Impact of the 2013 ASCO/CAP HER2 revised guidelines on HER2 results in breast core biopsies with invasive breast carcinoma: a retrospective study

Overcast, Wynton B.; Zhang, Jianying; Zynger, Debra L.; Tozbikian, Gary

doi:10.1007/s00428-016-1951-8

Cited by 11 publications

(7 citation statements)

References 24 publications

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“…Total 16 studies [11,[13][14][15][16][17][18][19][20][21][22][23][24][25][26][27] were reviewed; of these there were 20 estimates, which has been summarized in web Table 1. This table highlights frequency and percentage of various HER2 reporting categories by FISH and IHC method according to both 2007 and 2013 guidelines.…”

Section: Resultsmentioning

confidence: 99%

“…The results are shown in Table 3a and b. In IHC category, data of 3 studies [23][24][25] were pooled with effective total sample size was 3056 (cases reported by 2007 guidelines) and 1554 (cases reported by 2013 guidelines). The increase in the equivocal category was from 23.7 to 26.7 % (P value: 0.025) while the increase in the positive category was from 12.9 to 15.8 % (P value: 0.0088), [ Table 3a].…”

Section: Resultsmentioning

confidence: 99%

“…In FISH reporting category, data of 3 studies [23,25,26] were pooled with effective total sample size was 2811 (cases Therefore, on evaluating the trend of HER2 reporting categories, with updated 2013 guidelines there is a significant increase in equivocal cases by both IHC and FISH; while significant increase in the positive cases occurred by IHC and…”

Section: Resultsmentioning

confidence: 99%

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Impact of 2013 ASCO/CAP guidelines on various HER2 reporting categories in breast cancer by fluorescent in-situ hybridization and Immunohistochemistry: A meta-analysis with systematic review

Pasricha

Asthana

Labani

et al. 2020

IJMIO

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Objective: The ASCO/CAP guidelines for reporting HER2 in breast cancer, first released in 2007, aimed to standardize the reporting protocol, and were updated in 2013 and 2018, to ensure right treatment. Several studies have analyzed the changes attributed to 2013 updated guidelines, and majority of them found increase in positive and equivocal cases. However, the precise implication of these updated guidelines is still contentious, in spite of the latest update (2018 guidelines) addressing some of the issues. We conducted systematic review and meta- analysis to see the impact of 2013 guidelines on various HER2 reporting categories by both FISH and IHC. Materials and Methods: After extensively searching the pertinent literature, 16 studies were included for the systematic review. We divided our approach in three strategies: (1) Studies in which breast cancer cases were scored for HER2 by FISH or IHC as a primary test concurrently by both 2007 and 2013 guidelines, (2) Studies in which HER2 results were equivocal by IHC and were followed by reflex-FISH test by both 2007 and 2013 guidelines, and (3) Studies in which trends of HER2 reporting were compared in the two periods before and after implementation of updated 2013 guidelines. All the paired data in these respective categories was pooled and analyzed statistically to see the overall impact of the updated guidelines. Results: In the first category, by pooled analysis of primary FISH testing there has been a significant increase in the equivocal cases (P < 0.001) and positive cases (P = 0.037). We also found 8.3% and 0.8% of all the negative cases from 2007 guidelines shifted to equivocal and positive categories, respectively. Similarly by primary IHC testing there has been a significant increase in both equivocal cases (P < 0.001) and positive cases (P = 0.02). In the second category of reflex-FISH testing there was a substantial increase in the equivocal cases (P < 0.0001); however there is insignificant decrease (10% to 9.7%; P = 0.66) in the amplified cases. In the third approach for evaluating the trend, with the implementation of 2013 guidelines, there was increase in the equivocal category (P = 0.025) and positive category (P = 0.0088) by IHC. By FISH test also there was significant increase in the equivocal category (P < 0.001) while the increase in the positive category was non-significant (P = 0.159). Conclusions: The updated 2013 guidelines has significantly increased the positive and equivocal cases using primary FISH or IHC test and with further reflex testing, thereby increasing the double equivocal cases and increasing the cost and delaying the decision for definite management. However, whether the additional patients becoming eligible for HDT will derive treatment benefit needs to be answered by further large clinical trials.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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Impact of 2013 ASCO/CAP guidelines on various HER2 reporting categories in breast cancer by fluorescent in-situ hybridization and Immunohistochemistry: A meta-analysis with systematic review

