To update the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline recommendations for human epidermal growth factor receptor 2 (HER2) testing in breast ...cancer to improve the accuracy of HER2 testing and its utility as a predictive marker in invasive breast cancer.
ASCO/CAP convened an Update Committee that included coauthors of the 2007 guideline to conduct a systematic literature review and update recommendations for optimal HER2 testing.
The Update Committee identified criteria and areas requiring clarification to improve the accuracy of HER2 testing by immunohistochemistry (IHC) or in situ hybridization (ISH). The guideline was reviewed and approved by both organizations.
The Update Committee recommends that HER2 status (HER2 negative or positive) be determined in all patients with invasive (early stage or recurrence) breast cancer on the basis of one or more HER2 test results (negative, equivocal, or positive). Testing criteria define HER2-positive status when (on observing within an area of tumor that amounts to >10% of contiguous and homogeneous tumor cells) there is evidence of protein overexpression (IHC) or gene amplification (HER2 copy number or HER2/CEP17 ratio by ISH based on counting at least 20 cells within the area). If results are equivocal (revised criteria), reflex testing should be performed using an alternative assay (IHC or ISH). Repeat testing should be considered if results seem discordant with other histopathologic findings. Laboratories should demonstrate high concordance with a validated HER2 test on a sufficiently large and representative set of specimens. Testing must be performed in a laboratory accredited by CAP or another accrediting entity. The Update Committee urges providers and health systems to cooperate to ensure the highest quality testing.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, OILJ, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK, VSZLJ
To update recommendations on appropriate use of breast cancer biomarker assay results to guide adjuvant endocrine and chemotherapy decisions in early-stage breast cancer.
An updated literature search ...identified randomized clinical trials and prospective-retrospective studies published from January 2016 to October 2021. Outcomes of interest included overall survival and disease-free or recurrence-free survival. Expert Panel members used informal consensus to develop evidence-based recommendations.
The search identified 24 studies informing the evidence base.
Clinicians may use Onco
DX, MammaPrint, Breast Cancer Index (BCI), and EndoPredict to guide adjuvant endocrine and chemotherapy in patients who are postmenopausal or age > 50 years with early-stage estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative (ER+ and HER2-) breast cancer that is node-negative or with 1-3 positive nodes. Prosigna and BCI may be used in postmenopausal patients with node-negative ER+ and HER2- breast cancer. In premenopausal patients, clinicians may use Onco
in patients with node-negative ER+ and HER2- breast cancer. Current data suggest that premenopausal patients with 1-3 positive nodes benefit from chemotherapy regardless of genomic assay result. There are no data on use of genomic tests to guide adjuvant chemotherapy in patients with ≥ 4 positive nodes. Ki67 combined with other parameters or immunohistochemistry 4 score may be used in postmenopausal patients without access to genomic tests to guide adjuvant therapy decisions. BCI may be offered to patients with 0-3 positive nodes who received 5 years of endocrine therapy without evidence of recurrence to guide decisions about extended endocrine therapy. None of the assays are recommended for treatment guidance in individuals with HER2-positive or triple-negative breast cancer. Treatment decisions should also consider disease stage, comorbidities, and patient preferences.Additional information is available at www.asco.org/breast-cancer-guidelines.
A pilot study examined the extent to which eye movements occurring during interpretation of digitized breast biopsy whole slide images (WSI) can distinguish novice interpreters from experts, ...informing assessments of competency progression during training and across the physician-learning continuum. A pathologist with fellowship training in breast pathology interpreted digital WSI of breast tissue and marked the region of highest diagnostic relevance (dROI). These same images were then evaluated using computer vision techniques to identify visually salient regions of interest (vROI) without diagnostic relevance. A non-invasive eye tracking system recorded pathologists' (N = 7) visual behavior during image interpretation, and we measured differential viewing of vROIs versus dROIs according to their level of expertise. Pathologists with relatively low expertise in interpreting breast pathology were more likely to fixate on, and subsequently return to, diagnostically irrelevant vROIs relative to experts. Repeatedly fixating on the distracting vROI showed limited value in predicting diagnostic failure. These preliminary results suggest that eye movements occurring during digital slide interpretation can characterize expertise development by demonstrating differential attraction to diagnostically relevant versus visually distracting image regions. These results carry both theoretical implications and potential for monitoring and evaluating student progress and providing automated feedback and scanning guidance in educational settings.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
To update ASCO-College of American Pathologists (CAP) recommendations for human epidermal growth factor receptor 2 (HER2) testing in breast cancer. The Panel is aware that a new generation of ...antibody-drug conjugates (ADCs) targeting the HER2 protein is active against breast cancers that lack protein overexpression or gene amplification.
An Update Panel conducted a systematic literature review to identify signals for updating recommendations.
The search identified 173 abstracts. Of five potential publications reviewed, none constituted a signal for revising existing recommendations.
The 2018 ASCO-CAP recommendations for HER2 testing are affirmed.
HER2 testing guidelines have focused on identifying HER2 protein overexpression or gene amplification in breast cancer to identify patients for therapies that disrupt HER2 signaling. This update acknowledges a new indication for trastuzumab deruxtecan when HER2 is not overexpressed or amplified but is immunohistochemistry (IHC) 1+ or 2+ without amplification by in situ hybridization. Clinical trial data on tumors that tested IHC 0 are limited (excluded from DESTINY-Breast04), and evidence is lacking that these cancers behave differently or do not respond similarly to newer HER2 ADCs. Although current data do not support a new IHC 0 versus 1+ prognostic or predictive threshold for response to trastuzumab deruxtecan, this threshold is now relevant because of the trial entry criteria that supported its new regulatory approval. Therefore, while it is premature to create new result categories of HER2 expression (eg, HER2-Low, HER2-Ultra-Low), best practices to distinguish IHC 0 from 1+ are now clinically relevant. This Update affirms prior HER2 reporting recommendations and offers a new HER2 testing reporting comment to highlight the current relevance of IHC 0 versus 1+ results and best practice recommendations to distinguish these often subtle differences.Additional information is available at www.asco.org/breast-cancer-guidelines.
To quantify the prevalence of parental vaccine hesitancy (VH) in the United States and examine the association of VH with sociodemographics and childhood influenza vaccination coverage.
A 6-question ...VH module was included in the 2018 and 2019 National Immunization Survey-Flu, a telephone survey of households with children age 6 months to 17 years.
The percentage of children having a parent reporting they were "hesitant about childhood shots" was 25.8% in 2018 and 19.5% in 2019. The prevalence of concern about the number of vaccines a child gets at one time impacting the decision to get their child vaccinated was 22.8% in 2018 and 19.1% in 2019; the prevalence of concern about serious, long-term side effects impacting the parent's decision to get their child vaccinated was 27.3% in 2018 and 21.7% in 2019. Only small differences in VH by sociodemographic variables were found, except for an 11.9 percentage point higher prevalence of "hesitant about childhood shots" and 9.9 percentage point higher prevalence of concerns about serious, long-term side effects among parents of Black compared with white children. In both seasons studied, children of parents reporting they were "hesitant about childhood shots" had 26 percentage points lower influenza vaccination coverage compared with children of parents not reporting hesitancy.
One in 5 children in the United States have a parent who is vaccine hesitant, and hesitancy is negatively associated with childhood influenza vaccination. Monitoring VH could help inform immunization programs as they develop and target methods to increase vaccine confidence and vaccination coverage.
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