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Cited by 438

The DOI matches its Crossref record; 27 of the 27 references it cites were found in a registry or an index.

HER2 Testing by Local, Central, and Reference Laboratories in Specimens From the North Central Cancer Treatment Group N9831 Intergroup Adjuvant Trial

Open access
Perez, Edith A., Suman, Vera J., Davidson, Nancy E., Martino, Silvana, Kaufman, Peter A., Lingle, Wilma L., Flynn, Patrick J., Ingle, James N., Visscher, Daniel, Jenkins, Robert B.·2006·Journal of Clinical Oncology

Abstract

Purpose: To evaluate concordance between local and central laboratory HER2 testing results in patients from the North Central Cancer Treatment Group (NCCTG) N9831 adjuvant trial of trastuzumab. Patients and Methods: NCCTG N9831 is a randomized, phase III clinical trial comparing three drug regimens: doxorubicin/cyclophosphamide followed by paclitaxel with trastuzumab added concurrently, sequentially, or not at all as adjuvant therapy for women with HER2-positive resected breast cancer. Originally, patients were eligible if their tumors were HER2 positive by either local laboratory immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH). A protocol modification in 2002 made central laboratory testing mandatory, with additional testing of discordant cases conducted by a reference laboratory. Concordance between local and central laboratory, and level of agreement between central and reference laboratory HER2 findings in discordant cases were examined. Results: HER2 positivity was confirmed in 85.8% of 2,535 patients registered since March 2002. When local and central evaluation used the same methodology, concordance was 88.1% for FISH and 81.6% for a diagnostic test for presence of the HER2 protein. Among discordant cases examined at the reference laboratory, there was 94.3% agreement for IHC (0, 1+, 2+) and 95.2% agreement for FISH (not gene amplified). Conclusion: There was a high degree of discordance between local and central testing for IHC and FISH, but a high degree of agreement between central and reference laboratories. These findings support the importance of using high-volume, experienced laboratories for HER2 testing to improve the process of selecting patients likely to benefit from trastuzumab therapy.

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Metadata

Authors
Perez, E. A., Suman, V. J., Davidson, N. E., Martino, S., Kaufman, P. A., Lingle, W. L., Flynn, P. J., Ingle, J. N., Visscher, D., & Jenkins, R. B.
Venue
Journal of Clinical Oncology
Published
2006-07-01
Volume
24
Issue
19
Pages
3032-3038
ISSN
  • 0732-183X (ISSN-L)
  • 1527-7755
OpenAlex
W2099630695
Cited by
438
References
27
FWCI
17.21
Type
journal article
Language
en
Open access
bronze

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CoChat. (2026). Citation check: HER2 Testing by Local, Central, and Reference Laboratories in Specimens From the North Central Cancer Treatment Group N9831 Intergroup Adjuvant Trial. https://app.cochat.ai/papers/10.1200/jco.2005.03.4744
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Perez, E. A., Suman, V. J., Davidson, N. E., Martino, S., Kaufman, P. A., Lingle, W. L., Flynn, P. J., Ingle, J. N., Visscher, D., & Jenkins, R. B. (2006). HER2 Testing by Local, Central, and Reference Laboratories in Specimens From the North Central Cancer Treatment Group N9831 Intergroup Adjuvant Trial. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2005.03.4744

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

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