Anthracycline-based triplets do not improve the efficacy of platinum-fluoropyrimidine doublets in first-line treatment of advanced gastric cancer: real-world data from the AGAMEMON National Cancer Registry.

BACKGROUND: Although anthracycline-based triplets are one of the most widely used schedules to treat advanced gastric cancer (AGC), the benefit of including epirubicin in these therapeutic combinations remains unknown. This study aims to evaluate both the efficacy and tolerance of triplets with epirubicin vs. doublets with platinum-fluoropyrimidine in a national AGC registry. METHODS: Patients with AGC treated with polychemotherapy without trastuzumab at 28 hospitals in Spain between 2008 and 2016 were included. The effect of anthracycline-based triplets against doublets was evaluated by propensity score matching (PSM) and Cox proportional hazards (PH) regression. RESULT: A total of 1002 patients were included (doublets, n = 653; anthracycline-based triplets, n = 349). The multivariable Cox PH regression failed to detect significantly increased OS in favor of triplets with anthracyclines: HR 0.90 (95% CI, 0.78-1.05), p = 0.20035. After PSM, the sample contained 325 pairs with similar baseline characteristics. This method was also unable to reveal an increase in OS: 10.5 (95% CI, 9.7-12.3) vs. 9.9 (95% CI, 9.2-11.4) months, HR 0.91 (CI 95%, 0.76-1.083), and (log-rank test, p = 0.226). Response rates (42.1 vs. 33.1%, p = 0.12) and PFS (HR 0.95, CI 95%, 0.80-1.13, log-rank test, p = 0.873) were not significantly higher with epirubicin-based regimens. The triplets were associated with greater grade 3-4 hematological toxicity, and increased hospitalization due to toxicity by 68%. The addition of epirubicin is viable, but 23.7% discontinued treatment because of adverse effects or patient decision. CONCLUSION: Anthracyclines added to platinum-fluoropyrimidine doublets did not improve the response rate or survival outcomes in patients with AGC but entailed greater toxicity.

Nomogram-based prediction of survival in patients with advanced oesophagogastric adenocarcinoma receiving first-line chemotherapy: a multicenter prospective study in the era of trastuzumab.

BACKGROUND: To develop and validate a nomogram and web-based calculator to predict overall survival (OS) in Caucasian-advanced oesophagogastric adenocarcinoma (AOA) patients undergoing first-line combination chemotherapy. METHODS: Nine hundred twenty-four AOA patients treated at 28 Spanish teaching hospitals from January 2008 to September 2014 were used as derivation cohort. The result of an adjusted-Cox proportional hazards regression was represented as a nomogram and web-based calculator. The model was validated in 502 prospectively recruited patients treated between October 2014 and December 2016. Harrell's c-index was used to evaluate discrimination. RESULTS: The nomogram includes seven predictors associated with OS: HER2-positive tumours treated with trastuzumab, Eastern Cooperative Oncology Group performance status, number of metastatic sites, bone metastases, ascites, histological grade, and neutrophil-to-lymphocyte ratio. Median OS was 5.8 (95% confidence interval (CI), 4.5-6.6), 9.4 (95% CI, 8.5-10.6), and 14 months (95% CI, 11.8-16) for high-, intermediate-, and low-risk groups, respectively (P<0.001), in the derivation set and 4.6 (95% CI, 3.3-8.1), 12.7 (95% CI, 11.3-14.3), and 18.3 months (95% CI, 14.6-24.2) for high-, intermediate-, and low-risk groups, respectively (P<0.001), in the validation set. The nomogram is well-calibrated and reveals acceptable discriminatory capacity, with optimism-corrected c-indices of 0.618 (95% CI, 0.591-0.631) and 0.673 (95% CI, 0.636-0.709) in derivation and validation groups, respectively. The AGAMENON nomogram outperformed the Royal Marsden Hospital (c-index=0.583; P=0.00046) and Japan Clinical Oncology Group prognostic indices (c-index=0.611; P=0.03351). CONCLUSIONS: We developed and validated a straightforward model to predict survival in Caucasian AOA patients initiating first-line polychemotherapy. This model can contribute to inform clinical decision-making and optimise clinical trial design.

