Concordance between 21-gene recurrence score assay and clinicopathological predictive models in early-breast cancer patients cared for at a cancer center in Colombia.

INTRODUCTION: The genomic-based 21-gene recurrence score assay (21-GRSA) allows to determine the usefulness of adjuvant chemotherapy in patients with luminal-type early breast cancer (LTEBC). Additional predictive models have also been developed, such as Magee equations (ME), the Predict model (PM), and the Tennessee nomogram score (TNS). OBJECTIVE: To evaluate the concordance between 21-GRSA, ME, PM and TNS. METHODS: Patients with unifocal LTEBC and 21-GRSA, ME, PM and TNS results were included. A subgroup analysis of women older than 50 years was carried out. Concordance between the models and 21-GRSA was evaluated using Cohen's kappa index (KI). RESULTS: One-hundred and twenty-two women were included. Concordance between 21-GRSA and ME (KI = 0.35) and PM (KI = 0.24) was fair (p < 0.001). Concordance between 21-GRSA and TNS was inferior (KI = 0.16, p = 0.04). Eighty patients older than 50 years with sufficient data to calculate all three predictive models were included. Concordance was found between the low-risk classification on 21-GRSA and all three combined models in 36/37 patients (negative predictive value of 97.3%). CONCLUSION: 21-GRSA can be omitted in women older than 50 years with LTEBC classified with low risk scores on all three predictive models.

INTRODUCCIÓN: La prueba genómica de recurrencia de 21 genes (PGR21) permite determinar la utilidad de la quimioterapia adyuvante en pacientes con cáncer de mama temprano luminal (CMTL). Se han desarrollado modelos predictivos adicionales, como las ecuaciones de Magee (EM), el modelo Predict (MP) y la puntuación del nomograma de la Universidad de Tennessee (NT). OBJETIVO: Evaluar la concordancia entre PGR21, EM, MP y NT. MÉTODOS: Se incluyeron pacientes con CMTL unifocal y con resultados de PGR21, EM, MP y NT. Se efectuó subanálisis de mujeres mayores de 50 años. La concordancia se evaluó mediante índice kappa de Cohen (IK). RESULTADOS: Se incluyeron 122 mujeres. La concordancia entre PGR21 y EM (IK = 0.35) y MP (IK = 0.24) fue aceptable (p < 0.001); entre PGR21 y NT fue inferior (IK = 0.16, p = 0.04). Se incluyeron 80 pacientes mayores de 50 años con datos suficientes para calcular los tres modelos. Se encontró concordancia entre la clasificación de bajo riesgo mediante PGR21 y los tres modelos combinados en 36/37 pacientes (valor predictivo negativo de 97.3 %). CONCLUSIÓN: Se puede omitir la PGR21 en las mujeres mayores de 50 años con CMTL que se clasifica de bajo riesgo en los tres modelos predictivos.

Real-world evidence of nivolumab for non-small-cell lung cancer in a developing country.

Nivolumab is a human programmed death receptor-1 blocking antibody, used as treatment option in patients with advanced non-small-cell lung cancer (NSCLC). We assessed the nivolumab efficacy in terms of survival and response to treatment as second-line (2L) or third-line (3L) therapy in patients with advanced NSCLC. This is a multicentric observational study. Data of patients with advanced NSCLC who received nivolumab as 2L or 3L treatment were analyzed retrospectively. Information regarding patient demographics and clinical backgrounds, treatment patterns from diagnosis to post-nivolumab treatment, effectiveness, and safety of nivolumab treatment were collected. The outcomes evaluated were overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) to treatment. OS and PFS were estimated with the Kaplan-Meier method and the differences were evaluated through the log-rank test. Data of 178 patients were included. The median follow-up was 26.8 months (interquartile range (IQR): 20.3-40.4). Nivolumab was commonly used as a 2L treatment (77.5%). The outcomes in this setting (2L) were as follows: ORR was 21.0%, and the median PFS and OS were 5.5 months (95% confidence interval (CI): 4.5-6.5) and 12.4 months (95% CI: 10.8-14.0), respectively. In 3L, the ORR with nivolumab was 15.0%, the median PFS and OS were 4.1 months (95% CI: 3.1-5.1) and 10.1 months (95% CI: 9.4-10.6), respectively. Three patients (1.7%) required discontinuation due to toxicity. Nivolumab effectiveness and safety in this scenario was consistent with that reported by previous trials and other real-world data.

