12 mei 2005: Bron: THE ASSOCIATED PRESS

Hoewel algemeen wordt aangenomen dat operatie bij prostaatkanker niet erg zinvol is gezien de ernstige bijwerkingen die vaak oprtreden zoals incontinentie en importentie, blijkt nu uit langjarige Zweedse studie bij 695 mannen met niet uitgezaaide prostaatkanker dat een operatie wel degelijk zinvol is. De tijd tot sterfte verbeterde met meer dan de helft bij relatief jonge mannen. Bij mannen boven de 65 jaar wordt in eerste instantie een wait and see beleid gevoerd en deze mannen kunnen het vaak 20 jaar of langer volhouden met prostaatkanker. Hier een artikel uit The Times over deze nieuwste studie met origineel abstract daaronder en daaronder Zweedse gerandomiseerde studie uit 2002 over vergelijking in effect op overleving van operatie en niets doen.

Study Finds Benefit in Some Surgery for Prostate Cancer

A Scandinavian study of an agonizing decision faced by men who have early prostate cancer - whether to have surgery or wait to see if the disease spreads - found that for those under 65, operating clearly saved lives, cutting the death rate by more than half.

For men over 65, on the other hand, who account for a vast majority of prostate cancer patients, the jury is still out. Because of the new findings, being reported today in The New England Journal of Medicine, younger men "are much less likely to be encouraged to watch and wait," said Dr. Durado Brooks, director of prostate cancer at the American Cancer Society. But Dr. Brooks said more research was needed to determine how the results applied in this country, where prostate cancer is usually diagnosed at an early stage with a blood test; the cancer diagnoses among the Scandinavian subjects mostly occurred when the tumor was large enough to be felt in a rectal exam.

Surgery to remove a diseased prostate carries its own risks - impotence and incontinence - and doctors often instead recommend "watchful waiting," because in many patients the tumor grows so slowly that they die of something else before the cancer ever kills them. Another recent study found that for the 50 percent of men with relatively nonaggressive cancers, watchful waiting can be safe for 20 years. The latest study, however, in looking at men with both aggressive and less aggressive tumors, did not distinguish between the two groups. The study, led by Dr. Anna Bill-Axelson of University Hospital in Uppsala, Sweden, followed 695 Scandinavian men with tumors that had not spread beyond the prostate.

Radical Prostatectomy versus Watchful Waiting in Early Prostate Cancer

Anna Bill-Axelson, M.D., Lars Holmberg, M.D., Ph.D., Mirja Ruutu, M.D., Ph.D., Michael Häggman, M.D., Ph.D., Swen-Olof Andersson, M.D., Ph.D., Stefan Bratell, M.D., Ph.D., Anders Spångberg, M.D., Ph.D., Christer Busch, M.D., Ph.D., Stig Nordling, M.D., Ph.D., Hans Garmo, Ph.D., Juni Palmgren, Ph.D., Hans-Olov Adami, M.D., Ph.D., Bo Johan Norlén, M.D., Ph.D., Jan-Erik Johansson, M.D., Ph.D., for the Scandinavian Prostate Cancer Group Study No. 4

ABSTRACT

Background In 2002, we reported the initial results of a trial comparing radical prostatectomy with watchful waiting in the management of early prostate cancer. After three more years of follow-up, we report estimated 10-year results.

Methods From October 1989 through February 1999, 695 men with early prostate cancer (mean age, 64.7 years) were randomly assigned to radical prostatectomy (347 men) or watchful waiting (348 men). The follow-up was complete through 2003, with blinded evaluation of the causes of death. The primary end point was death due to prostate cancer; the secondary end points were death from any cause, metastasis, and local progression.

Results During a median of 8.2 years of follow-up, 83 men in the surgery group and 106 men in the watchful-waiting group died (P=0.04). In 30 of the 347 men assigned to surgery (8.6 percent) and 50 of the 348 men assigned to watchful waiting (14.4 percent), death was due to prostate cancer. The difference in the cumulative incidence of death due to prostate cancer increased from 2.0 percentage points after 5 years to 5.3 percentage points after 10 years, for a relative risk of 0.56 (95 percent confidence interval, 0.36 to 0.88; P=0.01 by Gray's test). For distant metastasis, the corresponding increase was from 1.7 to 10.2 percentage points, for a relative risk in the surgery group of 0.60 (95 percent confidence interval, 0.42 to 0.86; P=0.004 by Gray's test), and for local progression, the increase was from 19.1 to 25.1 percentage points, for a relative risk of 0.33 (95 percent confidence interval, 0.25 to 0.44; P<0.001 by Gray's test).

Conclusions Radical prostatectomy reduces disease-specific mortality, overall mortality, and the risks of metastasis and local progression. The absolute reduction in the risk of death after 10 years is small, but the reductions in the risks of metastasis and local tumor progression are substantial.

N Engl J Med. 2002 Sep 12;347(11):781-9.

Comment in
: Cancer Treat Rev. 2003 Jun;29(3):231-3.
J Fam Pract. 2003 Jan;52(1):22-3. N Engl J Med. 2002 Sep 12;347(11):839-40.
N Engl J Med. 2003 Jan 9;348(2):170-1; author reply 170-1
. N Engl J Med. 2003 Jan 9;348(2):170-1; author reply 170-1.
N Engl J Med. 2003 Jan 9;348(2):170-1; author reply 170-1.
N Engl J Med. 2003 Jan 9;348(2):170-1; author reply 170-1.
N Engl J Med. 2003 Jan 9;348(2):170-1; author reply 170-1.

A randomized trial comparing radical prostatectomy with watchful waiting in early prostate cancer.

Holmberg L, Bill-Axelson A, Helgesen F, Salo JO, Folmerz P, Haggman M, Andersson SO, Spangberg A, Busch C, Nordling S, Palmgren J, Adami HO, Johansson JE, Norlen BJ; Scandinavian Prostatic Cancer Group Study Number 4.
Regional Oncologic Center, University Hospital, Uppsala, Sweden.

BACKGROUND: Radical prostatectomy is widely used in the treatment of early prostate cancer. The possible survival benefit of this treatment, however, is unclear. We conducted a randomized trial to address this question.

METHODS: From October 1989 through February 1999, 695 men with newly diagnosed prostate cancer in International Union against Cancer clinical stage T1b, T1c, or T2 were randomly assigned to watchful waiting or radical prostatectomy. We achieved complete follow-up through the year 2000 with blinded evaluation of causes of death. The primary end point was death due to prostate cancer, and the secondary end points were overall mortality, metastasis-free survival, and local progression. RESULTS: During a median of 6.2 years of follow-up, 62 men in the watchful-waiting group and 53 in the radical-prostatectomy group died (P=0.31). Death due to prostate cancer occurred in 31 of 348 of those assigned to watchful waiting (8.9 percent) and in 16 of 347 of those assigned to radical prostatectomy (4.6 percent) (relative hazard, 0.50; 95 percent confidence interval, 0.27 to 0.91; P=0.02). Death due to other causes occurred in 31 of 348 men in the watchful-waiting group (8.9 percent) and in 37 of 347 men in the radical-prostatectomy group (10.6 percent). The men assigned to surgery had a lower relative risk of distant metastases than the men assigned to watchful waiting (relative hazard, 0.63; 95 percent confidence interval, 0.41 to 0.96).

CONCLUSIONS: In this randomized trial, radical prostatectomy significantly reduced disease-specific mortality, but there was no significant difference between surgery and watchful waiting in terms of overall survival. Copyright 2002 Massachusetts Medical Society

Randomized Controlled Trial

PMID: 12226148 [PubMed - indexed for MEDLINE]

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