A Phase II study of estramustine, docetaxel, and carboplatin with granulocyte-colony-stimulating factor support in patients with hormone-refractory prostate carcinoma

Autor: William Oh, Eric J. Small, Paul A. Godley, Cary P. Werner, W. Kevin Kelly, Nicholas J. Vogelzang, Susan Halabi
Rok vydání: 2003
Předmět:
Zdroj: Cancer. 98:2592-2598
ISSN: 1097-0142
0008-543X
Popis: BACKGROUND The authors determined the safety and efficacy of estramustine, docetaxel, and carboplatin with granulocyte–colony-stimulating factor (G-CSF) support in patients with hormone-refractory prostate carcinoma. METHODS In the current multicenter, cooperative group study, patients with advanced prostate carcinoma whose disease progressed despite androgen deprivation therapy were treated with a combination of oral estramustine(240 mg three times per day for 5 days), 70 mg/m2 of docetaxel, and carboplatin at a dose of (area under the curve) 5. G-CSF was used to minimize the neutropenia associated with this regimen. Each cycle was repeated every 21 days. RESULTS Forty patients were treated with a median of 7 cycles of therapy. Of the 34 evaluable patients with elevated pretreatment prostate-specific antigen (PSA) levels, 23 (68%) had a ≥ 50% decline in PSA and 20 (59%) had a ≥ 75% decline. Twenty-one patients had measurable disease, with 1 complete response (5%) and 10 partial responses (47%), for an overall measurable response rate of 52% (95% confidence interval [95% CI], 30–74%). The most common Grade 3 or Grade 4 toxicities (according to the National Cancer Institute Common Toxicity Criteria) included neutropenia in 23% of patients, thrombocytopenia in 13%, and fatigue in 13%. Febrile neutropenia occurred in 1 patient (3%). The overall median time to disease progression was 8.1 months (95% CI, 6–10 months) and the overall survival period was 19 months (95% CI, 13–26 months). CONCLUSIONS The combination of estramustine, docetaxel, and carboplatin with G-CSF support was found to have significant clinical activity with an acceptable toxicity profile in patients with progressive hormone-refractory prostate carcinoma. Cancer 2003;98:2592–8. © 2003 American Cancer Society.
Databáze: OpenAIRE
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