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
- Authors
- Park, S.H.; Lim, D.H.; Sohn, T.S.; Lee, J.; Zang, D.Y.; Kim, S.T.; Kang, J.H.; Oh, S.Y.; Hwang, I.G.; Ji, J.H.; Shin, D.B.; Yu, J.I.; Kim, K.-M.; An, J.Y.; Choi, M.G.; Lee, J.H.; Kim, S.; Hong, J.Y.; Park, J.O.; Park, Y.S.; Lim, H.Y.; Bae, J.M.; Kang, W.K.
- Issue Date
- Mar-2021
- Publisher
- ELSEVIER
- Keywords
- adjuvant chemotherapy; gastric cancer; radiotherapy
- Citation
- Annals of Oncology, v.32, no.3, pp.368 - 374
- Journal Title
- Annals of Oncology
- Volume
- 32
- Number
- 3
- Start Page
- 368
- End Page
- 374
- URI
- https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/80676
- DOI
- 10.1016/j.annonc.2020.11.017
- ISSN
- 0923-7534
- Abstract
- Background: Adjuvant chemotherapy and chemoradiotherapy are some of the standards of care for gastric cancer (GC). The Adjuvant chemoRadioTherapy In Stomach Tumors (ARTIST) 2 trial compares two adjuvant chemotherapy regimens and chemoradiotherapy in patients with D2-resected, stage II or III, node-positive GC. Patients and methods: The ARTIST 2 compared, in a 1:1:1 ratio, three adjuvant regimens: oral S-1 (40-60 mg twice daily 4 weeks on/2 weeks off) for 1 year, S-1 (2 weeks on/1 week off) plus oxaliplatin 130 mg/m2 every 3 weeks (SOX) for 6 months, and SOX plus chemoradiotherapy 45 Gy (SOXRT). Randomization was stratified according to surgery type (total or subtotal gastrectomy), pathologic stage (II or III), and Lauren histologic classification (diffuse or intestinal/mixed). The primary endpoint was disease-free survival (DFS) at 3 years; a reduction of 33% in the hazard ratio (HR) for DFS with SOX or SOXRT, when compared with S-1, was considered clinically meaningful. The trial is registered at clinicaltrials.gov (NCT0176146). Results: A total of 546 patients were recruited between February 2013 and January 2018 with 182, 181, and 183 patients in the S-1, SOX, and SOXRT arms, respectively. Median follow-up period was 47 months, with 178 DFS events observed. Estimated 3-year DFS rates were 64.8%, 74.3%, and 72.8% in the S-1, SOX, and SOXRT arms, respectively. HR for DFS in the control arm (S-1) was shorter than that in the SOX and SOXRT arms: S-1 versus SOX, 0.692 (P = 0.042) and S-1 versus SOXRT, 0.724 (P = 0.074). No difference in DFS was found between SOX and SOXRT (HR 0.971; P = 0.879). Adverse events were as anticipated in each arm, and were generally well-tolerated and manageable. Conclusions: In patients with curatively D2-resected, stage II/III, node-positive GC, adjuvant SOX or SOXRT was effective in prolonging DFS, when compared with S-1 monotherapy. The addition of radiotherapy to SOX did not significantly reduce the rate of recurrence after D2 gastrectomy. © 2020 The Authors
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