RESUMO
PURPOSE: In the United States, a comprehensive national breast cancer registry (CR) does not exist. Thus, care and coverage decisions are based on data from population subsets, other countries, or models. We report a prototype real-world research data mart to assess mortality, morbidity, and costs for breast cancer diagnosis and treatment. METHODS: With institutional review board approval and Health Insurance Portability and Accountability Act (HIPPA) compliance, a multidisciplinary clinical and research data warehouse (RDW) expert group curated demographic, risk, imaging, pathology, treatment, and outcome data from the electronic health records (EHR), radiology (RIS), and CR for patients having breast imaging and/or a diagnosis of breast cancer in our institution from January 1, 2004, to December 31, 2020. Domains were defined by prebuilt views to extract data denormalized according to requirements from the existing RDW using an export, transform, load pattern. Data dictionaries were included. Structured query language was used for data cleaning. RESULTS: Five-hundred eighty-nine elements (EHR 311, RIS 211, and CR 67) were mapped to 27 domains; all, except one containing CR elements, had cancer and noncancer cohort views, resulting in a total of 53 views (average 12 elements/view; range, 4-67). EHR and RIS queries returned 497,218 patients with 2,967,364 imaging examinations and associated visit details. Cancer biology, treatment, and outcome details for 15,619 breast cancer cases were imported from the CR of our primary breast care facility for this prototype mart. CONCLUSION: Institutional real-world data marts enable comprehensive understanding of care outcomes within an organization. As clinical data sources become increasingly structured, such marts may be an important source for future interinstitution analysis and potentially an opportunity to create robust real-world results that could be used to support evidence-based national policy and care decisions for breast cancer.
Assuntos
Neoplasias da Mama , Humanos , Estados Unidos/epidemiologia , Feminino , Neoplasias da Mama/diagnóstico por imagem , Neoplasias da Mama/terapia , Data Warehousing , Registros Eletrônicos de Saúde , Sistema de Registros , Diagnóstico por ImagemRESUMO
Magee equations (MEs) are a set of multivariable models that were developed to estimate the actual Onco type DX (ODX) recurrence score in invasive breast cancer. The equations were derived from standard histopathologic factors and semiquantitative immunohistochemical scores of routinely used biomarkers. The 3 equations use slightly different parameters but provide similar results. ME1 uses Nottingham score, tumor size, and semiquantitative results for estrogen receptor (ER), progesterone receptor, HER2, and Ki-67. ME2 is similar to ME1 but does not require Ki-67. ME3 includes only semiquantitative immunohistochemical expression levels for ER, progesterone receptor, HER2, and Ki-67. Several studies have validated the clinical usefulness of MEs in routine clinical practice. The new cut-off for ODX recurrence score, as reported in the Trial Assigning IndividuaLized Options for Treatment trial, necessitated the development of Magee Decision Algorithm (MDA). MEs, along with mitotic activity score can now be used algorithmically to safely forgo ODX testing. MDA can be used to triage cases for molecular testing and has the potential to save an estimated $300,000 per 100 clinical requests. Another potential use of MEs is in the neoadjuvant setting to appropriately select patients for chemotherapy. Both single and multi-institutional studies have shown that the rate of pathologic complete response (pCR) to neoadjuvant chemotherapy in ER+/HER2-negative patients can be predicted by ME3 scores. The estimated pCR rates are 0%, <5%, 14%, and 35 to 40% for ME3 score <18, 18 to 25, >25 to <31, and 31 or higher, respectively. This information is similar to or better than currently available molecular tests. MEs and MDA provide valuable information in a time-efficient manner and are available free of cost for anyone to use. The latter is certainly important for institutions in resource-poor settings but is also valuable for large institutions and integrated health systems.
Assuntos
Neoplasias da Mama , Receptores de Progesterona , Humanos , Feminino , Antígeno Ki-67 , Receptores de Progesterona/metabolismo , Imuno-Histoquímica , Neoplasias da Mama/metabolismo , Receptor ErbB-2/metabolismo , Biomarcadores Tumorais/análise , Recidiva Local de Neoplasia/metabolismoRESUMO
OBJECTIVES: We present a retrospective review of 111 breast core biopsy specimens with flat epithelial atypia (FEA) and corresponding excision to better understand rates of upgrade following this diagnosis. METHODS: In total, 252 breast core biopsy specimens were identified. Cases were excluded if biopsy slides or excision results were unavailable, for ipsilateral carcinoma or other findings warranting excision, or biopsy performed for indications other than mammographically detected calcifications. Coincident atypical lobular hyperplasia was not excluded. Diagnoses were confirmed by breast pathologists, and mammographic images were reviewed. RESULTS: Ultimately, 111 biopsy specimens with FEA were included. In subsequent excisions, one (1%) of 111 showed invasive carcinoma, 20 (18%) atypical ductal hyperplasia, 20 (18%) lobular neoplasia, 31 (28%) FEA, and 39 (35%) no atypical findings. CONCLUSIONS: FEA on core biopsy specimens is associated with a low rate of upgrade to invasive carcinoma. Close follow-up may be a reasonable alternative to excision for isolated FEA on core needle biopsy specimens.
