C Zhou1, Y L Wu2, G Chen3, J Feng4, X-Q Liu5, C Wang6, S Zhang7, J Wang8, S Zhou9, S Ren9, S Lu10, L Zhang22, C Hu13, C Hu13, Y Luo14, L Chen15, M Ye16, J Huang17, X Zhi18, Y Zhang19, Q Xiu20, J Ma21, L Zhang22, C You23. 1. Department of Oncology, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, Shanghai. Electronic address: caicunzhoudr@163.com. 2. Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences, Guangzhou. 3. Department of Tumour Medicine, Cancer Hospital of Harbin Medical University, Harbin. 4. Department of Medical Oncology, Jiangsu Province Cancer Hospital, Nanjing. 5. Department of Pulmonary Oncology, 307 Hospital of the Academy of Military Medical Sciences, Cancer Center, Beijing. 6. Department of Medical Oncology, Tianjin Cancer Hospital, Tianjin. 7. Beijing Chest Hospital, Capital Medical University, Beijing. 8. Peking University School of Oncology, Beijing Cancer Hospital, Beijing. 9. Department of Oncology, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, Shanghai. 10. Shanghai Chest Hospital, Affiliated to Shanghai Jiao Tong University, Shanghai. 11. Sun Yat-sen University Cancer Center, Guangzhou. 12. Xiangya Hospital, Central South University, Changsha. 13. Second Xiangya Hospital, Central South University, Changsha. 14. Hunan Province Cancer Hospital, Changsha. 15. Cancer Hospital of Shantou University Medical College, Shantou. 16. Renji Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai. 17. The First Affiliated Hospital of Suzhou University, Suzhou. 18. Department of Thoracic Surgery, Xuanwu Hospital of Capital Medical University, Beijing. 19. Zhejiang Cancer Hospital, Hangzhou. 20. Changzheng Hospital, The Second Military Medical University, Shanghai. 21. Harbin Institute of Hematology and Oncology, Harbin. 22. Peking Union Medical College Hospital, Beijing. 23. Nanfang Hospital, Southern Medical University, Guangzhou, China.
Abstract
BACKGROUND: The OPTIMAL study was the first study to compare efficacy and tolerability of the epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI) erlotinib, versus standard chemotherapy in first-line treatment of patients with EGFR mutation-positive advanced non-small-cell lung cancer (NSCLC). Findings from final overall survival (OS) analysis and assessment of post-study treatment impact are presented. PATIENTS AND METHODS: Of 165 randomised patients, 82 received erlotinib and 72 gemcitabine plus carboplatin. Final OS analyses were conducted when 70% of deaths had occurred in the intent-to-treat population. Subgroup OS was analysed by Cox proportional hazards model and included randomisation stratification factors and post-study treatments. RESULTS: Median OS was similar between the erlotinib (22.8 months) and chemotherapy (27.2 months) arms with no significant between-group differences in the overall population [hazard ratio (HR), 1.19; 95% confidence interval (CI) 0.83-1.71; P = 0.2663], the exon 19 deletion subpopulation (HR, 1.52; 95% CI 0.91-2.52; P = 0.1037) or the exon 21 L858 mutation subpopulation (HR, 0.92; 95% CI 0.55-1.54; P = 0.7392). More patients in the erlotinib arm versus the chemotherapy arm did not receive any post-study treatment (36.6% versus 22.2%). Patients who received sequential combination of EGFR-TKI and chemotherapy had significantly improved OS compared with those who received EGFR-TKI or chemotherapy only (29.7 versus 20.7 or 11.2 months, respectively; P < 0.0001). OS was significantly shorter in patients who did not receive post-study treatments compared with those who received subsequent treatments in both arms. CONCLUSION: The significant OS benefit observed in patients treated with EGFR-TKI emphasises its contribution to improving survival of EGFR mutant NSCLC patients, suggesting that erlotinib should be considered standard first-line treatment of EGFR mutant patients and EGFR-TKI treatment following first-line therapy also brings significant benefits to those patients. CLINICALTRIALSGOV IDENTIFIER: NCT00874419.
BACKGROUND: The OPTIMAL study was the first study to compare efficacy and tolerability of the epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI) erlotinib, versus standard chemotherapy in first-line treatment of patients with EGFR mutation-positive advanced non-small-cell lung cancer (NSCLC). Findings from final overall survival (OS) analysis and assessment of post-study treatment impact are presented. PATIENTS AND METHODS: Of 165 randomised patients, 82 received erlotinib and 72 gemcitabine plus carboplatin. Final OS analyses were conducted when 70% of deaths had occurred in the intent-to-treat population. Subgroup OS was analysed by Cox proportional hazards model and included randomisation stratification factors and post-study treatments. RESULTS: Median OS was similar between the erlotinib (22.8 months) and chemotherapy (27.2 months) arms with no significant between-group differences in the overall population [hazard ratio (HR), 1.19; 95% confidence interval (CI) 0.83-1.71; P = 0.2663], the exon 19 deletion subpopulation (HR, 1.52; 95% CI 0.91-2.52; P = 0.1037) or the exon 21 L858 mutation subpopulation (HR, 0.92; 95% CI 0.55-1.54; P = 0.7392). More patients in the erlotinib arm versus the chemotherapy arm did not receive any post-study treatment (36.6% versus 22.2%). Patients who received sequential combination of EGFR-TKI and chemotherapy had significantly improved OS compared with those who received EGFR-TKI or chemotherapy only (29.7 versus 20.7 or 11.2 months, respectively; P < 0.0001). OS was significantly shorter in patients who did not receive post-study treatments compared with those who received subsequent treatments in both arms. CONCLUSION: The significant OS benefit observed in patients treated with EGFR-TKI emphasises its contribution to improving survival of EGFR mutant NSCLC patients, suggesting that erlotinib should be considered standard first-line treatment of EGFR mutant patients and EGFR-TKI treatment following first-line therapy also brings significant benefits to those patients. CLINICALTRIALSGOV IDENTIFIER: NCT00874419.
Authors: Yong-Jin Kim; Mark Oremus; Helen H Chen; Thomas McFarlane; Danielle Fearon; Susan Horton Journal: Pharmacoeconomics Date: 2021-03-31 Impact factor: 4.981
Authors: Saiama N Waqar; Philip D Bonomi; Ramaswamy Govindan; Fred R Hirsch; Gregory J Riely; Vassiliki Papadimitrakopoulou; Dickran Kazandjian; Sean Khozin; Erin Larkins; Dane J Dickson; Shakun Malik; Leora Horn; Andrea Ferris; Alice T Shaw; Pasi A Jänne; Tony S K Mok; Roy Herbst; Patricia Keegan; Richard Pazdur; Gideon M Blumenthal Journal: J Thorac Oncol Date: 2016-07-09 Impact factor: 15.609