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Annals of Oncology Advance Access originally published online on January 29, 2009
Annals of Oncology 2009 20(6):1026-1031; doi:10.1093/annonc/mdn759
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© The Author 2009. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

breast cancer

Single-agent lapatinib for HER2-overexpressing advanced or metastatic breast cancer that progressed on first- or second-line trastuzumab-containing regimens

K. L. Blackwell1,*, M. D. Pegram2, E. Tan-Chiu3, L. S. Schwartzberg4, M. C. Arbushites5, J. D. Maltzman5, J. K. Forster5, S. D. Rubin5, S. H. Stein5 and H. J. Burstein6

1 Department of Medicine/Medical Oncology, Duke University Medical Center, Durham
2 Division of Hematology/Oncology, Geffen School of Medicine, University of California, Los Angeles
3 Internal Medicine, Oncology, Florida Cancer Care, Davie
4 The West Clinic, Memphis
5 Oncology Medicine Development Center, GlaxoSmithKline, Collegeville
6 Medical Oncology/Solid Tumor Oncology, Dana Farber Cancer Institute, Boston, USA

* Correspondence to: Dr K. L. Blackwell, Department of Medicine, Division of Medical Oncology, Box 3893, Duke University Medical Center, Durham, NC 27710, USA. Tel: +1-919-668-1748; Fax: +1-919-681-0889; E-mail: black034{at}mc.duke.edu

Background: This phase II study evaluated the efficacy and safety of lapatinib in patients with human epidermal growth factor receptor 2 (HER2)-positive advanced or metastatic breast cancer that progressed during prior trastuzumab therapy.

Patients and methods: Women with stage IIIB/IV HER2-overexpressing breast cancer were treated with single-agent lapatinib 1250 or 1500 mg once daily after protocol amendment. Tumor response according to RECIST was assessed every 8 weeks. HER2 expression was assessed in tumor tissue by immunohistochemistry and FISH.

Results: Seventy-eight patients were enrolled in the study. Investigator and independent review response rates [complete response (CR) or partial response (PR)] were 7.7% and 5.1%, and clinical benefit rates (CR, PR, or stable disease for ≥24 weeks) were 14.1% and 9.0%, respectively. Median time to progression was 15.3 weeks by independent review, and median overall survival was 79 weeks. The most common treatment-related adverse events were rash (47%), diarrhea (46%), nausea (31%), and fatigue (18%).

Conclusions: Single-agent lapatinib has clinical activity with manageable toxic effects in HER2-overexpressing breast cancer that progressed on trastuzumab-containing therapy. Studies of lapatinib-based combination regimens with chemotherapy and other targeted therapies in metastatic and earlier stages of breast cancer are warranted.

Key words: EGFR, ErbB1, ErbB2, lapatinib, tyrosine kinase inhibitor

Received for publication July 16, 2008. Revision received November 7, 2008. Accepted for publication November 10, 2008.


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