Evaluating health-related quality of life questionnaires in capturing common symptomatic adverse events in non-small cell lung cancer.

INTRODUCTION

Despite advancements in adverse events (AEs) reporting, discrepancies often arise between clinician-assessed and patient-reported symptomatic AEs, including in non-small cell lung cancer (NSCLC) trials. This study investigates the extent to which patient-reported questionnaires, particularly the EORTC Questionnaire - Core (QLQ-C30) and the lung cancer-specific module (QLQ-LC29) capture patient-reported symptomatic AEs in systemic treatments for NSCLC.

METHODS

A systematic comparison was conducted between symptomatic AEs reported in publicly available Summary of Product Characteristics (SmPC) of systemic NSCLC treatments and patient-reported outcomes captured by the EORTC QLQ-C30 and QLQ-LC29. AEs classified as very common (≥10%) or common (1%-10%) were included. A structured mapping exercise was undertaken to identify overlaps and gaps between symptomatic AEs captured by SmPC and EORTC questionnaires.

RESULTS

We analysed 38 systemic treatments and found that the EORTC QLQ-C30 and QLQ-LC29 effectively capture (very) common symptomatic AEs such as diarrhea, nausea and vomiting, pain and skin problems, which are reported in over 75% of SmPCs. A total of 62 symptomatic AEs identified were not captured by the EORTC measures. The majority (58.1%) of these were only reported once and only two symptomatic AEs were reported in >50% of SmPCs: oedema(65.8%) andpyrexia(57.9%). These AEs are well-covered in the EORTC item library.

CONCLUSIONS

This study highlights the need for a dual approach to AE reporting in clinical trials that combines clinician assessments with patient-reported outcomes. It also demonstrates the ability of the EORTC QLQ-C30 and QLQ-LC29 questionnaires to capture patient-reported common symptomatic AEs, with the addition of an item list from the EORTC Item Library to capture missing symptomatic AEs. Future research should concentrate on optimizing the integration of these tools to ensure that a broad spectrum of symptomatic AEs is captured, ultimately supporting the understanding of treatment impact on patient health and quality of life.