title: Combination therapy of lapatinib and Capecitabine for ErbB2-positive metastatic or locally advanced breast cancer: results from the Lapatinib Expanded Access Program (LEAP) in Central and Eastern Europe.
abstract: BACKGROUND
  The Lapatinib Expanded Access Program (LEAP) was initiated in 45 countries to provide lapatinib in combination with capecitabine to patients with ErbB2 (HER2)-positive breast cancer already treated with anthracyclines, taxanes and trastuzumab. We report the results from 12 Central and Eastern European countries.
  
  
  METHODS
  By 30 September 2008, 293 patients were enrolled. Patients were monitored for serious adverse events (SAEs) and for any decrease in left ventricular ejection fraction (LVEF). Overall survival and progression-free survival were also assessed.
  
  
  RESULTS
  Mean treatment duration was 30 weeks; 107 patients (36.5%) discontinued therapy during the study, mainly due to disease progression (n = 86; 29.4%). A total of 78 SAEs were reported from 47 patients; the most frequently reported was diarrhoea (13 reports). Treatment had a relatively small effect on LVEF. Decreases were minor (0 to < 20%) in 61% of patients at the end of the study. During the study, 3 patients had decreased LVEF meeting the definition of an SAE; these events all resolved. Median overall and median progression-free survival were 37.6 and 21.1 weeks, respectively.
  
  
  CONCLUSIONS
  Heavily pretreated patients with ErbB2-positive locally advanced or metastatic breast cancer may benefit from treatment with lapatinib and capecitabine, with a low risk of cardiac toxicity.
authors.affiliation: IIIrd Medical Department of Hematology and Medical Oncology, Private Medical University Hospital, Salzburg, Austria. r.greil@salk.at
authors.forename: Richard
authors.initials: R
authors.lastname: Greil
authors.forename: Simona
authors.initials: S
authors.lastname: Borštnar
authors.forename: Katarína
authors.initials: K
authors.lastname: Petráková
authors.forename: Yiola
authors.initials: Y
authors.lastname: Marcou
authors.forename: Joanna
authors.initials: J
authors.lastname: Pikiel
authors.forename: Marek Z
authors.initials: MZ
authors.lastname: Wojtukiewicz
authors.forename: Ivan
authors.initials: I
authors.lastname: Koza
authors.forename: Günther G
authors.initials: GG
authors.lastname: Steger
authors.forename: Meinolf
authors.initials: M
authors.lastname: Linn
authors.forename: Ash
authors.initials: A
authors.lastname: Das Gupta
authors.forename: Karel
authors.initials: K
authors.lastname: Cwiertka
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000556:secondary*; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D005060:Europe; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives*; D006801:Humans; D000077341:Lapatinib; D008875:Middle Aged; D011799:Quinazolines / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D011799:Quinazolines; D000077341:Lapatinib; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil