Small biopsies for pancreatic lesions: Is there still room for fine needle aspiration?

Pancreatic carcinoma is an aggressive tumour with increasing incidence in both sexes worldwide. Early detection is, therefore, essential for patient management. A recent advancement involves the utilization of larger, thicker gauge needles, which enable the collection of core-type biopsies (FNB). Here, we investigated the role of fine needle aspiration and cytopathology in the diagnostic workflow of pancreatic lesions. A search query was designed to search for articles in the PubMed database comparing FNA and FNB for biopsy of pancreatic lesions, and detailed data were extracted from selected studies. Statistical analyses were performed using the R package meta version 6.2. Twenty-one studies made the final cut for data extraction. Overall, median age was 64.3 years (±6.1; 47.6-71.5), male: female proportion 53.9 (±11.3; 27.6-67.4), lesion size 3.1 cm (±0.5; 1.9-4.2 cm) and percentage of malignant cases 78.3% (±26.8; 2.1-100). FNA and FNB diagnostic yield was 85.8% (±10.3; 70.0-100.0) and 89.2% (±7.7; 70.0-98.6), respectively. Average accuracy was 89.5% (±11.7; 63.0-100.0) for FNA and 90.8% (±7.1; 77.0-100.0) for FNB. Adverse effects rate was 1.0% (±1.3; 0-4.3) for FNA and 2.2% (±4.4; 0-16.1) for FNB. None of the selected variables had a significant statistical difference between both methods. FNA and FNB perform similarly for diagnostic material acquisition in pancreatic lesions. The best outcome comes from the association of both techniques, emphasizing the value of combining cytological and histological morphology for the most accurate analysis.

Core Needle Biopsy Accuracy for Androgen Receptor Expression in Invasive Breast Cancer.

OBJECTIVE: Breast cancer (BC) biomarkers, such as hormone receptors expression, are crucial to guide therapy in BC patients. Antiandrogens have been studied in BC; however, limited data are available on androgen receptor (AR) expression test methodology. We aim to report the core needle biopsy (CNB) accuracy for AR expression in BC. METHODS: Patients diagnosed with stage I-III invasive BC from a single institution were included. Androgen receptor expression was evaluated by immunohistochemistry (IHC) using 1 and 10% cutoff and the AR expression in surgical specimens (SS) was the gold standard. Kappa coefficients were used to evaluate the intraprocedural agreement. RESULTS: A total of 72 patients were included, with a mean age of 61 years old and 84% were Luminal A or B tumors. The prevalence of AR expression in all BC samples was 87.5% using a cutoff ≥ 10% in SS. With a cutoff value ≥ 1%, CNB had an accuracy of 95.8% (Kappa value = 0.645; 95% confidence interval [CI]: 0.272-1.000; p < 0.001) and 86.1% (Kappa value = 0.365; 95% CI: 0.052-0.679; p < 0.001) when ≥ 10% cutoff was used for AR positivity. Androgen receptor expression in CNB (cutoff ≥ 1%) had a sensitivity of 98.5%, specificity of 60%, positive predictive value of 97.0%, and a negative predictive value of 76.9% in the detection of AR expression in SS. CONCLUSION: Core needle biopsy has good accuracy in evaluating AR expression in BC. The accuracy of CNB decreases with higher cutoff values for AR positivity.

OBJETIVO: Biomarcadores, como a expressão de receptores hormonais, são cruciais para guiar a terapia de pacientes com câncer de mama. Apesar de ter sido estudado, poucos dados estão disponíveis sobre o método de testagem. Buscamos avaliar a precisão da biópsia com agulha de grande calibre (CNB, na sigla em inglês) para a expressão de receptores androgênicos (AR, na sigla em inglês) no câncer de mama. MéTODOS: Foram incluídos pacientes de uma única instituição diagnosticados com câncer de mama invasivo estágio I-III. A expressão de AR foi avaliada por imunohistoquímica, com valores de cutoff de 1 e 10%. A expressão de AR em espécimes cirúrgicos foi o padrão ouro. O coeficiente Kappa foi usado para avaliar a concordância entre procedimentos. RESULTADOS: Foi incluído um total de 72 pacientes, com idade média de 61 anos; 84% eram tumores luminais A ou B. A prevalência da expressão de AR em todas as amostras foi de 87.5%, com cutoff ≥ 10%. Com um valor de cutoff ≥ 1%, a CNB teve precisão de 95.8% (Kappa = 0.64; intervalo de confiança [IC] 95%: 0.272­1.000; p < 0.001) e 86.1% (Kappa = 0.365; CI95%: 0.052­0.679]; p < 0.001) quando um cutoff ≥ 10% foi usado para AR positivo. A expressão de AR na CNB (cutoff ≥ 1%) teve a sensibilidade de 98.5%, especificidade de 60%, valor preditivo positivo de 97.0% e valor preditivo negativo de 76.9% na detecção. CONCLUSãO: |Biópsia com agulha de grande calibre tem uma boa precisão em avaliar a expressão de AR no câncer de mama. A precisão do método cai com valores elevados de cutoff para AR positivo.

