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• W4241204152 abstract "9580 Background: Trastuzumab (Herceptin®, H) is a humanized monoclonal antibody which showed a significant survival benefit in a randomized trial comparing chemotherapy plus H vs. chemotherapy alone in patients (pts) with MBC whose HER2 status was determined by immunohistochemistry (IHC). Retrospective analysis of this trial showed that the survival benefit was limited to pts who tested HER2+ by fluorescence in situ hybridization (FISH). We report concordance results between local lab (LL) and central lab (CL) HER2 testing from this phase IV study of H plus a taxane in MBC. Methods: 1269 pts were screened and 401 pts were enrolled. Pts with LL FISH+ or IHC 3+ scores were enrolled immediately and confirmatory tests were done at the CL. Pts with LL IHC 0–2+ or FISH- scores had samples tested at the CL and were enrolled on the basis of CL FISH+ or IHC 3+ status. All enrolled pts received H weekly combined with either paclitaxel or docetaxel. Results: Concordance between LL IHC scores and CL IHC and FISH scores is shown below. Concordance was low for LL IHC2+ samples; these also had a substantial rate of FISH+ results at the CL. The overall response rate (ORR=CR+PR) for the 352 evaluable pts was 49% (95% CI, 44–55%). For CL FISH+ pts (n=241) the ORR was 51% (95% CI, 45–58%) and for CL FISH- pts (n=67) it was 42% (95% CI, 30–54%). Conclusions: LL IHC testing had variable reproducibility. LL IHC 2+ specimens were the least concordant with CL results (26%); in addition 32% of LL IHC 2+ specimens tested CL FISH+. This is in agreement with the NCCN recommendation that IHC 2+ specimens be retested by FISH to determine HER2 status. This data shows that patients selected by FISH respond to treatment with taxane/H, and since taxane/H has been shown to confer a survival benefit, it is critical that we identify patients for treatment with H using appropriate testing methods. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Genentech, Inc.; Laboratory Corp. of America Genentech, Inc.; Laboratory Corp. of America Genentech, Inc.; Laboratory Corp. of America" @default.
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• W4241204152 date "2004-07-15" @default.
• W4241204152 modified "2023-09-25" @default.
• W4241204152 title "Concordance between central and local lab IHC and FISH HER2 testing in a community-based trial of first-line trastuzumab plus a taxane in HER2+ metastatic breast cancer (MBC)" @default.
• W4241204152 doi "https://doi.org/10.1200/jco.2004.22.14_suppl.9580" @default.
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