Results from the safety interim analysis of the adjuvant chemoradiotherapy in stomach tumors 2 trial: a multicenter, randomized phase III clinical trial

Purpose: The Adjuvant chemoRadioTherapy In Stomach Tumors 2 (ARTIST 2) trial was conducted to compare the efficacy between adjuvant chemotherapy regimens and chemoradiotherapy in D2-resected, node-positive, stage 2 or 3 gastric cancer. Methods: In this prospective, multicenter, phase III trial, we randomly assigned patients to three treatment arms: patients who receive adjuvant S-1 for 1 year, S-1 plus oxaliplatin (SOX) for 6 months, or SOX plus chemoradiotherapy (SOXRT). Herein, we report the safety outcomes of patients who received adjuvant chemotherapy or chemoradiotherapy. Results: Among a total of 514 patients registered between February 2013 and December 2017, 499 patients who either completed or discontinued the assigned study treatments were included in the present analysis. All the three treatment arms were generally well-tolerated, with the overall treatment completion rate of 94% (96% in S-1, 93% in SOX, and 92% in SOXRT). The median delivered dose of radiotherapy in the SOXRT arm was 4,500 cGy (range, 0 to 4,500 cGy). The most frequently observed adverse events were fatigue (29%) in S-1 arm and peripheral neuropathy in the SOX and SOXRT arms (59% and 50%, respectively). Conclusion: Our preliminary data confirm that there are no significant safety concerns in ARTIST 2 trial (ClinicalTrials.gov, NCT0176146). According to the Independent Data Monitoring Committee, patient accrual is underway.