title: Clinical outcomes of HER2-positive metastatic breast cancer patients with brain metastasis treated with lapatinib and capecitabine: an open-label expanded access study in Korea.
abstract: BACKGROUND
  To evaluate efficacy in patients with brain metastasis (BM) on entry into the lapatinib expanded access program (LEAP).
  
  
  METHODS
  LEAP is a worldwide, single-arm, open-label study. HER2-positive, locally-advanced or metastatic breast cancer patients with progression after an anthracycline, taxane, and trastuzumab were eligible. Patients received capecitabine 2000 mg/m(2) daily in two divided doses, days 1-14, every 21 days and lapatinib 1250 mg once daily.
  
  
  RESULTS
  Among 186 patients enrolled in 6 Korean centers, 58 had BM. Progression-free survival (PFS) was 18.7 weeks in patients with BM and 19.4 weeks without BM (P = 0.88). In patients with BM, brain response was synchronized with systemic responses (P = 0.0001). Overall survival (OS) was 48.9 weeks in patients with BM and 64.6 weeks without BM (P = 0.23). Multivariable analysis found hormone receptor positivity (P = 0.003) and clinical benefit rate (CBR) of combined systemic and brain disease (P < 0.0001) significantly associated with prolonged brain PFS, and CBR of combined systemic and brain disease (P = 0.03) and longer trastuzumab use (P = 0.047) associated with prolonged OS in patients with BM; prior capecitabine did not affect PFS or OS in patients with BM.
  
  
  CONCLUSIONS
  Lapatinib plus capecitabine is equally effective in patients with or without BM.
  
  
  BACKGROUND
  ClinicalTrials.gov (NCT00338247).
authors: National Cancer Center Hospital and Research Institute, Goyang, Gyeonggi-do 410-769, Republic of Korea. jungsro@ncc.re.kr
authors: Jungsil
authors: J
authors: Ro
authors: Sohee
authors: S
authors: Park
authors: Sung- Bae
authors: S
authors: Kim
authors: Tae You
authors: TY
authors: Kim
authors: Young Hyuk
authors: YH
authors: Im
authors: Sun Young
authors: SY
authors: Rha
authors: Joo Seop
authors: JS
authors: Chung
authors: Hanlim
authors: H
authors: Moon
authors: Sergio
authors: S
authors: Santillana
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary*; D001943:Breast Neoplasms / Q000378:metabolism* / Q000473:pathology*; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D000077341:Lapatinib; D008875:Middle Aged; D011799:Quinazolines / Q000008:administration & dosage; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism*; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000069287:Capecitabine; D003841:Deoxycytidine; D005472:Fluorouracil; D000077341:Lapatinib; D011799:Quinazolines; D018719:Erb-b2 Receptor Tyrosine Kinases