Phase II Study of Low-Dose Docetaxel/Estramustine in Elderly Patients or Patients Aged 18-74 Years with Hormone-Refractory Prostate Cancer
| Autor: | Feng Zhan, William R. Berry, Sreeni Chittoor, John Fleagle, Stephanie Mull, Lina Asmar, Kristi A. Boehm, David M. Loesch, Keith W. Logie |
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| Rok vydání: | 2006 |
| Předmět: |
Male
Oncology medicine.medical_specialty Neoplasms Hormone-Dependent Urology medicine.medical_treatment Phases of clinical research Docetaxel Drug Administration Schedule Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Aged Aged 80 and over Chemotherapy Performance status business.industry Prostatic Neoplasms Middle Aged Prostate-Specific Antigen Prostate-specific antigen Regimen Treatment Outcome Estramustine Quality of Life Taxoids Premedication business medicine.drug |
| Zdroj: | Clinical Genitourinary Cancer. 5:212-218 |
| ISSN: | 1558-7673 |
| DOI: | 10.3816/cgc.2006.n.039 |
| Popis: | 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.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 receivedor = 6 cycles unless progression or intolerable toxicity occurred.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 receivedor = 1 cycle of treatment; and 4 participants were nonevaluable because they completed2 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).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. |
| Databáze: | OpenAIRE |
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