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

K. L. Blackwell, M. D. Pegram, E. Tan-Chiu, Lee Schwartzberg, M. C. Arbushites, J. D. Maltzman, J. K. Forster, S. D. Rubin, S. H. Stein, H. J. Burstein

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Abstract

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.

Original languageEnglish (US)
Pages (from-to)1026-1031
Number of pages6
JournalAnnals of Oncology
Volume20
Issue number6
DOIs
StatePublished - Jun 4 2009

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Breast Neoplasms
Poisons
Therapeutics
Exanthema
Nausea
Fatigue
Diarrhea
Neoplasms
Immunohistochemistry
Research Personnel
Safety
Drug Therapy
Survival
Trastuzumab
human ERBB2 protein
lapatinib
Response Evaluation Criteria in Solid Tumors

All Science Journal Classification (ASJC) codes

  • Hematology
  • Oncology

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Single-agent lapatinib for HER2-overexpressing advanced or metastatic breast cancer that progressed on first- or second-line trastuzumab-containing regimens. / Blackwell, K. L.; Pegram, M. D.; Tan-Chiu, E.; Schwartzberg, Lee; Arbushites, M. C.; Maltzman, J. D.; Forster, J. K.; Rubin, S. D.; Stein, S. H.; Burstein, H. J.

In: Annals of Oncology, Vol. 20, No. 6, 04.06.2009, p. 1026-1031.

Research output: Contribution to journalArticle

Blackwell, KL, Pegram, MD, Tan-Chiu, E, Schwartzberg, L, Arbushites, MC, Maltzman, JD, Forster, JK, Rubin, SD, Stein, SH & Burstein, HJ 2009, 'Single-agent lapatinib for HER2-overexpressing advanced or metastatic breast cancer that progressed on first- or second-line trastuzumab-containing regimens', Annals of Oncology, vol. 20, no. 6, pp. 1026-1031. https://doi.org/10.1093/annonc/mdn759
Blackwell, K. L. ; Pegram, M. D. ; Tan-Chiu, E. ; Schwartzberg, Lee ; Arbushites, M. C. ; Maltzman, J. D. ; Forster, J. K. ; Rubin, S. D. ; Stein, S. H. ; Burstein, H. J. / Single-agent lapatinib for HER2-overexpressing advanced or metastatic breast cancer that progressed on first- or second-line trastuzumab-containing regimens. In: Annals of Oncology. 2009 ; Vol. 20, No. 6. pp. 1026-1031.
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abstract = "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.",
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AU - Schwartzberg, Lee

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