Patient-Reported Outcomes and Quality of Life in Advanced ALK+ Non-Small-Cell Lung Cancer Trial of Brigatinib (ALTA)

Abstract

<b>Aim:</b> Patient-reported outcomes (PRO) can support clinically relevant primary end points. <b>Materials & methods:</b> The ALTA trial, an open-label, Phase II, randomized dose-comparison study, evaluated the safety and efficacy of brigatinib in ALK+ non-small-cell lung cancer. PRO data collection included the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (QLQ-C30). A linear mixed model for repeated measures was used to analyze change from baseline in the Global Health Status/Quality of Life subscale (GHS/QOL), with a change of greater than or equal to ten points deemed meaningful. <b>Results:</b> Improvement in mean GHS/QOL scores was statistically significant in the majority of treatment cycles; <10% of patients experienced a meaningful worsening of their GHS/QOL and symptom scores. <b>Conclusion:</b> PRO-measured benefits are consistent with objective response benefits associated with brigatinib.