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Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

4925 - A phase III study of adjuvant docetaxel, capecitabine and oxaliplatin triplet vs capecitabine and oxaliplatin doublet in patients with curatively resected stage IIIB or IV(M0) (AJCC 6th ed) gastric adenocarcinoma (TRIUMPH, KCSG ST14-05)

Date

21 Oct 2018

Session

Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

Topics

Cytotoxic Therapy

Tumour Site

Gastric Cancer

Presenters

Min-Hee Ryu

Citation

Annals of Oncology (2018) 29 (suppl_8): viii205-viii270. 10.1093/annonc/mdy282

Authors

M. Ryu1, D.Y. Zang2, K. Lee3, B.Y. Shim4, M.H. Lee5, S.Y. Rha6, Y. Kang1

Author affiliations

  • 1 Department Of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 138-736 - Seoul/KR
  • 2 Division Of Hematology And Oncology, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang/KR
  • 3 Department Of Internal Medicine, Seoul National University Bundang Hospital, Seoul/KR
  • 4 Medical Oncology, St. Vincent’s Hospital, Suwon/KR
  • 5 Internal Medicine, Inha University Hospital, 22332 - Incheon/KR
  • 6 Internal Medicine, Yonsei Cancer Center, Seoul/KR
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Resources

Abstract 4925

Background

In stage IIIB or IV(M0) (by AJCC 6th edition) gastric cancer (GC), recurrence rate is higher than 50% even with curative D2 surgery and current standard adjuvant chemotherapy with capecitabine and oxaliplatin (XO) or S-1. Accordingly, more effective treatment is needed to reduce recurrence rate in these far advanced GCs. Our previous phase II study of adjuvant chemotherapy in stage IIIB or IV(M0) GC (Yoon S, et al. Gastric Cancer. 2017;20:182) suggested that docetaxel-containing triplet was safe and might be better in terms of recurrence-free survival (RFS) when compared with historic data of fluoropyrimidine plus platinum or fluoropyrimidine alone. Based on this background, a phase III randomized study to evaluate adjuvant docetaxel, capecitabine and oxaliplatin (DXO) triplet vs current standard XO in patients (pts) with curatively resected stage IIIB or IV(M0) GC has been initiated (NCT01935778).

Trial design

Since October 2013, pts with curatively resected stage IIIB or IV(M0) gastric or gastroesophageal junction adenocarcinoma have been recruited from 6 sites in Korean Cancer Study Group (KCSG). Other key eligibility criteria include ECOG performance status 0-1, age of 20-75 years, D2 surgery, and adequate organ functions. Three to 8 weeks after surgery, pts are randomized 1:1 in open label to adjuvant DXO arm vs XO arm. Stratification factors for randomization include pathologic stage (IIIB vs IV(M0)) and extent of gastrectomy (total vs subtotal). In DXO arm, pts receive docetaxel 60 mg/m2 i.v. on day 1, capecitabine 800 mg/m2 p.o. twice daily on days 1-14, and oxaliplatin 100 mg/m2 i.v. on day 1, every 3 weeks for 6 cycles; in XO arm, pts receive capecitabine 1000 mg/m2 p.o. twice daily on days 1-14, and oxaliplatin 130 mg/m2 i.v. on day 1, every 3 weeks for 8 cycles. Primary endpoint is 3-year RFS rate. Secondary endpoints include overall survival and safety. With power of 80% and two-sided α level of 5%, 183 events are required to detect 15% difference in 3-year RFS rate, i.e., 50% in DXO arm vs 35% in XO arm (HR = 0.66). With 10% of drop-out rate, target enrollment is 286 subjects.

Clinical trial identification

NCT01935778.

Legal entity responsible for the study

Asan Medical Center.

Funding

Boryung.

Editorial Acknowledgement

Disclosure

M-H. Ryu: Consultant, Honoraria: DAE HWA Pharmaceutical, Bristol-Myers Squibb, Ono pharmaceutical. K-W. Lee: Research funding: Macrogenics, MSD, Green Cross Crop., ASLAN Pharmaceuticals, AstraZeneca/MedImmune, Five Prime Therapeutics, LSK BioPharma, Merck KGaA, Array BioPharma, Pharmacyclics, Pfizer, ONO Pharmaceuticals. M.H. Lee: Research funding: CJ Healthcare, Yuhan. Y-K. Kang: Consultant: Ono, BMS, Taiho, Roche, Lilly, Blueprint, Taiho, Daehwa, LSK Biopharma. All other authors have declared no conflicts of interest.

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