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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

Niho, Seiji, MD, PhD*; Ikeda, Norihiko, MD; Michimae, Hiroshi, PhD; Suzuki, Kenji, MD§; Sakai, Hiroshi, MD; Kaburagi, Takayuki, MD, PhD; Yoshiya, Katsuo, MD#; Minato, Koichi, MD**; Kato, Terufumi, MD††; Okamoto, Hiroaki, MD, PhD‡‡; Seto, Takashi, MD§§; Hosomi, Yukio, MD, PhD∥∥; Shimizu, Kimihiro, MD, PhD¶¶; Saito, Haruhiro, MD, PhD##; Tsuchida, Masanori, MD, PhD***; Kunitoh, Hideo, MD†††; Tsuboi, Masahiro, MD‡‡‡; Takeuchi, Masahiro, ScD; Watanabe, Koshiro, MD, PhD§§§

American Journal of Clinical Oncology: November 2018 - Volume 41 - Issue 11 - p 1113–1117
doi: 10.1097/COC.0000000000000438
Original Articles: Thoracic

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.

Departments of *Thoracic Oncology

‡‡‡Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa

Department of Surgery, Tokyo Medical University

Department of Biostatistics and Pharmaceutical Medicine, School of Pharmaceutical Sciences, Kitasato University School of Medicine

§Department of General Thoracic Surgery, Juntendo University School of Medicine

∥∥Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Komagome Hospital

†††Department of Medical Oncology, Japanese Red Cross Medical Center, Tokyo

Division of Respiratory Disease, Saitama Cancer Center, Saitama

Department of Respiratory Medicine, Ibaraki Prefectural Hospital, Kasama

#Division of Chest Surgery, Niigata Cancer Center Hospital

***Division of Thoracic and Cardiovascular Surgery, Niigata University Medical & Dental Hospital, Niigata

**Department of Respiratory Medicine, Gunma Prefectural Cancer Center, Ota

††Department of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center

‡‡Department of Respiratory Medicine, Yokohama Municipal Citizen’s Hospital

##Department of Thoracic Oncology, Kanagawa Cancer Center

§§§Thoracic Oncology Research Group, Yokohama

§§Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka

¶¶Department of Thoracic and Visceral Organ Surgery, Gunma University Faculty of Medicine, Maebashi, 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:

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