Risk factors associated to noninvasive ventilation failure in primary influenza A pneumonia in the critical care setting.

OBJECTIVE: To evaluate the risk factors associated to noninvasive mechanical ventilation (NIV) failure in patients with primary pneumonia due to influenza A (H1N1)pdm09 virus admitted to the intensive care unit (ICU), and to demonstrate the association of NIV failure to increased mortality and longer stays. DESIGN: A cohort study was carried out. SCOPE: A mixed ICU (16 beds) in a teaching hospital. PATIENTS: Adult patients admitted to the ICU with a diagnosis of pneumonia due to influenza A (H1N1)pdm09 virus requiring mechanical ventilation. MEASUREMENTS: Age, sex, severity scores, administration of corticosteroids, oseltamivir within 72h of symptoms onset, days of symptoms prior to admission, affected quadrants, hemodynamic parameters, renal failure, laboratory test data on admission, mortality and stay in ICU and in hospital. RESULTS: A total of 54 patients were admitted to the ICU and 49 were ventilated; 29 were females (59.2%), and the mean age±standard deviation was 66.77±14.77 years. Forty-three patients (87.75%) were ventilated with NIV, and 18 (41.9%) of them failed. Patients with NIV failure were younger (63 vs. 74 years; p=0.04), with a higher SOFA score (7 vs. 4; p=0.01) and greater early hemodynamic failure (61.1 vs. 8%; p=0.01). In addition, they presented longer ICU (26.28 vs. 6.88 days; p=0.01) and hospital stay (32.78 vs. 18.8 days; p=0.01). The ICU mortality rate was also higher in the NIV failure group (38.9 vs. 0%; p=0.02). In the multivariate analysis, corticosteroid therapy (OR 7.08; 95% CI 1.23-40.50) and early hemodynamic failure (OR 14.77; 95% CI 2.34-92.97) were identified as independent risk factors for NIV failure. CONCLUSIONS: Treatment with corticosteroids and early hemodynamic failure were associated to NIV failure in patients with primary pneumonia due to influenza A (H1N1)pdm09 virus infection admitted to the ICU. The failure of NIV was associated to increased mortality.

Optimal duration of first-line chemotherapy for advanced gastric cancer: data from the AGAMENON registry.

BACKGROUND: The optimal duration of first-line chemotherapy for patients with advanced gastric cancer is unknown. Diverse clinical trials have proposed different strategies including limited treatment, maintenance of some drugs, or treatment until progression. METHOD: The sample comprises patients from the AGAMENON multicenter registry without progression after second evaluation of response. The objective was to explore the optimal duration of first-line chemotherapy. A frailty multi-state model was conducted. RESULTS: 415 patients were divided into three strata: discontinuation of platinum and maintenance with fluoropyrimidine until progression (30%, n = 123), complete treatment withdrawal prior to progression (52%, n = 216), and full treatment until progression (18%, n = 76). The hazard of tumor progression decreased by 19% per month with the full treatment regimen. However, we found no evidence that fluoropyrimidine maintenance (hazard ratio [HR] 1.07, confidence interval [CI] 95%, 0.69-1.65) worsened progression-free survival (PFS) with respect to treatment until progression. Predictive factors for PFS were ECOG performance status, ≥ 3 metastatic sites, prior tumor response, and bone metastases. Toxicity grade 3/4 was more common in those who continued the full treatment until progression vs fluoropyrimidine maintenance (16% vs 6%). CONCLUSION: The longer duration of the full initial regimen exerted a protective effect on the patients of this registry. Platinum discontinuation followed by fluoropyrimidine maintenance yields comparable efficacy to treatment up to PD, with a lower rate of serious adverse events.

