Abstract
BackgroundTo evaluate efficacy in patients with brain metastasis (BM) on entry into the lapatinib expanded access program (LEAP).MethodsLEAP 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.ResultsAmong 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.ConclusionLapatinib plus capecitabine is equally effective in patients with or without BM.Trial registrationClinicalTrials.gov (NCT00338247)
Highlights
To evaluate efficacy in patients with brain metastasis (BM) on entry into the lapatinib expanded access program (LEAP)
Patients with HER2-positive breast cancer who have been treated with trastuzumab are at greater risk for developing brain metastasis, with the incidence ranging from 25% to 36% [1,2,3,4]
Certain patients were included in LEAP that would have been excluded from the registration study, including patients with symptomatic brain metastases and those with prior capecitabine exposure [5]
Summary
To evaluate efficacy in patients with brain metastasis (BM) on entry into the lapatinib expanded access program (LEAP). Patients with HER2-positive breast cancer who have been treated with trastuzumab are at greater risk for developing brain metastasis, with the incidence ranging from 25% to 36% [1,2,3,4]. Lapatinib offers a treatment option for HER2-positive patients who progress on trastuzumab the blood-brain barrier and has shown evidence of CNS activity based on preclinical and clinical evidence [9,10,11]. In order to accommodate patient demand for lapatinib after the positive results from the registration trial, two expanded access studies were initiated: Lapatinib Expanded Access Program (LEAP) and French Authorisation Temporaire d’Utilisation (ATU) [12,13,14]. Data from LEAP augments the information available from the registration trial
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