Journal of the National Cancer Institute Advance Access originally published online on January 29, 2008
JNCI Journal of the National Cancer Institute 2008 100(3):218-221; doi:10.1093/jnci/djm270
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© The Author 2008. Published by Oxford University Press.
Comparison of Estrogen Receptor Results From Pathology Reports With Results From Central Laboratory Testing
Affiliations of authors: Department of Pathology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA (LCC, JDM); Channing Laboratory, Department of Medicine, Brigham and Women’s Hospital, Boston, MA (HJB, RMT); Department of Epidemiology, Harvard School of Public Health, Boston, MA (HJB, RMT)
Correspondence to: Laura C. Collins, MD, Department of Pathology, Beth Israel Deaconess Medical Center and Harvard Medical School, 330 Brookline Avenue, Boston, MA 02215 (e-mail: lcollins{at}bidmc.harvard.edu).
We compared estrogen receptor (ER) assay results abstracted from pathology reports with ER results determined on the same specimens by a central laboratory with an immunohistochemical assay. Paraffin sections were cut from tissue microarrays containing 3093 breast cancer specimens from women enrolled in the Nurses’ Health Study, 1851 of which had both pathology reports and tissue available for central laboratory testing. All sections were immunostained for ER at the same time. The original assays were biochemical for 1512 (81.7%) of the 1851 specimens, immunohistochemical for 336 (18.2%), and immunofluorescent for three (0.2%). ER results from pathology reports and repeat central laboratory testing were in agreement for 87.3% of specimens (1615 of the 1851 specimens; kappa statistic = 0.64, P < .001). When the comparison was restricted to the specimens for which the ER assays were originally performed by immunohistochemistry, the agreement rate increased to 92.3% of specimens (310 of the 336 specimens; kappa statistic = 0.78, P < .001). Thus, ER assay results from pathology reports appear to be a reasonable alternative to central laboratory ER testing for large, population-based studies of patients with breast cancer.
| CONTEXT AND CAVEATS Prior knowledge Breast cancer clinical trials use estrogen receptor (ER) results from pathology reports instead of assaying the specimens again in a central laboratory, but the reliability of these data is unclear. Study design Results of ER assays abstracted from pathology reports were directly compared with immunohistochemical ER assay results on the same specimens in a tissue microarray from a central laboratory. Contribution ER results from pathology reports and central laboratory testing were in agreement for 87.3% of specimens and for 92.3% of specimens when the results were restricted to specimens originally tested with an immunohistochemical test. Implications ER assay results from pathology reports appear to be a reasonable alternative to central laboratory ER testing for large clinical trials of breast cancer patients. Limitations Tissue blocks from all cancers could not be obtained, and so only 52% of cancers were represented in the tissue microarray for testing by the central laboratory.
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The authors thank Drs Graham A. Colditz and Stuart J. Schnitt for their advice and support in the preparation of the manuscript.
The authors had full responsibility in the design of the study, the collection of the data, the analysis and interpretation of the data, the decision to submit the manuscript for publication, and the writing of the manuscript.
Manuscript received August 3, 2007; revised November 13, 2007; accepted November 16, 2007.
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