title: S-1 as monotherapy or in combination with leucovorin as second-line treatment in gemcitabine-refractory advanced pancreatic cancer: a randomized, open-label, multicenter, phase II study.
abstract: BACKGROUND
  In this study, we compared the efficacy and safety of the oral fluoropyrimidine S-1 as monotherapy or in combination with leucovorin as the second-line treatment for patients with metastatic pancreatic cancer whose disease had progressed on gemcitabine treatment.
  
  
  METHODS
  The study was a randomized, open-label, controlled study. Patients randomly received S-1 or S-1 in combination with leucovorin (SL arm) in 21-day cycles. The primary endpoint was the 6-month survival rate.
  
  
  RESULTS
  A total of 92 patients were randomized to S-1 (n = 47) and SL (n = 45). No statistically significant differences were observed between the two arms with regard to 6-month survival rates (40% vs. 49%), median overall survival (5.5 vs. 6.3 months), median progression-free survival (1.9 vs. 3.0 months), and overall response rate (4.7% vs. 8.3%). The rate of major grade 3-4 adverse events of digestive toxicity was significantly higher in the SL arm than in the S-1 arm.
  
  
  CONCLUSIONS
  Compared with S-1, SL did not improve the survival of patients with metastatic pancreatic cancer who had failed to benefit from prior gemcitabine treatment, but SL had a higher adverse event rate.
authors.affiliation: Affiliated Hospital Cancer Center, Academy of Military Medical Sciences, Beijing, People's Republic of China;
authors.forename: Feijiao
authors.initials: F
authors.lastname: Ge
authors.affiliation: The First Affiliated Hospital of Medical School of Zhejiang University, Hangzhou, People's Republic of China; jmxu2003@163.com.
authors.forename: Nong
authors.initials: N
authors.lastname: Xu
authors.affiliation: The Third Affiliated Hospital of Harbin Medical University, Harbin, People's Republic of China;
authors.forename: Yuxian
authors.initials: Y
authors.lastname: Bai
authors.affiliation: Cancer Hospital of Tianjin Medical University, Tianjin, People's Republic of China;
authors.forename: Yi
authors.initials: Y
authors.lastname: Ba
authors.affiliation: The Third Affiliated Hospital of Harbin Medical University, Harbin, People's Republic of China;
authors.forename: Yanqiao
authors.initials: Y
authors.lastname: Zhang
authors.affiliation: Xuanwu Hospital of Capital Medical University, Beijing, People's Republic of China jmxu2003@163.com.
authors.forename: Fei
authors.initials: F
authors.lastname: Li
authors.affiliation: Affiliated Hospital Cancer Center, Academy of Military Medical Sciences, Beijing, People's Republic of China; jmxu2003@163.com.
authors.forename: Huayan
authors.initials: H
authors.lastname: Xu
authors.affiliation: Affiliated Hospital Cancer Center, Academy of Military Medical Sciences, Beijing, People's Republic of China; jmxu2003@163.com.
authors.forename: Ru
authors.initials: R
authors.lastname: Jia
authors.affiliation: Affiliated Hospital Cancer Center, Academy of Military Medical Sciences, Beijing, People's Republic of China;
authors.forename: Yan
authors.initials: Y
authors.lastname: Wang
authors.affiliation: Affiliated Hospital Cancer Center, Academy of Military Medical Sciences, Beijing, People's Republic of China;
authors.forename: Li
authors.initials: L
authors.lastname: Lin
authors.affiliation: Affiliated Hospital Cancer Center, Academy of Military Medical Sciences, Beijing, People's Republic of China; jmxu2003@163.com.
authors.forename: Jianming
authors.initials: J
authors.lastname: Xu
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D004338:Drug Combinations; D005260:Female; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D010094:Oxonic Acid / Q000008:administration & dosage / Q000009:adverse effects; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D015996:Survival Rate; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D004338:Drug Combinations; D003841:Deoxycytidine; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D002955:Leucovorin; D000093542:Gemcitabine