title: Liver toxicity in colorectal cancer patients treated with first-line FOLFIRI-containing regimen: a single institution experience.
abstract: BACKGROUND
  Chemotherapy-induced toxic liver injury is a relevant issue in the clinical management of patients affected with metastatic colorectal cancer (mCRC). This retrospective study evaluated patterns of liver toxicity in patients treated with FOLinic acid, Fluorouracil, IRInotecan (FOLFIRI)-based regimens.
  
  
  METHODS
  One hundred and fifty-six mCRC patients treated at the University Campus Bio-Medico between January 2003 and January 2013 were included in this retrospective analysis. All patients received a FOLFIRI backbone-based chemotherapy. Basal liver enzymes levels were assessed before starting the treatment and before every therapy course. R ratio and the aspartate aminotransferase/alanine aminotransferase ratio were calculated.
  
  
  RESULTS
  Ninety-one patients were male versus 55 female, and the median age of the population was 62 years (range: 38-83). Most patients had liver involvement at the beginning of first-line regimen (101 patients, 64.74%) and 59 patients had received a previous 5-FU based therapy in the adjuvant setting (37.82%). Aspartate aminotransferase level (167.87 vs 41.05 U/l; p < 0.001), Alanine aminotransferase level (94.48 vs 39.80 U/l; p = 0.004) and alkaline phosphatase (289.0 vs 172.44 U/l; p = 0.02) were significantly increased during the first 3 months of treatment. In the entire population, the calculated R ratio was 3.96 (95% CI: 3.25-4.51). In all three regimens, the calculated R ratio was between 2 and 5, without any statistical differences.
  
  
  CONCLUSIONS
  FOLFIRI-based hepatotoxicity has been indirectly defined as a mixed pattern injury in all three regimens evaluated.
authors.affiliation: Medical Oncology, University Campus Bio-Medico, via Alvaro del portillo 200, Roma 00128, Italy.
authors.forename: Bruno
authors.initials: B
authors.lastname: Vincenzi
authors.forename: Marco
authors.initials: M
authors.lastname: Imperatori
authors.forename: Antonio
authors.initials: A
authors.lastname: Picardi
authors.forename: Umberto
authors.initials: U
authors.lastname: Vespasiani Gentilucci
authors.forename: Paolo
authors.initials: P
authors.lastname: Gallo
authors.forename: Valentina
authors.initials: V
authors.lastname: Fausti
authors.forename: Mariella
authors.initials: M
authors.lastname: Spalato Ceruso
authors.forename: Daniele
authors.initials: D
authors.lastname: Santini
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Tonini
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D056486:Chemical and Drug Induced Liver Injury / Q000453:epidemiology / Q000209:etiology*; D015179:Colorectal Neoplasms / Q000188:drug therapy*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies
chemical_list: D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin
keywords: AST\ALT ratio; R ratio; hepatotoxicity; irinotecan; retrospective study