Hyeong Su Kim1, Min-Hee Ryu2, Dae Young Zang3,4, Sook Ryun Park2, Boram Han1, Won Ki Kang5, Sun Young Rha6, Minkyu Jung6, Jin-Soo Kim7, Byung Woog Kang8, Kyung-Hee Lee9, Sang-Young Rho10, Jung Han Kim1, Kab Choong Kim11, Ji Woong Cho11, Dae Ro Choi1, Hyun Lim1, Ho Suk Kang1, Jae Seung Soh1, Min-Jeong Kim12, Jinwon Seo13, Yoon-Koo Kang2. 1. Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Anyang-si, Republic of Korea. 2. Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea. 3. Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Anyang-si, Republic of Korea. fhdzang@hallym.ac.kr. 4. Division of Hematology-Oncology, Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, 22, Gwanpyeong-ro 170beon-gil, Dongan-gu, Anyang-si, 14086, Republic of Korea. fhdzang@hallym.ac.kr. 5. Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. 6. Department of Medical Oncology, Yonsei Cancer Center, College of Medicine Yonsei University, Seoul, Republic of Korea. 7. Department of Internal Medicine, Seoul National University Boramae Medical Center, Seoul, Republic of Korea. 8. Department of Oncology/Hematology, Kyungpook National University Medical Center, Kyungpook National University School of Medicine, Daegu, Republic of Korea. 9. Department of Hematology-Oncology, Yeungnam University Medical Center, Daegu, Republic of Korea. 10. Department of Internal Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea College of Medicine, Seoul, Republic of Korea. 11. Department of Surgery, Hallym University Medical Center, Hallym University College of Medicine, Anyang-si, Republic of Korea. 12. Department of Radiology, Hallym University Medical Center, Hallym University College of Medicine, Anyang-si, Republic of Korea. 13. Department of Pathology, Hallym University Medical Center, Hallym University College of Medicine, Anyang-si, Republic of Korea.
Abstract
BACKGROUND: Doublet chemotherapy of platinum and 5-fluorouracil is a standard first-line treatment for patients with unresectable gastric cancer. Although the addition of taxane or irinotecan to this regimen has yielded promising efficacy, its use has been limited due to severe toxicities. To overcome this limitation, we evaluated the efficacy and safety of the combination of irinotecan, oxaliplatin, and S-1 (OIS) for the treatment of advanced gastric cancer. METHODS: Chemotherapy-naïve patients with pathologically proven advanced gastric adenocarcinoma were assessed for eligibility. Irinotecan (135 mg/m2) and oxaliplatin (65 mg/m2) were administered intravenously on day 1, and S-1 (80 mg/m2/day) was administered orally on days 1-7 of every 2-week cycle. RESULTS: Forty-four patients (median age 57 years) were enrolled and all but one patient had a good performance status (ECOG 0 or 1). A total of 529 cycles were administered, with a median of 9.5 (range 1-31) cycles per patient. The overall response rate was 61.4% (95% confidence interval [CI] 46.6-74.3). The median progression-free survival and overall survival were 10.8 months (95% CI 7.6-14.0) and 15.4 months (95% CI 12.6-18.2), respectively. Major toxicities included grade 3/4 neutropenia (38.6%), febrile neutropenia (13.6%), abdominal pain (9.1%), and diarrhea (9.1%). CONCLUSION: These data suggest that the OIS regimen is effective and relatively well tolerated in patients with advanced gastric cancer. Given that all the patients treated, but one, had a good performance status, these results must be confirmed in a patient population more representative of regular clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02527785.