Assuntos
Neoplasias da Mama/patologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Biópsia com Agulha de Grande Calibre , Carcinoma Intraductal não Infiltrante/patologia , Feminino , Humanos , Hiperplasia , Pessoa de Meia-Idade , Gradação de Tumores , Invasividade Neoplásica , Estudos RetrospectivosRESUMO
Objectives: To investigate use of Magee equations (MEs) to determine which breast cancer cases can be excluded from Oncotype DX testing. Methods: A prospective value study was carried out using data from pathology reports. Results: If all three MEs scores were less than 18 or 31 or higher, the cases were labeled do not send for testing. If any or all scores were 18 to 25, cases were labeled do not send if mitosis score was 1. Of the total 205 cases, 146 (71%) were labeled do not send; of these, the correct call was made in 143 (98%) cases. Two of the three discordant cases had associated nontumor factors, likely resulting in higher scores. Conclusions: Cases with ME scores less than 18, or 18 to 25 and mitosis score 1, do not require Oncotype DX testing, an estimated saving of US$280,000 per 100 clinical requests.
Assuntos
Neoplasias da Mama/genética , Mitose/genética , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/patologia , Testes Diagnósticos de Rotina , Feminino , Perfilação da Expressão Gênica , Humanos , Estudos ProspectivosRESUMO
PURPOSE: Recommendations for standardization of breast biomarkers including estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor 2 (HER2) led to the creation of American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines to provide continuous guidance. Included in these recommendations is the "ongoing assay assessment procedures." We report these biomarker metrics as there is a dearth of published information on this topic. MATERIALS AND METHODS: ER, PR, and HER2 positivity rates of all newly diagnosed, recurrent, and metastatic invasive breast cancers on core biopsies, and repeated testing on resection specimen by immunohistochemistry (IHC) and/or fluorescence in situ hybridization (FISH) were collected from April 1, 2008 to December 31, 2017. RESULTS: The positivity rates of ER, PR, and HER2 over almost 10 years of monitoring showed high fidelity. Total ER-positive rate was 83.6% (81.4% to 86.8%), ER+/PR+ was 71.7% (68.6% to 75.5%), ER+/PR- was 17.6% (11.0% to 15.0%), ER-/PR- was 16.0% (13.5% to 18.2%), and ER-/PR+ was 0.6% (0.2% to 1.0%). The HER2-positive rate was 13.7% (10.2% to 17.4%) including 9.9% (7.3% to 11.9%) by IHC and 3.8% (1.9% to 5.9%) by FISH reflexed from IHC 2+ results. FISH amplification rate of HER2 IHC 2+ cases was 11.0% (5.8% to 19.2%). Annual quality-assurance check for HER2 IHC/FISH percent positive and percent negative agreement (as defined by Food and Drug Administration) was 96% to 100%. CONCLUSIONS: This longitudinal active assessment of 9564 breast biomarker cases shows the achievement of high fidelity of breast biomarker results when following the ASCO/CAP guidelines. Continuous monitoring of breast biomarkers may minimize assay analytical drift and assure quality clinically relevant results.
Assuntos
Biomarcadores Tumorais/metabolismo , Neoplasias da Mama , Proteínas de Neoplasias/metabolismo , Neoplasias da Mama/epidemiologia , Neoplasias da Mama/metabolismo , Neoplasias da Mama/patologia , Feminino , Humanos , Imuno-Histoquímica , Hibridização in Situ Fluorescente , Estudos RetrospectivosRESUMO
OBJECTIVES: Pathologic complete response (pCR) rate after neoadjuvant chemotherapy was compared between 141 estrogen receptor (ER)-negative (43%), 41 low ER+ (13%), 47 moderate ER+ (14%), and 98 high ER+ (30%) tumors. METHODS: Human epidermal growth factor receptor 2-positive cases, cases without semiquantitative ER score, and patients treated with neoadjuvant endocrine therapy alone were excluded. RESULTS: The pCR rate of low ER+ tumors was similar to the pCR rate of ER- tumors (37% and 26% for low ER and ER- respectively, P = .1722) but significantly different from the pCR rate of moderately ER+ (11%, P = .0049) and high ER+ tumors (4%, P < .0001). Patients with pCR had an excellent prognosis regardless of the ER status. In patients with residual disease (no pCR), the recurrence and death rate were higher in ER- and low ER+ cases compared with moderate and high ER+ cases. CONCLUSIONS: Low ER+ breast cancers are biologically similar to ER- tumors. Semiquantitative ER H-score is an important determinant of response to neoadjuvant chemotherapy.
