661P - A phase II study for triplet combination of oxaliplatin, irinotecan, and S-1 in patients with metastatic or recurrent gastric cancer

Date 08 October 2016
Event ESMO 2016 Congress
Session Poster Display
Topics Gastric Cancer
Presenter Boram Han
Citation Annals of Oncology (2016) 27 (6): 207-242. 10.1093/annonc/mdw371
Authors B. Han1, S.R. Park2, H.S. Kim3, M. Ryu4, J. Kim5, S. Rho6, B.W. Kang7, K.H. Lee8, S.Y. Rha9, W.K. Kang10, Y. Kang4, D.Y. Zang3
  • 1Internal Medicine, Hallym University Medical Center Hallym University College of Medicine, 431-070 - Anyang/KR
  • 2Department Of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul/KR
  • 3Internal Medicine, Hallym University Medical Center Hallym University College of Medicine, Anyang/KR
  • 4Department Of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 05505 - Seoul/KR
  • 5Internal Medicine, Boramae Medical Center, Seoul/KR
  • 6Internal Medicine, Seoul St. Mary's Hospital, of the Catholic University, Seoul/KR
  • 7Oncology/hematology, Kyungpook National University Medical Center, 41404 - Daegu/KR
  • 8Internal Medicine, Yeungnam University Medical Center, Daegu/KR
  • 9Medical Oncology, Internal Medicine, Yonsei Severance Hospital Cancer Center, Seoul/KR
  • 10Division Of Hematology-oncology, Department Of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul/KR



Doublet chemotherapy of platinum and 5-fluorouracil is considered as a standard front-line treatment for patients with unresectable gastric cancer. Although addition of taxane or irinotecan to this regimen has yielded promising efficacy, it has been used in limited patients due to severe toxicities. To overcome this limitation, we evaluated the efficacy and safety of the combination of irinotecan, oxaliplatin, and S-1 for the treatment of unresectable gastric cancer.


Chemotherapy-naïve patients with pathologically proven unresectable recurrent or metastatic gastric adenocarcinoma were assessed for eligibility. Irinotecan at 135 mg/m2 and oxaliplatin at 65 mg/m2 were administered intravenously on day 1, and S-1 was administered orally at 80 mg/m2 on days 1–7 of every 14-day cycle, which have been derived from our phase I study.


Forty-three patients (median age 57 years) were enrolled. A total of 259 cycles of chemotherapy were administered (median of eight; range 1–23 cycles). Toxicities were evaluated in 41 patients, and the responses were evaluated in 32 patients. Major toxicities included grade 3/4 neutropenia (41.5%), febrile neutropenia (14.6%), abdominal pain (12.2%), and diarrhea (7.3%). The overall response rate was 59.4% [95% confidence interval (CI) 42.3-74.5%]. The median progression-free survival and overall survival were 8.4 months (95 % CI 5.5-11.3 months) and 13.1 months (95 % CI 11.8–14.5 months), respectively.


These data suggest that the oxaliplatin, irinotecan, and S-1 combination regimen is effective and relatively well tolerable, and it seems to have potential to be a reasonable therapeutic strategy in patients with unresectable gastric cancer.

Clinical trial identification

Legal entity responsible for the study

Hallym Sacred Heart Hospital Institutional Review Board


Korean Cancer Study Group


All authors have declared no conflicts of interest.