A dose-finding study for oxaliplatin, irinotecan, and S-1 (OIS) in patients with metastatic or recurrent gastrointestinal cancer

Han, Boram; Jung, Joo Young; Kim, Hyeong Su; Cho, Ji Woong; Kim, Kab Choong; Lim, Han Woong; Kang, Ho Suk; Ha, Hong Il; Kim, Minjeong; Choi, Dae Ro; Jang, Geundoo; Kim, Jung Han; Song, Hun Ho; Zang, Dae Young

doi:10.1007/s00280-016-3147-y

Cited by 2 publications

(4 citation statements)

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“…OIS was generally well-tolerated, with a toxicity profile consistent with that in the previous phase I study [ 8 ]. The dose intensities of oxaliplatin, irinotecan, and S-1 were well-maintained.…”

Section: Discussionsupporting

confidence: 59%

“…Patients received intravenous 65-mg/m 2 oxaliplatin and 135-mg/m 2 irinotecan on day 1 and 40-mg/m 2 oral S-1 twice daily on days 1-7, every 2 weeks. This dosing schedule was based on a previous phase I study [ 8 ]. Treatment continued until disease progression, intolerable toxicity, or patient’s withdrawal of consent.…”

Section: Methodsmentioning

confidence: 99%

“…Considering these success, gemcitabine-free triplets including irinotecan, oxaliplatin, and fluorouracil might also be effective in treating advanced BTC. Furthermore, in a previous phase I study, biweekly triplet combination of oxaliplatin, irinotecan, and S-1 (oral fluoropyrimidine) (OIS) for multiple cancer types was associated with remarkable preliminary efficacy outcomes in advanced BTC, with four of nine BTC patients achieving partial response (PR) [ 8 ].…”

Section: Introductionmentioning

confidence: 99%

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Multicenter Phase II Study of Oxaliplatin, Irinotecan, and S-1 as First-line Treatment for Patients with Recurrent or Metastatic Biliary Tract Cancer

et al. 2018

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PurposeAlthough gemcitabine plus cisplatin has been established as the standard first-line chemotherapy for patients with advanced biliary tract cancer (BTC), overall prognosis remains poor. We investigated the efficacy of a novel triplet combination of oxaliplatin, irinotecan, and S-1 (OIS) for advanced BTC.Materials and MethodsChemotherapy-naive patientswith histologically documented unresectable or metastatic BTC were eligible for this multicenter, single-arm phase II study. Patients received 65 mg/m2 oxaliplatin (day 1), 135 mg/m2 irinotecan (day 1), and 40 mg/m2 S-1 (twice a day, days 1-7) every 2 weeks. Primary endpoint was objective response rate. Targeted exome sequencing for biomarker analysis was performed using archival tissue.ResultsIn total, 32 patients were enrolled between October 2015 and June 2016. Median age was 64 years (range, 40 to 76 years), with 24 (75%) male patients; 97% patients had metastatic or recurrent disease. Response rate was 50%, and median progression-free survival and overall survival (OS) were 6.8 months (95% confidence interval [CI], 4.8 to 8.8) and 12.5 months (95% CI, 7.0 to 18.0), respectively. The most common grade 3-4 adverse events were neutropenia (32%), diarrhea (6%), and peripheral neuropathy (6%). TP53 and KRAS mutations were the most frequent genomic alterations (42% and 32%, respectively), and KRAS mutations showed a marginal relationship with worse OS (p=0.07).ConclusionOIS combination chemotherapy was feasible and associated with favorable efficacy outcomes as a first-line treatment in patients with advanced BTC. Randomized studies are needed to compare OIS with gemcitabine plus cisplatin.

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Section: Discussionsupporting

confidence: 59%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Multicenter Phase II Study of Oxaliplatin, Irinotecan, and S-1 as First-line Treatment for Patients with Recurrent or Metastatic Biliary Tract Cancer

et al. 2018

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“…We conducted a dose-finding study for the OIS regimen and identified the recommended dose (RD) for the phase II study [18]. Irinotecan (180 mg/m 2 ) was infused intravenously for 90 min, followed by intravenous administration of oxaliplatin (85 mg/m 2 ) for 2 h on day 1.…”

Section: Treatment Planmentioning

confidence: 99%

Phase II study of oxaliplatin, irinotecan and S-1 therapy in patients with advanced gastric cancer: the Korean Cancer Study Group ST14-11

et al. 2018

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A dose-finding study for oxaliplatin, irinotecan, and S-1 (OIS) in patients with metastatic or recurrent gastrointestinal cancer

Abstract: The combination of oxaliplatin, irinotecan, and S-1 provided an acceptable toxicity profile and modest clinical benefits in patients with advanced GI cancer. The RD was 85 mg/m of oxaliplatin, 180 mg/m of irinotecan, and 100 mg/m of S-1 every 2 weeks.

Cited by 2 publications

References 35 publications

Multicenter Phase II Study of Oxaliplatin, Irinotecan, and S-1 as First-line Treatment for Patients with Recurrent or Metastatic Biliary Tract Cancer

Multicenter Phase II Study of Oxaliplatin, Irinotecan, and S-1 as First-line Treatment for Patients with Recurrent or Metastatic Biliary Tract Cancer

Phase II study of oxaliplatin, irinotecan and S-1 therapy in patients with advanced gastric cancer: the Korean Cancer Study Group ST14-11

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