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/m2 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.Conclusion: Lapatinib plus capecitabine is equally effective in patients with or without BM.Trial registration: ClinicalTrials.gov (NCT00338247).
Bibliographical noteFunding Information:
Each patient provided written informed consent and participating institutional review boards approved the study. Financial support was provided by GlaxoSmithKline. The study is registered at ClinicalTrials.gov (NCT00338247).
All Science Journal Classification (ASJC) codes
- Cancer Research