Upgrade risk of image-targeted radial scar and complex sclerosing lesions diagnosed at needle-guided biopsy: a retrospective study.

OBJECTIVES: To determine the upgrade rate of radial scar (RS) and complex sclerosing lesions (CSL) diagnosed with percutaneous biopsy. The secondary objectives were to determine the new atypia rate after surgery and to assess the diagnosis of subsequent malignancy on follow-up. METHODS: This single-institution retrospective study had IRB approval. All image-targeted RS and CSL diagnosed with percutaneous biopsy between 2007 and 2020 were reviewed. Patient demographics, imaging presentation, biopsy characteristics, histological report, and follow-up data were collected. RESULTS: During the study period, 120 RS/CSL were diagnosed in 106 women (median age, 43.5 years; range, 23-74), and 101 lesions were analyzed. At biopsy, 91 (90.1%) lesions were not associated with another atypia or malignancy and 10 (9.9%) were associated with another atypia. Out of the 91 lesions that were not associated with malignancy or atypia, 75 (82.4%) underwent surgical excision, and one upgrade to low-grade CDIS was detected (1.3%). Among the 10 lesions initially associated with another atypia, 9 were surgically excised and no malignancy was detected. After a median follow-up of 47 months (range: 12-143 months), two (1.98%) developed malignancy in a different quadrant; in both cases, another atypia was present at biopsy. CONCLUSION: We found a low upgrade rate on image-detected RS/CSL, with or without another atypia associated. Associated atypia was underdiagnosed at biopsy in almost one-third of cases. Subsequent cancer risk could not be established because the only two cases were associated with another high-risk lesion (HRL), which might have increased the patient's risk of developing malignancy. CLINICAL RELEVANCE STATEMENT: Our upgrade rates of RS/CSL with or without atypia diagnosed with core needle biopsy are almost as low as the ones reported with larger sampling methods. This result has particular importance in places with limited accessibility to US-guided vacuum-assisted biopsy. KEY POINTS: •New evidence is showing lower upgrade rates of RS and CSL after surgery, leading to a more conservative management with extensive sampling using VAB or VAE. •Our study showed only one upgrade to a low-grade DCIS after surgery, yielding an upgrade rate of 1.33%. •During follow-up, no new malignancy was detected in the same quadrant where RS/CSL was diagnosed, including patients without surgery.

The effectiveness of ultrasound-guided core needle biopsy in detecting lymph node metastases in the axilla in patients with breast cancer: systematic review and meta-analysis.

OBJECTIVE: This study aimed to perform a meta-analysis to investigate the diagnostic safety and accuracy of Ultrasound-Guided Core Needle Biopsy (US-CNB) Axillary Lymph Nodes (ALNs) region in patients with Breast Cancer (BC). METHODS: The authors searched the electronic databases PubMed, Scopus, Embase, and Web of Science for clinical trials about US-CNB for the detection of ALNs in breast cancer patients. The authors extracted and pooled raw data from the included studies and performed statistical analyses using Meta-DiSc 1.4 and Review Manager 5.3 software. A random effects model was used to calculate the data. At the same time, data from the Ultrasound-guided Fine-Needle Aspiration (US-FNA) were introduced for comparison with the US-CNB. In addition, the subgroup was performed to explore the causes of heterogeneity. (PROSPERO ID: CRD42022369491). RESULTS: In total, 18 articles with 2521 patients were assessed as meeting the study criteria. The overall sensitivity was 0.90 (95% CI [Confidence Interval], 0.87‒0.91; p = 0.00), the overall specificity was 0.99 (95% CI 0.98‒1.00; p = 0.62), the overall area under the curve (AUC) was 0.98. Next, in the comparison of US-CNB and US-FNA, US-CNB is better than US-FNA in the diagnosis of ALNs metastases. The sensitivity was 0.88 (95% CI 0.84‒0.91; p = 0.12) vs. 0.73 (95% CI 0.69‒0.76; p = 0.91), the specificity was 1.00 (95% CI 0.99‒1.00; p = 1.00) vs. 0.99 (95% CI 0.67‒0.74; p = 0.92), and the AUC was 0.99 vs. 0.98. Subgroup analysis showed that heterogeneity may be related to preoperative Neoadjuvant Chemotherapy (NAC) treatment, region, size of tumor diameter, and the number of punctures. CONCLUSION: US-CNB has a satisfactory diagnostic performance with good specificity and sensitivity in the preoperative diagnosis of ALNs in BC patients.

