A randomized phase III trial comparing adjuvant single-agent S1, S-1 with oxaliplatin, and postoperative chemoradiation with S-1 and oxaliplatin in patients with node-positive gastric cancer after D2 resection: the ARTIST 2 trial?

•In patients with curatively D2-resected, stage II/III, node-positive GC, adjuvant SOX or SOXRT was effective in prolonging DFS, when compared S-1 monotherapy.•The addition of radiotherapy to chemotherapy did not significantly reduce the rate recurrence after D2 gastrectomy.•DFS between treated and chemoradiotherapy similar across all subgroups, including Lauren classification. BackgroundAdjuvant are some standards care for gastric cancer (GC). The Adjuvant chemoRadioTherapy In Stomach Tumors (ARTIST) 2 trial compares two regimens II III, GC.Patients methodsThe ARTIST compared, a 1:1:1 ratio, three regimens: oral (40-60 mg twice daily 4 weeks on/2 off) 1 year, (2 on/1 week plus oxaliplatin 130 mg/m2 every 3 (SOX) 6 months, 45 Gy (SOXRT). Randomization stratified according surgery type (total subtotal gastrectomy), pathologic (II III), histologic classification (diffuse intestinal/mixed). primary endpoint disease-free survival (DFS) at years; reduction 33% hazard ratio (HR) DFS SOXRT, S-1, considered clinically meaningful. is registered clinicaltrials.gov (NCT0176146).ResultsA total 546 were recruited February 2013 January 2018 182, 181, 183 SOX, arms, respectively. Median follow-up period 47 178 events observed. Estimated 3-year rates 64.8%, 74.3%, 72.8% HR control arm (S-1) shorter than that arms: versus 0.692 (P = 0.042) 0.724 0.074). No difference found (HR 0.971; P 0.879). Adverse as anticipated each arm, generally well-tolerated manageable.ConclusionsIn monotherapy. gastrectomy. GC. (NCT0176146). A manageable.