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Final overall survival (OS) results of the feasibility study of adjuvant chemotherapy with docetaxel (DOC) plus cisplatin (CDDP) followed by maintenance chemotherapy of S-1 in completely resected non-small cell lung cancer (NSCLC): Thoracic Oncology Research Group (TORG) 0809

Date

08 Oct 2016

Session

Poster Display

Presenters

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

Author affiliations

  • 1 Department Of Thoracic Oncology, National Cancer Center Hospital East, 277-8577 - Kashiwa/JP
  • 2 Department Of Surgery, Tokyo Medical University Hospital, Tokyo/JP
  • 3 Department Of Biostatistics And Pharmaceutical Medicine, School Of Pharmaceutical Sciences, Kitasato University School of Medicine, Tokyo/JP
  • 4 Thoracic Surgery, Juntendo University Hospital, Tokyo/JP
  • 5 Thoracic Oncology, Saitama Cancer Center, 362-0806 - Saitama/JP
  • 6 Department Of Respiratory Medicine, Ibaraki Prefectural Central Hospital, Kasama/JP
  • 7 Division Of Chest Surgery, Niigata Cancer Center Hospital, Niigata/JP
  • 8 Department Of Respiratory Medicine, Gunma Prefectural Cancer Center, Ota/JP
  • 9 Department Of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, 2360051 - Yokohama/JP
  • 10 Department Of Respiratory Medicine, Yokohama Municipal Citizen's Hospital, 240-8555 - Yokohama/JP
  • 11 Department Of Thoracic Oncology, National Kyushu Cancer Center, 811-1395 - Fukuoka/JP
  • 12 Department Of Thoracic Oncology And Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo/JP
  • 13 Department Of Thoracic And Visceral Organ Surgery, Gunma University Faculty of Medicine, Maebashi/JP
  • 14 Department Of Thoracic Oncology, Kanagawa Cancer Center, Yokohama/JP
  • 15 Division Of Thoracic And Cardiovascular Surgery, Niigata University Medical and Dental Hospital, Niigata/JP
  • 16 Division Of Chemotherapy, Department Of Internal Medicine, Japanese Red Cross Medical Center, Tokyo/JP
  • 17 Thoracic Surgery & Oncology, National Cancer Center Hospital East, 277-8577 - Kashiwa/JP
  • 18 Torg0809 Study Group, Thoracic Oncology Research Group, Yokohama/JP
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Resources

Background

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).

Methods

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).

Results

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.

Conclusions

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

Clinical trial identification

UMIN000001779

Legal entity responsible for the study

N/A

Funding

Taiho Pharmaceutical Co., Ltd. Funding

Disclosure

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.

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