Delay to formalin fixation ‘cold ischemia time': effect on ERBB2 detection by in-situ hybridization and immunohistochemistry

Portier, Bryce P.; Wang, Zhen; Downs‐Kelly, Erinn; Rowe, J. Jordi; Patil, Deepa T.; Lanigan, Chis; Budd, G. Thomas; Hicks, David G.; Rimm, David L.; Tubbs, Raymond R.

doi:10.1038/modpathol.2012.123

Cited by 81 publications

(54 citation statements)

References 28 publications

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“…HER2/neu signals were found to be more sensitive to cold ischemic time than CEP17 and this may result in underscoring the HER2/neu to CEP17 ratio. Cold ischemic time exceeding 3 hours can cause significant FISH signal intensity degradation, 27 leading to false-negative FISH results. Thus, proper handling of specimens is crucial to optimal IHC and FISH testing.…”

Section: Resultsmentioning

confidence: 99%

Implications of the Updated 2013 American Society of Clinical Oncology/College of American Pathologists Guideline Recommendations on Human Epidermal Growth Factor Receptor 2 Gene Testing Using Immunohistochemistry and Fluorescence In Situ Hybridization for Breast Cancer

Lim

Lim²,

Thike³

et al. 2016

Archives of Pathology &Amp; Laboratory Medicine

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Context.-Human epidermal growth factor receptor 2 (HER2/neu) amplification is used as a predictive marker for trastuzumab treatment in breast cancer. Objective.-To assess the impact of the revised ASCO/ CAP recommendations on both IHC and FISH results by using the dual-color HER2/neu and centromeric FISH probes.Design.-Retrospective analysis of 590 invasive carcinomas with concurrent IHC and dual-color HER2/neu and centromeric 17 (CEP17) FISH results, based on 2007 ASCO/CAP guidelines, was conducted from July 2011 to June 2013. With the revised guidelines, patients were recategorized and concordance rates between the 2 assays were recalculated.Results.-Overall concordance rates for FISH and IHC decreased from 94.9% to 93.8% with reclassification. Negative FISH cases decreased from 79.1% to 69.3%. However, equivocal FISH cases were significantly increased from 0.7% to 9.5%, leading to more retesting. Both positive IHC and FISH cases were also noted to be increased, leading to more patients being eligible for trastuzumab treatment, especially those patients with concurrent HER2/neu and CEP17 polysomy. Approximately 1% of patients with initial FISH negative results were reclassified as having positive results when both the ratios and average copy number of HER2/neu were considered under the revised guidelines.Conclusions.-The revised 2013 ASCO/CAP guidelines can potentially lead to more patients being eligible for trastuzumab therapy but additional retesting is to be expected owing to an increased number of equivocal FISH cases.

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Section: Resultsmentioning

confidence: 99%

Implications of the Updated 2013 American Society of Clinical Oncology/College of American Pathologists Guideline Recommendations on Human Epidermal Growth Factor Receptor 2 Gene Testing Using Immunohistochemistry and Fluorescence In Situ Hybridization for Breast Cancer

Lim

Lim²,

Thike³

et al. 2016

Archives of Pathology &Amp; Laboratory Medicine

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“…25 At the protein level, the following markers have been reported not to change within 8 hours or more of DFF: Ki67, PCNA, AE1/AE3, CK7, CK14, CAM 5.2, EMA, GCDFP-15, and mammaglobin. [25][26][27] As would be expected, the main controversies involve the important clinical markers in breast cancer, ER, PR, and HER2. The usual controversies involve the following question: Does a relatively small change in one of these biomarkers cause clinically important changes, that is, changes in the classification of a tumor (e.g., HER+ to HER2-) and hence the medical care of a patient?…”

Section: Lim3mentioning

confidence: 99%

“…The usual controversies involve the following question: Does a relatively small change in one of these biomarkers cause clinically important changes, that is, changes in the classification of a tumor (e.g., HER+ to HER2-) and hence the medical care of a patient? For example, Portier et al 27 found that up to 3 hours of DFF had no practicable effects on clinical interpretation of HER2 by IHC or FISH in 84 patients, and Pekmezci et al 28 found that in 164 cases of breast carcinoma, the HER2 status did not change when needle biopsies were compared with lumpectomies or mastectomies on the same patients.…”

Section: Lim3mentioning

confidence: 99%

Effects of Cold Ischemia on Gene Expression: A Review and Commentary

Grizzle

Otali

Sexton

et al. 2016

Biopreservation and Biobanking

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Frequently investigators request that tissues be collected and processed in less than one hour following removal from a patient. Some biorepositories expend significant personnel time and other resources in trying to meet such goals; however, it is unclear whether the perceived benefits of relatively short cold ischemia times warrant these added costs. The literature of human surgical tissues prospectively exposed to cold ischemia at several time points was reviewed to compare the changes in transcripts/genes and microRNA with time of cold ischemia. Also, reports of protein changes in response to cold ischemia were correlated to changes in genes. The literature is limited; however, for most tissues, only a small proportion of transcripts/genes (<1%) changes up to 3 hours following surgery and most transcripts increase rather than decrease in less than 2 hours of cold ischemia. Biorepositories and investigators must consider the literature for evidence of significant changes in molecular results from tissues before spending significant resources on relatively rapid collection of tissues to meet cold ischemia times of less than 3 hours. Instead, those using human tissues in research must consider if the cold ischemia times affect their use in specific research; hence are these tissues ''fit for purpose?''

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“…It is stated that standardization of tissue processing of specimens obtained from patients with metastatic colorectal cancer is hard to achieve [3]. The time from tissue sampling to fixation should be minimized to a few minutes to prevent degradation of proteins and nucleic acids [13,14]. Fixation with 10% neutral buffered formalin is recommended and fixation time should not be less than 6 hours and no greater than 48 hours [3].…”

Section: Pathological Report and Personalized Medicinementioning

confidence: 99%

Recommendations for histopathology report of colorectal carcinoma specimens

Demirović¹,

Krušlin²

2017

Rad Hrvatske akademije znanosti i umjetnosti

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SummaryIn the post-genomic era of medicine, histopathological assessment of colorectal carcinoma specimens plays the key role in the comprehensive management of patients with colorectal cancer. Adequate specimen handling and dissection is a crucial step in obtaining a precise and accurate pathohistologic report. Microscopic analysis must give information on: histological tumour type and differentiation, maximum extent of local invasion (pT stage), grade of tumour regression following pre-operative (neoadjuvant) therapy, resection margins (longitudinal and circumferential margins), lymph node status, venous invasion, MSI status and other abnormal findings. Latest ESMO consensus guidelines for the management of patients with metastatic colorectal cancer emphasize the pathologist' role in this process. Recently defined molecular subtypes of colorectal cancer will hopefully serve as the basis for future trials.

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Delay to formalin fixation ‘cold ischemia time': effect on ERBB2 detection by in-situ hybridization and immunohistochemistry

Cited by 81 publications

References 28 publications

Implications of the Updated 2013 American Society of Clinical Oncology/College of American Pathologists Guideline Recommendations on Human Epidermal Growth Factor Receptor 2 Gene Testing Using Immunohistochemistry and Fluorescence In Situ Hybridization for Breast Cancer

Implications of the Updated 2013 American Society of Clinical Oncology/College of American Pathologists Guideline Recommendations on Human Epidermal Growth Factor Receptor 2 Gene Testing Using Immunohistochemistry and Fluorescence In Situ Hybridization for Breast Cancer

Effects of Cold Ischemia on Gene Expression: A Review and Commentary

Recommendations for histopathology report of colorectal carcinoma specimens

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