📃 Paper Title: Radical Prostatectomy or Watchful Waiting in Prostate Cancer - 29-Year Follow-up
🧍 Author: Bill-Axelson A.
🕒 Year: 2018
📚 Journal: The New England Journal of Medicine
🌎 Country: Sweden
ㅤContext to the study:
Can you tell me about a study that showed a benefit for radical prostatectomy in men with clinically detected, localised prostate cancer?
ㅤ✅ Take-home message of study:
Men with clinically detected, localized prostate cancer and a long-life expectancy benefit from radical prostatectomy, with an estimate of 2.9 years of life gained.
Prostate cancer with extracapsular extension carries a 5-time higher risk of death compared to cancer specimens without extracapsular extension.
Prostate cancer with a Gleason score higher than 7 carries a 10-time higher risk of death compared to prostate cancer Gleason score 6 or lower.
ㅤ Randomized trial with long-term follow-up
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Study participants:
Participants:
Number included: 695 men (October 1989 to February 1999) randomized to either radical prostatectomy (n = 347) or watchful waiting (n = 348)
Follow-up: until 31st December 2017 or until patient death
Inclusion criteria:
Men < 75 years old, with life expectancy > 10 years and no other known cancer
PSA < 50 ng/ml
Localized and highly to moderately highly differentiated (WHO classification) prostate cancer
Negative bone scan
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Key study outcomes:
Outcomes:
Mortality: 553/695 (80%) died by the end of follow-up period:
181/553 from prostate cancer (71 in the radical prostatectomy group and 110 in the watchful-waiting group)
Cumulative incidence of death at 23 years (median follow-up):
71.9% in the radical prostatectomy group and 83.8% in the watchful-waiting group
Relative risk (RR) = 0.74 (95% CI 0.62-0.87, p<0.001)
Cumulative incidence of death from prostate cancer at 23 years:
19.6% in the radical prostatectomy group and 31.3% in the watchful-waiting group
Relative risk (RR) = 0.55 (95% CI 0.41-0.74, p<0.001)
Absolute difference in risk 11.7 percentage points (95% CI 5.2-18.2)
Cumulative incidence of distant metastases at 23 years:
26.6% in the radical prostatectomy group and 43.3% in the watchful-waiting group
Relative risk (RR) = 0.54 (95% CI 0.42-0.70, p<0.001)
Absolute difference in risk 16.7 percentage points (95% CI 9.6-23.7)
Numbers of years of life gained in the radical prostatectomy group at 23 years of follow-up: 2.9 years
Number needed to treat to avert one death from any cause: 8.4
No difference between findings from a per-protocol analysis with adjustment for nonadherence to the assigned treatment and from the intention-to-treat analysis.
Prognostic value of histopathological measures:
Extracapsular extension carries a 5-time higher risk of death compared to cancer specimens without extracapsular extension
Gleason score ≥ 7 carries a 10-time higher risk of death compared to Gleason score ≤ 6
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Study Limitations:
Drastic difference among diagnostic procedures currently used compared to those used in the enrollment period of the trial (1989-1999)
Analyses according to age not prespecified in the protocol and therefore sensitive to chance findings
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