Enriqueta Felip1, Vera Hirsh2, Sanjay Popat3, Manuel Cobo4, Andrea Fülöp5, Charles Dayen6, José M Trigo7, Richard Gregg8, Cornelius F Waller9, Jean-Charles Soria10, Glenwood D Goss11, James Gordon12, Bushi Wang13, Michael Palmer14, Eva Ehrnrooth15, Shirish M Gadgeel16. 1. Department of Medical Oncology, Vall d'Hebron University Hospital, Barcelona, Spain. Electronic address: efelip@vhebron.net. 2. Faculty of Medicine/Oncology, McGill University Health Centre, Royal Victoria Hospital, Montreal, Quebec, Canada. 3. Cancer Centre, Royal Marsden National Health Service Foundation Trust, London, United Kingdom. 4. FEA Oncología Médica, Hospital Carlos Haya, Malaga, Spain. 5. Department of Medical Oncology/Pulmonary Medicine, National Koranyi Institute, Budapest, Hungary. 6. Service de Pneumologie-Maladie Infectieuse, Centre Hospitalier Général, Saint Quentin, France. 7. Servicio de Oncología Médica, Virgen de la Victoria, Malaga, Spain. 8. Department of Medical Oncology, Cancer Centre of Southeastern Ontario at Kingston General Hospital, Kingston, Ontario, Canada. 9. Abteilung Hämatologie/Onkologie, Medizinische Universitätsklinik Freiburg, Freiburg, Germany. 10. Drug Development Department (DITEP), Gustave Roussy Cancer Campus and University Paris-Sud, Paris, France. 11. Division of Medical Oncology, University of Ottawa, Ottawa, Ontario, Canada. 12. TA Oncology, Boehringer Ingelheim GmbH, Ingelheim, Germany. 13. Department of Biometrics and Data Management, Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT. 14. Department of Medical Statistics, School of Health Care Science, Manchester Metropolitan University, Manchester, United Kingdom. 15. TA Oncology, Boehringer Ingelheim Danmark A/S, Copenhagen, Denmark. 16. Department of Oncology, Karmanos Cancer Institute, Wayne State University, Detroit, MI.
Abstract
INTRODUCTION: In the phase III LUX-Lung 8 trial, afatinib significantly improved progression-free survival (PFS) and overall survival (OS) versus erlotinib in patients with squamous cell carcinoma (SCC) of the lung progressing during or after platinum-based chemotherapy. Patient-reported outcomes (PROs) and health-related quality of life (QoL) in these patients are presented. PATIENTS AND METHODS: Patients (n = 795) were randomized 1:1 to oral afatinib (40 mg/d) or erlotinib (150 mg/d). PROs were collected (baseline, every 28 days until progression, 28 days after discontinuation) using the European Organization for Research and Treatment of Cancer QoL questionnaire and lung cancer-specific module. The percentage of patients improved during therapy, time to deterioration (TTD), and changes over time were analyzed for prespecified lung cancer-related symptoms and global health status (GHS)/QoL. RESULTS:Questionnaire compliance was 77.3% to 99.0% and 68.7% to 99.0% with afatinib and erlotinib, respectively. Significantly more patients who received afatinib versus erlotinib experienced improved scores for GHS/QoL (36% vs. 28%; P = .041) and cough (43% vs. 35%; P = .029). Afatinib significantly delayed TTD in dyspnea (P = .008) versus erlotinib, but not cough (P = .256) or pain (P = .869). Changes in mean scores favored afatinib for cough (P = .0022), dyspnea (P = .0007), pain (P = .0224), GHS/QoL (P = .0320), and all functional scales. Differences in adverse events between afatinib and erlotinib, specifically diarrhea, did not affect GHS/QoL. CONCLUSION: In patients with SCC of the lung, second-line afatinib was associated with improved prespecified disease-related symptoms and GHS/QoL versus erlotinib, complementing PFS and OS benefits with afatinib.
RCT Entities:
INTRODUCTION: In the phase III LUX-Lung 8 trial, afatinib significantly improved progression-free survival (PFS) and overall survival (OS) versus erlotinib in patients with squamous cell carcinoma (SCC) of the lung progressing during or after platinum-based chemotherapy. Patient-reported outcomes (PROs) and health-related quality of life (QoL) in these patients are presented. PATIENTS AND METHODS: Patients (n = 795) were randomized 1:1 to oral afatinib (40 mg/d) or erlotinib (150 mg/d). PROs were collected (baseline, every 28 days until progression, 28 days after discontinuation) using the European Organization for Research and Treatment of Cancer QoL questionnaire and lung cancer-specific module. The percentage of patients improved during therapy, time to deterioration (TTD), and changes over time were analyzed for prespecified lung cancer-related symptoms and global health status (GHS)/QoL. RESULTS: Questionnaire compliance was 77.3% to 99.0% and 68.7% to 99.0% with afatinib and erlotinib, respectively. Significantly more patients who received afatinib versus erlotinib experienced improved scores for GHS/QoL (36% vs. 28%; P = .041) and cough (43% vs. 35%; P = .029). Afatinib significantly delayed TTD in dyspnea (P = .008) versus erlotinib, but not cough (P = .256) or pain (P = .869). Changes in mean scores favored afatinib for cough (P = .0022), dyspnea (P = .0007), pain (P = .0224), GHS/QoL (P = .0320), and all functional scales. Differences in adverse events between afatinib and erlotinib, specifically diarrhea, did not affect GHS/QoL. CONCLUSION: In patients with SCC of the lung, second-line afatinib was associated with improved prespecified disease-related symptoms and GHS/QoL versus erlotinib, complementing PFS and OS benefits with afatinib.
Authors: E Charton; B Cuer; F Cottone; F Efficace; C Touraine; Z Hamidou; F Fiteni; F Bonnetain; M-C Woronoff-Lemsi; C Bascoul-Mollevi; A Anota Journal: Qual Life Res Date: 2019-11-27 Impact factor: 4.147