Maria Rosario Garcia Campelo1, Huamao M Lin2, Yanyan Zhu3, Maurice Pérol4, Mohammad Jahanzeb5, Sanjay Popat6, Pingkuan Zhang7, D Ross Camidge8. 1. Medical Oncology Service, University Hospital A Coruña (XXIAC-SERGAS), Xubias de Arriba, 84, 15006, A Coruña, Spain. Electronic address: MA.Rosario.Garcia.Campelo@sergas.es. 2. Millennium Pharmaceuticals, Inc, 35 Landsdowne Street, Cambridge, MA, 02139, USA(3). Electronic address: mark.lin@takeda.com. 3. Millennium Pharmaceuticals, Inc, 35 Landsdowne Street, Cambridge, MA, 02139, USA(3). Electronic address: Yanyan.zhu@takeda.com. 4. Department of Medical Oncology, Centre Léon Bérard, 28 Prom. Léa et Napoléon Bullukian, 69008, Lyon, France. Electronic address: maurice.perol@lyon.unicancer.fr. 5. Florida Precision Oncology, a division of 21st Century Oncology, 3651 FAU Boulevard, Suite 100, Boca Raton, FL, 33431, USA. Electronic address: mj@fponcology.com. 6. The Royal Marsden Hospital, 203 Fulham Road, Chelsea, London, SW3 6JJ, United Kingdom; The Institute of Cancer Research, 123 Old Brompton Road, London, SW7 3RP, United Kingdom. Electronic address: sanjay.popat@rmh.nhs.uk. 7. Millennium Pharmaceuticals, Inc, 300 Massachusetts Avenue, Cambridge, MA, 02139, USA(3). Electronic address: Pingkuan.Zhang@takeda.com. 8. University of Colorado Cancer Center, 1665 Aurora Court, Aurora, CO, 80045, USA. Electronic address: Ross.Camidge@CUAnschutz.edu.
Abstract
OBJECTIVE: In ALTA-1 L, first-line brigatinib versus crizotinib significantly prolonged progression-free survival in advanced ALK-positive (ALK+) non-small cell lung cancer (NSCLC). We report health-related quality of life (HRQOL) outcomes from ALTA-1 L. MATERIALS AND METHODS:HRQOL was assessed using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and lung cancer-specific module (QLQ-LC13). HRQOL time to worsening, change from baseline, and duration of improvement were analyzed. RESULTS:EORTC QLQ-C30 and QLQ-LC13 compliance was >90 % for both groups (n = 131 each). Brigatinib versus crizotinib significantly delayed time to worsening in the EORTC QLQ-C30 global health status (GHS)/QOL (median: 26.74 vs 8.31 months; hazard ratio [HR]: 0.70; 95 % CI: 0.49, 1.00; log-rank P = 0.0485); emotional functioning, social functioning, fatigue, nausea and vomiting, appetite loss, and constipation scales (log-rank P < 0.05); delays in time to worsening for the physical, role, and cognitive functioning scales were not statistically significant. Mean change from baseline showed greater improvement in GHS/QOL and most EORTC QLQ-C30 functional and symptom scales with brigatinib versus crizotinib. Among patients with GHS/QOL improvement, brigatinib had longer duration of improvement versus crizotinib (median: not reached vs 11.99 months); similar results were seen in the physical, role, emotional, and social functioning; fatigue; nausea and vomiting; and appetite loss scales. Median time to worsening in dyspnea (QLQ-LC13) was 23.98 versus 8.25 months (brigatinib vs crizotinib; HR: 0.64; 95 % CI: 0.39, 1.05). CONCLUSION: Brigatinib significantly delayed time to worsening and prolonged duration of improvement in GHS/QOL versus crizotinib, supported by improvement in functional and symptom scores. These preliminary analyses suggest brigatinib is the first ALK inhibitor with better HRQOL versus another ALK inhibitor in ALK inhibitor-naive advanced ALK + NSCLC.
RCT Entities:
OBJECTIVE: In ALTA-1 L, first-line brigatinib versus crizotinib significantly prolonged progression-free survival in advanced ALK-positive (ALK+) non-small cell lung cancer (NSCLC). We report health-related quality of life (HRQOL) outcomes from ALTA-1 L. MATERIALS AND METHODS: HRQOL was assessed using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and lung cancer-specific module (QLQ-LC13). HRQOL time to worsening, change from baseline, and duration of improvement were analyzed. RESULTS: EORTC QLQ-C30 and QLQ-LC13 compliance was >90 % for both groups (n = 131 each). Brigatinib versus crizotinib significantly delayed time to worsening in the EORTC QLQ-C30 global health status (GHS)/QOL (median: 26.74 vs 8.31 months; hazard ratio [HR]: 0.70; 95 % CI: 0.49, 1.00; log-rank P = 0.0485); emotional functioning, social functioning, fatigue, nausea and vomiting, appetite loss, and constipation scales (log-rank P < 0.05); delays in time to worsening for the physical, role, and cognitive functioning scales were not statistically significant. Mean change from baseline showed greater improvement in GHS/QOL and most EORTC QLQ-C30 functional and symptom scales with brigatinib versus crizotinib. Among patients with GHS/QOL improvement, brigatinib had longer duration of improvement versus crizotinib (median: not reached vs 11.99 months); similar results were seen in the physical, role, emotional, and social functioning; fatigue; nausea and vomiting; and appetite loss scales. Median time to worsening in dyspnea (QLQ-LC13) was 23.98 versus 8.25 months (brigatinib vs crizotinib; HR: 0.64; 95 % CI: 0.39, 1.05). CONCLUSION:Brigatinib significantly delayed time to worsening and prolonged duration of improvement in GHS/QOL versus crizotinib, supported by improvement in functional and symptom scores. These preliminary analyses suggest brigatinib is the first ALK inhibitor with better HRQOL versus another ALK inhibitor in ALK inhibitor-naive advanced ALK + NSCLC.