Interstitial nephritis with pembrolizumab: A case report and review.

INTRODUCTION: Pembrolizumab is a monoclonal antibody approved for adult patients with advanced non-small-cell lung cancer (NSCLC). Although immune related adverse events are considered to be well tolerated, complications may occur and discontinuation of the treatment could be required. CASE REPORT: A 62-year old patient diagnosed with advanced non-small cell lung cancer experienced a decline in the renal function after seven cycles with pembrolizumab.Management & outcome: After ruling out other common causes of interstitial nephritis, pembrolizumab was attributed as a cause of interstitial nephritis. At first, toxicity was managed with corticosteroids and closely monitoring the patient, but finally pembrolizumab had to be discontinued due to the kidney function did not recover. DISCUSSION: Renal and urinary disorders were reported in <3% of patients treated with pembrolizumab, being interstitial nephritis the most reported toxicity. The kidney damage can be a complication to consider in patients receiving pembrolizumab. Early identification of an increase in serum creatinine levels may help with prevention by establishing an effective treatment, although it may not mean a total recovery of kidney function.

Efectividad y seguridad del régimen FLAG-IDA en leucemias agudas resistentes o recidivantes / Effectiveness and safety of the FLAG-IDA regimen in acute refractory or recurrent leukaemia

Objetivo: Evaluar la efectividad y seguridad del esquema FLAG-IDA en pacientes con leucemias agudas refractarias o recidivantes. Método Estudio observacional descriptivo retrospectivo en el que se revisaron las historias clínicas de pacientes con el esquema FLAG-IDA en el periodo 2005-2010. La efectividad se evaluó mediante la respuesta objetiva, el intervalo libre de progresión y la supervivencia global. La seguridad se midió según el sistema de clasificación NCI, Criterios comunes de Toxicidad para Acontecimientos Adversos. Resultados Fueron 12 pacientes (52,17 ± 8,26 años entre las mujeres y 54,83 ± 7,22 años en los hombres), 11casos fueron leucemias mieloides agudas (5 resistentes, 3 en recaída, una secundaria a leucemia mieloide crónica (LMC) resistente y 2 secundarias a síndrome mielodisplásico (SMD), de las que una fue resistente y la otra no había sido tratada previamente) y un caso de leucemia linfoide aguda (LLA) resistente. Seis pacientes (50%) alcanzaron una respuesta completa (RC). Un paciente consiguió una respuesta parcial (RP) tras la cual se administró otro protocolo indicado consiguiendo posteriormente una RC, 2 fallecieron por progresión de la enfermedad y 3 por complicaciones secundarias al tratamiento. El intervalo libre de progresión para los pacientes que alcanzaron la RC fue de 24,38 semanas (6 meses). La mediana de supervivencia global fue de 8,4 semanas. La media del tiempo necesario para la recuperación de la neutropenia fue de 23 y 37 días en el primer y segundo ciclo respectivamente. La media del tiempo necesario para la recuperación de la trombocitopenia fue de 24 y 35 días en cada ciclo. Conclusiones El esquema de inducción FLAG-IDA para el tratamiento de pacientes con leucemias de alto riesgo es un esquema establecido, bien tolerado y con una toxicidad aceptable que ofrece una oportunidad para optar al trasplante de progenitores hematopoyéticos (AU)

Objective: To evaluate the effectiveness and safety of the FLAG-IDA regimen in patients with acute refractory and/or recurrent leukaemia. Method: Descriptive, retrospective, observational study of the clinical histories of patients with the FLAG-IDA regimen during the period of 2005-2010. Effectiveness was measured using objective response, progression-free interval, and global survival. Safety was measured using the NCI classification system of common toxicity criteria for adverse events. Results: We registered 12 patients (52.17±8.26 years in women, and 54.83±7.22 years in men),11 cases were acute myeloid leukaemia (5 refractory, 3 in recurrence, 1 secondary to chronicre fractory myeloid leukaemia (CML) and 2 secondary to myelodysplastic syndrome (MDS), one of which was refractory and the other had not been previously treated) and one case was acuterefractory lymphoblastic leukaemia (ALL). Six patients (50%) reached a complete response (CR).One patient reached a partial response (PR), which was followed by another protocol that produced a CR, two died due to disease progression, and three due to secondary complications from treatment. The progression-free interval for patients that reached a CR was 24.38 weeks (6 months).Median global survival was 8.4 weeks. Mean time needed for the recovery of neutropenia was 23 and 37 days in the first and second cycle, respectively. The mean time required for recuperation of thrombocytopenia was 24 and35 days in each cycle. Conclusions: The FLAG-IDA induction regimen for the treatment of high-risk leukaemia patients is an established protocol, with good tolerance and acceptable toxicity levels that offers an opportunity for facilitating the transplantation of haematopoietic progenitors (AU)

