After about 13 years of follow-up, men <65 years of age with prostate cancer diagnosed on the basis of obstructive urinary symptoms (rather than elevated prostate-specific antigen levels) and assigned to radical prostatectomy, as compared with watchful waiting, have improved survival. Bill-Axelson et al. present their findings in an Original Article this week in NEJM.
Determining whether there is a survival benefit for men with low-risk [prostate cancer] is relevant in light of the risk of overdiagnosis resulting from PSA testing and the adverse events associated with therapy.
• As compared to watchful waiting, was radical prostatectomy associated with a reduction in overall mortality?
The cumulative incidence of death at 15 years was 46.1% in the radical-prostatectomy group and 52.7% in the watchful-waiting group (a difference of 6.6 percentage points; 95% confidence interval [CI], -1.3 to 14.5), corresponding to a relative risk of death in the radical-prostatectomy group of 0.75 (95% CI, 0.61 to 0.92; P=0.007) and a number needed to treat of 15.
• As compared to watchful waiting, was radical prostatectomy associated with a reduction in prostate-specific mortality?
The cumulative incidence of death from prostate cancer at 15 years was 14.6 in the radical-prostatectomy group and 20.7 in the watchful-waiting group (a difference of 6.1 percentage points; 95% CI, 0.2 to 12.0), corresponding to a relative risk of death in the radical-prostatectomy group of 0.62 (95% CI, 0.44 to 0.87; P=0.01).
Morning Report Questions
Q: What subgroups of patients had a differential outcome following radical prostatectomy?
A: The interaction term between age at randomization (<65 years vs. greater than/equal to 65 years) and treatment was significant with respect to overall mortality (P=0.003) and remained so when age was considered as a continuous variable (P=0.001). The PSA level at the time of randomization (<10 vs. greater than/equal to 10 ng per milliliter) and the Gleason score (<7 vs. greater than/ equal to 7) did not alter the effect of radical prostatectomy.
Q: What were the most common adverse effects associated with radical prostatectomy?
A: The most common symptom reported postoperative was impotence (58% of patients), followed by urinary leakage (32%).