title: Phase II trial of capecitabine plus erlotinib versus capecitabine alone in patients with advanced colorectal cancer.
abstract: Aim & methods: Capecitabine monotherapy as palliation for advanced colorectal cancer (CRC) is generally well tolerated. Adding erlotinib, an EGFR-tyrosine kinase inhibitor, might improve efficacy versus capecitabine alone. 82 patients received capecitabine alone (Arm 1) or capecitabine with erlotinib (Arm 2).
  
  
  RESULTS
  Median time-to-progression (TTP) in Arm 1 was 7.9 months versus 9.2 in Arm 2. In KRAS-wild type (WT) patients TTP was 8.4 and 11.7 months in Arms 1 and 2, respectively. In KRAS-mutated patients TTP was 7.4 and 1.9 months in Arms 1 and 2, respectively (p = 0.023). Arm 2 KRAS-WT patients, left-sided primaries, had an overall survival of 16.0 versus 12.1 months in right-sided primaries.
  
  
  CONCLUSIONS
  Adding erlotinib to capecitabine increased TTP by 3.2 months in KRAS-WT patients. This study suggests that erlotinib harms patients with KRAS-mutated advanced CRC while it may provide benefit to those with KRAS-WT CRC. Further study of EGFR-tyrosine kinase inhibitors in patients with left-sided KRAS-WT CRC is warranted.
authors.affiliation: London Regional Cancer Program, London, ON, Canada.|Schulich School of Medicine & Dentistry, London, ON, Canada.
authors.forename: Mark D
authors.initials: MD
authors.lastname: Vincent
authors.affiliation: London Regional Cancer Program, London, ON, Canada.|Schulich School of Medicine & Dentistry, London, ON, Canada.
authors.forename: Daniel
authors.initials: D
authors.lastname: Breadner
authors.affiliation: Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada.
authors.forename: Denis
authors.initials: D
authors.lastname: Soulieres
authors.affiliation: London Regional Cancer Program, London, ON, Canada.|Schulich School of Medicine & Dentistry, London, ON, Canada.
authors.forename: Ian G
authors.initials: IG
authors.lastname: Kerr
authors.affiliation: London Regional Cancer Program, London, ON, Canada.|Schulich School of Medicine & Dentistry, London, ON, Canada.
authors.forename: Michael
authors.initials: M
authors.lastname: Sanatani
authors.affiliation: London Regional Cancer Program, London, ON, Canada.|Schulich School of Medicine & Dentistry, London, ON, Canada.
authors.forename: Walter
authors.initials: W
authors.lastname: Kocha
authors.affiliation: Medical Oncology, Lions Gate Hospital, North Vancouver, BC, Canada.
authors.forename: Peter
authors.initials: P
authors.lastname: Klimo
authors.affiliation: London Regional Cancer Program, London, ON, Canada.|Schulich School of Medicine & Dentistry, London, ON, Canada.
authors.forename: Mary J
authors.initials: MJ
authors.lastname: MacKenzie
authors.affiliation: London Regional Cancer Program, London, ON, Canada.
authors.forename: Anne
authors.initials: A
authors.lastname: O'Connell
authors.affiliation: London Regional Cancer Program, London, ON, Canada.
authors.forename: Frances
authors.initials: F
authors.lastname: Whiston
authors.affiliation: London Regional Cancer Program, London, ON, Canada.
authors.forename: Anne S
authors.initials: AS
authors.lastname: Malpage
authors.affiliation: London Regional Cancer Program, London, ON, Canada.
authors.forename: Larry
authors.initials: L
authors.lastname: Stitt
authors.affiliation: London Regional Cancer Program, London, ON, Canada.
authors.forename: Stephen A
authors.initials: SA
authors.lastname: Welch
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D014408:Biomarkers, Tumor; D000069287:Capecitabine / Q000008:administration & dosage / Q000627:therapeutic use*; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D003131:Combined Modality Therapy; D000069347:Erlotinib Hydrochloride / Q000008:administration & dosage; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009154:Mutation; D009367:Neoplasm Staging; D016283:Proto-Oncogene Proteins p21(ras) / Q000235:genetics; D016896:Treatment Outcome; D047368:Tumor Burden
chemical_list: D014408:Biomarkers, Tumor; D000069287:Capecitabine; D000069347:Erlotinib Hydrochloride; D016283:Proto-Oncogene Proteins p21(ras)
keywords: KRAS; capecitabine; colorectal cancer; elderly; erlotinib; frail; primary tumor location