Mark Boye1, Xin Wang2, Vichien Srimuninnimit3, Jin Hyoung Kang4, Chun-Ming Tsai5, Mauro Orlando6, Tarun Puri7, Jong Seok Kim8, Narayan Rajan9, James Chih-Hsin Yang10. 1. Global Patient Outcomes and Real World Evidence, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN. 2. Eli Lilly and Company, Shanghai, China. 3. Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand. 4. Division of Medical Oncology, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea. 5. Division of Thoracic Oncology, Department of Chest Medicine, Taipei Veterans General Hospital and Department of Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan. 6. Eli Lilly Interamerica Inc., Buenos Aires, Argentina. 7. Eli Lilly and Company, Gurgaon, India. 8. Eli Lilly and Company, Seoul, Republic of Korea. 9. Eli Lilly Australia, West Ryde, NSW, Australia. 10. Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan. Electronic address: chihyang@ntu.edu.tw.
Abstract
BACKGROUND: The efficacy results from an open-label, randomized, multicenter study found no significant difference in progression-free survival between pemetrexed plus cisplatin followed by maintenance gefitinib (PC/G) and gefitinib monotherapy (G) in patients with advanced nonsquamous non-small-cell lung cancer (NSCLC) and unknown epidermal growth factor receptor (EGFR) mutation status (hazard ratio favored PC/G). The present report describes the quality of life (QoL) results from that trial. PATIENTS AND METHODS: Chemotherapy-naive, East Asian, light ex-smokers or never-smokers with advanced nonsquamous NSCLC and unknown EGFR mutation status (n = 236) were randomly assigned (1:1) to PC/G or G. EGFR mutation status was subsequently determined for 74 patients. The symptoms and QoL were assessed using the Lung Cancer Symptom Scale (LCSS). The time to worsening of symptoms (TWS) was analyzed using the Kaplan-Meier method. RESULTS: In the overall population, the TWS was generally longer in the G group (n = 109) than in the PC/G group (n = 109) for the LCSS symptoms classified as treatment-related (loss of appetite, fatigue) and tumor-related (cough, dyspnea, hemoptysis, pain). In the subgroup of patients with wild-type EGFR, the TWS was generally longer in the PC/G group (n = 13) than in the G group (n = 8) for the tumor-related LCSS symptoms. CONCLUSION: In this study population clinically selected to respond to gefitinib, the LCSS scores were more favorable in the G group than in the PC/G group. Patients with wild-type EGFR tended to show greater improvement in tumor-related LCSS symptoms with chemotherapy than with gefitinib alone. These LCSS outcomes provide further evidence that patients with wild-type EGFR might not benefit from first-line treatment of advanced NSCLC with gefitinib.
RCT Entities:
BACKGROUND: The efficacy results from an open-label, randomized, multicenter study found no significant difference in progression-free survival between pemetrexed plus cisplatin followed by maintenance gefitinib (PC/G) and gefitinib monotherapy (G) in patients with advanced nonsquamous non-small-cell lung cancer (NSCLC) and unknown epidermal growth factor receptor (EGFR) mutation status (hazard ratio favored PC/G). The present report describes the quality of life (QoL) results from that trial. PATIENTS AND METHODS: Chemotherapy-naive, East Asian, light ex-smokers or never-smokers with advanced nonsquamous NSCLC and unknown EGFR mutation status (n = 236) were randomly assigned (1:1) to PC/G or G. EGFR mutation status was subsequently determined for 74 patients. The symptoms and QoL were assessed using the Lung Cancer Symptom Scale (LCSS). The time to worsening of symptoms (TWS) was analyzed using the Kaplan-Meier method. RESULTS: In the overall population, the TWS was generally longer in the G group (n = 109) than in the PC/G group (n = 109) for the LCSS symptoms classified as treatment-related (loss of appetite, fatigue) and tumor-related (cough, dyspnea, hemoptysis, pain). In the subgroup of patients with wild-type EGFR, the TWS was generally longer in the PC/G group (n = 13) than in the G group (n = 8) for the tumor-related LCSS symptoms. CONCLUSION: In this study population clinically selected to respond to gefitinib, the LCSS scores were more favorable in the G group than in the PC/G group. Patients with wild-type EGFR tended to show greater improvement in tumor-related LCSS symptoms with chemotherapy than with gefitinib alone. These LCSS outcomes provide further evidence that patients with wild-type EGFR might not benefit from first-line treatment of advanced NSCLC with gefitinib.
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
Authors: Michael Thomas; David R Spigel; Robert M Jotte; Michael McCleod; Mark A Socinski; Ray D Page; Laurent Gressot; Jeanna Knoble; Oscar Juan; Daniel Morgensztern; Dolores Isla; Edward S Kim; Howard West; Amy Ko; Teng Jin Ong; Nataliya Trunova; Cesare Gridelli Journal: Lung Cancer (Auckl) Date: 2017-10-30