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    Multicenter phase II study of lapatinib in patients with brain metastases from HER2-positive breast cancer.

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    Authors
    Lin, Nancy U
    Diéras, Véronique
    Paul, Devchand
    Lossignol, Dominique
    Christodoulou, Christos
    Stemmler, Hans-Joachim
    Roché, Henri
    Liu, Minetta C
    Greil, Richard
    Ciruelos, Eva
    Loibl, Sibylle
    Gori, Stefania
    Wardley, Andrew M
    Yardley, Denise
    Brufsky, Adam
    Blum, Joanne L
    Rubin, Stephen D
    Dharan, Bernie
    Steplewski, Klaudia
    Zembryki, Denise
    Oliva, Cristina
    Roychowdhury, Debasish F
    Paoletti, Paolo
    Winer, Eric P
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    Affiliation
    Dana-Farber Cancer Institute, Boston, Massachusetts 02115, USA.
    Issue Date
    2009-02-15
    
    Metadata
    Show full item record
    Abstract
    PURPOSE: Brain metastases develop in one third of patients with advanced HER2+ breast cancer. Effective therapy for patients with central nervous system (CNS) progression after cranial radiation is extremely limited and represents a major clinical challenge. Lapatinib, an epidermal growth factor receptor/HER2 inhibitor, was associated with regressions of CNS lesions in a small phase 2 trial. The current study was done to further evaluate the CNS activity of lapatinib. The study was later amended to allow patients who progressed on lapatinib the option of receiving lapatinib plus capecitabine. EXPERIMENTAL DESIGN: Eligible patients had HER2+ breast cancer, progressive brain metastases, prior trastuzumab, and cranial radiotherapy. The primary end point was CNS objective response, defined as >or=50% volumetric reduction of CNS lesion(s) in the absence of increasing steroid use, progressive neurologic signs and symptoms, or progressive extra-CNS disease. RESULTS: Two-hundred and forty-two patients entered the study. CNS objective responses to lapatinib were observed in 6% of patients. In an exploratory analysis, 21% of patients experienced a >or=20% volumetric reduction in their CNS lesions. An association was observed between volumetric reduction and improvement in progression-free survival and neurologic signs and symptoms. Of the 50 evaluable patients who entered the lapatinib plus capecitabine extension, 20% experienced a CNS objective response and 40% experienced a >or=20% volumetric reduction in their CNS lesions. CONCLUSIONS: This study confirms the modest CNS antitumor activity of lapatinib. Additional responses were observed with the combination of lapatinib and capecitabine. Further studies of lapatinib-based regimens for CNS metastases from HER2+ breast cancer are warranted.
    Citation
    Multicenter phase II study of lapatinib in patients with brain metastases from HER2-positive breast cancer. 2009, 15 (4):1452-9 Clin. Cancer Res.
    Journal
    Clinical Cancer Research
    URI
    http://hdl.handle.net/10541/69595
    DOI
    10.1158/1078-0432.CCR-08-1080
    PubMed ID
    19228746
    Type
    Article
    Language
    en
    ISSN
    1078-0432
    ae974a485f413a2113503eed53cd6c53
    10.1158/1078-0432.CCR-08-1080
    Scopus Count
    Collections
    All Christie Publications
    Medical Oncology

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