Multicancer Early Detection Technologies: A Review Informed by Past Cancer Screening Studies

Author:

Raoof Sana1ORCID,Lee Richard J.23ORCID,Jajoo Kunal34,Mancias Joseph D.345ORCID,Rebbeck Timothy R.56ORCID,Skates Steven J.23ORCID

Affiliation:

1. 1Memorial Sloan Kettering Cancer Center, New York, New York.

2. 2Massachusetts General Hospital, Boston, Massachusetts.

3. 3Harvard Medical School, Boston, Massachusetts.

4. 4Brigham and Women's Hospital, Boston, Massachusetts.

5. 5Dana-Farber Cancer Institute, Boston, Massachusetts.

6. 6Harvard TH Chan School of Public Health, Boston, Massachusetts.

Abstract

Abstract More than 75% of cancer-related deaths occur from cancers for which we do not screen. New screening liquid biopsies may help fill these clinical gaps, although evidence of benefit still needs to be assessed. Which lessons can we learn from previous efforts to guide those of the future? Screening trials for ovarian, prostate, pancreatic, and esophageal cancers are revisited to assess the evidence, which has been limited by small effect sizes, short duration of early-stage disease relative to screening frequency, study design, and confounding factors. Randomized controlled trials (RCT) to show mortality reduction have required millions of screening-years, two-decade durations, and been susceptible to external confounding. Future RCTs with late-stage incidence as a surrogate endpoint could substantially reduce these challenges, and clinical studies demonstrating safety and effectiveness of screening in high-risk populations may enable extrapolation to broader average-risk populations. Multicancer early detection tests provide an opportunity to advance these practical study designs. Conditional approvals based on RCTs with surrogate endpoints, contingent upon real world evidence generation and continuation of trials to definitive endpoints, may lower practical barriers to innovation in cancer screening and enable greater progress.

Publisher

American Association for Cancer Research (AACR)

Subject

Oncology,Epidemiology

Reference98 articles.

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