Prospective randomized trial comparing flutamide as adjuvant treatment versus observation after radical prostatectomy for locally advanced, lymph node-negative prostate cancer.

OBJECTIVE: To assess the efficacy and the tolerability of flutamide as adjuvant treatment after radical prostatectomy for locally advanced, lymph node-negative prostate cancer. METHODS: Men with locally advanced, lymph node-negative prostate cancer were randomized after radical prostatectomy to receive either flutamide 750mg daily or no adjuvant treatment. Recurrence-free and overall survival were the study end points. Recurrence was defined as a PSA value greater than 5ng/ml or two values greater than 2ng/ml more than three months apart with increasing tendency or three values greater than 1ng/ml more than three months apart with increasing tendency or any clinical recurrence. RESULTS: 309 patients (157 in the control arm and 152 in the flutamide arm) were eligible for efficacy analysis. The median follow-up was 6.1 years. Recurrence-free survival was better in the flutamide group ( P=0.0041), there was, however, no detectable difference in overall survival ( p=0.92 ). Moreover, there was a considerable toxicity reported in the flutamide group. CONCLUSION: Although having some effect on disease recurrence, adjuvant flutamide treatment does not improve median-term overall survival after radical prostatectomy for locally advanced, lymph node-negative prostate cancer.

Preoperative cardiopulmonary risk assessment as predictor of early noncancer and overall mortality after radical prostatectomy.

OBJECTIVES: To evaluate the capability of the preoperative cardiopulmonary risk assessment to predict early noncancer and overall mortality after radical prostatectomy for clinically localized prostate cancer. METHODS: In 444 consecutive radical prostatectomy patients, the American Society of Anesthesiologists Physical Status classification and the presence of cardiac insufficiency (New York Heart Association classification), angina pectoris (Canadian Cardiovascular Society classification), diabetes, hypertension, history of thromboembolism, and chronic obstructive or restrictive pulmonary disease were assessed. Kaplan-Meier time-event curves and Mantel-Haenszel hazard ratios were estimated for noncancer (other deaths were censored) and overall mortality. Cox proportional hazard models were used to analyze possible combined effects of risk factors. RESULTS: During an average follow-up of 4.7 years, 36 patients died: 15 of noncancer causes, 14 of prostate cancer, 6 of other cancers, and 1 in a car accident. The comorbidity scores for American Society of Anesthesiologists Physical Status classification, New York Heart Association classification, and Canadian Cardiovascular Society classification and combinations between the latter two scores were significantly associated with early noncancer mortality in a dose-response pattern. Furthermore, patients with chronic obstructive pulmonary disease were at increased risk. The association with overall mortality was less strong. CONCLUSIONS: The preoperative cardiopulmonary risk assessment may be used as a predictor of early noncancer and overall mortality after radical prostatectomy and should be evaluated further as a source of prognostic information in surgical oncology.