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Context.—: Biomarkers in breast cancer need strict monitoring given their role in patient management., Objective.—: To study the impact that regular participation in the National Cancer Grid (NCG) external quality assurance (EQA) system has on concordance rates for biomarkers in breast carcinoma., Design.—: Tissue microarrays (TMAs) containing breast carcinomas were circulated to participating laboratories that performed immunohistochemistry for breast biomarkers. The returned TMAs were then assessed for test concordance., Results.—: A total of 105 laboratories participated in the estrogen receptor (ER) and progesterone receptor (PR) EQA system cycles, and 99 centers participated in the human epidermal growth factor 2 (HER2) EQA system. In the ER EQA in the first cycle only 1 laboratory had a 100% concordance rate, which improved to 59 of 77 (76.6%) and 85 of 97 (87.6%) in the fourth and fifth cycles, respectively. In the PR EQA the 100% pass rate jumped from zero to 52 of 76 (68.4%) in the fourth cycle and 86 of 97 (88.6%) in the last cycle. For HER2 EQA, the 100% pass rates were seen in 7 of 23 laboratories (30.4%) in the first cycle, 49 of 78 laboratories (62.8%) in the fourth cycle, and 48 of 94 laboratories (51.1%) in fifth cycle of EQA. Centers that participated in the NCG EQA system for a longer period often changed testing methodology, with consequent improvement in their laboratory concordance rates. An increasing trend for the use of automated platforms and of the US Food and Drug Administration-approved antibody for HER2 testing was observed., Conclusions.—: Our experience demonstrates that laboratory performance improves with participation in an EQA system even in less perfect settings, and this drives the placement of more proficient practices across the country., Competing Interests: The authors have no relevant financial interest in the products or companies described in this article., (© 2024 College of American Pathologists.)

Background: Oesophageal cancer both squamous cell [SCC] and adenocarcinoma have poor outcomes with high morbidity and mortality. Our hospital-based registry for year 2017-2018 showed that oesophageal cancer constituted 22.7% of annual case load. The main objective of this study was to determine the presence of HER-2 receptors in patients with oesophageal carcinoma in our region., Methodology: From September 2018 to September 2019, data regarding expression of HER-2 receptors was analysed in 133 patients of oesophageal carcinoma. Data were statistically described as frequencies (number of cases) and percentages where appropriate. Chi-square and Fischer's exact test was used to find out the association between categorical variables. A P value less than 0.05 was considered as statistical significant at 95% confidence interval. The statistical analysis was performed using SSPS [statistical package for the social sciences] software version 17.0., Results: A total of 133 patients were taken into study. Majority of patients were males (96) with mean age of 52 years. Squamous cell carcinoma was predominant histology. HER-2 receptor positivity was seen in 6.01% of patients. Patients with HER-2 receptor positivity presented in advanced stage with poor functional status and poor grades of differentiation. Statistically significant correlation of Her-2 expression was seen with stage (p = 0.001) and pathology of tumour (p = 0.0001)., Conclusion: Squamous cell carcinoma of oesophagus still predominates in North-eastern part of India. For studying the role of effective targeted therapies knowledge of frequency of HER-2 receptor positivity is of utmost importance in our population, and our study aims to answer this question. The present study shows low prevalence of HER-2 neu overexpression in our community, probably due to disproportionately high incidence of SCC compared to adenocarcinoma. Patients with HER-2 receptor positivity presented in advanced stage with poor functional status and poor grades of differentiation.

The aim was to assess the association of histological tumor grade with other clinical features and epidemiological factors of women with invasive breast carcinoma. A retrospective study of 103 Mizo breast cancer patients visiting hospitals was made in Aizawl, Mizoram, Northeast India. With a prior consent, information on epidemiological factors and family history in relation to cancer was obtained. Clinical reports were obtained from their medical records. The frequency of distribution was calculated for age at diagnosis and tumor characteristics. Statistical analysis for different variables was done using a chi-square test. p < 0.05 was considered significant. The histological tumor grades in our studies were found to be associated with lymph node invasion (p < 0.021), different subtype of hormone receptor such as ER status (p < 0.004), ER/PR status (p < 0.007), HER2/neu status (p < 0.014), and ER/PR/HER2 status (p < 0.025). A patient with a family history of breast cancer in their 1st degree relative is also seen to have association in determining the tumor grade (p < 0.003). Reproductive history, lifestyle and dietary habits, tobacco, and alcohol consumption were found to have no influence on breast cancer tumor grade. Our results showing significant correlation between status of lymph node, ER, PR, and HER2/neu oncoprotein and family history with 1st degree relative breast cancer are the first time report to target and focus on the possible role of biomarkers for diagnosis among the Mizo tribal breast cancer patients.

