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. CONCLUSION:Lapatinib plus capecitabine is equally effective in patients with or without BM. TRIAL REGISTRATION:ClinicalTrials.gov (NCT00338247).
journal_name
BMC Cancerjournal_title
BMC cancerauthors
Ro J,Park S,Kim S,Kim TY,Im YH,Rha SY,Chung JS,Moon H,Santillana Sdoi
10.1186/1471-2407-12-322subject
Has Abstractpub_date
2012-07-28 00:00:00pages
322issn
1471-2407pii
1471-2407-12-322journal_volume
12pub_type
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