HER2 Testing and Clinical Decision Making in Gastroesophageal Adenocarcinoma: Guideline From the College of American Pathologists, American Society for Clinical Pathology, and American Society of Clinical Oncology

Bartley, Angela N.; Washington, Mary Kay; Ventura, Christina B.; Ismaila, Nofisat; Colasacco, Carol; Benson, Al B.; Carrato, Alfredo; Gulley, Margaret L.; Jain, Dhanpat; Kakar, Sanjay; Mackay, Helen; Streutker, Catherine; Tang, Laura H.; Troxell, Megan L.; Ajani, Jaffer A.

doi:10.5858/arpa.2016-0331-cp

Cited by 165 publications

(123 citation statements)

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“…Some recommended such cases should be subjected to in situ hybridization (ISH) test, and if amplification was detected, the case should be considered positive [6, 18]. A recent consensus from the College of American Pathologists, American Society for Clinical Pathology, and American Society of Clinical Oncology indicated that following the Ruschoff/Hofmann method, IHC results should be scored based on the staining pattern which accounted for ≥ 10% of tumor cells, and whether to perform ISH was determined by the IHC score [9]. Based on the current study, it might be reasonable to deduce that HER2 focal positive(< 10%) cases may also be eligible for trastuzumab treatment.…”

Section: Discussionmentioning

confidence: 99%

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Poor efficacy response to trastuzumab therapy in advanced gastric cancer with homogeneous HER2 positive and non-intestinal type

Jiang

et al. 2017

Oncotarget

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IntroductionFactors affecting trastuzumab efficacy in advanced gastric cancer (GC) are largely unknown. Heterogeneity is a notable feature of HER2 in GC. Whether the heterogeneity influences trastuzumab efficacy is still unknown.ResultsThe HER2homogeneous group and HER2heterogeneous group showed no statistical difference in RR (46.4% vs 55.0%, P = 0.558), PFS (5.80 vs 6.30 months, P = 0.804) and OS (16.00 vs 16.00 months, P = 0.787). The Laurenintestinal group and Laurennon-intestinal group demonstrated no discrepancy in PFS (6.00 vs 6.00 months, P = 0.912) and OS (16.50 vs 14.00 months, P = 0.227). However, by combining HER2 heterogeneity and Lauren classification, PFS and OS of HER2homogeneous/Laurennon-intestinal subgroup was the shortest among the 4 subgroups (P = 0.012 and P = 0.037), which was much shorter than the other patients (PFS:3.00 vs 6.30 months, P = 0.003; OS: 4.50 vs 16.50 months, P = 0.004). Univariate and multivariate analysis showed that HER2 heterogeneity combined with Lauren classification was an independent prognostic factor in both PFS (P = 0.031 and P = 0.002) and OS (P = 0.039 and P = 0.013).Materials and Methods48 patients with HER2 positive advanced GCs accepting trastuzumab treatment were retrospectively analyzed. Based on HER2 heterogeneity, the patients were divided into a HER2homogeneous group and a HER2heterogeneous group. Response rate (RR), progression free survival (PFS), and overall survival (OS) were compared. Main clinicopathological factors including Lauren classification were subjected to subgroup analysis.ConclusionsHER2 heterogeneity alone may not correlate with trastuzumab efficacy in HER2 positive advanced GCs. HER2 heterogeneity combined with Lauren classification may help to identify a subgroup with poor response to trastuzumab which is homogeneous HER2 positive and non-intestinal type.

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Section: Discussionmentioning

confidence: 99%

“…HER2 status has been studied extensively in GC, and criteria for HER2 interpretation has been established and standardized during these years [6–9]. HER2 is associated with Lauren classification, and HER2 positive GCs are mainly intestinal type [10–12].…”

Section: Introductionmentioning

confidence: 99%

Poor efficacy response to trastuzumab therapy in advanced gastric cancer with homogeneous HER2 positive and non-intestinal type

Jiang

et al. 2017

Oncotarget

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“…Evaluation of HER3 expression was performed by an experienced gynecological pathologist and two additional observers that independently evaluated HER3 scores in accordance with the HER2 testing guidelines for gastroesophageal cancer from the College of American Pathologists, American Society for Clinical Pathology, and American Society of Clinical Oncology ( 19 ). High HER3 expression (HER3-high) was defined as a score of 2+ or 3+, and low HER3 expression (HER3-low) was defined as a score of 0 or 1+; discrepancies were resolved by discussion and consensus.…”

Section: Methodsmentioning

confidence: 99%

Neoadjuvant chemotherapy promotes the expression of HER3 in patients with ovarian cancer

