Mise à jour 2021 des recommandations du GEFPICS pour l’évaluation du statut HER2 dans les cancers infiltrants du sein en France

Franchet, Camille; Djerroudi, Lounes; Maran-Gonzalez, Aurélie; Abramovici, Olivia; Antoine, Martine; Becette, Véronique; Berghian, Anca; Blanc-Fournier, Cécile; Brabencová, Eva; Charafe‐Jauffret, Emmanuelle; Chenard, Marie–Pierre; Dauplat, Marie-Mélanie; Delrée, P.; Duprez-Paumier, Raphaëlle; Fleury, Clémence; Ghnassia, Jean-Pierre; Haudebourg, Juliette; Leroux, Agnès; MacGrogan, Gaëtan; Mathieu, Marie‐Christine; Michenet, Patrick; Penault‐Llorca, Frédérique; Poulet, Bruno; Robin, Y.; Roger, Pascal; Russ, Elisabeth; Tixier, L.; Treilleux, Isabelle; Valent, Alexander; Verrièle, Véronique; Vincent‐Salomon, Anne; Arnould́, Laurent; Lacroix-Triki, Magali

doi:10.1016/j.annpat.2021.07.014

Cited by 31 publications

(17 citation statements)

References 45 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Future HER2 scoring will need to include more training for the HER2-low category of patients, and ASCO/CAP may refine their guidelines appropriately. Recently, French GEFPICS group published the first national recommendation for HER2 status evaluation in breast cancer with emphasis on the HER2-low concept underlining the need for harmonized testing guidelines [39]. Finally, we regard the results of this study as representative for all HER2 scores including the recently delineated HER2 low category as the carefully pre-selected case series representing the entire range of IHC scores and amplification levels, including different ISH subgroups [11,18].…”

Section: Discussionmentioning

confidence: 99%

Comparison of HercepTest™ mAb pharmDx (Dako Omnis, GE001) with Ventana PATHWAY anti-HER-2/neu (4B5) in breast cancer: correlation with HER2 amplification and HER2 low status

Rüschoff¹,

Friedrich²,

Nagelmeier³

et al. 2022

Virchows Arch

View full text Add to dashboard Cite

Performance of the new CE-IVD-marked HercepTest™ mAb pharmDx (Dako Omnis) assay (HercepTest (mAb)) was compared against the PATHWAY® anti-HER-2/neu (4B5) (PATHWAY 4B5) assay using 119 pre-selected breast cancer samples covering the entire range of HER2 immunohistochemistry (IHC) expression scores (0, 1 + , 2 + , 3 +). The sensitivity and specificity of both assays were assessed based on consensus IHC scores and amplification status, as determined by fluorescence in situ hybridization (FISH) according to 2018 ASCO/CAP testing guidelines. There was a high concordance between results from the HercepTest (mAb) and PATHWAY 4B5 assays for HER2-negative (IHC 0, 1 + , 2 + and FISH negative) and HER2-positive (IHC 3 + , 2 + and FISH positive) breast carcinomas (98.2%). Regarding individual IHC scores, complete agreement was achieved in 69.7% (83/119) of cases, and all but one of the discordant cases were due to higher HER2-status scoring using the HercepTest (mAb). Thus, more tumors were overscored as IHC 2 + by HercepTest (mAb) (27 versus 15) as evidenced by their lower FISH positivity rate (48.1% versus 80%). However, two amplified tumors identified as IHC 2 + by HercepTest (mAb) were missed by PATHWAY 4B5 (IHC 1 +). Four additional cases identified as IHC 2 + by HercepTest (mAb), with FISH ratio < 2 but elevated gene counts (≥ 4 to < 6), were recorded negative by PATHWAY 4B5. The HercepTest (mAb) detects HER2 expression with higher sensitivity in tumors with gene amplification (ISH group 1) and increased gene counts (ISH group 4) as well as in HER2-low tumors (HER2 IHC2 + /FISH negative or IHC 1 +). Future studies will demonstrate whether this translates into improved patient selection especially for new HER2-directed therapies.

show abstract

Section: Discussionmentioning

confidence: 99%

Comparison of HercepTest™ mAb pharmDx (Dako Omnis, GE001) with Ventana PATHWAY anti-HER-2/neu (4B5) in breast cancer: correlation with HER2 amplification and HER2 low status

Rüschoff¹,

Friedrich²,

Nagelmeier³

et al. 2022

Virchows Arch

View full text Add to dashboard Cite

show abstract

“…(Table 2) It is important to note these recommendations are not a revision to current ASCO-CAP HER2 Guideline Recommendation, the HER2 IHC cutoffs and scoring criteria are unchanged. What was added are suggestions for what magnification (objective lens) is needed to most accurately make these score determinations, and was meant to be a practical guide to assist pathologists better adhere to the current scoring guidelines 36,37 . Indeed, the importance of high power magnification is reiterated in the most recent 2023 ASCO-CAP HER2 Guideline Recommendation Update that explicitly indicates the need for examining HER2 IHC using the 40x objective lens when discriminating Score 0 versus 1+ results as a best practice 17 .…”

