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Gepubliceerd in: Quality of Life Research 8/2022

Open Access 31-01-2022

Time to deterioration of patient-reported outcomes in non-small cell lung cancer: exploring different definitions

Auteurs: Andrew Walding, Konstantina Skaltsa, Montserrat Casamayor, Anna Rydén

Gepubliceerd in: Quality of Life Research | Uitgave 8/2022

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Abstract

Purpose

The clinical relevance of different time-to-deterioration (TTD) definitions for patient-reported outcomes were explored.

Methods

TTD definitions differing by reference score and deterioration event were used to analyse data from the phase 3 FLAURA trial of first-line osimertinib versus erlotinib or gefitinib in patients with EGFR-mutated advanced non-small cell lung cancer. Pre-specified key symptoms were fatigue, appetite loss, cough, chest pain and dyspnoea, scored using the European Organisation for Research and Treatment of Cancer QLQ-C30 and QLQ-LC13 questionnaires (≥ 10-point difference = clinically relevant).

Results

No significant treatment differences in TTD (distributions) were observed using definitions based on transient or definitive deterioration alone. TTD definitions based on definitive, sustained deterioration, with death not included as an event, yielded a significant treatment difference for dyspnoea (hazard ratio [HR] 0.71; P = 0.034) when baseline was the reference, and for cough (HR 0.70; P = 0.009) and dyspnoea (HR 0.71; P = 0.004) when best previous score was the reference. With death included as an event, treatment differences were significant for dyspnoea (HR 0.70; P = 0.025) when baseline was the reference, and for cough (HR 0.70; P = 0.011), dyspnoea (HR 0.71; P = 0.003) and chest pain (HR 0.71; P = 0.038) when best previous score was the reference. Irrespective of definition, TTD for appetite loss and fatigue did not differ significantly between arms.

Conclusion

This exploratory work showed that different TTD definitions yield different magnitudes of treatment difference, highlighting the importance of pre-specifying TTD definitions upfront in clinical trials.

Clinical trial registration

ClinicalTrials.gov NCT02296125.
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Metagegevens
Titel
Time to deterioration of patient-reported outcomes in non-small cell lung cancer: exploring different definitions
Auteurs
Andrew Walding
Konstantina Skaltsa
Montserrat Casamayor
Anna Rydén
Publicatiedatum
31-01-2022
Uitgeverij
Springer International Publishing
Gepubliceerd in
Quality of Life Research / Uitgave 8/2022
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-022-03088-0

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