Mizuno¹,

Kojima²,

Yonemori³

et al. 2020

Oncol Lett

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HER3 (erbB3) signaling serves an important role in the development and chemoresistance of ovarian cancer, and is activated by chemotherapy. To evaluate the influence of neoadjuvant chemotherapy and other clinical factors on the expression of HER3, as well as to examine its role as a prognostic marker, the present study evaluated archived tissues from patients who underwent surgery for ovarian cancer between 2011 and 2018 at our hospital. Immunohistochemical staining for HER3 was performed using formalin-fixed paraffin-embedded surgical specimens and biopsy samples. In total, data from 111 patients with sufficient surgically resected tumor samples were extracted. A total of 28 patients with histology type high-grade serous carcinoma (HGSC) had specimens available from both pre-chemotherapy biopsies and post-chemotherapy surgery. High HER3 expression (HER3-high) was observed in 64 patients (58%), whereas low HER3 expression (HER3-low) was observed in 47 patients (42%). Multivariate logistic regression analysis identified neoadjuvant chemotherapy [odds ratio (OR), 7.49; 95% confidence interval (CI), 2.48–22.64; P<0.001) and non-HGSC histology (OR, 5.42; 95% CI, 1.99–14.78; P<0.001) as significant predictive factors for HER3-high. In pre-chemotherapy biopsy specimens, 15 patients were HER3-high and 13 were HER3-low. After chemotherapy, eight of 13 patients with HER3-low exhibited a change in status to HER3-high, with a trend toward poorer progression-free survival compared to that of patients whose status remained HER3-low. In conclusion, HER3 overexpression was revealed to be common among patients with ovarian cancer, especially in those with non-HGSC histology. In addition, HER3 expression may be promoted by chemotherapy. These findings suggested that patients with ovarian cancer are good candidates for emerging HER3-targeting therapies.

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“…Her2 testing methods and algorithm for EAC is similar to those in gastric adenocarcinoma, first by immunohistochemistry (IHC) followed by in situ hybridization (ISH) when immunohistochemistry result is 2+ (equivocal). Positive (3+) or negative (0 or 1+) immunohistochemistry results do not require further ISH testing [72]. Her2 IHC is graded as negative 0 (on membranous staining in any of the tumor cells), negative 1+ (faint/barely perceptible membranous staining), equivocal 2+ (weak to moderate, complete, basolateral and lateral membranous staining), and positive 3+ (strong, complete, basolateral and lateral membranous staining) and the cutoff of at least 10% of tumor resection specimen or a small cluster of at least 5 tumor cells in biopsy specimen is used [72].…”

Section: Ancillary Biomarkers For Be Dysplasia and Early Stage Eacmentioning

confidence: 99%

“…Positive (3+) or negative (0 or 1+) immunohistochemistry results do not require further ISH testing [72]. Her2 IHC is graded as negative 0 (on membranous staining in any of the tumor cells), negative 1+ (faint/barely perceptible membranous staining), equivocal 2+ (weak to moderate, complete, basolateral and lateral membranous staining), and positive 3+ (strong, complete, basolateral and lateral membranous staining) and the cutoff of at least 10% of tumor resection specimen or a small cluster of at least 5 tumor cells in biopsy specimen is used [72]. Cases with Her2 equivocal 2+ IHC result should be tested by ISH for Her2 amplification with positivity defined as Her2/CEP17 ratio ≥2.…”

Section: Ancillary Biomarkers For Be Dysplasia and Early Stage Eacmentioning

confidence: 99%

Histopathology of Barrett’s Esophagus and Early-Stage Esophageal Adenocarcinoma: An Updated Review

Yin

Gonzálo

Lai

et al. 2018

Gastrointestinal Disorders

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Esophageal adenocarcinoma carries a very poor prognosis. For this reason, it is critical to have cost-effective surveillance and prevention strategies and early and accurate diagnosis, as well as evidence-based treatment guidelines. Barrett’s esophagus is the most important precursor lesion for esophageal adenocarcinoma, which follows a defined metaplasia–dysplasia–carcinoma sequence. Accurate recognition of dysplasia in Barrett’s esophagus is crucial due to its pivotal prognostic value. For early-stage esophageal adenocarcinoma, depth of submucosal invasion is a key prognostic factor. Our systematic review of all published data demonstrates a “rule of doubling” for the frequency of lymph node metastases: tumor invasion into each progressively deeper third of submucosal layer corresponds with a twofold increase in the risk of nodal metastases (9.9% in the superficial third of submucosa (sm1) group, 22.0% in the middle third of submucosa (sm2) group, and 40.7% in deep third of submucosa (sm3) group). Other important risk factors include lymphovascular invasion, tumor differentiation, and the recently reported tumor budding. In this review, we provide a concise update on the histopathological features, ancillary studies, molecular signatures, and surveillance/management guidelines along the natural history from Barrett’s esophagus to early stage invasive adenocarcinoma for practicing pathologists.

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HER2 Testing and Clinical Decision Making in Gastroesophageal Adenocarcinoma: Guideline From the College of American Pathologists, American Society for Clinical Pathology, and American Society of Clinical Oncology

Abstract: - This guideline provides specific recommendations for assessment of HER2 in patients with advanced GEA while addressing pertinent technical issues and clinical implications of the results.

Cited by 165 publications

References 123 publications

Poor efficacy response to trastuzumab therapy in advanced gastric cancer with homogeneous HER2 positive and non-intestinal type

Poor efficacy response to trastuzumab therapy in advanced gastric cancer with homogeneous HER2 positive and non-intestinal type

Neoadjuvant chemotherapy promotes the expression of HER3 in patients with ovarian cancer

Histopathology of Barrett’s Esophagus and Early-Stage Esophageal Adenocarcinoma: An Updated Review

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