Outcomes in Localized Prostate Cancer: National Prostate Cancer Register
Outcomes in Localized Prostate Cancer: National Prostate Cancer Register
Background Treatment for localized prostate cancer remains controversial. To our knowledge, there are no outcome studies from contemporary population-based cohorts that include data on stage, Gleason score, and serum levels of prostate-specific antigen (PSA).
Methods In the National Prostate Cancer Register of Sweden Follow-up Study, a nationwide cohort, we identified 6849 patients aged 70 years or younger. Inclusion criteria were diagnosis with local clinical stage T1–2 prostate cancer from January 1, 1997, through December 31, 2002, a Gleason score of 7 or less, a serum PSA level of less than 20 ng/mL, and treatment with surveillance (including active surveillance and watchful waiting, n = 2021) or curative intent (including radical prostatectomy, n = 3399, and radiation therapy, n = 1429). Among the 6849 patients, 2686 had low-risk prostate cancer (ie, clinical stage T1, Gleason score 2–6, and serum PSA level of <10 ng/mL). The study cohort was linked to the Cause of Death Register, and cumulative incidence of death from prostate cancer and competing causes was calculated.
Results For the combination of low- and intermediate-risk prostate cancers, calculated cumulative 10-year prostate cancer–specific mortality was 3.6% (95% confidence interval [CI] = 2.7% to 4.8%) in the surveillance group and 2.7% (95% CI = 2.1% to 3.45) in the curative intent group. For those with low-risk disease, the corresponding values were 2.4% (95% CI = 1.2% to 4.1%) among the 1085 patients in the surveillance group and 0.7% (95% CI = 0.3% to 1.4%) among the 1601 patients in the curative intent group. The 10-year risk of dying from competing causes was 19.2% (95% CI = 17.2% to 21.3%) in the surveillance group and 10.2% (95% CI = 9.0% to 11.4%) in the curative intent group.
Conclusion A 10-year prostate cancer–specific mortality of 2.4% among patients with low-risk prostate cancer in the surveillance group indicates that surveillance may be a suitable treatment option for many patients with low-risk disease.
There is a growing concern for overtreatment of localized prostate cancer because patients currently have earlier-stage disease than before the introduction of prostate-specific antigen (PSA). Therefore, active surveillance (ie, deferred curative treatment for low-risk prostate cancer until the perceived disease progression) has attracted increasing attention. Some information has been published on intermediate- and long-term outcomes of surveillance from patients at single institutions, but, to the best of our knowledge, since the introduction of PSA, no results have been published from outcome studies of nationwide population-based cohorts that include data on clinical stage, Gleason score, serum levels of PSA, and primary treatment.
After a median follow-up time of 9 years, the European Randomized Study of Screening for Prostate Cancer (ERSPC) reported lower prostate cancer–specific death rates (0.29%) in the screening arm than in the control arm (0.36%) (relative risk [RR] = 0.80, 95% confidence interval [CI] = 0.67 to 0.95). There was considerable overdiagnosis and overtreatment in the screening arm because 1068 men had to be screened and 48 men had to undergo curative treatment to save one life. After 11 years of follow-up, the Scandinavian Prostate Cancer Group study number 4 (SPCG-4), the only sufficiently large randomized clinical trial on curative treatment for localized prostate cancer to date, reported a prostate cancer–specific mortality of 12.5% in the prostatectomy arm and of 17.9% in the control arm (RR = 0.65, 95% CI = 0.45 to 0.94). It should be noted that patients in the SPCG-4 trial had advanced prostate cancer by current standards and that watchful waiting, not active surveillance, was used in the control arm. Finally, a study of data from the Surveillance, Epidemiology, and End Results (SEER) program in the United States reported a 10-year prostate cancer–specific mortality of 8.3% (which was substantially lower than the value reported in the control arm of the SPCG-4 trial) among elderly patients with localized prostate cancer who were treated conservatively.
The aim of this nationwide population-based cohort study was to assess prostate cancer mortality and risk of death from competing causes in patients in the National Prostate Cancer Register (NPCR) of Sweden Follow-up Study (hereafter the NPCR Follow-up Study) who had low- or intermediate-risk prostate cancer and who were treated with surveillance, radical prostatectomy, or radiation therapy as received in routine clinical practice in Sweden from January 1, 1997, through December 31, 2002. Data were collected on clinical stage, Gleason score, serum PSA level, comorbidity, and socioeconomic status.
