KEY TAKEAWAYS
- Keynote-598 (NCT03302234)- Phase 3 study assessed the FDA expectations.
- The participants with stage IV metastatic NSCLC with programmed death-ligand one tumor proportion scored more or around 50% to assess the NSCLC-SAQ’s reliability, construct validity, responsiveness, and estimate.
- Participants were primarily men and had a mean age of 64 years. Internal consistency at baseline and test-retest reliability after three weeks were satisfactory.
- NSCLC-SAQ assessed the symptoms of improvement in NSCLC. It is recommended in the trial participants with worsened symptoms.
To assess NSCLC symptom severity in compliance with FDA evidentiary requirements, the NSCLC Symptom Assessment Questionnaire (NSCLC-SAQ) was created. In 2018, it was qualified by the Food and Drug Administration (FDA). This research aimed to assess the NSCLC-SAQ’s measurement properties within a clinical trial.
The KEYNOTE-598 phase 3 study was used to evaluate the NSCLC-reliability, SAQ’s construct validity, responsiveness, and estimate clinically meaningful within-person change in patients with stage IV metastatic NSCLC a programmed death-ligand 1 tumor proportion score of greater than or equal to 50%. Patient global impression items of severity and change in lung cancer symptoms and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire core 30 and lung cancer module LC13 were also used as patient-reported outcomes.
Men accounted for 70% of the total number of participants (N = 560), the average age was 64 years old, and the majority of the patients had a performance status of 1 (64%) or 0 (36%) ECOG. Both initial test-retest reliability (intraclass correlation coefficient = 0.79) and internal consistency at baseline (Cronbach’s α = 0.74) met expectations after 3 weeks. NSCLC-SAQ items, domains, and total score differentiated across patient groups based on outcome measures capturing similar content, and the total score differentiated among patient global impression of severity groups (p < 0.001). The overall score indicated a progressive enhancement over a period of time, and the estimated threshold for significant improvement within an individual ranged between three to five points on the 0 to 20 scale. The number of patients who showed a deterioration of symptoms was low (n=38), thereby restricting the conclusions that can be drawn from this group.
Researchers discovered that the NSCLC-SAQ was a valid, reliable, responsive, and interpretable tool for measuring symptom improvement in NSCLC patients. Those study participants whose symptoms increase over time should be examined further.
Source: https://clinicaltrials.gov/ct2/show/NCT03302234
Clinical Trial: https://pubmed.ncbi.nlm.nih.gov/35400081/
Williams, P., Burke, T., Norquist, J. M., Daskalopoulou, C., Speck, R. M., Samkari, A., Eremenco, S., & Coons, S. J. (2022). Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ): Measurement Properties and Estimated Clinically Meaningful Thresholds From a Phase 3 Study. JTO Clinical and Research Reports, 3(4), 100298. https://doi.org/10.1016/j.jtocrr.2022.100298