Hiperplasia estromal pseudoangiomatosa de la mama / Pseudoangiomatous stromal hyperplasia of the breast

La hiperplasia estromal pseudoangiomatosa de mama es una lesión mesenquimal benigna poco frecuente de la mama. Se presenta un caso de paciente femenina de 49 años, quien consultó por presentar tumoración en mama izquierda de crecimiento rápido y progresivo. La ecografía mamaria mostró lesión heterogénea e hipoecoica con varios nódulos. La mamografía mostró tumoración ovalada con márgenes difusos sin microcalcificaciones. La biopsia con aguja gruesa guiada por ecografía reveló hallazgos celulares compatibles con fibroma mamario. El diagnóstico anatomopatológico fue de hiperplasia estromal pseudoangiomatosa de mama. Este es un tumor mesenquimal benigno, poco frecuente, secundario a la proliferación exacerbada de fibroblastos y miofibroblastos maduros, cuyo factor desencadenante aún es desconocido. La mayoría se presenta como lesiones difusas, y el diagnóstico es a menudo incidental o en un contexto de otras patologías mamarias(AU)

Pseudoangiomatous stromal hyperplasia of the breast is a rare benign mesenchymal lesion of the breast. We present a case of a 49-year-old female patient who consulted for having a rapidly and progressively growing tumor in her left breast. Breast ultrasound showed a heterogeneous and hypoechoic lesion with several nodules. Mammography showed an oval tumor with diffuse margins without microcalcifications. Ultrasound-guided core needle biopsy revealed cellular findings compatible with breast fibroma. The anatomopathological diagnosis was pseudoangiomatous stromal hyperplasia of the breast. This is a rare benign mesenchymal tumor secondary to exacerbated proliferation of mature fibroblasts and myofibroblasts, whose triggering factor is still unknown. Most present as diffuse lesions, and the diagnosis is often incidental or in the context of other breast pathologies(AU)

Core Needle Biopsy Accuracy for Androgen Receptor Expression in Invasive Breast Cancer / Precisão da biópsia com agulha de grande calibre para expressão de receptores androgênicos no câncer de mama invasivo

Abstract Objective Breast cancer (BC) biomarkers, such as hormone receptors expression, are crucial to guide therapy in BC patients. Antiandrogens have been studied in BC; however, limited data are available on androgen receptor (AR) expression test methodology. We aim to report the core needle biopsy (CNB) accuracy for AR expression in BC. Methods Patients diagnosed with stage I-III invasive BC from a single institution were included. Androgen receptor expression was evaluated by immunohistochemistry (IHC) using 1 and 10% cutoff and the AR expression in surgical specimens (SS) was the gold standard. Kappa coefficients were used to evaluate the intraprocedural agreement. Results A total of 72 patients were included, with a mean age of 61 years old and 84% were Luminal A or B tumors. The prevalence of AR expression in all BC samples was 87.5% using a cutoff ≥ 10% in SS. With a cutoff value ≥ 1%, CNB had an accuracy of 95.8% (Kappa value = 0.645; 95% confidence interval [CI]: 0.272-1.000; p< 0.001) and 86.1% (Kappa value = 0.365; 95% CI: 0.052-0.679; p< 0.001) when ≥ 10% cutoff was used for AR positivity. Androgen receptor expression in CNB (cutoff ≥ 1%) had a sensitivity of 98.5%, specificity of 60%, positive predictive value of 97.0%, and a negative predictive value of 76.9% in the detection of AR expression in SS. Conclusion Core needle biopsy has good accuracy in evaluating AR expression in BC. The accuracy of CNB decreases with higher cutoff values for AR positivity.

Resumo Objetivo Biomarcadores, como a expressão de receptores hormonais, são cruciais para guiar a terapia de pacientes com câncer de mama. Apesar de ter sido estudado, poucos dados estão disponíveis sobre o método de testagem. Buscamos avaliar a precisão da biópsia com agulha de grande calibre (CNB, na sigla em inglês) para a expressão de receptores androgênicos (AR, na sigla em inglês) no câncer de mama. Métodos Foram incluídos pacientes de uma única instituição diagnosticados com câncer de mama invasivo estágio I-III. A expressão de AR foi avaliada por imunohistoquímica, com valores de cutoff de 1 e 10%. A expressão de AR em espécimes cirúrgicos foi o padrão ouro. O coeficiente Kappa foi usado para avaliar a concordância entre procedimentos. Resultados Foi incluído um total de 72 pacientes, com idade média de 61 anos; 84% eram tumores luminais A ou B. A prevalência da expressão de AR em todas as amostras foi de 87.5%, com cutoff ≥ 10%. Com um valor de cutoff ≥ 1%, a CNB teve precisão de 95.8% (Kappa = 0.64; intervalo de confiança [IC] 95%: 0.272-1.000; p< 0.001) e 86.1% (Kappa = 0.365; CI95%: 0.052-0.679]; p< 0.001) quando um cutoff ≥ 10% foi usado para AR positivo. A expressão de AR na CNB (cutoff ≥ 1%) teve a sensibilidade de 98.5%, especificidade de 60%, valor preditivo positivo de 97.0% e valor preditivo negativo de 76.9% na detecção. Conclusão -Biópsia com agulha de grande calibre tem uma boa precisão em avaliar a expressão de AR no câncer de mama. A precisão do método cai com valores elevados de cutoff para AR positivo.

