Y-L Wu1, C Zhou2, C-K Liam3, G Wu4, X Liu5, Z Zhong6, S Lu7, Y Cheng8, B Han7, L Chen9, C Huang10, S Qin11, Y Zhu12, H Pan13, H Liang14, E Li15, G Jiang16, S H How17, M C L Fernando18, Y Zhang19, F Xia19, Y Zuo19. 1. Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou. Electronic address: syylwu@live.cn. 2. Department of Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China. 3. Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia. 4. Cancer Center of Union Hospital, Tongji Medical College, Huzhong University of Science and Technology, Wuhan. 5. Department of Internal Medicine Tumor, Academy of Military Medical Sciences Affiliated Hospital (307 Hospital of PLA), Beijing. 6. Cancer Centre, Research Institute of Surgery, Daping Hospital, Third Military Medical University, Chongqing. 7. Department of Lung Cancer, Shanghai Chest Hospital, Shanghai. 8. Jilin Cancer Hospital, Changchun. 9. Department of Medical Oncology, Cancer Hospital of Shantou University Medical College, Shantou. 10. Fujian Provincial Tumor Hospital, Fujian. 11. Nanjing Bayi Hospital, Nanjing. 12. Department of Lung Cancer, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing. 13. Department of Oncology, Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine, Hangzhou. 14. Affiliated Xinan Hospital of Third Military Medical University, Chongqing. 15. First Affiliated Hospital, Medical School Xi'an Jiaotong University, Xi'an. 16. Cancer Hospital, Fudan University, Shanghai, China. 17. Department of Medicine, International Islamic University Malaysia, Kuala Lumpur, Malaysia. 18. Manila Doctors Hospital, Manila, The Philippines. 19. Roche (China) Holding Ltd, Shanghai, China.
Abstract
BACKGROUND: The phase III, randomized, open-label ENSURE study (NCT01342965) evaluated first-line erlotinib versus gemcitabine/cisplatin (GP) in patients from China, Malaysia and the Philippines with epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: Patients ≥18 years old with histologically/cytologically confirmed stage IIIB/IV EGFR mutation-positive NSCLC and Eastern Cooperative Oncology Group performance status 0-2 were randomized 1:1 to receive erlotinib (oral; 150 mg once daily until progression/unacceptable toxicity) or GP [G 1250 mg/m(2) i.v. days 1 and 8 (3-weekly cycle); P 75 mg/m(2) i.v. day 1, (3-weekly cycle) for up to four cycles]. Primary end point: investigator-assessed progression-free survival (PFS). Other end points include objective response rate (ORR), overall survival (OS), and safety. RESULTS: A total of 217 patients were randomized: 110 to erlotinib and 107 to GP. Investigator-assessed median PFS was 11.0 months versus 5.5 months, erlotinib versus GP, respectively [hazard ratio (HR), 0.34, 95% confidence interval (CI) 0.22-0.51; log-rank P < 0.0001]. Independent Review Committee-assessed median PFS was consistent (HR, 0.42). Median OS was 26.3 versus 25.5 months, erlotinib versus GP, respectively (HR, 0.91, 95% CI 0.63-1.31; log-rank P = .607). ORR was 62.7% for erlotinib and 33.6% for GP. Treatment-related serious adverse events (AEs) occurred in 2.7% versus 10.6% of erlotinib and GP patients, respectively. The most common grade ≥3 AEs were rash (6.4%) with erlotinib, and neutropenia (25.0%), leukopenia (14.4%), and anemia (12.5%) with GP. CONCLUSION: These analyses demonstrate that first-line erlotinib provides a statistically significant improvement in PFS versus GP in Asian patients with EGFR mutation-positive NSCLC (NCT01342965).
RCT Entities:
BACKGROUND: The phase III, randomized, open-label ENSURE study (NCT01342965) evaluated first-line erlotinib versus gemcitabine/cisplatin (GP) in patients from China, Malaysia and the Philippines with epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: Patients ≥18 years old with histologically/cytologically confirmed stage IIIB/IV EGFR mutation-positive NSCLC and Eastern Cooperative Oncology Group performance status 0-2 were randomized 1:1 to receive erlotinib (oral; 150 mg once daily until progression/unacceptable toxicity) or GP [G 1250 mg/m(2) i.v. days 1 and 8 (3-weekly cycle); P 75 mg/m(2) i.v. day 1, (3-weekly cycle) for up to four cycles]. Primary end point: investigator-assessed progression-free survival (PFS). Other end points include objective response rate (ORR), overall survival (OS), and safety. RESULTS: A total of 217 patients were randomized: 110 to erlotinib and 107 to GP. Investigator-assessed median PFS was 11.0 months versus 5.5 months, erlotinib versus GP, respectively [hazard ratio (HR), 0.34, 95% confidence interval (CI) 0.22-0.51; log-rank P < 0.0001]. Independent Review Committee-assessed median PFS was consistent (HR, 0.42). Median OS was 26.3 versus 25.5 months, erlotinib versus GP, respectively (HR, 0.91, 95% CI 0.63-1.31; log-rank P = .607). ORR was 62.7% for erlotinib and 33.6% for GP. Treatment-related serious adverse events (AEs) occurred in 2.7% versus 10.6% of erlotinib and GP patients, respectively. The most common grade ≥3 AEs were rash (6.4%) with erlotinib, and neutropenia (25.0%), leukopenia (14.4%), and anemia (12.5%) with GP. CONCLUSION: These analyses demonstrate that first-line erlotinib provides a statistically significant improvement in PFS versus GP in Asian patients with EGFR mutation-positive NSCLC (NCT01342965).
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