Association between diastolic stress test and H2FPEF score. / Asociación entre prueba de estrés diastólico y puntuación H2FPEF

OBJECTIVE: Heart failure with preserved ejection fraction is a highly prevalent disease; some advances for improving the diagnosis are the development of the H2FPEF score and the diastolic stress test for the evaluation of diastolic function. The objective is to describe the clinical and echocardiographic characteristics of patients referred for stress tests, and the association between the H2FPEF score and the results of the diastolic test. METHODS: This is an analytical, observational, retrospective study. An exercise stress test was performed. The Chi-square test was used to establish an association between H2FpEF score and diastolic stress test results. Patients over the age of 18, in sinus rhythm, with the left ventricular ejection fraction > 54%, with no more than mild diastolic dysfunction on the baseline echocardiogram were included in the study. RESULTS: A total of 99 patients met the eligibility criteria. About 49.5% were women, median age was 62.2 years. The H2FPEF score was low in 27.2%, intermediate 71.7%, and 1% in the high range. There was a high prevalence of hypertension 58.6%, diabetes 12.1%, and coronary disease 20.2%. The stress test was positive for diastolic dysfunction in 36.4% of the patients. A statistically significant association was found between the H2FPEF score and the diastolic stress test (p = 0.02). CONCLUSIONS: Although clinical scores such as H2FPEF help identify patients, a high percentage of patients are classified in the intermediate range. The diastolic stress test can help to make the diagnosis of diastolic function in this group of patients.

OBJETIVO: La insuficiencia cardíaca con fracción de eyección preservada (FCFEp) es una enfermedad de alta prevalencia, sin embargo, aún falta una estrategia de referencia para establecer el diagnóstico de FCFEp. Algunos de los avances más importantes para mejorar el diagnóstico de FCFEp son la puntuación H2FPEF y la prueba de esfuerzo para la evaluación de la función diastólica durante el ejercicio. El objetivo es describir las características clínicas y ecocardiográficas de los pacientes remitidos para pruebas de esfuerzo en un centro de referencia colombiano, y la asociación entre el puntaje H2FPEF con los resultados de la prueba de estrés diastólica. MÉTODOS: Se trata de un estudio analítico, observacional y retrospectivo. Se realizó una ecocardiografía de esfuerzo solicitada por disnea o fatiga. La prueba Chi cuadrado se utilizó para establecer una asociación entre la puntuación H2FpEF y los resultados de la prueba diastólica. Se incluyeron pacientes mayores de 18 años, en ritmo sinusal, con fracción de eyección del ventrículo izquierdo igual o superior al 55%, con una disfunción diastólica no mayor de leve en el ecocardiograma basal. RESULTADOS: Un total de 99 pacientes cumplieron los criterios de inclusión. El 49,5% de la población eran mujeres, la edad media fue de 62.2 años. La puntuación H2FPEF fue baja en 27.2%, intermedia 71,7% y 1% en el rango alto. Hubo una alta prevalencia de hipertensión 58.6%, diabetes 12.1% y enfermedad coronaria 20.2%. La prueba de esfuerzo fue positiva para disfunción diastólica en el 36,4% de los pacientes. Se encontró una asociación estadísticamente significativa entre la puntuación H2FPEF y la prueba de esfuerzo diastólico (p = 0.02). CONCLUSIONES: Aunque puntuaciones clínicas como H2FPEF ayudan a identificar a los pacientes, un alto porcentaje de pacientes se clasifican en el rango intermedio. La prueba de esfuerzo diastólico puede ayudar a realizar el diagnóstico de función diastólica en este grupo de pacientes.

