1195P - Final overall survival (OS) results of the feasibility study of adjuvant chemotherapy with docetaxel (DOC) plus cisplatin (CDDP) followed by mainte...

Date 08 October 2016
Event ESMO 2016 Congress
Session Poster Display
Topics Cytotoxic agents
Non-small-cell lung cancer
Biological therapy
Presenter Seiji Niho
Citation Annals of Oncology (2016) 27 (6): 411-415. 10.1093/annonc/mdw382
Authors S. Niho1, N. Ikeda2, H. Michimae3, K. Suzuki4, H. Sakai5, T. Kaburagi6, K. Yoshiya7, K. Minato8, T. Kato9, H. Okamoto10, T. Seto11, Y. Hosomi12, K. Shimizu13, H. Saito14, M. Tsuchida15, H. Kunitoh16, M. Tsuboi17, M. Takeuchi3, K. Watanabe18
  • 1Department Of Thoracic Oncology, National Cancer Center Hospital East, 277-8577 - Kashiwa/JP
  • 2Department Of Surgery, Tokyo Medical University Hospital, Tokyo/JP
  • 3Department Of Biostatistics And Pharmaceutical Medicine, School Of Pharmaceutical Sciences, Kitasato University School of Medicine, Tokyo/JP
  • 4Thoracic Surgery, Juntendo University Hospital, Tokyo/JP
  • 5Thoracic Oncology, Saitama Cancer Center, 362-0806 - Saitama/JP
  • 6Department Of Respiratory Medicine, Ibaraki Prefectural Central Hospital, Kasama/JP
  • 7Division Of Chest Surgery, Niigata Cancer Center Hospital, Niigata/JP
  • 8Department Of Respiratory Medicine, Gunma Prefectural Cancer Center, Ota/JP
  • 9Department Of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, 2360051 - Yokohama/JP
  • 10Department Of Respiratory Medicine, Yokohama Municipal Citizen's Hospital, 240-8555 - Yokohama/JP
  • 11Department Of Thoracic Oncology, National Kyushu Cancer Center, 811-1395 - Fukuoka/JP
  • 12Department Of Thoracic Oncology And Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo/JP
  • 13Department Of Thoracic And Visceral Organ Surgery, Gunma University Faculty of Medicine, Maebashi/JP
  • 14Department Of Thoracic Oncology, Kanagawa Cancer Center, Yokohama/JP
  • 15Division Of Thoracic And Cardiovascular Surgery, Niigata University Medical and Dental Hospital, Niigata/JP
  • 16Division Of Chemotherapy, Department Of Internal Medicine, Japanese Red Cross Medical Center, Tokyo/JP
  • 17Thoracic Surgery & Oncology, National Cancer Center Hospital East, 277-8577 - Kashiwa/JP
  • 18Torg0809 Study Group, Thoracic Oncology Research Group, Yokohama/JP



Efficacy of maintenance chemotherapy with oral S-1 (tegafur, 5-chloro-2, 4-dihydroxypyridine, and potassium oxonate) following post-operative DOC + CDDP in patients with completely resected stage II and IIIA (according to the UICC 5th edition) NSCLC was evaluated; feasibility, safety and compliance data were previously reported (Niho S, et al. BJC 2013; 109, 545-51).


Patients received 3 cycles of DOC (60mg/m2, d1) plus CDDP (80mg/m2, d1), q3-4w, and subsequently received S-1 at 40mg/m2 twice daily for 14 consecutive days, q3w, for more than 6 months (maximum, 1 year).


Between June 2009 and November 2010, 131 patients were enrolled in this study from 20 institutions in Japan. A total of 129 patients were eligible and assessable. The median age was 63 years (range, 23-74 years); 17 patients had p-stage IIA, 32 had IIB, and 80 had IIIA; 100 patients had adenocarcinoma, and 29 had non-adenocarcinoma. Of the 129 patients, 109 patients (84.5%) completed 3 cycles of DOC + CDDP, and 66 patients (51.2%) completed 8 or more cycles of S-1 treatment. At the cutoff date of April 13, 2016, median follow-up time was 5.9 years. Forty-three patients had died, and 74 patients had recurred or died. Median OS time has not been reached. The five-year OS rate was 70% (95%CI, 61 to 77). The-five-year OS rates among patients with stage II and IIIA were 73% and 68%, respectively. Median recurrence-free survival (RFS) time was 3.6 years (95%CI, 2.4-). The five-year RFS rate was 44% (95%CI, 35 to 53). The five-year RFS rates among patients with stage II and IIIA were 57% and 36%, respectively.


Survival data in this study is promising. Analysis about post-study treatment after recurrence will be also presented.

Clinical trial identification


Legal entity responsible for the study



Taiho Pharmaceutical Co., Ltd. Funding


S. Niho: Honoraria from Taiho. Research funding from Pfizer, Lilly, and AstraZeneca. N. Ikeda: Honoraria from Taiho and Aventis. Research funding from Taiho and Aventis. K. Suzuki, M. Tsuboi: Honoraria from Taiho. H. Sakai: Honoraria form Taiho, Aventis, Chugai, and Lilly. T. Kato, H. Kunitoh: Honoraria from Taiho and Aventis. H. Okamoto: Honoraria from Chugai, Aventis, Lilly, Kyowa, Taiho, and Janssen.

T. Seto: Honoraria from Taiho and Aventis. Research funding from Taiho. All other authors have declared no conflicts of interest.