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Could Differences in Treatment Between Trial Arms Explain the Reduction in Prostate Cancer Mortality in the European
Sigrid V Carlsson1, Marianne Månsson2, Sue Moss3
1Department of Surgery (Urology Service), Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at University of Gothenburg, Sweden.
European Urology
|April 1, 2019
Summary
Differential treatment did not significantly impact prostate cancer (PC) mortality reduction in the European Randomized Study of Screening for Prostate Cancer (ERSPC). Early diagnosis via prostate-specific antigen screening, not varied treatment, explains the observed PC mortality decrease.
Area of Science:
- Urology
- Oncology
- Clinical Trials
Background:
- Differential treatment allocation between arms may bias prostate cancer (PC) mortality findings in the European Randomized Study of Screening for Prostate Cancer (ERSPC).
- Quantifying treatment differences is crucial for accurate interpretation of PC mortality reduction in screening trials.
Purpose of the Study:
- To assess the impact of differential treatment on observed prostate cancer mortality reduction in the ERSPC trial.
- To determine if treatment variations between the screening arm (SA) and control arm (CA) explain the mortality benefit.
Main Methods:
- Analysis of 14,136 men with PC in the ERSPC core age group (55-69 years) over 16 years.
- Modeling of primary treatment allocation using multinomial logistic regression, adjusting for clinical variables.
- Comparison of observed PC deaths with estimated deaths under identical treatment scenarios in both arms.
Main Results:
- Differences in treatment distributions between arms were minimal (-3.3% to 3.3%) and smaller than observed outcome differences (7.2% to 10.1%).
- Estimated PC mortality differences due to treatment variations were trivial (0.05% and -0.01%) when applying models across arms.
- Differential treatment explained only a minor proportion of the overall 4.2% PC mortality reduction observed in the ERSPC trial.
Conclusions:
- The reduction in prostate cancer mortality in the ERSPC trial is primarily attributed to earlier diagnosis through prostate-specific antigen screening.
- Differential treatment between the screening and control arms did not significantly contribute to the observed mortality benefit.
- Findings underscore the importance of screening in reducing prostate cancer mortality, independent of treatment variations.
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