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 language | English |
|---|---|
| Pages (from-to) | 802-810 |
| Number of pages | 9 |
| Journal | Gastric Cancer |
| Volume | 21 |
| Issue number | 5 |
| DOIs | |
| Publication status | Published - 2018 Sep 1 |
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All Science Journal Classification (ASJC) codes
- Oncology
- Gastroenterology
- Cancer Research
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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 journal › Article
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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U2 - 10.1007/s10120-018-0794-1
DO - 10.1007/s10120-018-0794-1
M3 - Article
VL - 21
SP - 802
EP - 810
JO - Gastric Cancer
JF - Gastric Cancer
SN - 1436-3291
IS - 5
ER -