Abstract and Introduction
Abstract
Background Treatment for localized prostate cancer remains controversial. To our knowledge, there are no outcome studies from contemporary population-based cohorts that include data on stage, Gleason score, and serum levels of prostate-specific antigen (PSA).
Methods In the National Prostate Cancer Register of Sweden Follow-up Study, a nationwide cohort, we identified 6849 patients aged 70 years or younger. Inclusion criteria were diagnosis with local clinical stage T1–2 prostate cancer from January 1, 1997, through December 31, 2002, a Gleason score of 7 or less, a serum PSA level of less than 20 ng/mL, and treatment with surveillance (including active surveillance and watchful waiting, n = 2021) or curative intent (including radical prostatectomy, n = 3399, and radiation therapy, n = 1429). Among the 6849 patients, 2686 had low-risk prostate cancer (ie, clinical stage T1, Gleason score 2–6, and serum PSA level of <10 ng/mL). The study cohort was linked to the Cause of Death Register, and cumulative incidence of death from prostate cancer and competing causes was calculated.
Results For the combination of low- and intermediate-risk prostate cancers, calculated cumulative 10-year prostate cancer–specific mortality was 3.6% (95% confidence interval [CI] = 2.7% to 4.8%) in the surveillance group and 2.7% (95% CI = 2.1% to 3.45) in the curative intent group. For those with low-risk disease, the corresponding values were 2.4% (95% CI = 1.2% to 4.1%) among the 1085 patients in the surveillance group and 0.7% (95% CI = 0.3% to 1.4%) among the 1601 patients in the curative intent group. The 10-year risk of dying from competing causes was 19.2% (95% CI = 17.2% to 21.3%) in the surveillance group and 10.2% (95% CI = 9.0% to 11.4%) in the curative intent group.
Conclusion A 10-year prostate cancer–specific mortality of 2.4% among patients with low-risk prostate cancer in the surveillance group indicates that surveillance may be a suitable treatment option for many patients with low-risk disease.
Introduction
There is a growing concern for overtreatment of localized prostate cancer because patients currently have earlier-stage disease than before the introduction of prostate-specific antigen (PSA). Therefore, active surveillance (ie, deferred curative treatment for low-risk prostate cancer until the perceived disease progression) has attracted increasing attention. Some information has been published on intermediate- and long-term outcomes of surveillance from patients at single institutions, but, to the best of our knowledge, since the introduction of PSA, no results have been published from outcome studies of nationwide population-based cohorts that include data on clinical stage, Gleason score, serum levels of PSA, and primary treatment.
After a median follow-up time of 9 years, the European Randomized Study of Screening for Prostate Cancer (ERSPC) reported lower prostate cancer–specific death rates (0.29%) in the screening arm than in the control arm (0.36%) (relative risk [RR] = 0.80, 95% confidence interval [CI] = 0.67 to 0.95). There was considerable overdiagnosis and overtreatment in the screening arm because 1068 men had to be screened and 48 men had to undergo curative treatment to save one life. After 11 years of follow-up, the Scandinavian Prostate Cancer Group study number 4 (SPCG-4), the only sufficiently large randomized clinical trial on curative treatment for localized prostate cancer to date, reported a prostate cancer–specific mortality of 12.5% in the prostatectomy arm and of 17.9% in the control arm (RR = 0.65, 95% CI = 0.45 to 0.94). It should be noted that patients in the SPCG-4 trial had advanced prostate cancer by current standards and that watchful waiting, not active surveillance, was used in the control arm. Finally, a study of data from the Surveillance, Epidemiology, and End Results (SEER) program in the United States reported a 10-year prostate cancer–specific mortality of 8.3% (which was substantially lower than the value reported in the control arm of the SPCG-4 trial) among elderly patients with localized prostate cancer who were treated conservatively.
The aim of this nationwide population-based cohort study was to assess prostate cancer mortality and risk of death from competing causes in patients in the National Prostate Cancer Register (NPCR) of Sweden Follow-up Study (hereafter the NPCR Follow-up Study) who had low- or intermediate-risk prostate cancer and who were treated with surveillance, radical prostatectomy, or radiation therapy as received in routine clinical practice in Sweden from January 1, 1997, through December 31, 2002. Data were collected on clinical stage, Gleason score, serum PSA level, comorbidity, and socioeconomic status.
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