title: Lapatinib-based therapy in heavily pretreated HER2-positive metastatic breast cancer: a single institution experience.
abstract: OBJECTIVE
  Lapatinib in combination with capecitabine is feasible in patients with HER2-positive metastatic breast cancer pretreated with anthracyclines, taxanes and trastuzumab, but inferior results were reported in the global lapatinib expanded access program in comparison with the phase III registration trial.
  
  
  METHODS
  and study design. Women with HER2-positive metastatic breast carcinoma after antracycline, taxane and trastuzumab-based regimens were treated at progression with lapatinib plus capecitabine. The outcome of these patients was evaluated. From April 2007 to August 2010, 68 patients were treated overall.
  
  
  RESULTS
  Median progression-free survival was 6 months (range, 1-29), and median overall survival was 26 months (range, 1-39). Eight (12%; 95% CI, 4-25) patients experienced a complete response. Partial response was observed in 22 patients (31%; 95% CI, 20-42), for an overall response rate of 43% (95% CI, 31-55). The treatment with lapatinib plus capecitabine was well tolerated, with grade 3-4 toxicity reported in few patients, and no treatment-related deaths were noted. Of note, no cardiac toxicity was reported in this highly pretreated group of patients or in the subgroup of 10 elderly patients.
  
  
  CONCLUSIONS
  Our data confirm that lapatinib plus capecitabine is an active regimen even in heavily pretreated patients with visceral and brain metastases and is feasible and active also in selected elderly patients.
authors.affiliation: National Cancer Institute, Division of Medical Oncology C, CRO, Aviano (PN), Italy. dcrivellari@cro.it
authors.forename: Diana
authors.initials: D
authors.lastname: Crivellari
authors.forename: Simon
authors.initials: S
authors.lastname: Spazzapan
authors.forename: Davide
authors.initials: D
authors.lastname: Lombardi
authors.forename: Loredana
authors.initials: L
authors.lastname: Militello
authors.forename: Elena
authors.initials: E
authors.lastname: Torrisi
authors.forename: Alessia E
authors.initials: AE
authors.lastname: Russo
authors.forename: Roberto
authors.initials: R
authors.lastname: Sorio
authors.forename: Renato
authors.initials: R
authors.lastname: Talamini
authors.forename: Gianmaria
authors.initials: G
authors.lastname: Miolo
authors.forename: Paolo
authors.initials: P
authors.lastname: Carli
authors.forename: Andrea
authors.initials: A
authors.lastname: Veronesi
mesh_terms: D000328:Adult; D000368:Aged; D018943:Anthracyclines / Q000008:administration & dosage; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000032:analysis*; D001943:Breast Neoplasms / Q000737:chemistry / Q000188:drug therapy* / Q000473:pathology*; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D018450:Disease Progression; D004334:Drug Administration Schedule; D019008:Drug Resistance, Neoplasm; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives*; D006801:Humans; D000077341:Lapatinib; D008875:Middle Aged; D047428:Protein Kinase Inhibitors / Q000008:administration & dosage; D011799:Quinazolines / Q000008:administration & dosage*; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000032:analysis*; D043823:Taxoids / Q000008:administration & dosage; D000068878:Trastuzumab; D017211:Treatment Failure; D016896:Treatment Outcome
chemical_list: D018943:Anthracyclines; D061067:Antibodies, Monoclonal, Humanized; D014408:Biomarkers, Tumor; D000069287:Capecitabine; D003841:Deoxycytidine; D005472:Fluorouracil; D000077341:Lapatinib; D047428:Protein Kinase Inhibitors; D011799:Quinazolines; D018719:Erb-b2 Receptor Tyrosine Kinases; D043823:Taxoids; D000068878:Trastuzumab; C508053:ERBB2 protein, human