1H NMR serum metabolomic profiling of patients at risk of cardiovascular diseases performing stress test.

Cardiovascular diseases are the leading cause of death worldwide. Changes in lifestyle and/or pharmacological treatment are able to reduce the burden of coronary artery diseases (CAD) and early diagnosis is crucial for the timely and optimal management of the disease. Stress testing is a good method to measure the burden of CAD but it is time consuming and pharmacological testing may not fully mimic exercise test. The objectives of the present project were to characterize the metabolic profile of the population undergoing pharmacological and exercise stress testing to evaluate possible differences between them, and to assess the capacity of 1H NMR spectroscopy to predict positive stress testing. Pattern recognition was applied to 1H NMR spectra from serum of patients undergoing stress test and metabolites were quantified. The effects of the stress test, confounding variables and the ability to predict ischemia were evaluated using OPLS-DA. There was an increase in lactate and alanine concentrations in post-test samples in patients undergoing exercise test, but not in those submitted to pharmacological testing. However, when considering only pharmacological patients, those with a positive test result, showed increased serum lactate, that was masked by the much larger amount of lactate associated to exercise testing. In conclusion, we have established that pharmacological stress test does not reproduce the dynamic changes observed in exercise stress. Although there is promising evidence suggesting that 1H NMR based metabolomics could predict stress test results, further studies with much larger populations will be required in order to obtain a definitive answer.

Concordancia entre la prueba de puntuación de recurrencia de 21 genes y modelos clínico-patológicos predictivos en pacientes con cáncer de mama temprano en un centro oncológico en Colombia / Concordance between 21-gene recurrence score assay and clinicopathological predictive models in early-breast cancer patients cared for at a cancer center in Colombia

Resumen Introducción: La prueba genómica de recurrencia de 21 genes (PGR21) permite determinar la utilidad de la quimioterapia adyuvante en pacientes con cáncer de mama temprano luminal (CMTL). Se han desarrollado modelos predictivos adicionales, como las ecuaciones de Magee (EM), el modelo Predict (MP) y la puntuación del nomograma de la Universidad de Tennessee (NT). Objetivo: Evaluar la concordancia entre PGR21, EM, MP y NT. Métodos: Se incluyeron pacientes con CMTL unifocal y con resultados de PGR21, EM, MP y NT. Se efectuó subanálisis de mujeres mayores de 50 años. La concordancia se evaluó mediante índice kappa de Cohen (IK). Resultados: Se incluyeron 122 mujeres. La concordancia entre PGR21 y EM (IK = 0.35) y MP (IK = 0.24) fue aceptable (p < 0.001); entre PGR21 y NT fue inferior (IK = 0.16, p = 0.04). Se incluyeron 80 pacientes mayores de 50 años con datos suficientes para calcular los tres modelos. Se encontró concordancia entre la clasificación de bajo riesgo mediante PGR21 y los tres modelos combinados en 36/37 pacientes (valor predictivo negativo de 97.3 %). Conclusión: Se puede omitir la PGR21 en las mujeres mayores de 50 años con CMTL que se clasifica de bajo riesgo en los tres modelos predictivos.

Abstract Introduction: The genomic-based 21-gene recurrence score assay (21-GRSA) allows to determine the usefulness of adjuvant chemotherapy in patients with luminal-type early breast cancer (LTEBC). Additional predictive models have also been developed, such as Magee equations (ME), the Predict model (PM), and the Tennessee nomogram score (TNS). Objective: To evaluate the concordance between 21-GRSA, ME, PM and TNS. Methods: Patients with unifocal LTEBC and 21-GRSA, ME, PM and TNS results were included. A subgroup analysis of women older than 50 years was carried out. Concordance between the models and 21-GRSA was evaluated using Cohen's kappa index (KI). Results: One-hundred and twenty-two women were included. Concordance between 21-GRSA and ME (KI = 0.35) and PM (KI = 0.24) was fair (p < 0.001). Concordance between 21-GRSA and TNS was inferior (KI = 0.16, p = 0.04). Eighty patients older than 50 years with sufficient data to calculate all three predictive models were included. Concordance was found between the low-risk classification on 21-GRSA and all three combined models in 36/37 patients (negative predictive value of 97.3%). Conclusion: 21-GRSA can be omitted in women older than 50 years with LTEBC classified with low risk scores on all three predictive models.