BACKGROUND: Doublet chemotherapy of platinum and 5-fluorouracil is a standard first-line treatment for patients with unresectable gastric cancer. Although the addition of taxane or irinotecan to this regimen has yielded promising efficacy, its use has been limited due to severe toxicities. To overcome this limitation, we evaluated the efficacy and safety of the combination of irinotecan, oxaliplatin, and S-1 (OIS) for the treatment of advanced gastric cancer. METHODS: Chemotherapy-naïve patients with pathologically proven advanced gastric adenocarcinoma were assessed for eligibility. Irinotecan (135 mg/m2) and oxaliplatin (65 mg/m2) were administered intravenously on day 1, and S-1 (80 mg/m2/day) was administered orally on days 1-7 of every 2-week cycle. RESULTS: Forty-four patients (median age 57 years) were enrolled and all but one patient had a good performance status (ECOG 0 or 1). A total of 529 cycles were administered, with a median of 9.5 (range 1-31) cycles per patient. The overall response rate was 61.4% (95% confidence interval [CI] 46.6-74.3). The median progression-free survival and overall survival were 10.8 months (95% CI 7.6-14.0) and 15.4 months (95% CI 12.6-18.2), respectively. Major toxicities included grade 3/4 neutropenia (38.6%), febrile neutropenia (13.6%), abdominal pain (9.1%), and diarrhea (9.1%). CONCLUSION: These data suggest that the OIS regimen is effective and relatively well tolerated in patients with advanced gastric cancer. Given that all the patients treated, but one, had a good performance status, these results must be confirmed in a patient population more representative of regular clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02527785.
Entities:
Keywords:
Irinotecan; Oxaliplatin; Phase II clinical trial; S-1; Stomach neoplasm
Authors: Y Yamada; K Higuchi; K Nishikawa; M Gotoh; N Fuse; N Sugimoto; T Nishina; K Amagai; K Chin; Y Niwa; A Tsuji; H Imamura; M Tsuda; H Yasui; H Fujii; K Yamaguchi; H Yasui; S Hironaka; K Shimada; H Miwa; C Hamada; I Hyodo Journal: Ann Oncol Date: 2014-10-14 Impact factor: 32.976
Authors: H Iwase; M Shimada; T Tsuzuki; K Ina; M Sugihara; J Haruta; M Shinoda; T Kumada; H Goto Journal: Oncology Date: 2011-06-10 Impact factor: 2.935
Authors: S R Park; S-Y Kong; J Rhee; Y-I Park; K W Ryu; J H Lee; Y-W Kim; I J Choi; C G Kim; J Y Lee; S-J Cho; N K Kim Journal: Ann Oncol Date: 2010-09-22 Impact factor: 32.976
Authors: Anna Dorothea Wagner; Susanne Unverzagt; Wilfried Grothe; Gerhard Kleber; Axel Grothey; Johannes Haerting; Wolfgang E Fleig Journal: Cochrane Database Syst Rev Date: 2010-03-17
Authors: Jin Young Kim; Young Rok Do; Keon Uk Park; Jong Gwang Kim; Yee Soo Chae; Min Kyoung Kim; Kyung Hee Lee; Hun Mo Ryoo; Sung Hwa Bae; Jin Ho Baek; Hong Suk Song Journal: Cancer Chemother Pharmacol Date: 2010-05-12 Impact factor: 3.333
Authors: Eric Van Cutsem; Vladimir M Moiseyenko; Sergei Tjulandin; Alejandro Majlis; Manuel Constenla; Corrado Boni; Adriano Rodrigues; Miguel Fodor; Yee Chao; Edouard Voznyi; Marie-Laure Risse; Jaffer A Ajani Journal: J Clin Oncol Date: 2006-11-01 Impact factor: 44.544
Authors: David Cunningham; Naureen Starling; Sheela Rao; Timothy Iveson; Marianne Nicolson; Fareeda Coxon; Gary Middleton; Francis Daniel; Jacqueline Oates; Andrew Richard Norman Journal: N Engl J Med Date: 2008-01-03 Impact factor: 91.245
Authors: M Dank; J Zaluski; C Barone; V Valvere; S Yalcin; C Peschel; M Wenczl; E Goker; L Cisar; K Wang; R Bugat Journal: Ann Oncol Date: 2008-06-16 Impact factor: 32.976
Authors: Luigi Di Lauro; Laura Giacinti; Maria Grazia Arena; Domenico Sergi; Silvia Ileana Fattoruso; Diana Giannarelli; Massimo Lopez Journal: J Exp Clin Cancer Res Date: 2009-03-09
Authors: Youn I Choi; Jun-Won Chung; Kyoung Oh Kim; Kwang An Kwon; Yoon Jae Kim; Dong Kyun Park; Sung Min Ahn; So Hyun Park; Sun Jin Sym; Dong Bok Shin; Young Saing Kim; Ki Hoon Sung; Jeong-Heum Baek; Uhn Lee Journal: Can J Gastroenterol Hepatol Date: 2019-02-03