Variable specimen handling affects hormone receptor test results in women with breast cancer: a large multihospital retrospective study.

Author(s): Nkoy FL, Hammond ME, Rees W, Belnap T, Rowley B, Catmull S, Sause W

Publication: Arch Pathol Lab Med, 2010, Vol. 134, Page 606-12

PubMed ID: 20367311 PubMed Review Paper? No

Purpose of Paper

Conclusion of Paper

Studies

1. Study Purpose

   The purpose of this paper was to assess levels and sources of variability in ER and PR negative test results among retrospectively collected breast cancer specimens collected at seven different hospitals. A common laboratory that performed automated testing was used by all seven hospitals. A total of 5,077 specimens collected between 1997 and 2003 were retrospectively examined. Tumor positive/negative status was based upon a 10% threshold of tumor cells with nuclear ER or PR staining. Of note, the number of cases examined varied by collection day, ranging between 784 and 1252 cases for Monday through Thursday, 919 cases on Friday, 26 cases on Saturday, and 16 cases on Sunday.

   Summary of Findings:

   The frequencies of ER and PR negative test results were 21% and 28%, respectively, for patients 45 years and younger and 15% and 24%, respectively, for patients older than 75 years. The frequency of ER and PR negative test results were significantly influenced by tumor size, with higher percentages observed among larger tumors (both p<0.001). ER negative test results (p=0.03), but not PR negative results (p=0.59), were also significantly influenced by the day of the week on which specimens were collected. The mean percentage of ER negative test results was 20.2% among specimens collected Sunday through Thursday and 25.21% among specimens collected on Friday or Saturday. Although the duration of fixation was not recorded for each specimen, the authors state that specimens obtained Sunday through Thursday were more likely to be tested within 24 h of surgery while specimens collected on Friday or Saturday were more likely to be tested more than 24 h after surgery. When the authors controlled for age and tumor size, the frequency of both ER (p=0.02) and PR (p=0.02) negative results differed between hospitals despite the use of a common standardized laboratory, ranging from 16.5-28.6% for ER and 22.5-31.4% for PR. Using the same dataset, the frequency of negative test results was also significantly associated with the longer fixation time inferred by the authors for specimens collected on Friday or Saturday for ER (p=0.04) but not PR (p=0.09).

   Biospecimens

   • Tissue - Breast

   Preservative Types

   • Formalin

   Diagnoses:

   • Neoplastic - Benign
   • Neoplastic - Carcinoma

   Platform:

   Analyte	Technology Platform
   Protein	Immunohistochemistry

   Pre-analytical Factors:

   Classification	Pre-analytical Factor	Value(s)
   Biospecimen Acquisition	Time of biospecimen collection	Sunday-Thursday Friday or Saturday
   Biospecimen Preservation	Time in fixative	Less than 24 h Greater than 24 h
   Preaquisition	Patient age	24-100 y

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