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Testing Whether Cancer Screening Saves Lives: Implications for Randomized Clinical Trials of Multicancer Screening.
H Gilbert Welch1, Tanujit Dey1
1Center for Surgery & Public Health, Department of Surgery, Brigham and Women's Hospital, Boston, Massachusetts.
JAMA Internal Medicine
|August 28, 2023
Summary
Multicancer screening blood tests may reduce all-cause mortality, but require large trials to confirm. Researchers calculated sample sizes for cancer screening trials, finding fewer participants are needed for multicancer screening to assess overall survival benefits.
Area of Science:
- Oncology
- Clinical Trials
- Biostatistics
Background:
- Cancer screening aims to reduce mortality, with new multicancer detection blood tests (liquid biopsies) increasing interest.
- Previous randomized clinical trials (RCTs) for individual cancer screening often require over 100,000 participants to show cancer-specific mortality reduction.
- Assessing all-cause mortality in individual cancer screening RCTs necessitates over a million participants, posing significant feasibility challenges.
Purpose of the Study:
- To explore the feasibility of powering studies to evaluate cancer-specific versus all-cause mortality in cancer screening.
- To determine the sample size requirements for randomized clinical trials assessing the impact of multicancer screening on mortality.
Main Methods:
- Performed sample size calculations for selected individual cancers (breast, colorectal, liver, pancreas, prostate) and for all cancers combined.
- Compared sample size needs for testing cancer-specific mortality versus all-cause mortality in both individual and multicancer screening scenarios.
Main Results:
- Individual cancer screening trials require large sample sizes (≥100,000 for cancer-specific, >1 million for all-cause mortality).
- Multicancer screening trials can assess all-cause mortality with fewer than 100,000 participants due to the significant contribution of cancer deaths to overall mortality.
- Observational data on cancer screening effects are deemed misleading; RCTs are essential for both efficacy and harm assessment.
Conclusions:
- It is feasible to conduct RCTs evaluating all-cause mortality for multicancer screening, unlike for individual cancer screening.
- Multicancer screening, while promising, carries potential costs and harms necessitating rigorous evaluation through RCTs.
- Randomized clinical trials are mandatory to definitively establish the life-saving potential and safety profile of multicancer screening.
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