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 pati

SUBMITTER: Ro J 

PROVIDER: S-EPMC3480888 | biostudies-literature | 2012 Jul

REPOSITORIES: biostudies-literature