Background: Preoperative or neoadjuvant chemotherapy is an option in patients with large operable breast cancer to facilitate the breast conservation and to downstage the disease to make inoperable breast cancer to operable one. It is also called the window of opportunity; it provides a unique opportunity to derive biological information related to tumor response. Neoadjuvant chemotherapy has been compared with standard, postoperative adjuvant chemotherapy with goals of improving survival and facilitating local therapies. Unfortunately, neoadjuvant chemotherapy does not seem to improve overall survival. There is a lack of data from India regarding the neoadjuvant chemotherapy. The present study was carried out to assess the response to neoadjuvant chemotherapy in breast cancer., Materials and Methods: We retrospectively analyzed the records of patients who were started on neoadjuvant chemotherapy (NACT) at our center for 1 year (August 2012 to July 2013). Case files were thoroughly reviewed, and patient's characteristics (age, pre-/postmenopausal status, family history of breast/ovarian/other cancer), mode of detection, treatment, and histological features were analyzed., Results: Out of 322 patients with breast cancer registered in our institute, 80 patients received neoadjuvant chemotherapy. Median age was 45 years. The most common presentation was left-sided breast lump (Lt > Rt) with a median duration of symptoms was 4 months. Postmenopausal patients (53.75 %) were more than premenopausal (46.25 %). Seventy-two patients were stage III and 8 were stage II disease. Bilateral breast cancer was seen in 8 patients. Most common histological type was invasive ductal carcinoma (95 %). Estrogen receptor (ER) and/or progesterone (PR) positive were seen in 47 (58.75 %) patients. Ten patients were HER2 positive and ER/PR negative, and 5 patients were triple positive. Triple-negative patients were 22 (27.5 %). The most common neoadjuvant chemotherapy protocol used was FEC. Clinical response before surgery was CR 13 %, PR 68.68 %, stable disease 11.62 %, and progressive disease 4.65 %. Pathological CR was seen in 6.9 % of tumors. Nodal status at surgery was ypN0-40 %, ypN1-28. 5 %. ypN2-27 %, and ypN3-4.28 %., Conclusion: In a population of predominantly locally advanced patients, NACT with anthracyclines yielded pCR rates comparable to published studies. There were a high proportion of HER2-positive patients, most of whom could not receive anti-HER2 therapy due to financial reasons.

Background: In India, the incidence of breast cancer has increased in the urban population, with 1 in every 22 women diagnosed with breast cancer. It is important to know the HER2/neu gene status for a better prognostication of these patients., Aim: The aim of this study was to compare the efficacy of fluorescence in situ hybridization (FISH) and immunohistochemistry (IHC) for determining HER2/neu alteration in breast carcinoma., Materials and Methods: A total of 188 histologically proven breast carcinoma cases between the years 2007 and 2011 were retrospectively analyzed on the paraffin tissue sections by both IHC and FISH techniques. FISH for HER2/neu gene amplification was performed on cases where the IHC status was already known and the results were compared., Results: A total of 64 (30%) patients were found to be amplified and the remaining 124 (65.9%) cases were found to be unamplified through FISH. Patients observed with 3+ reading on IHC were later confirmed as unamplified in 29.5% cases through FISH., Conclusion: It has been confirmed with the present study that IHC is a prudent first-step technique to screen tissue samples for HER2/neu gene status, but should be supplemented with the FISH technique especially in equivocal cases.

Oral cancer is commonly preceded by premalignant lesions and conditions. The clinician's ability to identify lesions at an increased risk of cancer development is critical for its control. The purpose of this study was to compare the expression of tumor suppressor gene p53, proliferation marker Ki-67, and oncogene c-erbB2 and to evaluate the relevance of their co-expression in the diagnosis of, and prognosis for, oral leukoplakia. In the present study, the expression of biomarkers was studied immunohistochemically in 55 cases of leukoplakia (26 without dysplasia, 29 with dysplasia) and 10 cases of normal epithelia. The Labeling Indices (LI) of p53 and Ki-67 were found to increase significantly with an increase in the grade of dysplasia. A significant correlation was also found between the LI of p53 and that of Ki-67. It was also observed that c-erbB2 expression was only cytoplasmic, indicating incomplete receptor degradation. Hence, it can be concluded from the present study that the increased expression of p53 and Ki-67 with an increase in the grade of dysplasia suggests that their co-expression may be used for the identification of high-risk lesions. Also, c-erbB2 has no pathogenetic role in early carcinogenesis in the studied population, although incomplete receptor degradation, as evidenced by cytoplasmic staining, may indicate an early change.

