Phase II study of oxaliplatin, irinotecan and S-1 therapy in patients with advanced gastric cancer

the Korean Cancer Study Group ST14-11

Hyeong Su Kim, Min Hee Ryu, Dae Young Zang, Sook Ryun Park, Boram Han, Won Ki Kang, SunYoung Rha, Minkyu Jung, Jin Soo Kim, Byung Woog Kang, Kyung Hee Lee, Sang Young Rho, Jung Han Kim, Kab Choong Kim, Ji Woong Cho, Dae Ro Choi, Hyun Lim, Ho Suk Kang, Jae Seung Soh, Min Jeong Kim & 2 others Jinwon Seo, Yoon Koo Kang

Research output: Contribution to journalArticle

2 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)802-810
Number of pages9
JournalGastric Cancer
Volume21
Issue number5
DOIs
Publication statusPublished - 2018 Sep 1

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oxaliplatin
irinotecan
Stomach Neoplasms
Neoplasms
Confidence Intervals
Therapeutics
Drug Therapy
Febrile Neutropenia
Neutropenia
Platinum

All Science Journal Classification (ASJC) codes

  • Oncology
  • Gastroenterology
  • Cancer Research

Cite this

Kim, Hyeong Su ; Ryu, Min Hee ; Zang, Dae Young ; Park, Sook Ryun ; Han, Boram ; Kang, Won Ki ; Rha, SunYoung ; Jung, Minkyu ; Kim, Jin Soo ; Kang, Byung Woog ; Lee, Kyung Hee ; Rho, Sang Young ; Kim, Jung Han ; Kim, Kab Choong ; Cho, Ji Woong ; Choi, Dae Ro ; Lim, Hyun ; Kang, Ho Suk ; Soh, Jae Seung ; Kim, Min Jeong ; Seo, Jinwon ; Kang, Yoon Koo. / Phase II study of oxaliplatin, irinotecan and S-1 therapy in patients with advanced gastric cancer : the Korean Cancer Study Group ST14-11. In: Gastric Cancer. 2018 ; Vol. 21, No. 5. pp. 802-810.
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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-na{\"i}ve 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.",
author = "Kim, {Hyeong Su} and Ryu, {Min Hee} and Zang, {Dae Young} and Park, {Sook Ryun} and Boram Han and Kang, {Won Ki} and SunYoung Rha and Minkyu Jung and Kim, {Jin Soo} and Kang, {Byung Woog} and Lee, {Kyung Hee} and Rho, {Sang Young} and Kim, {Jung Han} and Kim, {Kab Choong} and Cho, {Ji Woong} and Choi, {Dae Ro} and Hyun Lim and Kang, {Ho Suk} and Soh, {Jae Seung} and Kim, {Min Jeong} and Jinwon Seo and Kang, {Yoon Koo}",
year = "2018",
month = "9",
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doi = "10.1007/s10120-018-0794-1",
language = "English",
volume = "21",
pages = "802--810",
journal = "Gastric Cancer",
issn = "1436-3291",
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Kim, HS, Ryu, MH, Zang, DY, Park, SR, Han, B, Kang, WK, Rha, S, Jung, M, Kim, JS, Kang, BW, Lee, KH, Rho, SY, Kim, JH, Kim, KC, Cho, JW, Choi, DR, Lim, H, Kang, HS, Soh, JS, Kim, MJ, Seo, J & Kang, YK 2018, 'Phase II study of oxaliplatin, irinotecan and S-1 therapy in patients with advanced gastric cancer: the Korean Cancer Study Group ST14-11', Gastric Cancer, vol. 21, no. 5, pp. 802-810. https://doi.org/10.1007/s10120-018-0794-1

Phase II study of oxaliplatin, irinotecan and S-1 therapy in patients with advanced gastric cancer : the Korean Cancer Study Group ST14-11. / Kim, Hyeong Su; Ryu, Min Hee; Zang, Dae Young; Park, Sook Ryun; Han, Boram; Kang, Won Ki; Rha, SunYoung; Jung, Minkyu; Kim, Jin Soo; Kang, Byung Woog; Lee, Kyung Hee; Rho, Sang Young; Kim, Jung Han; Kim, Kab Choong; Cho, Ji Woong; Choi, Dae Ro; Lim, Hyun; Kang, Ho Suk; Soh, Jae Seung; Kim, Min Jeong; Seo, Jinwon; Kang, Yoon Koo.

In: Gastric Cancer, Vol. 21, No. 5, 01.09.2018, p. 802-810.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Phase II study of oxaliplatin, irinotecan and S-1 therapy in patients with advanced gastric cancer

T2 - the Korean Cancer Study Group ST14-11

AU - Kim, Hyeong Su

AU - Ryu, Min Hee

AU - Zang, Dae Young

AU - Park, Sook Ryun

AU - Han, Boram

AU - Kang, Won Ki

AU - Rha, SunYoung

AU - Jung, Minkyu

AU - Kim, Jin Soo

AU - Kang, Byung Woog

AU - Lee, Kyung Hee

AU - Rho, Sang Young

AU - Kim, Jung Han

AU - Kim, Kab Choong

AU - Cho, Ji Woong

AU - Choi, Dae Ro

AU - Lim, Hyun

AU - Kang, Ho Suk

AU - Soh, Jae Seung

AU - Kim, Min Jeong

AU - Seo, Jinwon

AU - Kang, Yoon Koo

PY - 2018/9/1

Y1 - 2018/9/1

N2 - 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.

AB - 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.

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