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 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.”
Recently, Bill-Axelson et al. have updated the data on this trial as of December 31, 2006. Their updated results at 10.8 years of follow-up, as published in the Journal of the National Cancer Institute, are as follows:
- 137 men in the surgery group (39.5 percent) and 156 in the watchful waiting group (44.8 percent) have died.
- For 47 of the 347 men (13.5 percent) who were randomly assigned to surgery and 68 of the 348 men (19.5 percent) assigned to the watchful waiting group, death was due to prostate cancer.
- The difference in cumulative incidence of death due to prostate cancer remained stable at 5.4 percentage points at 12 years of follow-up.
- The difference in cumulative incidence of distant metastases fell slightly to 6.7 percentage points at 12 years of follow-up.
- Among men who underwent radical prostatectomy, those with extracapsular tumor growth had 14 times the risk of prostate cancer death as those without it.
In their conclusion to the most recent update, the authors state that, ”Radical prostatectomy reduces prostate cancer mortality and risk of metastases with little or no further increase in benefit 10 or more years after surgery.”
What are we to make of these unexpected data?
The original conclusion of the 2005 report appears to be valid for the data as of 8.2 years of follow-up. But after 10.8 years of follow-up there is no incremental improvement in overall or prostate-specific survival benefit compared to the result at 8.2 years. Frankly, it is difficult to understand what these data may be trying to tell us.
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 diagnosed in 2008. 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 benefitted most at a follow-up of 8.2 years were those who were aged 65 or younger. In this group of men, at that time point, surgery did appear to offer a benefit bordering on 50 percent improvement in prostate cancer-specific survival compared to watchful waiting.
Given these statements, The “New” Prostate Cancer InfoLink still believes that, as stated elsewhere, there is preliminary evidence, based on this single study, to suggest 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, these data are less compelling than they were in 2005.
[...] 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 [...]
[...] 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. [...]