Presentación clínica y hallazgos radiográficos de pacientes con diagnóstico histopatológico de mastitis granulomatosa idiopática / Clinical presentation and radiological findings of patients with histopathological diagnosis of idiopathic granulomatous mastitis

INTRODUCCIÓN. La mastitis granulomatosa idiopática es una patología inflamatoria benigna de mama con clínica y hallazgos imagenológicos no específicos; usualmente confundida con cáncer de mama. El síntoma más frecuente es una masa mamaria palpable. El diagnóstico es histopatológico. OBJETIVO. Describir el perfil demográfico, presentación clínica y hallazgos radiográficos de pacientes con diagnóstico histopatológico de mastitis granulomatosa idiopática. MATERIALES Y MÉTODOS. Estudio observacional, descriptivo, retrospectivo. Población de 1130 y muestra de 49 datos de historias clínicas electrónicas de pacientes con diagnóstico histológico de mastitis granulomatosa idiopática con el código CIE10 N61x Trastornos Inflamatorios de la mama, atendidas en la Unidad Técnica de Imagenología del Hospital de Especialidades Carlos Andrade Marín en la ciudad de Quito entre enero 2019 hasta diciembre 2021. El criterio de inclusión fue la confirmación histopatológica de mastitis granulomatosa idiopática. Los criterios de exclusión: antecedentes de neoplasia maligna de mama, antecedentes de HIV, patología inflamatoria sistémica como granulomatosis de Wegener, sarcoidosis, infecciones granulomatosas crónicas como tuberculosis, brucelosis, histoplasmosis, sífilis y reacciones a cuerpos extraños como material de implantes mamarios. Se analizaron datos demográficos, presentación clínica, hallazgos mamográficos, ecográficos y la categorización BIRADS. Se efectuó un análisis univarial; para las variables cualitativas se realizó frecuencias y porcentajes; para las variables cuantitativas se realizó medidas de tendencia central. La información recolectada fue analizada en el programa estadístico International Business Machines Statistical Package for the Social Sciences. RESULTADOS La mediana de la edad fue 36 años. El 94,00% de pacientes tenían por lo menos un hijo; 77,50% presentaron con una masa palpable; 55,10% se acompañaron de signos inflamatorios; 16,00% asociaron fístulas y 24,40% presentaron secreción. Solo 1 caso presentó afectación bilateral. CONCLUSIÓN En este estudio, la mastitis granulomatosa idiopática afecta a mujeres en edad reproductiva sin antecedentes de malignidad quienes presentan una masa mamaria palpable que puede estar acompañada de signos inflamatorios, colecciones y fístulas. La realización de una biopsia core eco guiada, para confirmar su diagnóstico.

INTRODUCTION. Idiopathic granulomatous mastitis is a benign inflammatory breast pathology with nonspecific clinical and imaging findings; usually mistaken for breast cancer. The most frequent symptom is a palpable breast mass. The diagnosis is histopathologic. OBJECTIVE. To describe the demographic profile, clinical presentation and radiographic findings of patients with histopathologic diagnosis of idiopathic granulomatous mastitis. MATERIALS AND METHODS. Observational, descriptive, retrospective study. Population of 1130 and sample of 49 data from electronic medical records of patients with histological diagnosis of idiopathic granulomatous mastitis with ICD10 code N61x Inflammatory disorders of the breast, attended at the Technical Imaging Unit of the Carlos Andrade Marín Specialties Hospital in the city of Quito between January 2019 and December 2021. The inclusion criterion was histopathological confirmation of idiopathic granulomatous mastitis. Exclusion criteria: history of malignant breast neoplasia, history of HIV, systemic inflammatory pathology such as Wegener's granulomatosis, sarcoidosis, chronic granulomatous infections such as tuberculosis, brucellosis, histoplasmosis, syphilis and reactions to foreign bodies such as breast implant material. Demographic data, clinical presentation, mammographic and ultrasound findings and BIRADS categorization were analyzed. Univariate analysis was performed; frequencies and percentages were used for qualitative variables; measures of central tendency were used for quantitative variables. RESULTS. The median age was 36 years. 94,00% of patients had at least one child; 77,50% presented with a palpable mass; 55,10% were accompanied by inflammatory signs; 16,00% were associated with fistulas and 24,40% presented with discharge. Only 1 case presented bilateral involvement. CONCLUSION. In this study, idiopathic granulomatous mastitis affects women of reproductive age with no history of malignancy who present with a palpable breast mass that may be accompanied by inflammatory signs, collections and fistulas. The performance of an echo-guided core biopsy to confirm the diagnosis.

A New Method for Obtaining Tumor Interstitial Fluid Applied to Cytokine Analysis of Breast Carcinoma Samples.

BACKGROUND/AIM: Tumor interstitial fluid (TIF), a component of the tumor microenvironment, is a valuable source of molecules and substances that help in diagnosis and prognosis of solid tumors. There is still no consensus on the optimal method for collecting TIF. Therefore, this study aimed to evaluate the effectiveness of a new method of collecting TIF in invasive ductal carcinoma (IDC) samples for cytokine interleukin 1ß (IL1ß) quantification. MATERIALS AND METHODS: Forty women allowed the collection of TIF using absorbent paper strips during the performance of the core biopsy. The samples were stored at a temperature of -80°C and then analyzed using an enzyme-linked immunoassay. RESULTS: The mean values for IL1ß and total protein were 11.39 mg/ml and 2.15 mg/ml, respectively. CONCLUSION: it was possible to quantify the cytokine IL1ß and the total protein concentration present in the tumor tissue through TIF collection with the use of absorbent paper filters, demonstrating the effectiveness of this new method in oncology.

