title: All-oral combination of lapatinib and capecitabine in patients with brain metastases from HER2-positive breast cancer--a phase II study.
abstract: OBJECTIVE
  Approximately one-third of patients with advanced, HER2+ve breast cancer (BC) develop brain metastases (BMs). The aim of this study is to investigate efficacy and tolerability of the combination of lapatinib and capecitabine (LC) in HER2+ve BC patients with brain metastases (BCBM).
  
  
  METHODS
  Between January 2011 and January 2013, 21 patients with HER2+ve BCBM were included. Sixteen patients (76.19%) progressed after whole brain radiotherapy (WBRT) and 5 patients (23.81%) were treatment-naïve for BM. Patients received lapatinib (1250 mg/day continuously) and capecitabine (2000 mg/m2 on days 1-14 of a 21-day cycle). All patients were treated with trastuzumab either in the adjuvant or metastatic setting. No patients had received prior lapatinib and/or capecitabine. End-points were response rate (RR), progression free survival (PFS), overall survival (OS) and toxicity.
  
  
  RESULTS
  The overall response rate (ORR) was 33.3% (7/21) and all were partial response. For patients receiving prior WBRT and patients receiving LC as first line treatment for BCBM the ORR was 31.2% (5/16) and 40.0% (2/5) respectively. Median PFS was 5.5 months. Median OS was 11 months. Treatment-related adverse events were manageable. Grade 3-4 toxicities were hand-foot syndrome (14.3%), diarrhea (14.3%), nausea/vomiting (9.5%), mucositis (4.8%), and skin rash (4.8%).
  
  
  CONCLUSIONS
  The combination of LC is active and well-tolerated treatment in patients with HER2+ve BCBM.
authors.affiliation: Clinical Oncology Department, Faculty of Medicine, Tanta University Hospital, Egypt. Electronic address: hannshawky@yahoo.com.
authors.forename: Hanan
authors.initials: H
authors.lastname: Shawky
authors.affiliation: Clinical Oncology Department, Faculty of Medicine, Tanta University Hospital, Egypt.
authors.forename: Hesham
authors.initials: H
authors.lastname: Tawfik
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy / Q000556:secondary*; D001943:Breast Neoplasms / Q000473:pathology*; D000069287:Capecitabine / Q000008:administration & dosage*; D018450:Disease Progression; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D000077341:Lapatinib; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011379:Prognosis; D011446:Prospective Studies; D011799:Quinazolines / Q000008:administration & dosage*; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism*; D016896:Treatment Outcome
chemical_list: D000069287:Capecitabine; D000077341:Lapatinib; D011799:Quinazolines; D018719:Erb-b2 Receptor Tyrosine Kinases; C508053:ERBB2 protein, human
keywords: Brain metastases; Capecitabine; HER2-positive breast cancer; Lapatinib