title: A phase II study of lapatinib in patients with advanced biliary tree and hepatocellular cancer.
abstract: OBJECTIVE
  To evaluate the response to lapatinib, an inhibitor of epidermal growth factor receptors 1 and 2, in patients with advanced bilary tree cancer (BTC) and hepatocellular cancer (HCC).
  
  
  METHODS
  Lapatinib was dosed at 1,500 mg/day orally continuously.
  
  
  RESULTS
  Fifty-seven patients were accrued (BTC 17, HCC 40). Therapy was well tolerated. The response in BTC was 0% and in HCC was 5%. The progression free survival (PFS) for BTC and HCC patients was 1.8 (95% CI: 1.7-5.2) months and 2.3 (95% CI: 1.7-5.6) months. The median survival for BTC and HCC patients was 5.2 (95% CI 3.3-infinity) months and 6.2 (95% CI: 5.1-infinity) months. EGFR genotyping indicated HCC patients with <20 repeats have the lowest PFS. The occurrence of any skin rash significantly prolonged PFS and survival.
  
  
  CONCLUSIONS
  Lapatinib was well-tolerated. There was evidence of activity in HCC, but therapy with lapatinib did not meet the predefined efficacy rate.
authors.affiliation: University of Pittsburgh Cancer Institute, Pittsburgh, PA, USA. rramanathan@tgen.org
authors.forename: Ramesh K
authors.initials: RK
authors.lastname: Ramanathan
authors.forename: Chandra P
authors.initials: CP
authors.lastname: Belani
authors.forename: Deepti A
authors.initials: DA
authors.lastname: Singh
authors.forename: Michael
authors.initials: M
authors.lastname: Tanaka
authors.forename: Heinz-Josef
authors.initials: HJ
authors.lastname: Lenz
authors.forename: Yun
authors.initials: Y
authors.lastname: Yen
authors.forename: Hedy L
authors.initials: HL
authors.lastname: Kindler
authors.forename: Syma
authors.initials: S
authors.lastname: Iqbal
authors.forename: Jeff
authors.initials: J
authors.lastname: Longmate
authors.forename: Philip C
authors.initials: PC
authors.lastname: Mack
authors.forename: Georg
authors.initials: G
authors.lastname: Lurje
authors.forename: Regina
authors.initials: R
authors.lastname: Gandour-Edwards
authors.forename: Janet
authors.initials: J
authors.lastname: Dancey
authors.forename: David R
authors.initials: DR
authors.lastname: Gandara
mesh_terms: D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001661:Biliary Tract Neoplasms / Q000188:drug therapy* / Q000473:pathology; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D000077341:Lapatinib; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000473:pathology; D011799:Quinazolines / Q000009:adverse effects / Q000627:therapeutic use*; D016019:Survival Analysis
chemical_list: D000970:Antineoplastic Agents; D011799:Quinazolines; D000077341:Lapatinib