Background
Phase III RCT (ARTIST). 458 patients with gastric cancer who underwent D2 gastrectomy at Samsung Medical Center, Seoul. Randomized 1:1 to adjuvant XP chemotherapy alone vs XPRT (XP + radiation). Final report includes OS data and subset analyses with 7-year follow-up.
Interventions and follow up
Arm A: XPRT — XP × 2 cycles → chemoradiotherapy (45 Gy/25 fr + capecitabine) → XP × 2 cycles (total 4 cycles XP)
Arm B: XP — capecitabine 1000 mg/m² BID d1–14 + cisplatin 60 mg/m² d1, q3wks × 6 cycle
Primary endpoint: Disease-free survival
mFollow up: 7 year
Arm B: XP — capecitabine 1000 mg/m² BID d1–14 + cisplatin 60 mg/m² d1, q3wks × 6 cycle
Primary endpoint: Disease-free survival
mFollow up: 7 year
Results
DFS: HR 0.740 (95% CI 0.520–1.050), P=.0922 — not significant
OS: HR 1.130 (95% CI 0.775–1.647), P=.5272 — not significant
Subgroup DFS (node-positive): Significant benefit with XPRT (P<.05, interaction P<.01)
Subgroup DFS (intestinal-type): Significant benefit with XPRT (interaction P=.04)
OS: HR 1.130 (95% CI 0.775–1.647), P=.5272 — not significant
Subgroup DFS (node-positive): Significant benefit with XPRT (P<.05, interaction P<.01)
Subgroup DFS (intestinal-type): Significant benefit with XPRT (interaction P=.04)
Adverse events
Main adverse events: Both arms tolerated; similar treatment completion. Radiation did not add significant grade 3/4 toxicity beyond chemotherapy. Locoregional recurrence lower with XPRT (P=.03), particularly regional nodal recurrence.
Conclusions
Adjuvant chemoradiotherapy did not significantly improve DFS or OS compared to chemotherapy alone in D2-resected gastric cancer overall. However, exploratory subgroup analyses suggested DFS benefit in node-positive and intestinal-type patients, motivating the subsequent ARTIST-II trial.
Key Limitations
Key Limitations: Single-institution Korean trial — results may not generalize to Western populations or diverse surgical settings. Trial was underpowered for the OS endpoint. Overall DFS P=.09 narrowly missed significance; modest sample size. Subgroup findings (node-positive, intestinal-type benefit) are hypothesis-generating only. XP chemotherapy backbone is less commonly used now (capecitabine/oxaliplatin preferred in many centers).
Clinical Context
ARTIST confirmed that in the setting of adequate D2 dissection, adjuvant CRT offers no significant overall benefit over chemotherapy alone — contrasting with INT-0116 where suboptimal surgery dominated. The node-positive subgroup signal informed ARTIST-II, which added oxaliplatin and tested CRT in node-positive D2-resected patients. In the US, adjuvant CRT remains an option when D2 dissection is incomplete.
References