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Ann Oncol. 2011 Sep;22(9):2007-13. doi: 10.1093/annonc/mdq710. Epub 2011 Feb 1.

Very high quantitative tumor HER2 content and outcome in early breast cancer.

Author information

1
Department of Oncology, Helsinki University Central Hospital and University of Helsinki, Helsinki, Finland. heikki.joensuu@hus.fi

Abstract

BACKGROUND:

It is unknown how a very high tumor total HER2 (human epidermal growth factor receptor-2) content (H2T) influences outcome in early breast cancer treated with adjuvant trastuzumab plus chemotherapy.

PATIENTS AND METHODS:

H2T was measured using a novel quantitative assay (HERmark(®)) from formalin-fixed tumor tissue of 899 women who participated in the FinHer trial (ISRCTN76560285). In a chromogenic in situ hybridization (CISH) test, 197 (21.9%) patients had HER2-positive cancer and were randomly assigned to receive trastuzumab or control.

RESULTS:

Cancer H2T levels varied 1808-fold. High H2T levels were correlated with a positive HER2 status by CISH (P < 0.0001). A nonlinear association was present between H2T and the hazard of distant recurrence in a subpopulation treatment effect pattern plot analysis in CISH-positive disease. Patients with very high H2T (defined by ≥22-fold the median of HER2-negative cancers; 13% of CISH-positive cancers) did not benefit from adjuvant trastuzumab [hazard ratio (HR) 1.23; 95% confidence interval (CI) 0.33-4.62; P = 0.75], whereas the rest of the patients with HER2-positive disease by CISH (87%) did benefit (HR 0.52; 95% CI 0.28-1.00; P = 0.050).

CONCLUSION:

Patients with HER2-positive breast cancer with very high tumor HER2 content may benefit less from adjuvant trastuzumab compared with those whose cancer has more moderate HER2 content.

PMID:
21285132
DOI:
10.1093/annonc/mdq710
[Indexed for MEDLINE]

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