Factores de riesgo de fracaso de ventilación no invasiva en neumonía primaria por influenza A en pacientes críticos / Risk factors associated to noninvasive ventilation failure in primary influenza A pneumonia in the critical care setting

Objetivo Analizar factores de riesgo de fracaso de la ventilación no invasiva (VNI) en pacientes que ingresan en una unidad de cuidados intensivos (UCI) por neumonía primaria por virus influenza A (H1N1)pdm09. Demostrar que los pacientes que fracasan con la VNI tienen mayor mortalidad y estancias más largas. Diseño Estudio de cohorte. Ámbito UCI polivalente de un hospital universitario de 16 camas. Pacientes Pacientes adultos que ingresaron en la UCI en los que se confirmó el diagnóstico de neumonía por influenza A (H1N1)pdm09 y que recibieron ventilación mecánica. Variables Edad, sexo, puntuaciones de gravedad, administración de corticoides, oseltamivir dentro de las 72h de la sintomatología, días de sintomatología previos al ingreso, cuadrantes afectados, fracaso hemodinámico, renal y datos analíticos al ingreso, mortalidad y estancia en UCI y hospitalaria. Resultados Ingresaron 54 pacientes y 49 fueron ventilados. Sexo femenino, 29 (59,2%) y una edad media±desviación estándar de 66,77±14,77 años. Fueron ventilados con VNI 43 (87,75%), de los que fracasaron 18 (41,9%). Los pacientes que fracasaron presentaron menor edad (63 vs. 74 años; p=0,04), mayor puntuación SOFA (7 vs. 4; p=0,01) y mayor fracaso hemodinámico (61,1 vs. 8%; p=0,01). Además, presentaron estancias más largas tanto en UCI (26,28 vs. 6,88 días; p=0,01) como hospitalarias (32,78 vs. 18,8 días; p=0,01), y mayor mortalidad en UCI (38,9 vs. 0%; p=0,02). Se identificaron como factores de riesgo de fracaso a VNI recibir corticoides (OR 7,08; IC 95% 1,23-40,50) y el fallo hemodinámico precoz (OR 14,77; IC 95% 2,34-92,97). Conclusiones El tratamiento con corticoides y el fracaso hemodinámico precoz se asociaron con el fracaso de la VNI en pacientes con neumonía primaria por virus influenza A (H1N1)pdm09. Estos tienen una mortalidad superior. (AU)

Objective To evaluate the risk factors associated to noninvasive mechanical ventilation (NIV) failure in patients with primary pneumonia due to influenza A (H1N1)pdm09 virus admitted to the intensive care unit (ICU), and to demonstrate the association of NIV failure to increased mortality and longer stays. Design A cohort study was carried out. Scope A mixed ICU (16 beds) in a teaching hospital. Patients Adult patients admitted to the ICU with a diagnosis of pneumonia due to influenza A (H1N1)pdm09 virus requiring mechanical ventilation. Measurements Age, sex, severity scores, administration of corticosteroids, oseltamivir within 72h of symptoms onset, days of symptoms prior to admission, affected quadrants, hemodynamic parameters, renal failure, laboratory test data on admission, mortality and stay in ICU and in hospital. Results A total of 54 patients were admitted to the ICU and 49 were ventilated; 29 were females (59.2%), and the mean age±standard deviation was 66.77±14.77 years. Forty-three patients (87.75%) were ventilated with NIV, and 18 (41.9%) of them failed. Patients with NIV failure were younger (63 vs. 74 years; P=.04), with a higher SOFA score (7 vs. 4; P=.01) and greater early hemodynamic failure (61.1 vs. 8%; P=.01). In addition, they presented longer ICU (26.28 vs. 6.88 days; P=.01) and hospital stay (32.78 vs. 18.8 days; P=.01). The ICU mortality rate was also higher in the NIV failure group (38.9 vs. 0%; P=.02). In the multivariate analysis, corticosteroid therapy (OR 7.08; 95% CI 1.23-40.50) and early hemodynamic failure (OR 14.77; 95% CI 2.34-92.97) were identified as independent risk factors for NIV failure. Conclusions Treatment with corticosteroids and early hemodynamic failure were associated to NIV failure in patients with primary pneumonia due to influenza A (H1N1)pdm09 virus infection admitted to the ICU. The failure of NIV was associated to increased mortality. (AU)

