title: A pilot trial of chemohormonal therapy for metastatic prostate carcinoma.
abstract: Fifteen patients with previously untreated metastatic prostate cancer were treated on a pilot trial with a combination of maximal androgen blockade plus intermittent cytotoxic therapy after androgen priming to stimulate cell division. Androgen blockage was carried out using a gonadotropin-releasing hormone analog (leuprolide) plus a nonsteroidal antiandrogen (flutamide). Carboplatin (CBDCA) (800 mg/m2) was given intravenously every 28 days, preceded for 3 days and followed for 3 days by androgen treatment with fluoxymesterone (5 mg orally twice a day), during which time flutamide was discontinued. Three patients (20%) achieved a complete response (CR), and eight patients (53.3%) achieved a partial response (PR). Four patients (26.7%) had stable disease (SD). The median progression-free survival (PFS) time was 31 months. Nine of 15 patients (60%) remain alive with a median follow-up time of 42+ months (range, 22 to 54 months). Grade 4 thrombocytopenia and Grades 3 or 4 leukopenia were experienced in 87% and 80% of patients, respectively, requiring dose reductions of CBDCA in 85% of the cycles. Six of 15 patients experienced a flare in bone pain with androgen priming. There were no associated spinal cord compressions; however, exclusion of impending spinal cord compression was required before entrance on study.
authors.affiliation: Department of Medicine, Walter Reed Army Medical Center, Washington, DC 20307-5001.
authors.forename: N A
authors.initials: NA
authors.lastname: Dawson
authors.forename: G
authors.initials: G
authors.lastname: Wilding
authors.forename: R B
authors.initials: RB
authors.lastname: Weiss
authors.forename: D G
authors.initials: DG
authors.lastname: McLeod
authors.forename: W M
authors.initials: WM
authors.lastname: Linehan
authors.forename: J A
authors.initials: JA
authors.lastname: Frank
authors.forename: J L
authors.initials: JL
authors.lastname: Jacob
authors.forename: E P
authors.initials: EP
authors.lastname: Gelmann
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary*; D000368:Aged; D000728:Androgens / Q000502:physiology*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D004341:Drug Evaluation; D005474:Fluoxymesterone / Q000627:therapeutic use; D005485:Flutamide / Q000627:therapeutic use; D006801:Humans; D016729:Leuprolide / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009376:Neoplasms, Hormone-Dependent / Q000188:drug therapy*; D010865:Pilot Projects; D011471:Prostatic Neoplasms / Q000188:drug therapy*; D012074:Remission Induction; D016019:Survival Analysis
chemical_list: D000728:Androgens; D005485:Flutamide; D005474:Fluoxymesterone; D016190:Carboplatin; D016729:Leuprolide