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N Engl J Med. 2018 Dec 13;379(24):2319-2329. doi: 10.1056/NEJMoa1807801.

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

Author information

1
From the Department of Surgical Sciences (A.B.-A., L.H., M.H.), Regional Cancer Center Uppsala Örebro (H.G.), and the Department of Pathology (C.B.), Uppsala University Hospital, Uppsala, the School of Health and Medical Sciences, Örebro University, and the Department of Urology, Örebro University Hospital, Örebro (S.-O.A., O.A., J.-E.J.), the Department of Medical Epidemiology and Biostatistics (H.-O.A.), Karolinska Institutet, Stockholm, and the Division of Clinical Cancer Epidemiology, Sahlgrenska Academy, Gothenburg (G.S.) - all in Sweden; the School of Medicine, Division of Cancer Studies (L.H., H.G.), and the School of Cancer and Pharmaceutical Sciences (L.H.), King's College London, London; the Department of Urology, Helsinki University Hospital (K.T.), and the Department of Pathology, University of Helsinki (S.N.), Helsinki; the Department of Epidemiology, Harvard T.C. Chan School of Public Health, Boston (H.-O.A.); and the Clinical Effectiveness Research Group, Institute of Health and Society, University of Oslo, Oslo (H.-O.A.).

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.).

PMID:
30575473
DOI:
10.1056/NEJMoa1807801
[Indexed for MEDLINE]

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