Hemangioendotelioma epitelioide de alta agresividad: caso clínico / Highly aggressive pulmonary epithelioid hemangioendothelioma: a case report

El hemangioendotelioma epitelioide pulmonar es una enfermedad oncológica infrecuente de origen endotelial, con una incidencia inferior a un caso por millón de habitantes. Habitualmente se comporta como un neoplasia de bajo grado; sin embargo, se han descrito algunos casos en los que el tumor manifiesta una alta agresividad, extendiéndose con rapidez por todo el organismo. Presentamos el caso de una mujer de 77 años que fue diagnosticada de un hemangioendotelioma epitelioide pulmonar metastásico con sintomatología severa, precisando tratamiento urgente para su paliación (AU)

Pulmonary epithelioid hemangioendothelioma is an uncommon neoplastic disease of endothelial origin, with an incidence inferior to one in a million. It usually behaves as a low-grade malignancy; nevertheless, a few cases have been described in which this tumour manifests a highly aggressive behavior, spreading throughout the organism. We report the case of a 77-year-old woman who was diagnosed with metastatic pulmonary epithelioid hemangioendothelioma with severe symptoms, requiring urgent treatment to palliate them (AU)

Alerta ante medicación inesperada en hemodiálisis / Warning against unexpected medication in haemodialysis

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Hemospermia en la hipertensión maligna / No disponible

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Hipertensión arterial y menopausia reciente: estudio comparativo de dos fármacos hipotensores

Objetivo. Analizar durante doce semanas la eficacia antihipertensiva, tolerancia clínica y perfil metabólico del amlodipino y el carvedilol en mujeres hipertensas con menopausia de comienzo reciente. Diseño. Estudio prospectivo y aleatorio. Material y métodos. Cuarenta mujeres (edad media: 51,1 ñ 0,89 años; tiempo de menopausia: 1,6ñ0,53 años; meses desde el diagnóstico de la hipertensión arterial [HTA]: 20,70ñ9,31). Se excluye menopausia quirúrgica. Treinta y dos (80 por ciento) HTA grado I y 8 (20 por ciento) grado II de la Organización Mundial de la Salud (OMS). Previamente y durante dos semanas se suspendió el tratamiento previo: 16 (40 por ciento) no tratadas, 14 (35 por ciento) tratadas no controladas y 10 (25 por ciento) tenían intolerancia. Se establecieron dos grupos de tratamiento a los que las pacientes se asignaron de manera aleatoria: 20 pasaron a recibir 5 mg de amlodipino y las otras 25 mg de carvedilol, todas en dosis única por las mañanas. Al inicio y final del estudio se determinaron las cifras de presión arterial sistólica (PAS), presión arterial diastólica (PAD), frecuencia cardíaca, índice de masa corporal de Quetelet y analítica sanguínea: colesterol total y HDL, triglicéridos, glucosa, ácido úrico, creatinina, sodio y potasio. Consideramos que existía control de la presión arterial con cifras de PAS < 130 mmHg y de PAD < 85 mmHg. Se recogieron los efectos que cada paciente atribuía a la medicación del estudio. La significación estadística se estableció para una p < 0,05.Resultados. Se analizan los resultados de 37 pacientes; tres del grupo amlodipino se excluyeron por edemas en miembros inferiores. En ambos grupos se produjo un descenso (p < 0,001) de las cifras de PAS y de PAD, existiendo únicamente control de la PAD. La frecuencia cardíaca disminuyó (p < 0,01) en el grupo del carvedilol. No existieron diferencias significativas en el resto de los parámetros analizados. Efectos secundarios: 2 (10 por ciento) en el grupo del carvedilol y 5 (25 por ciento) en el de amlodipino. Conclusión. Ambos fármacos mostraron eficacia antihipertensiva y perfil metabólico neutro en el tratamiento de la HTA en la mujer postmenopáusica, con mejor tolerancia clínica del carvedilol (AU)