II study of weekly docetaxel with a short course of estramustine and enoxaparine in hormone-resistant prostate cancer patients.
OBJECTIVE
The objective was to define the toxicity and activity of weekly docetaxel administered with a short course of estramustine and enoxaparine in patients with hormone-resistant prostate cancer (HRPC).


METHODS
Twenty-four patients were treated with the next regimen: weekly docetaxel 36 mg/m(2) iv for three consecutive weeks every 28 days, and estramustine 280 mg three times a day for three consecutive days beginning the day before docetaxel (days 1-3, 8-10 and 15-17). In order to prevent thromboembolic events, 40 mg of subcutaneous enoxaparine was administered daily sc on the same days as estramustine. Primary endpoints were: toxicity, especially the presence of thromboembolic events, PSA response rate and response in measurable disease. Secondary endpoints were: time to PSA progression and overall survival.


RESULTS
Nineteen of 24 patients (79.1%, 95% CI 71-87%) had a PSA response = or >50%. Four of the eleven patients with measurable disease had a partial response. The median time to PSA progression was 7 months (CI 95%: 6.5-9) and the median survival was 19 months (IC 95%: 11-24). Toxicity was manageable with no treatment- related mortality. Only two patients had grade 4 neutropenia. Two patients had thrombotic events, one deep venous thrombosis and one stroke. The main grade 3 non-haematologic toxicity was diarrhoea and asthenia, both in 25% of patients.


CONCLUSIONS
Weekly docetaxel with a short course of estramustine and enoxaparine is active and tolerable in HRPC patients. The observed incidence of thrombosis was lower than previously reported but the association of enoxaparine was not enough to completely prevent the thromboembolic events.
González-Martín
A
A
Medical Oncology Service, Hospital Universitario Ramón y Cajal, Madrid, Spain. agonzalezm@seom.org
Fernández
E
E
Vaz
M A
MA
Burgos
J
J
López García
M
M
Rodríguez Patrón
R
R
Guillén
C
C
Mayayo
T
T
Allona
A
A
Arias
F
F
Moyano
A
A
D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage*; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use; D000077143:Docetaxel; D004334:Drug Administration Schedule; D019008:Drug Resistance, Neoplasm; D017984:Enoxaparin / Q000008:administration & dosage*; D004961:Estramustine / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011471:Prostatic Neoplasms / Q000188:drug therapy*; D043823:Taxoids / Q000008:administration & dosage*; D013997:Time Factors; D016896:Treatment Outcome
D000925:Anticoagulants; D000970:Antineoplastic Agents; D018931:Antineoplastic Agents, Hormonal; D017984:Enoxaparin; D043823:Taxoids; D000077143:Docetaxel; D004961:Estramustine