ArticleJTO clinical and research reports2025
Patient-Reported Outcomes From LIBRETTO-431: First-Line Selpercatinib Versus Chemotherapy With Pembrolizumab in
Article in JTO clinical and research reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Abstract
Introduction: The benefit of first-line selpercatinib versus platinum-based chemotherapy with or without pembrolizumab in patients with advanced Methods: In the intention-to-treat pembrolizumab population, 129 patients received selpercatinib and 83 patients received platinum chemotherapy with pembrolizumab (control). Time to confirmed deterioration (TTCD) of the NSCLC Symptom Assessment Questionnaire (NSCLC-SAQ) total score was a secondary end point. Additional PROs included changes in the NSCLC-SAQ total and individual symptom scores, European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire health-related quality of life, functioning and symptoms, patient-reported tolerability by the Functional Assessment of Cancer Therapy GP5 item (GP5), and symptomatic adverse events by PROs version of the Common Terminology Criteria for Adverse Events up to 1 year were reported. TTCD was defined as the time from randomization to first deterioration in score that met prespecified thresholds, confirmed at next assessment. Patient-reported tolerability was reported as the proportion of patients with side effect bother over time. Results: Selpercatinib delayed TTCD of all individual NSCLC-SAQ symptoms versus control. A clinically meaningful improvement in the NSCLC-SAQ total score (mean difference = -2.00, 95% confidence interval [CI]: -2.94 to -1.05) was also observed at 1 year for selpercatinib versus control. Selpercatinib delayed TTCD of physical (hazard ratio = 0.54, 95% CI: 0.38-0.76) and role (hazard ratio = 0.59, 95% CI: 0.37-0.93) functioning measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire, with significantly improved physical functioning at 1 year versus control (mean difference = 8.09, 95% CI: 2.82-13.37; Conclusions: These PROs, combined with the established efficacy and safety profile of selpercatinib, further support the use of first-line selpercatinib as a standard of care and highlight the importance of early and comprehensive genomic testing in patients with
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