title: First-line panitumumab plus irinotecan/5-fluorouracil/leucovorin treatment in patients with metastatic colorectal cancer.
abstract: OBJECTIVE
  Panitumumab monotherapy is approved for KRAS wild-type (WT) metastatic colorectal cancer (mCRC) progressing after standard chemotherapy. This study evaluated first-line panitumumab plus FOLFIRI in patients with mCRC.
  
  
  METHODS
  In this phase II, single-arm study, panitumumab (6 mg/kg) and FOLFIRI [irinotecan (180 mg/m(2)) and leucovorin (400 mg/m(2)) followed by a 5-fluorouracil 400 mg/m(2) bolus and a 2,400-3,000 mg/m(2) continuous infusion] were administered every 14 days until progression. Data were analysed descriptively overall and by tumour KRAS status.
  
  
  RESULTS
  KRAS data were available for 145/154 (94%) patients: 59% KRAS WT and 41% mutant (MT); mean follow-up was 39.5 versus 35.8 weeks, respectively. Objective responses occurred in 49% of patients: 56% versus 38% in the KRAS WT versus MT groups [(18% difference (95% CI 1-35%); odds ratio 2.1 (95% CI 1.0-4.4)]; median duration of response was 13.0 versus 7.4 months. More patients in the WT group underwent R0 resection (8% vs. 5%); median progression-free survival also favoured this group (8.9 vs. 7.2 months). The most common adverse events (any grade) were integument toxicities (98%), diarrhoea (79%) and stomatitis/oral mucositis (51%).
  
  
  CONCLUSIONS
  As expected, consistently favourable efficacy was observed in patients with KRAS WT versus MT tumours receiving first-line panitumumab plus FOLFIRI treatment.
authors.affiliation: Department of Hematology and Oncology, Onkologie Klinikum Oldenburg, 26133, Oldenburg, Germany. Onkologie@klinikum-oldenburg.de
authors.forename: Claus-Henning
authors.initials: CH
authors.lastname: Köhne
authors.forename: Ralf
authors.initials: R
authors.lastname: Hofheinz
authors.forename: Laurent
authors.initials: L
authors.lastname: Mineur
authors.forename: Henry
authors.initials: H
authors.lastname: Letocha
authors.forename: Richard
authors.initials: R
authors.lastname: Greil
authors.forename: Josef
authors.initials: J
authors.lastname: Thaler
authors.forename: Eva
authors.initials: E
authors.lastname: Fernebro
authors.forename: Erick
authors.initials: E
authors.lastname: Gamelin
authors.forename: Lucy
authors.initials: L
authors.lastname: Decosta
authors.forename: Meinolf
authors.initials: M
authors.lastname: Karthaus
mesh_terms: D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects; 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; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000235:genetics; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D011905:Genes, ras; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D000077544:Panitumumab
chemical_list: D000911:Antibodies, Monoclonal; D000077544:Panitumumab; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin