Phase II trial of vinorelbine and estramustine in the treatment of metastatic hormone-resistant prostate cancer

The purpose of this study was to investigate the efficacy and safety of combination chemotherapy using estramustine and vinorelbine in chemotherapy-naı̈ve patients with hormone-resistant prostate cancer (HRPC). The patients ( n = 54) received oral estramustine 840 mg/day on Days 1 to 14 a...

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Bibliographic Details
Published in:	Urologic oncology Vol. 22; no. 1; pp. 32 - 35
Main Authors:	Borrega, Pablo, Velasco, Amalia, Bolaños, Matilde, del Mar Páerez, Maráia, Mel, Josáe Ramáon, Reina, Juan Josáe, Rodráiguez-Jaraiz, Maráia Angeles, Chaves, Manuel, Gonzáalez-Baráon, Manuel
Format:	Journal Article
Language:	English
Published:	New York, NY Elsevier Inc 2004 Elsevier Science
Subjects:	Antineoplastic Agents - adverse effects Antineoplastic Agents - therapeutic use Antineoplastic Combined Chemotherapy Protocols - administration & dosage Antineoplastic Combined Chemotherapy Protocols - adverse effects Biological and medical sciences Disease-Free Survival Drug Resistance, Neoplasm Estramustine Estramustine - administration & dosage Estramustine - adverse effects Gynecology. Andrology. Obstetrics Humans Male Male genital diseases Medical sciences Nephrology. Urinary tract diseases Phase II Prostate cancer Prostate-Specific Antigen - blood Prostatic Neoplasms - drug therapy Prostatic Neoplasms - mortality Treatment Outcome Tumors Tumors of the urinary system Urinary tract. Prostate gland Vinblastine - administration & dosage Vinblastine - adverse effects Vinblastine - analogs & derivatives Vinorelbine Phase II Estramustine Prostate cancer Vinorelbine Antineoplastic agent Hormone Nephrology Urinary system disease Prostate disease Malignant tumor Metastasis Urology Resistance Alkylating agent Alkaloid Cancerology Treatment Phase II trial Metastatic Antimitotic Male genital diseases
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Summary:	The purpose of this study was to investigate the efficacy and safety of combination chemotherapy using estramustine and vinorelbine in chemotherapy-naı̈ve patients with hormone-resistant prostate cancer (HRPC). The patients ( n = 54) received oral estramustine 840 mg/day on Days 1 to 14 and IV vinorelbine 25 mg/m 2 on Days 1 and 8 of every 3 wk cycle. The median number of cycles per patient was 9 (range, 1 to 27). Fifty-three patients were evaluable for toxicity and survival and 52 for prostate specific antigen (PSA) response. Median age was 68 (range, 46–80). PSA sustained decrease >50% was seen in 52% of patients (95% CI: 38–66%). A complete response was seen in 3 and a partial response in 12 of 25 patients with measurable disease, for an overall objective response of 60% (95% CI: 41–79%). Improvement in performance status was observed in 30 out of 43 evaluable for clinical benefit response. The median duration of response was 7 mo and median time to progression was 6 mo. The median survival time was 15 mo. The most common adverse event was mild gastrointestinal toxicity. In general, toxicity G3–4 was low: granulocytopenia Grade 3–4 (8%), thrombocytopenia Grade 3 (6%), and anemia Grade 3 (13%). Other Grade 3 toxicities included deep vein thrombosis (4%), hepatic (2%), cardiac ischemia (2%), fatigue (6%), and sensory neuropathy (2%). There were 2 treatment-related deaths (4%). We conclude that vinorelbine and estramustine as used in this trial is an efficacious and well-tolerated therapeutic regimen in the management of HRPC.
ISSN:	1078-1439 1873-2496
DOI:	10.1016/S1078-1439(03)00102-9