Efectividad, eficacia, eficiencia y seguridad de la citología con evaluación in situ en punción aspiración con aguja fina y biopsia con aguja gruesa ecoguiadas / Effectiveness, efficacy, efficiency and safety of citology with on-site assessment in ultrasound-guided fine needle aspiration and core needle biopsy. Executive summary

INTRODUCCIÓN: La evaluación de la citología in situ (ROSE, del inglés rapid on-site evaluation) se plantea como una posible mejora de la técnica diagnóstica de lesiones oncológicas tras la obtención de la muestra por punción aspirativa con aguja fina o biopsia con aguja gruesa. Esta técnica podría mejorar el método de valoración de la idoneidad de la muestra, e incluso permitir un rápido diagnóstico preliminar. OBJETIVO: Evaluar la eficacia, efectividad, eficiencia y seguridad de la citología con evaluación in situ en punción aspiración con aguja fina y biopsia con aguja gruesa ecoguiadas con respecto al protocolo de evaluación habitual. MÉTODO: Revisión sistemática de la literatura, incluyendo informes de evaluación de tecnologías, revisiones sistemáticas y metaanálisis. Para su elaboración se consultaron las siguientes bases de datos referenciales hasta septiembre de 2021 (con lenguaje libre y controlado): Medline (Ovid), Embase (Excerpta Medica DataBase), Cochrane Library (Cochrane Review Database), INAHTA (International HTA Database), WOS (SCI Science Citation Index) y PubMed (Ahead of print/First on line). También se exploraron EvidenceSearch y TripDataBase, así como las principales webs de agencias europeas: National Institute for Health and Care Excellence (NICE), Canadian Agency for Drugs and Technologies in Health (CADTH), Agency for Healthcare Research and Quality (AHRQ) y la Red española de Agencias de Evaluación de Tecnologías Sanitarias y Prestaciones del SNS (RedETS). La selección de los estudios y el análisis de su calidad se realizaron por dos investigadores independientes. La síntesis de los resultados se llevó a cabo de forma cualitativa. La calidad de los estudios fue evaluada mediante las herramientas AMSTAR-2 para revisiones sistemáticas. RESULTADOS: Se incluyeron 2 revisiones sistemáticas con metaanálisis. Se identificaron algunas debilidades en el análisis de la calidad de los trabajos seleccionados y la calidad general fue moderada-baja. Se evaluó la eficacia de la técnica ROSE para la indicación de sospecha de cáncer de mama, gracias a una de las revisiones sistemáticas incluidas. La diferencia en la eficacia entre las intervenciones en las que se usó esta técnica y en las que no se usó, no resultó estadísticamente significativa. Los autores de la revisión destacan que esta diferencia no significativa puede deberse a que la tasa de adecuación de las muestras sin la utilización de ROSE ya es alta por lo que el margen de posible mejora con esta técnica es limitado. Se evaluó la eficacia, la seguridad y la eficiencia de la técnica ROSE para la indicación de sospecha de cáncer de pulmón, gracias a una de las revisiones sistemáticas incluidas. En cuanto a la seguridad de la técnica en esta indicación, no se observaron diferencias significativas en el ratio de complicaciones en pacientes en los que se usó la técnica ROSE frente a pacientes en los que no se usó. En cuanto a la eficacia, todas las variables resultado mostraron valores de mayor eficacia cuando se aplicó la técnica ROSE, aunque cabe destacar la variabilidad de dichos valores entre los diferentes estudios incluidos en la revisión. CONCLUSIONES: La técnica ROSE puede suponer una mejora en la adecuación de las muestras oncológicas y proveer un prediagnóstico de utilidad clínica para el posible tratamiento del paciente. Esta mejora es especialmente significativa en las muestras de sospecha de cáncer de pulmón, a diferencia de las pacientes con sospecha de cáncer de mama en las cuales la eficacia de la técnica no muestra diferencias significativas. Se necesitan más estudios prospectivos, controlados y aleatorizados para ambas indicaciones. Se recomienda que estos estudios homogenicen los parámetros de la técnica ROSE para evitar posibles fuentes de heterogeneidad. Además, se aconseja que estos estudios incluyan aspectos económicos que permitan la evaluación de la eficiencia.

