Efficacy
Three year DFS rates were 78.2% vs 74.2% in the chemoradiation therapy arm and chemotherapy arm respectively (P=0.0862).r DFS remained similar between both arms after 7 years of follow up (HR 0.74, 95% CI, 0.52 to 1.05, P =0.922). After a median follow up of 7 years, 5 year OS was 73% in the chemoradiation therapy arm and 75% in the chemotherapy arm (HR 1.130, 95% CI, 0.775 to 1.647, P = 0.5272).r In a subset analysis of 396 patients with lymph nodes involvement, DFS rates were 76% vs 72% in the chemoradiation therapy arm and chemotherapy arm respectively (P=0.04).r Treatment was completed as planned by 75.4% of patients (172/228) in chemotherapy arm and 81.7% (188/230) in chemoradiation therapy arm.
The ARTIST trial only included patients who underwent a D2 resection for pathologically staged 1B to IV (M0) gastric cancer. Although there was no difference in the primary end point of three year DFS between both arms, there was some indication of benefit for patients with lymph-node positive gastric cancer in the chemoradiation therapy arm. Locoregional relapse occurred more frequently in the chemotherapy arm than chemoradiation therapy arm (13% vs 7%, P =0.0033) but no significant difference in rates of distant metastasis (27% vs 24%, P =0.5568).r A subsequent trial (ARTIST-II) is ongoing in patients with lymph node positive gastric cancer after D2 resection.
(A) Kaplan-Meier analysis for Disease Free Survival in all patients in the ARTIST trial:r
© Journal of Clinical Oncology 2012
(B) Kaplan Meier analysis for Disease-free Survival in lymph node positive patients in the ARTIST trial:r
© Journal of Clinical Oncology 2012