Watchful waiting vs. radical surgery: the Scandinavian trial

In 2005, Bill-Axelson et al. reported the estimated 10-year results of this trial, which enrolled 695 men with early stage prostate cancer at 14 hospitals in Sweden, Finland, and Iceland between October 1989 and February 1999. The men had a mean (average) age of 64.7 years at the time of enrollment and were randomly assigned to radical prostatectomy (347 men) or watchful waiting (348 men).

The results of this trial, at a median of 8.2 years of follow-up, were as follows:

  • 83 men in the surgery group (23.9 percent) and 106 men in the watchful waiting group (30.5 percent) died.
  • 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 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.
  • For local progression, the increase was from 19.1 to 25.1 percentage points, for a relative risk in the surgery group of 0.33.

Bill-Axelson and her colleagues concluded that, compared to watchful waiting, “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.”

Most recently, Bill-Axelson et al. updated the data from this trial as of December 31, 2009. Their updated results at a median 12.8 years of follow-up, as published in the New England Journal of Medicine, are as follows:

  • 166 men in the surgery group (47.8 percent) and 201 in the watchful waiting group (57.7 percent) have died.
  • For 55 of the 347 men (15.9 percent) who were randomly assigned to surgery and 81 of the 348 men (23.3 percent) assigned to the watchful waiting group, death was due to prostate cancer.
  • The cumulative incidence of death from prostate cancer at 15 years was 14.6 percent for the radical prostatectomy group and 20.7 percent for the watchful waiting group.
  • The relative risk with surgery was 0.62.
  • The survival benefit was similar before and after 9 years of follow-up, was observed among men with low-risk prostate cancer, and was confined to men younger than 65 years of age.
  • The number needed to treat to avert one death was 15 overall and 7 for men younger than 65 years of age.
  • Among men treated by radical prostatectomy, the relative risk of prostate cancer-specific mortality was 6.9 times as high among those with extracapsular prostate cancer compared to men with organ-confined disease.

The original conclusion of the 2005 report appears to be valid for the data as of 12.8 years of follow-up. This study continues to show a clear benefit of radical prostatectomy compared to watchful waiting (in contrast to active surveillance) in a cohort of men diagnosed based on clinical criteria alone. But the benefit is only evident in men diagnosed at < 65 years of age.

The second issue that has to be addressed is whether the patients randomized to this trial in 1989-99 are representative of early stage patients being diagnosed today. The problem is that they probably aren’t. The men in this Scandinavian trial were all initially diagnosed with prostate cancer because they had a suspicious digital rectal examination (DRE). By comparison, the majority of early stage patients diagnosed in Europe and North America today have a negative DRE and an elevated PSA.

The third issue to be dealt with is that, in this Scandinavian study, the men who benefited most at a follow-up of 12.8 years were those who were aged 65 or younger. In men ≥ 65 years at the time of enrollment into this study, there was no overall survival benefit from surgery.

Given these statements, The “New” Prostate Cancer InfoLink still believes that radical surgery is a better treatment option than watchful waiting for younger men (i.e., men aged 65 years and younger) who have a reasonable life expectancy of 10-15 years, strong evidence of localized disease, and no contraindications to surgery. However, we wish to clearly emphasize that these data do not in any way imply that immediate surgery would have a better clinical outcome than active surveillance in a cohort of patients with low-risk prostate cancer and a life expectancy of 15+ years who were diagnosed today.

Content on this page last reviewed and updated May 6, 2011.

2 Responses

  1. […] a detailed update on this study, please read the article entitled “Watchful waiting vs. radical surgery: the Scandinavian trial” elsewhere on this site. However, the crucial information is that at 10.8 years of follow-up […]

  2. […] our national sample of eligible men declining PIVOT participation as well as to men enrolled in the earlier Scandinavian trial indicated that PIVOT enrollees are representative of men being diagnosed and treated in the U.S. […]

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