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Response- and Progression-Based End Points in Trial and Observational Cohorts of Patients With NSCLC
Yichen Lu1, Spencer S Langerman1, Emily McCain1
1Flatiron Health, New York City, New York.
JAMA Network Open
|May 3, 2024
Summary
Response and progression end points were similar between clinical trial and observational cohorts for non-small cell lung cancer patients. This validates observational data for clinical decision-making and future research.
Area of Science:
- Oncology
- Clinical Trials
- Real-World Evidence
Background:
- Response Evaluation Criteria in Solid Tumors (RECIST) are standard in clinical trials but not routine care, limiting their use in observational studies.
- Clinician-anchored response measures are validated but lack comparison with clinical trial data, hindering their application in decision-making.
Purpose of the Study:
- To compare response- and progression-based end points in clinical trial and observational cohorts of non-small cell lung cancer (NSCLC) patients.
- To assess the reliability of observational data for clinical decision-making.
Main Methods:
- Retrospective cohort study using data from the IMpower132 trial and an electronic health record (EHR)-derived database.
- Comparison of response rates, duration of response, and progression-free survival between weighted observational and trial cohorts.
Main Results:
- Response and progression end points were comparable between the clinical trial and weighted observational cohorts.
- EHR-derived response rates were numerically higher than objective response rates, influenced by the inclusion of patients with no response assessment.
Conclusions:
- Response- and progression-based end points are similar between clinical trial and weighted observational cohorts, increasing confidence in observational data reliability.
- Findings support the use of observational data for clinical decision-making and inform future research on EHR-derived response rates.
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