INTRODUCTION: Rapid on-site evaluation (ROSE) is proposed as a possible improvement of the diagnostic technique for oncological lesions after specimen collection by fine needle aspiration or core needle biopsy. This technique could improve the method of assessing the suitability of the sample, and even allow a rapid preliminary diagnosis. OBJECTIVE: To evaluate the efficacy, effectiveness, efficiency and safety of on-site assessment cytology in ultrasound-guided fine needle aspiration and core needle biopsy with respect to the standard assessment protocol. METHODS: Systematic literature review, including technology assessment reports, systematic reviews and meta-analyses. The following reference databases were consulted until September 2021 (with free and controlled language): Medline (Ovid), Embase (Excerpta Medica DataBase), Cochrane Library (Cochrane Review Database), INAHTA (International HTA Database), WOS (SCI Science Citation Index) y PubMed (Ahead of print/ First on line). EvidenceSearch, TripDataBase, National Institute for Health and Care Excellence (NICE), Canadian Agency for Drugs and Technologies in Health (CADTH), Agency for Healthcare Research and Quality (AHRQ) and Red española de Agencias de Evaluación de Tecnologías Sanitarias y Prestaciones del SNS (RedETS) were also explored. Study selection and quality analysis were performed by two independent researchers. Synthesis of the results was carried out qualitatively. Study quality was assessed using the AMSTAR-2 tools for systematic reviews. RESULTS: Two systematic reviews with meta-analyses were included. Some weaknesses were identified in the quality analysis of the selected papers and the overall quality was moderate-low. The efficacy of the ROSE technique for the indication of suspected breast cancer was evaluated using one of the included systematic reviews. The difference in efficacy between interventions in which ROSE was used and those in which it was not was not statistically significant. The authors of the review highlight that this non-significant difference may be due to the fact that the sample adequacy rate without the use of ROSE is already high and the scope for possible improvement with this technique is limited. The safety and efficacy of the ROSE technique for the indication of suspected lung cancer was assessed by one of the included systematic reviews. Regarding the safety of the technique in this indication, no significant differences in the complication rate were observed in patients in whom the ROSE technique was used versus patients in whom it was not used. In terms of efficacy, all the outcome variables showed higher efficacy values when the ROSE technique was applied, although the variability of these values between the different studies included should be noted. CONCLUSIONS: The ROSE technique can improve the adequacy of oncological samples and provide a clinically useful pre-diagnosis for the possible treatment of the patient. This improvement is especially significant in lung cancer suspicion samples, but not in breast cancer samples. Further prospective, randomised and controlled studies are needed for both indications. It is recommended that these studies homogenise the parameters of the ROSE technique to avoid potential sources of heterogeneity. In addition, it is advised that these studies include economic aspects to allow assessment of efficiency.

Feasibility and Outcomes of Renal Mass Biopsy for Anatomically Complex Renal Tumors.

OBJECTIVE: To compare the feasibility and outcomes of renal mass biopsies (RMB) of anatomically complex vs non-complex renal masses. METHODS: Our institutional renal tumor database was queried for patients who underwent RMB between 2005 and 2019 and with available nephrometry score. Complex masses were: (1) small (<2 cm), (2) entirely endophytic (nephrometry E=3), (3) hilar (h) or (4) partially endophytic (E=2) and anterior. Demographic and pathologic data were compared. Biopsies were deemed adequate if they resulted in a diagnosis. Concordance with surgical pathology was assessed. These were both presented using proportions. Factors associated with biopsy outcomes were identified using multivariable logistic regression. RMB sensitivity and specificity were calculated using contingency methods. RESULTS: A total of 306 RBMs were included, 179 complex and 127 non-complex. A total of 199 (65%) had an extirpative procedure. Complex lesions were less likely to have an adequate biopsy (89% vs 96%, P = .03), and to be concordant with final surgical pathology from an oncologic standpoint (89% vs 97%, P = .03). There was no significant difference in concordance of histology (76% vs 86%, P = .10) or grade (48 vs 51%, P = .66). On multivariable analyses, only male gender was associated with biopsy adequacy (OR 3.31, 95% CI 1.28-8.55, P = .01). Our overall sensitivity was 93%, specificity 93%, and accuracy 93%. There were no significant differences over time in biopsy outcomes during the study period. CONCLUSION: RMB of complex lesions is associated with excellent diagnostic yield, albeit lower than non-complex lesions. RMB should not be deferred in cases of anatomically complex lesions where additional data could improve clinical decision-making.

Independent real-world application of a clinical-grade automated prostate cancer detection system.

