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A phase II study of lapatinib monotherapy in chemotherapy-refractory HER2-positive and HER2-negative advanced or metastatic breast cancer.

Publication ,  Journal Article
Burstein, HJ; Storniolo, AM; Franco, S; Forster, J; Stein, S; Rubin, S; Salazar, VM; Blackwell, KL
Published in: Ann Oncol
June 2008

BACKGROUND: The efficacy and tolerability of the epidermal growth factor receptor/human epidermal growth factor receptor type 2 (HER2) tyrosine kinase inhibitor lapatinib in refractory metastatic breast cancer were assessed. PATIENTS AND METHODS: In a phase II, open-label study, patients with previously treated HER2-positive (n = 140) or HER2-negative (n = 89) metastatic breast cancer received once-daily oral lapatinib 1500 mg/day. RESULTS: Most (76%) patients had received four or more lines of prior therapy. The response rate in the HER2-positive cohort was 4.3% by investigator assessment and 1.4% by independent assessment. Both assessments established that approximately 6% of HER2-positive patients derived clinical benefit from lapatinib, being progression free for >/=6 months. No objective tumor responses occurred in the HER2-negative cohort. Independent review assessments of median time to progression and median progression-free survival were similar in the HER2-positive and HER2-negative cohorts (9.1 and 7.6 weeks, respectively). All responders exhibited HER2 overexpression (3+ by immunohistochemistry), and five of six responders were HER2 amplified by FISH. Lapatinib-related adverse events, including diarrhea (54%), rash (30%), and nausea (24%), were primarily mild to moderate in severity. CONCLUSIONS: Lapatinib monotherapy had modest clinical activity in HER2-positive metastatic breast cancer that progressed on prior trastuzumab regimens. No apparent clinical activity was observed in chemotherapy-refractory, HER2-negative disease.

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Published In

Ann Oncol

DOI

EISSN

1569-8041

Publication Date

June 2008

Volume

19

Issue

6

Start / End Page

1068 / 1074

Location

England

Related Subject Headings

  • Quinazolines
  • Oncology & Carcinogenesis
  • Middle Aged
  • Lapatinib
  • Humans
  • Genes, erbB-2
  • Female
  • Breast Neoplasms
  • Antineoplastic Agents
  • Aged
 

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APA
Chicago
ICMJE
MLA
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Burstein, H. J., Storniolo, A. M., Franco, S., Forster, J., Stein, S., Rubin, S., … Blackwell, K. L. (2008). A phase II study of lapatinib monotherapy in chemotherapy-refractory HER2-positive and HER2-negative advanced or metastatic breast cancer. Ann Oncol, 19(6), 1068–1074. https://doi.org/10.1093/annonc/mdm601
Burstein, H. J., A. M. Storniolo, S. Franco, J. Forster, S. Stein, S. Rubin, V. M. Salazar, and K. L. Blackwell. “A phase II study of lapatinib monotherapy in chemotherapy-refractory HER2-positive and HER2-negative advanced or metastatic breast cancer.Ann Oncol 19, no. 6 (June 2008): 1068–74. https://doi.org/10.1093/annonc/mdm601.
Burstein HJ, Storniolo AM, Franco S, Forster J, Stein S, Rubin S, et al. A phase II study of lapatinib monotherapy in chemotherapy-refractory HER2-positive and HER2-negative advanced or metastatic breast cancer. Ann Oncol. 2008 Jun;19(6):1068–74.
Burstein, H. J., et al. “A phase II study of lapatinib monotherapy in chemotherapy-refractory HER2-positive and HER2-negative advanced or metastatic breast cancer.Ann Oncol, vol. 19, no. 6, June 2008, pp. 1068–74. Pubmed, doi:10.1093/annonc/mdm601.
Burstein HJ, Storniolo AM, Franco S, Forster J, Stein S, Rubin S, Salazar VM, Blackwell KL. A phase II study of lapatinib monotherapy in chemotherapy-refractory HER2-positive and HER2-negative advanced or metastatic breast cancer. Ann Oncol. 2008 Jun;19(6):1068–1074.
Journal cover image

Published In

Ann Oncol

DOI

EISSN

1569-8041

Publication Date

June 2008

Volume

19

Issue

6

Start / End Page

1068 / 1074

Location

England

Related Subject Headings

  • Quinazolines
  • Oncology & Carcinogenesis
  • Middle Aged
  • Lapatinib
  • Humans
  • Genes, erbB-2
  • Female
  • Breast Neoplasms
  • Antineoplastic Agents
  • Aged