Pasricha

Asthana

Labani

et al. 2020

IJMIO

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“…85 Also, a greater proportion of tumors were reassigned to an equivocal ERBB2 status from an ERBB2 À status, which enabled these patients to receive trastuzumab and potentially benefit from this treatment. 86 Thus, it is important to interpret with caution any findings generated from publicly available microarray data sets, because an expectation would exist that a proportion of the tumors would have inaccurate hormone receptor status.…”

Section: Anita Muthukaruppan Et Almentioning

confidence: 99%

Multimodal Assessment of Estrogen Receptor mRNA Profiles to Quantify Estrogen Pathway Activity in Breast Tumors

Muthukaruppan

Lasham

Woad

et al. 2017

Clinical Breast Cancer

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“…In 2013, ASCO/CAP revised the HER2 guideline recommendations and interpretation criteria for both IHC and fluorescent ISH (FISH) assays . Published studies have shown that the HER2 equivocal rates increased under the revised guidelines, primarily due to increases in HER2 FISH equivocal rates . Consequently, HER2 equivocal breast cancer now represents a significant percentage of breast cancer patients diagnosed on core needle biopsy (CNB) …”

Section: Introductionmentioning

confidence: 99%

HER2 equivocal breast cancer that is positive by alternative probe HER2 FISH are classified as HER2 negative by Oncotype DX

Tozbikian

Zynger

2018

Breast J

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In breast cancer, human epidermal growth factor receptor 2 (HER2) status is determined by immunohistochemistry (IHC) and/or in situ hybridization. Oncotype DX also reports HER2 status by an rt-PCR-based assay. Assay concordance between IHC and fluorescent in situ hybridization (FISH) (including alternative probe HER2 FISH) vs Oncotype DX HER2 rt-PCR has not been described in the post-2013 American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) HER2 Guideline revision setting. We performed a retrospective review of HER2 equivocal invasive breast carcinoma from 2014 to 2016 with the Oncotype DX HER2 result. Fifteen patients with HER2 equivocal invasive breast cancer had Oncotype DX performed. Of these, 13 underwent alternative probe HER2 FISH yielding 4 negative, 6 equivocal and 3 positive results. All 15 cases were classified as HER2 negative by Oncotype DX rt-PCR, including the three cases which were positive by alternative probe HER2 FISH, yielding a discordance rate for Oncotype DX rt-PCR HER2 of 20% (3/15). All three patients with HER2-positive breast cancer on the basis of alternative probe HER2 FISH received anti-HER2-targeted therapy. Treatment decisions based on HER2 status should utilize the IHC/FISH result as Oncotype DX results may incorrectly disqualify some patients from being eligible for anti-HER2 therapy based on the current 2013 ASCO/CAP HER2 Guidelines.

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Impact of the 2013 ASCO/CAP HER2 revised guidelines on HER2 results in breast core biopsies with invasive breast carcinoma: a retrospective study

Cited by 11 publications

References 24 publications

Impact of 2013 ASCO/CAP guidelines on various HER2 reporting categories in breast cancer by fluorescent in-situ hybridization and Immunohistochemistry: A meta-analysis with systematic review

Impact of 2013 ASCO/CAP guidelines on various HER2 reporting categories in breast cancer by fluorescent in-situ hybridization and Immunohistochemistry: A meta-analysis with systematic review

Multimodal Assessment of Estrogen Receptor mRNA Profiles to Quantify Estrogen Pathway Activity in Breast Tumors

HER2 equivocal breast cancer that is positive by alternative probe HER2 FISH are classified as HER2 negative by Oncotype DX

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