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

Journal Article (Journal Article;Multicenter Study)

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 >or=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.

Full Text

Duke Authors

Cited Authors

  • Blackwell, KL; Pegram, MD; Tan-Chiu, E; Schwartzberg, LS; Arbushites, MC; Maltzman, JD; Forster, JK; Rubin, SD; Stein, SH; Burstein, HJ

Published Date

  • June 2009

Published In

Volume / Issue

  • 20 / 6

Start / End Page

  • 1026 - 1031

PubMed ID

  • 19179558

Electronic International Standard Serial Number (EISSN)

  • 1569-8041

Digital Object Identifier (DOI)

  • 10.1093/annonc/mdn759


  • eng

Conference Location

  • England