In their fourth report on a randomized trial of prostatectomy vs watchful waiting, the Scandinavian Prostate Cancer Group Study ( 1 ) provided a comprehensive account of the patients’ baseline clinical characteristics, factors influencing overall and cause-specific mortality and distant metastases, and associations of mortality with extracapsular spread and Gleason score. This report described a most remarkable clinical study that should be widely emulated, especially by the advocates of new but unproven treatments and technologies.
Similar to the abstract of their previous report ( 2 ), the authors of the latest again concluded 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.” However, based on the authors’ own data, it is clear that their up-front blanket endorsement of prostatectomy does not apply to upwards of three-quarters of the patients in their study.
In terms of overall mortality, that is, death from any cause (their figure 3, A), the probability of death after 10 years was 33% for men over the age of 65 years who were assigned to prostatectomy as well as for men over and under the age of 65 years who were assigned to watchful waiting, whereas it was 16% for men younger than 65 years who had prostatectomies. Clearly, a substantial fraction of men younger than 65 years benefited from prostatectomy, but men who were 65 years and older fared no better than those who were assigned to watchful waiting.
As for cause-specific mortality, the data in figure 3, B, showed the 10-year probability of death to be 19% for men younger than 65 years who were assigned to watchful waiting compared with 9% for men aged 65 years and older who were assigned to this treatment and for men in both age groups who underwent prostatectomy. Presumably, had the men who were younger than 65 years and assigned to watchful waiting undergone prostatectomy, their cause-specific mortality would have decreased to about 9%. However, as with overall mortality, these data showed no benefit of prostatectomy for men aged 65 years or older.
The probability of distant metastases at 10 years (figure 3, C) was 26% for men younger than 65 years who were assigned to watchful waiting, but, in an overlapping pattern of incidence curves, it was in the range of 12%–18% for the other three groups. Again, in what proved to be a consistent pattern, these data make clear that the probability of distant metastases in men aged 65 years and older who were assigned to watchful waiting was essentially the same as that for men in both age groups who underwent prostatectomy.
In the 2002 Scandinavian report ( 3 ), which deals with the quality of life after radical prostatectomy or watchful waiting, the conclusion is reached that “… on average, the choice has little if any influence on well being or the subjective quality of life after a mean follow-up of four years.” This paints a rosier picture than the report of Litwin et al. ( 4 ), who concluded that “… those receiving therapeutic interventions for their prostate cancer were found to have poorer disease-targeted health-related quality of life.”
If the primary goal of prostatectomy is to reduce the probability of death from prostate cancer while minimizing its impact on quality of life, it is clear from the Scandinavian report ( 1 ) that prostatectomy benefits mainly men under 65 years. This is not to suggest that aggressive treatment is inappropriate for early-stage patients over the age of 65 years, but only that many such treatments could be delayed or avoided entirely by the adoption of active surveillance as described by Klotz ( 5 ), Dall’Era et al. ( 6 ), and others.