University of Oklahoma Health Sciences Center

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Author/s:

Bill-Axelson, Anna, Holmberg, Lars, Garmo, Hans, Taari, Kimmo, Busch, Christer, Nordling, Stig, Häggman, Michael, Andersson, Swen-Olof, Andrén, Ove, Steineck, Gunnar, Adami, Hans-Olov, Johansson, Jan-Erik

Date Added:

January 13, 2019

Journal/Publication:

The New England Journal of Medicine

Publisher:

Massachusetts Medical Society

Publication Date:

December 13, 2018

Issue:

Volume:

379

Pages:

2319-2329

URL:

Radical Prostatectomy or Watchful Waiting in Prostate Cancer - 29-Year Follow-up.

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1056/NEJMoa1807801

PMID (1):

30575473

Keywords

prostate cancer

radical prostatectomy

MeSH

prostatectomy

prostatic neoplasms

RPR Commentary

This RCT comparing prostatectomy to watchful waiting in men with a long life expectancy otherwise found, after an average of 23 years of follow-up, that prostatectomy extended life by an average of 2.9 years.

Abstract

BACKGROUND

Radical prostatectomy reduces mortality among men with clinically detected localized prostate cancer, but evidence from randomized trials with long-term follow-up is sparse.

METHODS

We randomly assigned 695 men with localized prostate cancer to watchful waiting or radical prostatectomy from October 1989 through February 1999 and collected follow-up data through 2017. Cumulative incidence and relative risks with 95% confidence intervals for death from any cause, death from prostate cancer, and metastasis were estimated in intention-to-treat and per-protocol analyses, and numbers of years of life gained were estimated. We evaluated the prognostic value of histopathological measures with a Cox proportional-hazards model.

RESULTS

By December 31, 2017, a total of 261 of the 347 men in the radical-prostatectomy group and 292 of the 348 men in the watchful-waiting group had died; 71 deaths in the radical-prostatectomy group and 110 in the watchful-waiting group were due to prostate cancer (relative risk, 0.55; 95% confidence interval [CI], 0.41 to 0.74; P<0.001; absolute difference in risk, 11.7 percentage points; 95% CI, 5.2 to 18.2). The number needed to treat to avert one death from any cause was 8.4. At 23 years, a mean of 2.9 extra years of life were gained with radical prostatectomy. Among the men who underwent radical prostatectomy, extracapsular extension was associated with a risk of death from prostate cancer that was 5 times as high as that among men without extracapsular extension, and a Gleason score higher than 7 was associated with a risk that was 10 times as high as that with a score of 6 or lower (scores range from 2 to 10, with higher scores indicating more aggressive cancer).

CONCLUSIONS

Men with clinically detected, localized prostate cancer and a long life expectancy benefited from radical prostatectomy, with a mean of 2.9 years of life gained. A high Gleason score and the presence of extracapsular extension in the radical prostatectomy specimens were highly predictive of death from prostate cancer. (Funded by the Swedish Cancer Society and others.)

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