Results
death, armIncidence
ADVERSE EVENTS, RECURRENCES, RECURRENCE, METASTASIS
Final survival analyses were conducted at a median follow-up of 63.7 months (range: 3.5–111.9 months). Time from the date of randomization of the last enrolled case to the data cutoff date was 66.8 months. Data from the 55 patients lost to follow-up within 5 years from the date of random assignment were censored as of the last day of follow-up.Among the 912 patients, 190 patients in the S-1 plus docetaxel group and 236 patients in the S-1 monotherapy group showed recurrence during the 5 years of follow-up, with the death of 167 patients and 206 patients, respectively. Five-year OS rates were 67.91% in the S-1 plus docetaxel group and 60.27% in the S-1 monotherapy group (HR 0.752, 95% CI 0.613–0.922; Overall survival (OS) at termination of the preplanned follow-up for 5 years. Kaplan–Meier estimates of OS in all patients (Five-year RFS rates were 59.78% in the S-1 plus docetaxel group and 50.63% in the S-1 group (HR 0.726, 95%CI 0.599–0.879; Relapse-free survival (RFS) at termination of the preplanned follow-up for 5 years. Kaplan–Meier estimates of RFS in all patients (The number of patients with late recurrence diagnosed > 3 years after randomization was similar in each treatment arm (Table Sites of relapse at ≤ 3 years and > 3 years after randomizationSome patients recorded more than one metastatic siteSite of relapse during the 5 years after randomization, stratified by treatment armIncidence of relapse tended to be lower in the S-1 plus docetaxel arm for all patterns of metastasis, with significant differences in the incidence of relapse through lymphatic and hematogenous routesDetails on adverse events and compliance with each of the two drug regimens have been reported in our previous studies [Regarding the histological type, recurrences were more frequent among the undifferentiated type at 261 of 544 patients (48%) as opposed to the differentiated type (125 of 368 patients, 34%). Nevertheless, similar risk reduction for relapse was observed across the two types through addition of docetaxel (HR 0.743, 95% CI 0.531–1.038; 