Artificial intelligence (AI)-based systems applied to histopathology whole-slide images have the potential to improve patient care through mitigation of challenges posed by diagnostic variability, histopathology caseload, and shortage of pathologists. We sought to define the performance of an AI-based automated prostate cancer detection system, Paige Prostate, when applied to independent real-world data. The algorithm was employed to classify slides into two categories: benign (no further review needed) or suspicious (additional histologic and/or immunohistochemical analysis required). We assessed the sensitivity, specificity, positive predictive values (PPVs), and negative predictive values (NPVs) of a local pathologist, two central pathologists, and Paige Prostate in the diagnosis of 600 transrectal ultrasound-guided prostate needle core biopsy regions ('part-specimens') from 100 consecutive patients, and to ascertain the impact of Paige Prostate on diagnostic accuracy and efficiency. Paige Prostate displayed high sensitivity (0.99; CI 0.96-1.0), NPV (1.0; CI 0.98-1.0), and specificity (0.93; CI 0.90-0.96) at the part-specimen level. At the patient level, Paige Prostate displayed optimal sensitivity (1.0; CI 0.93-1.0) and NPV (1.0; CI 0.91-1.0) at a specificity of 0.78 (CI 0.64-0.89). The 27 part-specimens considered by Paige Prostate as suspicious, whose final diagnosis was benign, were found to comprise atrophy (n = 14), atrophy and apical prostate tissue (n = 1), apical/benign prostate tissue (n = 9), adenosis (n = 2), and post-atrophic hyperplasia (n = 1). Paige Prostate resulted in the identification of four additional patients whose diagnoses were upgraded from benign/suspicious to malignant. Additionally, this AI-based test provided an estimated 65.5% reduction of the diagnostic time for the material analyzed. Given its optimal sensitivity and NPV, Paige Prostate has the potential to be employed for the automated identification of patients whose histologic slides could forgo full histopathologic review. In addition to providing incremental improvements in diagnostic accuracy and efficiency, this AI-based system identified patients whose prostate cancers were not initially diagnosed by three experienced histopathologists. © 2021 The Authors. The Journal of Pathology published by John Wiley & Sons, Ltd. on behalf of The Pathological Society of Great Britain and Ireland.

Core needle biopsy in fibroepithelial tumors: predicting factors for phyllodes tumors.

OBJECTIVES: This study aimed to evaluate the clinical and imaging predictive factors for the diagnosis of phyllodes tumors in patients with inconclusive results from core needle biopsy (fibroepithelial lesions). METHODS: We retrospectively analyzed data of patients who underwent surgical excision of breast lesions previously diagnosed as fibroepithelial lesions. Numeric variables were analyzed using the Shapiro-Wilk and t-tests, and categorical variables were analyzed using the chi-square and Fisher's exact tests. Multivariate logistic regression was performed to calculate odds ratios and detect predictive factors for the diagnosis of PT. RESULTS: A total of 89 biopsy samples were obtained from 77 patients, of which 43 were confirmed as fibroadenomas, 43 as phyllodes tumors, and 3 as other benign, non-fibroepithelial breast lesions. The mean tumor size was 3.61 cm (range, 0.8-10 cm) for phyllodes tumors and 2.4 cm (range, 0.8-7.9 cm) for fibroadenomas. The predictive factor for phyllodes tumor diagnosis was lesion size >3 cm (p<0.001). CONCLUSION: Our data indicate that fibroepithelial lesions of the breast larger than 3 cm are more likely to be phyllodes tumors.

Pseudoaneurysm after an ultrasound-guided breast core needle biopsy in a lactating woman.

This is a case report of a lactating woman in her twenties diagnosed with a breast pseudoaneurysm following a 14-gauge ultrasound-guided core needle biopsy detected by a Color Doppler exam, and treated with surgery. Further discussion concerning the patient's symptoms, useful imaging modalities, and treatment options are included. Knowledge on this complication is crucial for the correct diagnosis and best management and treatment.

Histomorphometric analysis of liver biopsies of treated patients with Gaucher disease type 1

Gaucher disease (GD) is an autosomal recessive lysosomal disorder caused by a disturbance in the metabolism of glucocerebroside in the macrophages. Most of its manifestations - hepatosplenomegaly, anemia, thrombocytopenia, and bone pain - are amenable to a macrophage-target therapy such as enzyme replacement. However, there is increasing evidence that abnormalities of the liver persist despite the specific GD treatment. In this work, we adapted histomorphometry techniques to the study of hepatocytes in GD using liver tissue of treated patients, developing the first morphometrical method for canalicular quantification in immunohistochemistry-stained liver biopsies, and exploring histomorphometric characteristics of GD. This is the first histomorphometric technique developed for canalicular analysis on histological liver biopsy samples.

Core needle biopsy in fibroepithelial tumors: predicting factors for phyllodes tumors

OBJECTIVES: This study aimed to evaluate the clinical and imaging predictive factors for the diagnosis of phyllodes tumors in patients with inconclusive results from core needle biopsy (fibroepithelial lesions). METHODS: We retrospectively analyzed data of patients who underwent surgical excision of breast lesions previously diagnosed as fibroepithelial lesions. Numeric variables were analyzed using the Shapiro-Wilk and t-tests, and categorical variables were analyzed using the chi-square and Fisher's exact tests. Multivariate logistic regression was performed to calculate odds ratios and detect predictive factors for the diagnosis of PT. RESULTS: A total of 89 biopsy samples were obtained from 77 patients, of which 43 were confirmed as fibroadenomas, 43 as phyllodes tumors, and 3 as other benign, non-fibroepithelial breast lesions. The mean tumor size was 3.61 cm (range, 0.8-10 cm) for phyllodes tumors and 2.4 cm (range, 0.8-7.9 cm) for fibroadenomas. The predictive factor for phyllodes tumor diagnosis was lesion size >3 cm (p<0.001). CONCLUSION: Our data indicate that fibroepithelial lesions of the breast larger than 3 cm are more likely to be phyllodes tumors.

Effect of neoadjuvant therapy on breast cancer biomarker profile.

