title: S-1-based regimens and the risk of oral and gastrointestinal mucosal injury: a meta-analysis with comparison to other fluoropyrimidines.
abstract: BACKGROUND
  We performed a meta-analysis of the risk of oral and gastrointestinal (GI) mucosal injury associated with S-1-based regimens.
  
  
  METHODS
  Randomized phase II and III trials of patients with solid tumors on S-1; describing events of all-grade and high-grade stomatitis and diarrhea constituted the eligible studies.
  
  
  RESULTS
  After exclusion of ineligible studies, a total of 26 clinical trials were considered eligible for the meta-analysis. The odds ratio (OR) of all-grade and high-grade stomatitis for S-1 vs. non-fluoropyrimidine controls was 4.39 [95% CI: 1.05, 18.37; p = 0.04] and 5.64 [95% CI: 1.46, 21.77; p = 0.01], respectively; while the OR of all-grade and high-grade stomatitis for S-1 vs. infusional 5-fluorouracil (5-FU) control was -1.01 [95% CI: 0.22, 4.63; p = 0.99] and 0.32 [95% CI: 0.20, 0.49; p < 0.00001], respectively. The OR of all-grade and high-grade diarrhea for S-1 vs. non-fluoropyrimidine controls was 2.48 [95% CI: 2.12, 2.90; p < 0.00001] and 1.95 [95% CI: 1.29, 2.96; p = 0.002], respectively; while the OR of all-grade and high-grade diarrhea for S-1 vs. infusional 5-FU control was -1.03 [95% CI: 0.87, 1.22; p = 0.76] and 2.52 [95% CI: 1.80, 3.52; p < 0.00001], respectively.
  
  
  CONCLUSIONS
  Compared to non-fluoropyrimidine control, patients treated with S-1-based regimens have an increased risk of all-grade and high-grade stomatitis and diarrhea; while on the other hand, patients treated with infusional 5-FU have a greater risk of high-grade stomatitis and diarrhea compared to patients treated with S-1-based regimens.
authors.affiliation: a Clinical Oncology Department, Faculty of Medicine , Ain Shams University , Cairo 11665 , Egypt.
authors.forename: Omar
authors.initials: O
authors.lastname: Abdel-Rahman
authors.affiliation: a Clinical Oncology Department, Faculty of Medicine , Ain Shams University , Cairo 11665 , Egypt.
authors.forename: Hesham
authors.initials: H
authors.lastname: ElHalawani
authors.affiliation: a Clinical Oncology Department, Faculty of Medicine , Ain Shams University , Cairo 11665 , Egypt.
authors.forename: Shaimaa
authors.initials: S
authors.lastname: Essam-Eldin
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D003967:Diarrhea / Q000139:chemically induced* / Q000453:epidemiology; D004338:Drug Combinations; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D007413:Intestinal Mucosa / Q000187:drug effects / Q000473:pathology; D009061:Mouth Mucosa / Q000187:drug effects / Q000473:pathology; D009369:Neoplasms / Q000188:drug therapy; D010094:Oxonic Acid / Q000008:administration & dosage; D016032:Randomized Controlled Trials as Topic; D013280:Stomatitis / Q000139:chemically induced* / Q000453:epidemiology; D005641:Tegafur / Q000008:administration & dosage
chemical_list: D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D005472:Fluorouracil
keywords: S-1; diarrhea; mucositis; stomatitis