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Radical prostatectomy or watchful waiting in early prostate cancer.

Bill-Axelson A. Holmberg L. Garmo H. Rider J.R. Taari K. Busch C. Nordling S. Haggman M. Andersson S.-O. Spangberg A. Andren O. Palmgren J. Steineck G. Adami H.-O. Johansson J.-E.

Comment by Henk van der Poel

In clinical prostate cancer prostatectomy was shown to improve survival also at longer follow up with an absolute risk reduction in death from prostate cancer of 11% and a number needed to treat to prevent one prostate cancer death of 8. Younger men and men with intermediate risk prostate cancer were most likely to benefit. Interestingly, prostatectomy did reduce the risk of metastases in older men. For men treated with watchful-waiting the risk of dying at 18 years was 68.9% versus 56.1% for the prostatectomy treated men. This all comes with a price: earlier data show an almost 4x higher risk of urinary leakage in the prostatectomy group, with surprisingly, comparable erectile dysfunction rates for both arms. Is 18 years long enough. Certainly for men under 65 years of age longer follow up is warranted, in particular considering the risk of metastases in the prostatectomy arm of 26.1% at 18 years.

New England Journal of Medicine 2014 Mar 6;370(10):932-42.

Abstract

Bachground Radical prostatectomy reduces mortality among men with localized prostate cancer; however, important questions regarding long-term benefit remain.

Methods Between 1989 and 1999, we randomly assigned 695 men with early prostate cancer to watchful waiting or radical prostatectomy and followed them through the end of 2012. The primary end points in the Scandinavian Prostate Cancer Group Study Number 4 (SPCG-4) were death from any cause, death from prostate cancer, and the risk of metastases. Secondary end points included the initiation of androgen-deprivation therapy.

Results During 23.2 years of follow-up, 200 of 347 men in the surgery group and 247 of the 348 men in the watchful-waiting group died. Of the deaths, 63 in the surgery group and 99 in the watchful-waiting group were due to prostate cancer; the relative risk was 0.56 (95% confidence interval [CI], 0.41 to 0.77; P=0.001), and the absolute difference was 11.0 percentage points (95% CI, 4.5 to 17.5). The number needed to treat to prevent one death was 8. One man died after surgery in the radical-prostatectomy group. Androgen-deprivation therapy was used in fewer patients who underwent prostatectomy (a difference of 25.0 percentage points; 95% CI, 17.7 to 32.3). The benefit of surgery with respect to death from prostate cancer was largest in men younger than 65 years of age (relative risk, 0.45) and in those with intermediate-risk prostate cancer (relative risk, 0.38). However, radical prostatectomy was associated with a reduced risk of metastases among older men (relative risk, 0.68; P=0.04).

Conclusions Extended follow-up confirmed a substantial reduction in mortality after radical prostatectomy; the number needed to treat to prevent one death continued to decrease when the treatment was modified according to age at diagnosis and tumor risk. A large proportion of long-term survivors in the watchful-waiting group have not required any palliative treatment. (Funded by the Swedish Cancer Society and others.).

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