The incidence of breast cancer is increasing worldwide. In this review article, the authors compare and contrast the incidence of breast cancer, and the inherent differences in the United States (US) and India in screening techniques used for diagnosing breast cancer. In spite of these differences, core biopsies of the breast are common for diagnosis of breast cancer in both countries. The authors describe "Best Practices" in the reporting and processing of core biopsies and in the analysis of estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor Receptor 2 (Her2/neu). The pitfalls in the diagnosis of fibroepithelial lesions of the breast on core biopsy are discussed, as also the significance of pseudoangiomatous stromal hyperplasia of the breast (PASH) is discussed in core biopsy. In this review, the management and diagnosis of flat epithelial atypia and radiation atypia are elaborated and the use of immunohistochemistry (IHC) in papillary lesions, phyllodes tumor, and complex sclerosing lesions (radial scars) is illustrated. Rarer lesions such as mucinous and histiocytoid carcinoma are also discussed.

Background & Objectives: Determination of HER2 status in breast cancer has become important to identify potential candidates for anti-HER2 therapy. In this study we compared fluorescence in situ hybridization (FISH) and immunohistochemistry (IHC) for the determination of HER2 status in breast cancer patients referred to a tertiary care referral centre., Methods: A total of 200 cases of invasive breast cancer were evaluated for HER2 status using IHC and FISH and results were compared., Results: The IHC 3+ (93.9%) and IHC negative (85.9%) cases showed good concordance with the corresponding FISH results; while 66.6 per cent of IHC 2+ cases showed gene amplification by FISH. In addition, hormone receptor expression and HER2 gene status showed a statistically significant inverse association (P<0.05)., Interpretation & Conclusion: These findings reaffirm IHC as a prudent first-step to screen tissue samples for HER2 status and to determine suitability for technically demanding FISH test and the dual coloured FISH as a gold standard for determination of HER2/neu status in IHC equivocal cases of breast carcinoma.

Aims: To document the pathological features of breast carcinoma diagnosed in women aged 35 years or less., Methods: The files of the Department of Pathology, Singapore General Hospital, were searched for cases of breast cancer diagnosed in individuals aged 35 years or less between January 1993 and December 2004. Histological slides and pathology reports were retrieved and reviewed. Pathologic parameters of tumour size, histological grade, accompanying ductal carcinoma in situ (DCIS), lymphovascular invasion, nodal status, hormone receptor and c-erbB-2 profiles, were documented., Results: Of 112 cases of breast cancer, 91 (81.3%) were invasive carcinomas, 17 (15.2%) pure DCIS, three (2.7%) were diagnosed on needle aspirates. No residual tumour was available for microscopic assessment in one (0.9%) patient who underwent bilateral mastectomy in our institution but had her initial surgery elsewhere. Invasive tumour size ranged from 0.3 to 11.5 cm (mean 2.7 cm, median 2.1 cm), with 84 (92.3%) infiltrative ductal, two (2.2%) lobular, two (2.2%) mucinous, two (2.2%) atypical medullary, and one (1.1%) mixed ductal-lobular. The majority were grade 3 (54 cases, 59.3%), with 24 (26.4%) grade 2 and 7 (7.7%) grade 1, while grading was not accomplished in six (6.6%) cases. Nodal status was positive in 39 (42.9%), negative in 25 (27.4%), unknown in the rest (27 cases, 29.7%). Oestrogen and progesterone receptors (ER, PR) were positive in 51 (61.4%) and 43 (51.8%) cases, respectively, out of 83 (91.2%) cases in which they were evaluated. c-erbB-2 immunostaining, carried out in 54 (59.3%) invasive cancers, showed positivity in 16 (29.6%) cases.DCIS cases ranged from 0.25 to 6.2 cm (mean 2.2 cm, median 2 cm) in size. Nuclear grade was low in seven (41.2%), intermediate in four (23.5%), and high in six (35.3%)., Conclusion: The majority of breast carcinomas in young women are invasive, with T2 disease at presentation, and of poor histological grade. The recent rise in numbers suggests increased detection, plausibly due to improved awareness of breast disease among the younger female population. Pathogenetic causes that differ from breast carcinogenesis in older women have to be further clarified.