Assuntos
Neoplasias da Mama/patologia , Terapia Neoadjuvante , Receptor ErbB-2/metabolismo , Área Sob a Curva , Neoplasias da Mama/diagnóstico , Neoplasias da Mama/tratamento farmacológico , Intervalo Livre de Doença , Humanos , Imuno-Histoquímica , Modelos Logísticos , Pessoa de Meia-Idade , Recidiva Local de Neoplasia , PrognósticoRESUMO
OBJECTIVES: We hypothesized that prognostic accuracy of the residual disease in breast and lymph nodes (RDBN) method, which is calculated using residual tumor size, nodal involvement, and tumor grade, may be improved by incorporating residual tumor cellularity. METHODS: Cases included 614 patients who underwent neoadjuvant therapy for breast cancer. Tumor size was adjusted for residual cellularity of invasive carcinoma and used to calculate modified RDBN (mRDBN) and compared with unmodified gross tumor size (gRDBN). RESULTS: RDBN could be calculated in 428 cases. Relative risks of recurrence and death were significantly higher for RDBN-3 and RDBN-4 compared with RDBN-1. Kaplan-Meier analysis showed significant differences in disease-free survival and overall survival for estrogen receptor (ER)-negative/human epidermal growth factor receptor 2 (HER2)-negative and ER-positive/HER2-negative subgroups (P < .0001). CONCLUSIONS: Both mRDBN and gRDBN provide prognostic information, particularly in HER2-negative carcinoma; however, mRDBN showed better stratification of RDBN-3 and RDBN-4 patients.
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Algoritmos , Antineoplásicos/uso terapêutico , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/patologia , Carcinoma Ductal de Mama/tratamento farmacológico , Carcinoma Ductal de Mama/patologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Neoplasias da Mama/mortalidade , Neoplasias da Mama/cirurgia , Carcinoma Ductal de Mama/mortalidade , Carcinoma Ductal de Mama/cirurgia , Quimioterapia Adjuvante , Feminino , Seguimentos , Humanos , Metástase Linfática , Mastectomia , Pessoa de Meia-Idade , Terapia Neoadjuvante , Gradação de Tumores , Neoplasia Residual , Prognóstico , Estudos Retrospectivos , Análise de Sobrevida , Carga TumoralRESUMO
OBJECTIVES: Breast tumor resembling tall cell variant of papillary thyroid carcinoma (BTRPTC) is a rare breast lesion that is unrelated to thyroid carcinoma. Morphologically, it shows a solid papillary lesion with bland cytology, eosinophilic/amphophilic secretions, nuclear grooves, reversal of nuclear polarity (recently described), and nuclear inclusions. Clinical course is often uneventful with few exceptions reported in the literature. Herein, we report three additional cases. METHODS: Immunohistochemical staining and next-generation sequencing was performed on all three cases. RESULTS: The lesional cells on all cases were positive for cytokeratin 5 and S100, with weak expression/lack of estrogen receptor. No staining was observed for myoepithelial markers (p63 and myosin heavy chain) around the lesion. IDH2 mutations were identified in two cases at nucleotide 172 (cases 1 and 3). ATM gene mutation was identified in cases 2 and 3 and PIK3CA mutation in case 3. All patients are currently without disease. CONCLUSIONS: BTRPTC is a slow-growing neoplastic lesion that needs to be distinguished from other papillary lesions for optimizing therapy.
Assuntos
Neoplasias da Mama/patologia , Carcinoma/patologia , Mutação , Neoplasias da Glândula Tireoide/patologia , Idoso , Neoplasias da Mama/química , Neoplasias da Mama/genética , Carcinoma Papilar , Feminino , Humanos , Imuno-Histoquímica , Queratina-5/análise , Proteínas de Membrana/análise , Pessoa de Meia-Idade , Cadeias Pesadas de Miosina/análise , Receptores de Estrogênio/análise , Câncer Papilífero da TireoideRESUMO
Objectives: A clinicopathologic study with an emphasis on tumor immunohistochemical profile is presented. Methods: Sixty-one cases of male invasive breast cancers were studied. Median age of the cohort was 65 years. Results: Ninety-seven percent were estrogen receptor positive+ and 10% human epidermal growth factor receptor 2 positive. The individual diagnostic marker positivity was 98% for GATA-binding protein 3, 95% for androgen receptor, 90% for progesterone receptor, 88% for deleted in pancreatic cancer 4, 75% for gross cystic disease fluid protein 15, 72% for cytokeratin 7, 55% for mammaglobin, and 15% for vimentin and Wilms tumor protein 1. Caudal type homeobox 2 protein, cytokeratin 20, Napsin A, paired box gene 8, prostate-specific antigen, thyroid transcription factor 1, and uroplakin II were negative in all cases. Survival analyses showed tumor stage, receptor status, and Nottingham prognostic index to be prognostic. The overall survival was 70%, but the breast cancerspecific survival was 92% (mean follow-up, 59 months); 33% developed second malignancy. The immunohistochemistry profile was similar to female breast cancers. Conclusions: The second malignancies in this cohort affected overall survival and suggest the possibility of other germline mutations in addition to BRCA2 in male patients with breast cancer.