OBJECTIVES: This study converted European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (QLQ-C30; version 3.0) scores from the Anaplastic Lymphoma Kinase (ALK) in Lung Cancer Trial of Brigatinib (ALTA; NCT02094573) into utility values using available mapping algorithms.

METHODS: The study was based on data from the open-label, randomized, international, phase 2 ALTA study as of February 21, 2017 (Ahn et al. 2017). Eligible patients had locally advanced or metastatic ALK+ non–small cell lung cancer (NSCLC) that progressed on prior therapy with crizotinib with ≥1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Patients were randomized 1:1 to 90 mg brigatinib once daily (QD) (Arm A) or 180 mg QD with a 7-day lead-in dose of 90 mg QD (Arm B). Health-related quality of life (HRQoL) was measured using the QLQ-C30 (v3.0) as a secondary endpoint. QLQ-C30 domain scores were mapped to European Quality of Life Five Dimensions scale (EQ-5D) utility scores using two published algorithms (Khan et al. 2014 for EQ-5D-5L; Longworth et al. 2014 for EQ-5D-3L). Utility scores and change from baseline were assessed at each cycle.

RESULTS: The analysis included 207 patients. The mean baseline EQ-5D utility score was 0.64 (Arm A: 0.60, Arm B: 0.67). Mean utility scores improved to 0.78 by Cycle 5 (Arm A: 0.79, Arm B: 0.78). The significant improvement from baseline was observed for both arms through Cycle 7, and when considering both arms combined, was statistically significant through Cycle 21. The overall pattern of post-baseline increases in utilities was similar for both algorithms.

CONCLUSIONS: Converting QLQ-C30 scores into utilities in trials is a methodological advance that can improve evaluation of medicines from the patient perspective. Both algorithms suggested that brigatinib improved health utility in crizotinib-refractory ALK+ NSCLC patients and improvements were maintained.