ORIGINAL RESEARCH article
Front. Oncol.
Sec. Thoracic Oncology
This article is part of the Research TopicAdvancing Drug Design to Counteract Resistance in Lung Cancer TreatmentView all articles
Composite Patient-Reported Outcomes and Risk Prediction for Overall Survival in Advanced Non-Small Cell Lung Cancer With First-Line Cemiplimab
Provisionally accepted
David Gandara1*
Miranda Gogishvili2
Ahmet Sezer3Tamta Makharadze4Mahmut Gümüş5
Eric Yan6James Harnett7Ruben GW Quek7- 1Division of Hematology and Oncology, Department of Medicine, University of California Davis Comprehensive Cancer Center, Sacramento, United States
- 2High Technology Medical Centre, University Clinic Ltd, Tbilisi, Georgia
- 3Department of Medical Oncology, Baskent Universitesi, Ankara, Türkiye
- 4LTD High Technology Hospital Med Center, Batumi, Georgia
- 5Department of Medical Oncology, School of Medicine, Istanbul Medeniyet Universitesi, Istanbul, Türkiye
- 6Cyan Global Inc., San Diego, United States
- 7Regeneron Pharmaceuticals Inc, Tarrytown, United States
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Introduction: Patient-reported outcomes (PROs) are associated with overall survival (OS) in advanced cancer. Risk modeling of OS based on a single PRO scale was previously evaluated in patients with advanced non-small cell lung cancer (NSCLC) in two pivotal cemiplimab ± chemotherapy phase III trials. Here we report evaluation of predictive performance for a composite of two PRO scales. Methods: Data from two previously published phase 3 clinical trials (EMPOWER-Lung 1 and EMPOWER-Lung 3) were used to develop a Cox proportional hazards model evaluating the association between baseline PRO burden and OS, stratified by treatment, histology, and programmed cell death-ligand 1 (PD-L1) level. PRO data were collected using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) and Lung Cancer 13 (QLQ-LC13) modules. Single-scale PROs and composite PROs based on a combination of one functioning and one symptom scale were evaluated for prognostic value for OS using hazard ratios (HRs; a higher HR indicates a higher risk of death). Results: The top 10 composite PROs that predicted the highest risk for death (nominal P values <0.05 and HRs ≥2) included combinations of functioning scales (ie, social, role, and physical) and select symptom scales (ie, dyspnea, appetite loss, and pain from the EORTC QLQ-C30; dyspnea and coughing from the EORTC QLQ LC13). Patients with composite PROs of low functioning and high symptom burden had worse OS than those with high functioning and low symptom burden. A clear separation in Kaplan–Meier survival curves was observed between high-risk and low-risk groups based on the composite PRO measure of role functioning and dyspnea. Discussion: In patients with advanced NSCLC receiving first-line cemiplimab-based therapy, composite PROs consisting of one functioning and one symptom scale had greater prognostic value than single PRO scales. Further development and analysis of composite PROs for clinical trials is warranted.
Keywords: Cemiplimab, Immunotherapy, Non-smal cell lung cancer, Patient-Reported Outcomes, PD-1
Received: 08 Oct 2025; Accepted: 30 Jan 2026.
Copyright: © 2026 Gandara, Gogishvili, Sezer, Makharadze, Gümüş, Yan, Harnett and Quek. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: David Gandara
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