Section: Continued Diagnostic Challenges and Unresolved Questions In ...mentioning

confidence: 99%

The Significance of Recognition of Human Epidermal Growth Factor 2 Low in Breast Cancer Therapy

Tozbikian

2023

Advances in Anatomic Pathology

View full text Add to dashboard Cite

In response to recent clinical trials that demonstrate the clinical benefit of antibody-drug conjugate drug therapy in breast cancer (BC) with human epidermal growth factor 2 (HER2) immunohistochemical scores of 1+ or 2+ and negative in situ hybridization results, a new concept of “HER2-low BC” has emerged to describe this newly relevant therapeutic category of BC. Clinical recognition of HER2-low BC has caused a paradigm shift in the therapeutic landscape and management of patients with BC and resulted in rapid changes in clinical practice guidelines. In addition the American Society of Clinical Oncology-College of American Pathologists (ASCO-CAP) recently updated their HER2 Guidelines Recommendations to specifically address HER2-low BC. A literature search in PubMed of peer-reviewed articles, regulatory communications, and relevant practice guidelines pertaining to HER2-low BC was conducted. In this review, we have summarized current published knowledge regarding the clinicopathologic and molecular features, diagnostic criteria, and most current guideline recommendations regarding HER2-low BC, and also highlight ongoing practical and diagnostic challenges when identifying HER2-low BC in routine clinical practice.

show abstract

“…HER2 test results were interpreted according to the 2018 ASCO/CAP guidelines 16 . The sections were interpreted by two experienced pathologists (> 15 years' experience) according to the 2018 ASCO/CAP guidelines and 2021 French recommendations 17 for the assessment of HER2 status. Cases in which the assessments of the two pathologists were inconsistent, were reassessed by a third experienced pathologist.…”

Section: Clinical Datamentioning

confidence: 99%

The role of artificial intelligence in accurate interpretation of HER2 IHC 0 and 1+ in breast cancers

Yue

Zhang

et al. 2022

Preprint

View full text Add to dashboard Cite

The new HER2-targeting antibody drug conjugate offers the opportunity to treat patients with HER2-low breast cancer. Distinguishing HER2 immunohistochemistry (IHC) scores of 0 and 1+, is critical but also challenging due to HER2 heterogeneity and variability of observers. In this study, we aimed to increase interpretation accuracy and consistency of HER2 IHC 0 and 1 + evaluations through assistance from artificial intelligence (AI) algorithm. In addition, we examined the value of AI algorithm in evaluating HER2 IHC scores in tumors with heterogeneity. The AI-assisted interpretation consisted of AI algorithms and an augmenting reality module with microscope. Fifteen pathologists (5 junior, 5 mid-level and 5 senior) participated this multi-institutional two-round ring study that included 246 infiltrating duct carcinoma not otherwise specified (NOS) cases. In round 1, pathologists analyzed 246 HER2 IHC slides by microscope without AI assistance. After 2 weeks of washout period, the pathologists read the same slides with AI algorithm assistance and rendered the final results by adjusting to the AI algorithm. The interpretation accuracy was significantly increased with AI assistance (Accuracy 0.93 vs 0.80), as well as the evaluation precision of HER2 0 and the recall of HER2 1+. The AI algorithm also improved the total consistency (ICC = 0.542 to 0.812), especially in HER2 1 + cases. In cases with heterogeneity, the accuracy was improved significantly (Accuracy 0.68 to 0.89) and to similar level as cases without heterogeneity (Accuracy 0.95). Both accuracy and the consistency of junior pathologists were better improved than the mid-level and senior pathologists. To the best of our knowledge, it is the first study to show that the accuracy and consistency of HER2 IHC 0 and 1 + evaluations and the accuracy of HER2 IHC evaluation in breast cancers with heterogeneity can be significantly improved using AI-assisted interpretation.

show abstract

Mise à jour 2021 des recommandations du GEFPICS pour l’évaluation du statut HER2 dans les cancers infiltrants du sein en France

Cited by 31 publications

References 45 publications

Comparison of HercepTest™ mAb pharmDx (Dako Omnis, GE001) with Ventana PATHWAY anti-HER-2/neu (4B5) in breast cancer: correlation with HER2 amplification and HER2 low status

Comparison of HercepTest™ mAb pharmDx (Dako Omnis, GE001) with Ventana PATHWAY anti-HER-2/neu (4B5) in breast cancer: correlation with HER2 amplification and HER2 low status

The Significance of Recognition of Human Epidermal Growth Factor 2 Low in Breast Cancer Therapy

The role of artificial intelligence in accurate interpretation of HER2 IHC 0 and 1+ in breast cancers

Contact Info

Product

Resources

About