ABSTRACT
OBJECTIVE: To compare the efficacy and tolerability of peripheral androgen blockade using combined low-dose flutamide plus finasteride vs low-dose flutamide monotherapy for treating biochemical relapse after the definitive management of prostate adenocarcinoma. PATIENTS AND METHODS: Fifty-six men treated for biochemical relapse of prostate cancer were enrolled prospectively in a phase II trial at the Walter Reed Army Medical Center from 1997 to 2001. Thirty-six men were treated with flutamide (125 mg twice daily) and finasteride (5 mg twice daily), and 20 men received low-dose flutamide only after biochemical recurrence (prostate-specific antigen, PSA, level > or =0.4 ng/mL). Cox proportional hazards analyses were used to compare the risk of progression between the groups. RESULTS: Patients on combined and monotherapy had a median follow-up of 54 and 43.5 months, respectively. Seven men (19%) in the combined arm remain in the study with no progression, while five (25%) on monotherapy continue and are progression-free. Men on combined therapy had a greater decrease in their PSA level (P = 0.002). Multivariate analysis showed that men on combined therapy had significantly less risk of progression than men on monotherapy (hazard ratio 0.21, 95% confidence interval 0.07-0.63, P = 0.005). There was no significant difference in the frequency of side-effects between the groups. Toxicities were reported to be mild. CONCLUSIONS: Our analysis suggests the therapeutic value of low-dose flutamide alone or combined with finasteride as first-line agents in a possible graduated approach for treating PSA-only recurrent prostate cancer. Due to unwanted metabolic effects associated with traditional hormonal agents, phase III trials comparing both regimens with current therapies are warranted.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Finasteride/administration & dosage , Flutamide/administration & dosage , Neoplasm Recurrence, Local/drug therapy , Prostatic Neoplasms/drug therapy , Aged , Androgen Antagonists/administration & dosage , Antineoplastic Agents, Hormonal/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Epidemiologic Methods , Humans , Male , Middle Aged , Prostate-Specific Antigen/metabolism , Treatment OutcomeABSTRACT
PRIMARY OBJECTIVE: To evaluate the effectiveness of the Bikes, Blades and Boards (BB&B) programme. It was hypothesized that children who participated in the BB&B programme would demonstrate greater knowledge of how to wear their helmets safely than a control group who did not participate in the programme and retain their skills when assessed 1 year later. RESEARCH DESIGN: Single blind cluster randomized design. METHODS AND PROCEDURES: Twelve classes of grade 2 students (n = 162) participated; six classes were assigned to an experimental or control group. A blinded research assistant, taking 3-5 minutes per child, completed the Helmet Checklist with each group on two occasions and scores of the experimental group (post-BB&B programme) were compared to the control group. The experimental group was reassessed using the Helmet Checklist, 1 year later. EXPERIMENTAL INTERVENTIONS: The BB&B programme consisted of a presentation, bicycle helmet checklist, demonstration and individual practice and feedback. MAIN OUTCOMES AND RESULTS: Children in the experimental group showed a better knowledge of how to wear their helmets safely compared to the control group (F = 51.84, CI = 9.11-9.71) and retained this knowledge 1 year after participating in the BB&B programme. CONCLUSIONS: The BB&B programme is effective in teaching grade 2 children how to wear their helmets correctly, which is knowledge they retain for at least 1 year.
