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A randomized phase III study comparing S-1 plus docetaxel with S-1 alone as a postoperative adjuvant chemotherapy for curatively resected stage III gastric cancer (JACCRO GC-07 trial).
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2018
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Surgical OncologyCancer ManagementGastroenterologySurgeryPharmacotherapyUpper Gastrointestinal SurgeryOncologyGastrointestinal OncologyMetronomic TherapyClinical TrialsJaccro Gc-07 TrialBlock RandomizationRadiation OncologyCancer ResearchHealth SciencesPstage Iii GcPostoperative Adjuvant ChemotherapyCancer TreatmentPostoperative S-1/docetaxelMedicine
4007 Background: Although postoperative adjuvant chemotherapy with S-1 is among the standard treatments for curatively resected pStage II/III gastric cancer (GC) in Asia, the outcome of pStage III GC remains unsatisfactory. Postoperative S-1/docetaxel had been among candidates for the new standard treatment. Methods: JACCRO GC-7, a randomized controlled trial to explore postoperative S-1/docetaxel, was participated by 138 Japanese institutions. After R0 resection by D2 gastrectomy, patients with pStage III GC were randomly assigned to either the S-1/docetaxel group (oral S-1 at 80-120mg/body on days 1-14 with 7 days of rest was followed by 6 cycles of S-1 at the same dosage and schedule combined with docetaxel 40mg/m2 on day 1 of each cycle, and then 4 further cycles of S-1 at 80-120mg/body on days 1-28 every 42 days) or the control group (8 cycles of S-1 at 80-120mg/body on days 1-28 every 42 days). Block randomization was performed by a central interactive computerized system stratified by the institution, stage (IIIA, IIIB, or IIIC) and histological type (differentiated or undifferentiated). The sample size of 1,100 was necessary to detect a 7% increase in the 3-year RFS, the primary endpoint, in the S-1/docetaxel group (HR 0.78, 2-sided alpha = 0.05, beta = 0.2). The secondary endpoints were OS, TTF and safety. Results: At the planned second interim analysis, the 3y RFS of the S-1/docetaxel arm (65.9%) was significantly superior to that of the S-1 arm at 49,6% (HR 0.632, 99% CI: 0.400~0.998, p = 0.0007), and the independent data and safety monitoring committee recommended termination of the trial. S-1/docetaxel suppressed all types of recurrences including hematogenous, lymphatic and peritoneal. Although ≥grade 3 adverse events including leucopenia, anorexia, stomatitis and anemia were more frequent, postoperative S-1/docetaxel was safe and manageable. Conclusions: Postoperative adjuvant S-1/docetaxel after D2 gastrectomy is recommended as the new standard of care for patients with pStage III GC. Clinical trial information: UMIN 000010337.