Overall Survival Results of the Feasibility Study of Adjuvant Chemotherapy With Docetaxel Plus Cisplatin Followed by Long-term Single-agent Administration of S-1 in Patients With Completely Resected Non–Small Cell Lung Cancer: Thoracic Oncology Research Group (TORG) 0809

Objectives: The TORG0809 study was a multicenter feasibility study of long-term single-agent therapy with S-1 after docetaxel plus cisplatin therapy in patients with completely resected stage II or stage IIIA non–small cell lung cancer. We report the results of the final overall survival (OS) analysis. Patients and Methods: A total of 129 eligible patients received 3 cycles of docetaxel (60 mg/m2, day 1) plus cisplatin (80 mg/m2, day 1), followed by S-1 at 40 mg/m2 twice daily for 14 consecutive days, for >6 months (maximum, 1 y). Results: At the cutoff date of April 13, 2016, the median follow-up time was 6.0 years. Of the 129 patients, 43 had died, and 74 patients developed disease recurrence or died. The median OS had not been reached. The 5-year OS rate was 71% [95% confidence interval (CI), 62-78]. The 5-year OS rates in the patients with stage II and stage IIIA were 76% and 68%, respectively. The median recurrence-free survival (RFS) duration was 3.4 years (95% CI, 2.3-5.7). The 5-year RFS rate was 44% (95% CI, 36-53). The 5-year RFS rates in patients with stage II and stage IIIA disease were 57% and 38%, respectively. Disease recurrence occurred in 68 patients, and 62 of these patients received second-line chemotherapy. The most common sites of recurrence were the brain (n=22) and mediastinal lymph nodes (n=22). Conclusion: The survival data obtained from this study are promising and comparable to those reported from a previous study conducted in Japan. Supported by TORG by Taiho Pharmaceutical Co. Ltd under the research contract. Presented in part at the Congress of European Society of Medical Oncology, October 7-11, 2016, Copenhagen, Denmark. S.N., N.I., K.S., H.S., T.K., H.O., T.S., H.K., and M.T. have received honoraria from Taiho Pharmaceutical Co. Ltd. N.I. and T.S. received research funding from Taiho Pharmaceutical Co. Ltd. The other authors declare no conflicts of interest. Reprints: Seiji Niho, MD, PhD, Department of Thoracic Oncology, National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa, Chiba 277-8577, Japan. E-mail: siniho@east.ncc.go.jp. Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.

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