Patient-reported outcomes (PROs), including quality of life, were a secondary endpoint in the CROWN study. PROs were assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)* and its corresponding module for lung cancer (QLQ-LC13)† and the EQ-5D-5L questionnaire‡.1
The PROs were scored according to their respective user guides/scoring manuals. In the symptom scales, improvement is defined as a decrease of at least 10 points and worsening defined as an increase of at least 10 points. In the functioning and global QOL scales, improvement is defined as an increase of at least 10 points and worsening defined as a decrease of at least 10 points. Global QOL, functioning scales, and symptom scales that have not improved nor worsened were considered stable.2
A change in score from baseline of ≥10 points on the scales of the EORTC QLQ-C30 correlates with significant change in disease symptoms and functioning.2
These data are from an updated analysis that was not prespecified. As such, these data are descriptive and exploratory in nature, and formal statistical comparisons between the treatment groups are not available.1
Overall Change from Baseline in Global QoL
Adapted from Solomon BJ, et al. Lancet Respir Med. 2022. Supplementary Appendix.2
Data cutoff: September 20, 2021.2
Adapted from Solomon BJ, et al. Lancet Respir Med. 2022. Supplementary Appendix.2
Data cutoff: September 20, 2021.2
Adapted from Solomon BJ, et al. Lancet Respir Med. 2022. Supplementary Appendix.2
Data cutoff: September 20, 2021.2
Adapted from Solomon BJ, et al. Lancet Respir Med. 2022. Supplementary Appendix.2
Data cutoff: September 20, 2021.2
*The EORTC QLQ-30 (Version 3) is a published, validated, and self-administered PRO questionnaire. The EORTC QLQ-C30 consists of 30 questions and includes five functional scales (physical, role, cognitive, emotional, and social); a global health status/global quality of life scale; three symptom scales (fatigue, pain, nausea and vomiting); and six single items that assess additional symptoms (dyspnoea, appetite loss, sleep disturbance, constipation, and diarrhoea) and financial impact.2
† The EORTC QLQ-LC13 is the lung cancer-specific module of the EORTC Quality of Life Questionnaire. The EORTC QLQ-LC13 consists of 13 questions and includes one multi-item scale and nine single items assessing symptoms (dyspnoea, cough, haemoptysis, and site-specific pain), side effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and pain medication use.2
‡ The EuroQol EQ-5D-5L is a participant-completed questionnaire designed to assess health status in terms of a single index value or utility score. There are two components: a descriptive system in which individuals rate their level of problems (none, slight, moderate, severe, extreme/unable) in five areas (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a Visual Analogue Scale (VAS) in which participants rate their overall health status from 0 (worst imaginable) to 100 (best imaginable). Published weights are available that allow for the creation of a single summary score.2
§At the time of analysis, the median follow-up for PFS was 36.7 months (IQR: 31.3-41.9) in the LORVIQUA® arm and 29.3 months (IQR: 10.8-35.0) in the crizotinib arm.1
CI: confidence interval, EORTC: European Organisation for Research and Treatment of Cancer, EQ-5D-5L: EuroQol 5 dimension 5 level questionnaire, IQR: interquartile range, PRO: patient-reported outcome, QLQ-C30: quality of life questionnaire, QLQ-LC13: quality of life questionnaire for lung cancer, QoL: quality of life
References
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