[Effectiveness and safety of the FLAG-IDA regimen in acute refractory or recurrent leukaemia]. / Efectividad y seguridad del régimen FLAG-IDA en leucemias agudas resistentes o recidivantes.

OBJECTIVE: To evaluate the effectiveness and safety of the FLAG-IDA regimen in patients with acute refractory and/or recurrent leukaemia. METHOD: Descriptive, retrospective, observational study of the clinical histories of patients with the FLAG-IDA regimen during the period of 2005-2010. Effectiveness was measured using objective response, progression-free interval, and global survival. Safety was measured using the NCI classification system of common toxicity criteria for adverse events. RESULTS: We registered 12 patients (52.17±8.26 years in women, and 54.83±7.22 years in men), 11 cases were acute myeloid leukaemia (5 refractory, 3 in recurrence, 1 secondary to chronic refractory myeloid leukaemia (CML) and 2 secondary to myelodysplastic syndrome (MDS), one of which was refractory and the other had not been previously treated) and one case was acute refractory lymphoblastic leukaemia (ALL). Six patients (50%) reached a complete response (CR). One patient reached a partial response (PR), which was followed by another protocol that produced a CR, two died due to disease progression, and three due to secondary complications from treatment. The progression-free interval for patients that reached a CR was 24.38 weeks (6 months). Median global survival was 8.4 weeks. Mean time needed for the recovery of neutropenia was 23 and 37 days in the first and second cycle, respectively. The mean time required for recuperation of thrombocytopenia was 24 and 35 days in each cycle. CONCLUSIONS: The FLAG-IDA induction regimen for the treatment of high-risk leukaemia patients is an established protocol, with good tolerance and acceptable toxicity levels that offers an opportunity for facilitating the transplantation of haematopoietic progenitors.

[Suitability of the use of low-molecular-weight heparins in the prevention of venous thromboembolism]. / Adecuación de la utilización de heparinas de bajo peso molecular en la prevención de la enfermedad tromboembólica venosa.

OBJECTIVE: To investigate the prevalence of low-molecular-weight heparin (LMWH) prescription in venous thromboembolism prophylaxis in a general hospital and the suitability of the recommendations from the clinical practice guidelines. METHOD: A descriptive, observational and cross-sectional study of the indication-prescription type, carried out on patients admitted to medical departments and for surgery. RESULTS: 345 patients were included. The prevalence of HBPM use was 44.6% (95% CI, 39.3-50.1). Depending on the risk of thromboembolism, the decision to treat prophylactically (or not) was appropriate in 261 cases (75.7%; 95% CI, 70.7-80.1), and the action guidelines were not suitable for the remainder of patients. 55 patients (15.9%; 95% CI, 12.2-20.2) presented a high risk and were not prescribed prophylactically (underuse); and 29 patients (8.4%; 95% CI, 5.7-11.8) at low risk were treated prophylactically (overuse). There was a relationship between the appropriateness of the prescription and the type of patient (p<0.01). In the group of medical patients the prevalence of prescription was 22.6% (95% CI, 16.9-29.1) and only 33.3% of patients with a high to moderate risk of thromboembolism received prophylaxis. The prevalence of prescription in general surgery was 84.2% and 91.3% in traumatology. CONCLUSIONS: The degree of prophylaxis is adequate in surgical patients, but there was a significant percentage of medical patients with a high to moderate risk who did not receive suitable prophylaxis (underuse), despite recommendations with scientific and professional backing.