BACKGROUND: Breast cancer clinical management requires the assessment of hormone receptors (estrogen (ER) and progesterone receptor (PR)), human epidermal growth factor receptor 2 (HER2) and cellular proliferation index Ki67, by immunohistochemistry (IHC), in order to choose and guide therapy according to tumor biology. Many studies have reported contradictory results regarding changes in the biomarker profile after neoadjuvant therapy (NAT). Given its clinical implications for the disease management, we aimed to analyze changes in ER, PR, HER2, and Ki67 expression in paired core-needle biopsies and surgical samples in breast cancer patients that had either been treated or not with NAT. METHODS: We included 139 patients with confirmed diagnosis of invasive ductal breast carcinoma from the Colombian National Cancer Institute. Variation in biomarker profile were assessed according to NAT administration (NAT and no-NAT treated cases) and NAT scheme (hormonal, cytotoxic, cytotoxic + trastuzumab, combined). Chi-squared and Wilcoxon signed-rank test were used to identify changes in biomarker status and percentage expression, respectively, in the corresponding groups. RESULTS: We did not find any significant variations in biomarker status or expression values in the no-NAT group. In cases previously treated with NAT, we did find a statistically significant decrease in Ki67 (p < 0.001) and PR (p = 0.02605) expression. When changes were evaluated according to NAT scheme, we found a significant decrease in both Ki67 status (p = 0.02977) and its expression values (p < 0.001) in cases that received the cytotoxic treatment. CONCLUSIONS: Our results suggest that PR and Ki67 expression can be altered by NAT administration, whereas cases not previously treated with NAT do not present IHC biomarker profile variations. The re-evaluation of these two biomarkers after NAT could provide valuable information regarding treatment response and prognosis for breast cancer patients.

Biopsy core length in white versus African descendant prostate cancer patients.

Objective: To explore whether distinct prostate cancer (PCa) prognoses between ethnicities could be explained by diverse characteristics in the prostate biopsy.Methods: Clinical, prostate biopsy and surgical single-institution data of whites and African descendants with similar access to the health system who underwent radical prostatectomy whole gland histopathology within 60 days after biopsy from 2010 to 2011 and followed for 5 years minimum were compared.Results: Among 203 included patients, 153 (75.4%) were whites and 50 (24.6%) were African descendants. The mean patients' age was 63.7 (± 6.8) years. Digital rectal examination (DRE) was suspected of cancer in 45.2% of the patients. The prostate biopsy core length was smaller in African descendants than in whites, overall 11.0 ± 3.2 vs 12.0 ± 2.9 mm, p = 0.037, and without neoplasia, 10.4 ± 3.8 vs 11.7 ± 3.1 mm, p = 0.038, respectively. Also, suspicious DRE showed smaller biopsy core length, overall 11.1 ± 3.2 mm vs 12.4 ± 2.6, p = 0.003, cancer positive 12.0 ± 4.8 mm vs 13.3 ± 3.7, p = 0.022 and negative 10.6 ± 3.6 mm vs 12.2 ± 3.0, p = 0.002. On 81 months median follow-up, more African descendants were lost to follow-up (10%, n = 5 vs 3.9%, n = 6) and the biochemical recurrence rate was the same between the groups (33.3%).Conclusion: In a PCa population with similar access to the health system, prostate biopsy core length in African descendant men is significantly smaller than in whites. This finding is new and may add to the controversial argument of PCa having a worse prognosis in African descendant patients.

Transrectal Subharmonic Ultrasound Imaging for Prostate Cancer Detection.

OBJECTIVE: To assess the prostate cancer (CaP) detection rates of contrast-enhanced, transrectal subharmonic ultrasound imaging (SHI). MATERIALS AND METHODS: This IRB-approved study enrolled 55 subjects. The initial 5 subjects were studied for SHI optimization, while the remaining 50 were evaluated with contrast-enhanced sonography using continuous SHI, color, and power Doppler as well as conventional grayscale, continuous color, and power Doppler and SHI combined with maximum flash replenishment. A maximum of 6 directed biopsy cores were obtained from sites of greatest asymmetrical enhancement, followed by spatially distributed cores in a double sextant distribution. Subharmonic time-intensity parameters, including time to peak intensity, peak intensity, and estimated perfusion were also evaluated for each directed biopsy core. Receiver operating characteristic curve analysis and conditional logistic regression were employed to assess the benefit of each modality and the quantitative SHI parameters. RESULTS: Cancer was detected in 22 of 50 subjects. Among subjects with clinically significant CaP (n = 11), targeted cores were more likely to be positive (odds ratio 1.39, P = .02). The majority of patients detected by SHI demonstrated significant CaP (5/8); SHI remained an independent marker of malignancy in a multivariate logistic regression model (P = .027). Receiver operating characteristic curve analysis of imaging findings compared to biopsy results yielded diagnostic accuracies ranging from 0.59 to 0.80 for all imaging modalities with the highest being for quantitative subharmonic perfusion estimates. CONCLUSION: This first-in-humans study provides a preliminary estimate of the diagnostic accuracy of SHI for detection of clinically significant CaP (up to 80%).