H Yoshioka1, M Shimokawa2, T Seto3, S Morita4, Y Yatabe5, I Okamoto6, J Tsurutani7, M Satouchi8, T Hirashima9, S Atagi10, K Shibata11, H Saito12, S Toyooka13, N Yamamoto14, K Nakagawa15, T Mitsudomi16. 1. Department of Thoracic Oncology, Kansai Medical University Hospital, Hirakata. 2. Department of Cancer Information Research, National Hospital Organization Kyushu Cancer Center, Fukuoka; Department of Biostatistics, Yamaguchi University Graduate School of Medicine, Ube. 3. Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka. 4. Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto. 5. Department of Pathology and Molecular Genetics, Aichi Cancer Center Hospital, Nagoya. 6. Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyusyu University, Fukuoka. 7. Advanced Cancer Translational Research Institute, Showa University, Tokyo. 8. Department of Thoracic Oncology, Hyogo Cancer Center, Akashi. 9. Department of Thoracic Oncology, Osaka Habikino Medical Center, Habikino. 10. Department of Thoracic Oncology, National Hospital Organization Kinki-chuo Chest Medical Center, Sakai. 11. Department of Medical Oncology, Kouseiren Takaoka Hospital, Takaoka. 12. Department of Respiratory Medicine, Aichi Cancer Center Aichi Hospital, Okazaki. 13. Department of General Thoracic Surgery and Breast and Endocrinological Surgery, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama. 14. Internal Medicine III, Wakayama Medical University Hospital, Wakayama. 15. Department of Medical Oncology, Kindai University Hospital, Osaka-Sayama. 16. Division of Thoracic Surgery, Department of Surgery, Kindai University Hospital, Osaka-Sayama, Japan. Electronic address: mitsudom@med.kindai.ac.jp.
Abstract
BACKGROUND: Primary analysis of the phase III study WJTOG 3405 demonstrated superiority of progression-free survival (PFS) for gefitinib (G) in patients treated with the epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI) gefitinib compared withcisplatin plus docetaxel (CD) as the first-line treatment of stage IIIB/IV or postoperative recurrent EGFR mutation-positive non-small-cell lung cancer. This report presents final overall survival (OS) data. PATIENTS AND METHODS: Patients were randomized between G (250 mg/day orally) and cisplatin (80 mg/m2 intravenously) plus docetaxel (60 mg/m2 i.v.), administered every 21 days for three to six cycles. After the exclusion of 5 patients, 172 patients (86 in each group, modified intention-to-treat population) were included in the survival analysis. OS was re-evaluated using updated data (data cutoff, 30 September 2013; median follow-up time 59.1 months). The Kaplan-Meier method and the log-rank test were used for analysis, and hazard ratios (HRs) for death were calculated using the Cox proportional hazards model. RESULTS:OS events in the G group and CD group were 68 (79.1%) out of 86 and 59 (68.6%) out of 86, respectively. Median survival time for G and CD were 34.9 and 37.3 months, respectively, with an HR of 1.252 [95% confidence interval (CI): 0.883-1.775, P = 0.2070]. Multivariate analysis identified postoperative recurrence and stage IIIB/IV disease as independent prognostic factors, with an HR of 0.459 (95% CI: 0.312-0.673, P < 0.001). Median survival time (postoperative recurrence versus stage IIIB/IV disease) were 44.5 and 27.5 months in the G group and 45.5 and 32.8 months in the CD group, respectively. CONCLUSION: G did not show OS benefits over CD as the first-line treatment. OS of patients with postoperative recurrence was better than that of stage IIIB/IV disease, even though both groups had metastatic disease.This study was registered with UMIN (University Hospital Medical Information Network in Japan), number 000000539.
RCT Entities:
BACKGROUND: Primary analysis of the phase III study WJTOG 3405 demonstrated superiority of progression-free survival (PFS) for gefitinib (G) in patients treated with the epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI) gefitinib compared with cisplatin plus docetaxel (CD) as the first-line treatment of stage IIIB/IV or postoperative recurrent EGFR mutation-positive non-small-cell lung cancer. This report presents final overall survival (OS) data. PATIENTS AND METHODS: Patients were randomized between G (250 mg/day orally) and cisplatin (80 mg/m2 intravenously) plus docetaxel (60 mg/m2 i.v.), administered every 21 days for three to six cycles. After the exclusion of 5 patients, 172 patients (86 in each group, modified intention-to-treat population) were included in the survival analysis. OS was re-evaluated using updated data (data cutoff, 30 September 2013; median follow-up time 59.1 months). The Kaplan-Meier method and the log-rank test were used for analysis, and hazard ratios (HRs) for death were calculated using the Cox proportional hazards model. RESULTS: OS events in the G group and CD group were 68 (79.1%) out of 86 and 59 (68.6%) out of 86, respectively. Median survival time for G and CD were 34.9 and 37.3 months, respectively, with an HR of 1.252 [95% confidence interval (CI): 0.883-1.775, P = 0.2070]. Multivariate analysis identified postoperative recurrence and stage IIIB/IV disease as independent prognostic factors, with an HR of 0.459 (95% CI: 0.312-0.673, P < 0.001). Median survival time (postoperative recurrence versus stage IIIB/IV disease) were 44.5 and 27.5 months in the G group and 45.5 and 32.8 months in the CD group, respectively. CONCLUSION: G did not show OS benefits over CD as the first-line treatment. OS of patients with postoperative recurrence was better than that of stage IIIB/IV disease, even though both groups had metastatic disease.This study was registered with UMIN (University Hospital Medical Information Network in Japan), number 000000539.
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