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☆
| Autor: | Y.S. Park, Wonyoung Kang, T.S. Sohn, S.H. Park, D.Y. Zang, Artist investigators, S.J. Kim, Ji Yeong An, J.H. Ji, J.H. Lee, S.T. Kim, Dongbok Shin, J.W. Lee, Min-Gew Choi, J.O. Park, S.Y. Oh, J.M. Bae, In Gyu Hwang, J.Y. Hong, Dong Hui Lim, Jeong Il Yu, Jung-Hun Kang, Kyeongdeok Kim, H.Y. Lim |
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| Rok vydání: | 2021 |
| Předmět: |
0301 basic medicine
medicine.medical_specialty Randomization medicine.medical_treatment Gastroenterology Disease-Free Survival 03 medical and health sciences 0302 clinical medicine Stomach Neoplasms Internal medicine Antineoplastic Combined Chemotherapy Protocols Clinical endpoint medicine Humans Capecitabine Neoplasm Staging business.industry Hazard ratio Cancer Hematology medicine.disease Oxaliplatin Radiation therapy 030104 developmental biology Oncology Chemotherapy Adjuvant 030220 oncology & carcinogenesis Fluorouracil Neoplasm Recurrence Local business Adjuvant Chemoradiotherapy medicine.drug |
| Zdroj: | Annals of Oncology. 32:368-374 |
| ISSN: | 0923-7534 |
| DOI: | 10.1016/j.annonc.2020.11.017 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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