A propósito de la cardiopatía periparto: una etiología olvidada / Regarding peripartum heart disease: a forgotten etiology

Resumen Objetivo: Identificar la epidemiología clínica y los procesos diagnósticos y terapéuticos de las mujeres con miocardiopatía periparto en un centro de referencia cardiovascular. Método: Se realizó un estudio observacional descriptivo retrospectivo con pacientes de sexo femenino de entre 15 y 50 años con diagnóstico de cardiopatía periparto durante los últimos 10 años en una institución especializada de la ciudad de Medellín. Resultados: Hubo 17 mujeres con diagnóstico de cardiopatía periparto, con una edad media de 31 años (± 6.7). El número promedio de embarazos fue de 1.0, con un 52.9%. Las condiciones más frecuentes durante la gestación fueron obesidad y preeclampsia, con un 23.5% para ambas; se halló diabetes gestacional en una paciente (5.9%) y dos presentaron hemorragia del primer trimestre (11.8%). El 41.2% de las mujeres tuvieron parto vértice espontáneo. Ninguna mujer tuvo antecedentes cardiovasculares. Los síntomas presentados al momento del diagnóstico fueron deterioro de la clase funcional (100%), edema en miembros inferiores (52.9%), ortopnea (76.4%) y disnea paroxística nocturna (88.2%). La terapia farmacológica iniciada incluyó diuréticos (58.8%), inhibidores de la enzima convertidora de angiotensina (IECA) (64.7%), betabloqueadores (82.4%), bromocriptina (5.8%), ivabradina (23.5%) y antagonistas de la aldosterona (64.7%). Conclusiones: Este registro señala la similitud en nuestro medio de esta enfermedad, respecto a la epidemiología, la presentación y el manejo, con el resto del mundo. Muestra que el tratamiento farmacológico para falla cardiaca con la combinación de betabloqueadores, IECA y diuréticos sigue siendo el pilar fundamental en el tratamiento; además, destaca que la miocardiopatía periparto aún es una afección grave, con alta morbilidad y que permanece en insuficiencia cardiaca después del diagnóstico y con un riesgo importante de mortalidad.

Abstract Objective: To identify the epidemiology and the diagnostic and therapeutic processes of women with peripartum cardiomyopathy on a cardiovascular reference center. Method: A retrospective descriptive observational study was conducted with female patients between 15 and 50 years of age with a diagnosis of peripartum cardiomyopathy during the last 10 years. Results: 17 women with a diagnosis of peripartum cardiomyopathy where included, with a mean age of 31 (± 6,7) years at the time of diagnosis. The average number of previous pregnancies was 1.0 in 52.9% of the population. Obesity and preeclampsia were present in 23.5% and 18.8%, respectively. Diabetes was found in one patient (5.9%) and two had hemorrhage of the first trimester (11.8%). 41.2% of the women had a spontaneous vertex delivery. The symptoms presented at the time of diagnosis were deterioration of their functional class in 100.0%, edema in the lower limbs in 52.9%, orthopnea in 76.4% and paroxysmal nocturnal dyspnea in 88.2%. Conclusions: Our data show that peripartum cardiomyopathy occurs with a mode of presentation similar to the rest of the world, pharmacological treatment for heart failure with the combination of beta blockers, ACE inhibitors/ARBs, and diuretics continue to be the fundamental pillar in the treatment of peripartum cardiomyopathy; It is also important to note that peripartum cardiomyopathy remains a serious condition with a high rate of critically ill patients who remain in heart failure after diagnosis with a significant risk of mortality.