title: Phase II study of oxaliplatin combined with S-1 and leucovorin (SOL) for Chinese patients with metastatic colorectal cancer.
abstract: 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/m(2)) 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.
  
  
  CONCLUSIONS
  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 survival 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.
  
  
  BACKGROUND
  
  
  
  BACKGROUND
  ChiCTR-TNRC-100000838.
authors.affiliation: 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. wangzhq@sysucc.org.cn.|Department of Medical Oncology, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, 510060, Guangzhou, Guangdong, P. R. China. wangzhq@sysucc.org.cn.
authors.forename: Zhi-Qiang
authors.initials: ZQ
authors.lastname: Wang
authors.affiliation: 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. zhangdsh@sysucc.org.cn.|Department of Medical Oncology, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, 510060, Guangzhou, Guangdong, P. R. China. zhangdsh@sysucc.org.cn.
authors.forename: Dong-Sheng
authors.initials: DS
authors.lastname: Zhang
authors.affiliation: Department of Medical Oncology, The First Affiliated Hospital of College of Medicine, Zhejiang University, 310003, Hangzhou, Zhejiang, P. R. China. xunonghz@163.com.
authors.forename: Nong
authors.initials: N
authors.lastname: Xu
authors.affiliation: Department of Medical Oncology, West China Hospital of Sichuan University, 610041, Chengdu, Sichuan, P. R. China. luodeyun999@163.com.
authors.forename: De-Yun
authors.initials: DY
authors.lastname: Luo
authors.affiliation: Department of Medical Oncology, The Sixth Affiliated Hospital of Sun Yat-sen University, 510655, Guangzhou, Guangdong, P. R. China. 13925106525@139.com.
authors.forename: Yan-Hong
authors.initials: YH
authors.lastname: Deng
authors.affiliation: 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. wangfh@sysucc.org.cn.|Department of Medical Oncology, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, 510060, Guangzhou, Guangdong, P. R. China. wangfh@sysucc.org.cn.
authors.forename: Feng-Hua
authors.initials: FH
authors.lastname: Wang
authors.affiliation: 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. luohy@sysucc.org.cn.|Department of Medical Oncology, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, 510060, Guangzhou, Guangdong, P. R. China. luohy@sysucc.org.cn.
authors.forename: Hui-Yan
authors.initials: HY
authors.lastname: Luo
authors.affiliation: 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. qiumzh@sysucc.org.cn.|Department of Medical Oncology, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, 510060, Guangzhou, Guangdong, P. R. China. qiumzh@sysucc.org.cn.
authors.forename: Miao-Zhen
authors.initials: MZ
authors.lastname: Qiu
authors.affiliation: 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. liyh@sysucc.org.cn.|Department of Medical Oncology, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, 510060, Guangzhou, Guangdong, P. R. China. liyh@sysucc.org.cn.
authors.forename: Yu-Hong
authors.initials: YH
authors.lastname: Li
authors.affiliation: 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. xurh@sysucc.org.cn.|Department of Medical Oncology, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, 510060, Guangzhou, Guangdong, P. R. China. xurh@sysucc.org.cn.
authors.forename: Rui-Hua
authors.initials: RH
authors.lastname: Xu
mesh_terms: D061605:Administration, Intravenous; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000627:therapeutic use; D002681:China; D015179:Colorectal Neoplasms / Q000188:drug therapy*; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage* / Q000494:pharmacology; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009944:Organoplatinum Compounds / Q000008:administration & dosage* / Q000627:therapeutic use; D000077150:Oxaliplatin; D010094:Oxonic Acid / Q000008:administration & dosage* / Q000627:therapeutic use; D016019:Survival Analysis; D005641:Tegafur / Q000008:administration & dosage* / Q000627:therapeutic use; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D004338:Drug Combinations; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D002955:Leucovorin