Originally published as JCO Early Release 10.1200/JCO.2005.11.111 on February 28 2005

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Effect of Docetaxel in Patients With Hormone-Dependent Prostate-Specific Antigen Progression After Local Therapy for Prostate Cancer

From the Department of Medicine, University of Medicine and Dentistry of New Jersey/Robert Wood Johnson Medical School; Division of Biostatistics, The Cancer Institute of New Jersey; The Dean and Betty Gallo Prostate Cancer Center; Ernest Mario School of Pharmacy, Rutgers, The State University of New Jersey, Piscataway, NJ

Address reprint requests to Robert S. DiPaola, MD, The Cancer Institute of New Jersey, 195 Little Albany St, New Brunswick, NJ 08901; e-mail: dipaolrs{at}umdnj.edu

PURPOSE: To evaluate docetaxel in the treatment of patients with early-stage prostate cancer with prostate-specific antigen (PSA) progression after local therapy without androgen ablation therapy.

PATIENTS AND METHODS: Twenty-five patients with adenocarcinoma of the prostate with PSA progression despite local therapy were treated with 70 mg/m² docetaxel every 21 days. Treatment was planned for eight cycles. Patients were followed up for effects on PSA, testosterone, and toxicity.

RESULTS: Twenty-three of 25 patients completed at least one full cycle of therapy. Ten (43%) of 23 patients demonstrated a decrease in PSA by 50% for at least 4 weeks. The nadir decrease in PSA occurred beyond 150 days of therapy in most patients. Therapy was well tolerated. Grade 4 neutropenia with fever occurred in only six cycles (4.5%). Two patients required 25% dose reductions, both occurring with cycle 6, secondary to increased transaminases in one patient, and grade 3 lacrimation in the other patient. Two patients were removed after the first cycle of therapy due to toxicity (deep venous thrombosis, chest palpitations). Mean testosterone levels were not reduced in 17 patients assessed before and during therapy (P = .12).

CONCLUSION: This study demonstrated the activity of docetaxel alone, without androgen ablation, in patients with PSA progression after completion of local therapy. Treatment with docetaxel in this population with early disease progression was well tolerated, biochemically active, and was not androgen ablative. Accrual to national phase III studies in early disease is now critical and should be strongly encouraged to determine the ability of early chemotherapy to improve survival.

Supported by a grant from Aventis, and National Cancer Institute grant No. CCSG 72,720.

Authors’ disclosures of potential conflicts of interest are found at the end of this article.

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