Impact of 2013 ASCO/CAP guidelines on HER2 determination of invasive breast cancer: A single institution experience using frontline dual-color FISH

Ragazzi, Moira; Bisagni, Alessandra; Gasparini, Elisa; Kuhn, Elisabetta; Bassano, Cristina; Tamagnini, Ione; Foroni, Monica; Bortesi, M; Falco, Giuseppe; Ferrari, Guglielmo; Braglia, Luca; Savoldi, Luisa; Bologna, Alessandra; Cicilia, Roberto Di; Bisagni, Giancarlo; Gardini, Giorgio

doi:10.1016/j.breast.2017.05.001

Cited by 15 publications

(18 citation statements)

References 32 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%

“…In the first category we compared the results of pooled sample of 9074 cases from seven studies [11,[13][14][15][16][17][18] in which the primary HER2 testing was performed by FISH and the cases were concurrently classified by both 2007 and 2013 ASCO/ CAP guidelines [Table 1a-c]. As clearly evident, with updated 2013 guidelines, using primary FISH reporting, there has been a substantial increase (1.7 to 6.5%) in the equivocal cases (P = <0.001) [ Table 1b] and significant increase (22.6 to 23.9%) in the HER2 amplified cases (P = 0.037) [ Table 1c].…”

Section: Resultsmentioning

confidence: 99%

“…On evaluation of the pooled data of 7 studies, [11,[13][14][15][16][17][18] which comprised of 9074 cases subjected to primary HER2 FISH testing, and concurrently classified by both 2007 and 2013 ASCO/CAP guidelines, a substantial increase in the equivocal and amplified cases has been seen with updated 2013 guidelines. Hence the updated (2013) guidelines selected more patients for HDT along with increase in the reflex testing and double equivocal cases, thereby increasing the cost and delaying the definite status.…”

Section: Discussionmentioning

confidence: 99%

“…Ragazzi et al [11] found that 58.9% (112 out of 190) of the equivocal cases by 2013 guidelines, were solved by reflex IHC and the rest remained double equivocal without any other additional testing.…”

Section: Discussionmentioning

confidence: 99%

“…Moreover, as by decreasing the threshold for the HER2 positive cases and increasing the additional patients eligible for HDT therapy, whether the clinical outcome is superior in these additional cases is an important research question which has been addressed to in some studies. [10,11] This systematic review and meta-analysis has been undertaken to see the impact of these updated 2013 ASCO/ CAP guidelines on various HER2 reporting categories by both FISH and IHC, and to assess the burden of additional reflex testing, which is more relevant in developing countries with financial constraints in the health sector. The paper also attends to see the impact of revised 2013 guidelines on the performance of reflex-FISH testing in equivocal IHC category on primary HER2 testing in comparison to 2007 guidelines.…”

Section: Introductionmentioning

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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