PhaseⅡstudy of oxaliplatin combined with S-1 and leucovorin(SOL)for Chinese patients with metastatic colorectal cancer  

作　　者：zhi-qiang wang dong-sheng zhang nong xu de-yun luo yan-hong deng feng-hua wang hui-yan luo miao-zhen qiu yu-hong li rui-hua xu 

机构地区：[1]Sun Yat‑sen University Cancer Center,State Key Laboratory of Oncology in South China,Collaborative Innovation Center of Cancer Medicine,510060 Guangzhou,Guangdong,P.R.China [2]Department of Medical Oncology,Sun Yat-sen University Cancer Center,651 Dongfeng Road East,510060 Guangzhou,Guangdong,P.R.China [3]Department of Medical Oncology,The First Affiliated Hospital of College of Medicine,Zhejiang University,310003 Hangzhou,Zhejiang,P.R.China [4]Department of Medical Oncology,West China Hospital of Sichuan University,610041 Chengdu,Sichuan,P.R.China [5]Department of Medical Oncology,The Sixth Affiliated Hospital of Sun Yat-sen University,510655 Guangzhou,Guangdong,P.R.China

出　　处：《Chinese Journal of Cancer》2016年第3期126-132,共7页

摘　　要：Background:Fluoropyrimidine and oxaliplatin are widely used for patients with colorectal cancer.This phase II study was conducted to evaluate the efficacy and safety of the combination of S-1,oxaliplatin,and leucovorin(SOL) in the treatment of Chinese patients with metastatic colorectal cancer(mCRC).Methods:Eligible patients with untreated mCRC from four hospitals in China received intravenous oxaliplatin(85 mg/m2) on day 1,oral S-1 twice daily(80-120 mg per day) on day 1-7,and leucovorin twice daily(50 mg per day)simultaneously with S-1,every 2 weeks.Results and discussion:Forty patients were enrolled in our study.In total,296 cycles of SOL were administered.The overall response rate was 50.0%.At a median follow-up of 27 months,progression-free survival and overall surviva were 7.0 months(95%confidence interval[CI]6.0-10.6 months) and 22.2 months(95%CI 15.1-29.3 months),respectively.The most common grade 3/4 non-hematological adverse events were diarrhea(n = 8,20.0%),nausea(n = 3,7.5%),and vomiting(n = 3,7.5%).The most common grade 3/4 hematological toxicities were thrombocytopenia(n = 3,7.5%),neutropenia(n = 1,2.5%),and abnormal alanine transaminase/aspartate transaminase levels(n = 1,2.5%).There was one treatment-related death.Conclusions:The data indicate that the SOL regimen is effective and moderately tolerated in Chinese patients with mCRC.Trial registration:Clinical trialBackground:Fluoropyrimidine and oxaliplatin are widely used for patients with colorectal cancer.This phase II study was conducted to evaluate the efficacy and safety of the combination of S-1,oxaliplatin,and leucovorin(SOL) in the treatment of Chinese patients with metastatic colorectal cancer(mCRC).Methods:Eligible patients with untreated mCRC from four hospitals in China received intravenous oxaliplatin(85 mg/m2) on day 1,oral S-1 twice daily(80-120 mg per day) on day 1-7,and leucovorin twice daily(50 mg per day)simultaneously with S-1,every 2 weeks.Results and discussion:Forty patients were enrolled in our study.In total,296 cycles of SOL were administered.The overall response rate was 50.0%.At a median follow-up of 27 months,progression-free survival and overall surviva were 7.0 months(95%confidence interval[CI]6.0-10.6 months) and 22.2 months(95%CI 15.1-29.3 months),respectively.The most common grade 3/4 non-hematological adverse events were diarrhea(n = 8,20.0%),nausea(n = 3,7.5%),and vomiting(n = 3,7.5%).The most common grade 3/4 hematological toxicities were thrombocytopenia(n = 3,7.5%),neutropenia(n = 1,2.5%),and abnormal alanine transaminase/aspartate transaminase levels(n = 1,2.5%).There was one treatment-related death.Conclusions:The data indicate that the SOL regimen is effective and moderately tolerated in Chinese patients with mCRC.Trial registration:Clinical trial information:ChiCTR-TNRC-100000838

关 键 词：COLORECTAL cancer  Oxaliplatin  S-1  LEUCOVORIN 

分 类 号：R735.34[医药卫生—肿瘤]