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Association Between Patient-Reported Outcomes and Overall Survival in Patients with Advanced NSCLC Treated with
David R Gandara1, Tamta Makharadze2, Mahmut Gümüş3
1Division of Hematology/Oncology, Department of Medicine, UC Davis Comprehensive Cancer Center, 2279 45th Street, Sacramento, CA 95817, USA.
Patient-reported outcomes (PROs) significantly impact overall survival (OS) in advanced non-small-cell lung cancer (NSCLC) patients treated with cemiplimab. Improvements in quality of life correlate with a reduced risk of death.
Area of Science:
- Oncology
- Clinical Trials
- Patient-Reported Outcomes
Background:
- Existing research explores the link between patient-reported outcomes (PROs) and overall survival (OS) in advanced non-small-cell lung cancer (NSCLC).
- This study specifically investigates this association in advanced NSCLC patients receiving first-line cemiplimab-based therapy.
Purpose of the Study:
- To evaluate the association between post-baseline PROs and OS in advanced NSCLC patients treated with cemiplimab.
- To determine if improvements in quality of life predict survival outcomes.
Main Methods:
- Analysis of PRO data from two Phase III clinical trials (EMPOWER-Lung 1 and EMPOWER-Lung 3).
- Utilized Cox proportional hazards models and landmark analyses at 3, 6, 9, and 12 months.
- Employed time-dependent analyses assessing change from baseline PROs as a covariate for OS.
Main Results:
- At 3 months, stable/improved global health status/quality of life (GHS/QoL) showed a 56% reduction in mortality risk (HR=0.44).
- Consistent results were observed at 6, 9, and 12-month landmarks.
- Every 10-point GHS/QoL improvement correlated with a 31% decreased risk of death (HR=0.69).
Conclusions:
- Improvements in post-baseline PROs, particularly GHS/QoL, are significantly associated with improved OS in advanced NSCLC patients on first-line cemiplimab.
- These findings support the use of PROs as important endpoints in clinical trials for advanced NSCLC.
- Results may guide endpoint selection and interpretation in future oncology trials.
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