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.