[Cost-effectiveness analysis of tenofovir versus zidovudine in combination therapy with efavirenz and lamivudine for the treatment of HIV in naive patients]. / Análisis coste-eficacia de tenofovir versus zidovudina en terapia combinada con efavirenz y lamivudina para el tratamiento de VIH en pacientes no pretratados.

OBJECTIVES: To assess tenofovir + lamivudine + efavirenz versus zidovudine + lamivudine + efavirenz in treatment-naive patients using a cost-effectiveness analysis. METHODS: A decision tree was designed. Effectiveness was estimated from clinical trials. Viral load and CD4 cells count were chosen as endpoints for health outcome. Both healthcare and treatment costs were considered, and univariate sensitivity tests were performed. RESULTS: The regimen including tenofovir would have a yearly cost of 10,116.61 Euros when effective, and of 12,140.40 Euros in case of therapeutic failure. The regimen including zidovudine would have a yearly cost of 7,470.36 Euros when effective, and of 8,964.90 Euros in case of therapeutic failure. The cost of switching to the regimen with tenofovir represents 14,765.86 Euros per year per additional patient with non-detectable viral load. After 3 years, the expected yearly cost is 8,765.83 Euros for the regimen including tenofovir versus 8,894.36 Euros for the regimen including zidovudine. CONCLUSION: The regimen including zidovudine is less costly in the short run when compared to the regimen including tenofovir. Both regimens become financially similar when extending the study horizon.

Análisis coste-eficacia de tenofovir versus zidovudina en terapia combinada con efavirenz y lamivudina para el tratamiento de VIH en pacientes no pretratados / Cost-effectiveness analysis of tenofovir versus zidovudine in combination therapy with efavirenz and lamivudine for the treatment of HIV in naive patients

Objetivos: Evaluar los regímenes en pacientes no pretratados de tenofovir + lamivudina + efavirenz versus zidovudina + lamivudina + efavirenz mediante un estudio coste-eficacia. Métodos: Se diseñó un árbol de decisiones. Se estimó la eficaciaa través de ensayos clínicos. Para valorar la medida sobre los resultados de la salud se consideró la carga viral y los CD4. Se consideraron costes asistenciales y de tratamiento, y se realizó un análisis de sensibilidad univariante. Resultados: El régimen con tenofovir tendría un coste anual, en caso de ser efectivo, de 10.116,61 €, mientras que si existefallo terapéutico el coste sería de 12.140,40 €. El régimen que incluye zidovudina tendría un coste anual de 7.470,36 € en caso de ser efectivo, y un coste de 8.964,90 €, en caso de fallo terapéutico.El coste de pasar al régimen que incluye tenofovir supone 14.765,86 € al año por paciente adicional con carga viral indetectable. En 3 años, el coste anual esperado es de 8.765,83 € para el régimen que incluye tenofovir frente a 8.894,36 € del régimen que incluye zidovudina. Conclusión: El régimen que incluye zidovudina es menos costoso a corto plazo que el que incluye tenofovir. Si ampliamos el horizonte del estudio, los dos regímenes se equiparan económicamente

Objectives: To assess tenofovir + lamivudine + efavirenz versus zidovudine + lamivudine + efavirenz in treatment-naive patients using a cost-effectiveness analysis. Methods: A decision tree was designed. Effectiveness was estimated from clinical trials. Viral load and CD4 cells count were chosen as end points for health outcome. Both healthcare and treatment costs were considered, and univariate sensitivity tests were performed. Results: The regimen including tenofovir would have a yearly cost of € 10,116.61 when effective, and of € 12,140.40 in case of therapeutic failure. The regimen including zidovudine would have a yearly cost of € 7,470.36 when effective, and of € 8,964.90 incase of therapeutic failure. The cost of switching to the regimen with tenofovir represents € 14,765.86 per year per additional patient with non-detectable viral load. After 3 years, the expected yearly cost is € 8,765.83 for the regimen including tenofovir versus € 8,894.36 for the regimen including zidovudine. Conclusion: The regimen including zidovudine is less costly in the short run when compared to the regimen including tenofovir. Both regimens become financially similar when extending the study horizon