Docetaxel, with or without estramustine phosphate, as first‐line chemotherapy for hormone‐refractory prostate cancer: results of a multicentre, randomized phase II trial

• Published in: BJU international Vol. 102; no. 9; pp. 1080 - 1085
• Main Authors: Caffo, Orazio, Sava, Teodoro, Comploj, Evi, Fariello, Annamaria, Zustovich, Fable, Segati, Romana, Sacco, Cosimo, Valduga, Francesco, Cetto, Gianluigi, Galligioni, Enzo
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01.11.2008; Blackwell
• Subjects: Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; docetaxel; Estramustine - administration & dosage; estramustine phosphate; Gynecology. Andrology. Obstetrics; Humans; Male; Male genital diseases; Medical sciences; Middle Aged; Nephrology. Urinary tract diseases; prostate cancer; Prostate-Specific Antigen - metabolism; Prostatic Neoplasms - drug therapy; Prostatic Neoplasms - metabolism; randomized trial; Survival Analysis; Taxoids - therapeutic use; Treatment Outcome; Tumors; Tumors of the urinary system; Urinary tract. Prostate gland; Antineoplastic agent; Phosphates; Nephrology; Treatment resistance; Urinary system disease; Prostate disease; Hormone therapy; randomized trial; Docetaxel; Malignant tumor; Estramustine; Urology; First line treatment; Alkylating agent; Randomization; estramustine phosphate; Taxane derivatives; Nitrogen mustard; Phase II trial; Clinical trial; Antimitotic; Male genital diseases; Prostate cancer; Cancer
• ISSN: 1464-4096; 1464-410X
• DOI: 10.1111/j.1464-410X.2008.07779.x

OBJECTIVE To report the results of a randomized phase II trial of docetaxel with and without estramustine phosphate (EP) in patients with hormone‐refractory prostate cancer (HRPC). PATIENTS AND METHODS Patients with progressive HRPC were randomized to receive docetaxel 70 mg/m2 on day 1 (arm A), or docetaxel 70 mg/m2 on day 2 plus oral EP three times daily, at a total daily dose of 840 mg, on days 1–5 (arm B). The primary objective of the trial was to evaluate the activity of the treatments in terms of the response in prostate‐specific antigen (PSA) level. RESULTS Forty‐five of the 49 patients centrally randomized to arm A and 44 of the 46 in arm B were evaluable for activity. The PSA level decreased by ≥50% in 40% of the patients in arm A and in 75% of those in arm B. The median time to PSA progression was 20 weeks in arm A and 30 weeks in arm B. The patients in arm B had an improvement in pain over time. CONCLUSION These data support the existence of a possible advantage in combining docetaxel and EP, which should be verified in a specific randomized phase III study.