Patient-reported outcomes and quality of life in advanced ALK+ non-small-cell lung cancer trial of brigatinib (ALTA).

Patient-reported outcomes (PRO) can support clinically relevant primary end points. 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. 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. PRO-measured benefits are consistent with objective response benefits associated with brigatinib.