Clinical experience with nimotuzumab in cuban pediatric patients with brain tumors, 2005 to 2007.

Introduction Nimotuzumab, developed in Cuba, is a humanized monoclonal antibody that targets the epidermal growth factor receptor (EGFR). It has been evaluated in malignant brain tumors in adults and children, and shown to be therapeutically safe and effective in terms of increased survival and improved quality of life. Objective Describe nimotuzumab's safety profile and clinical benefits in terms of disease control and survival in pediatric patients with progressive or recurrent primary brain tumors who were included in an expanded access program. Methods An open, prospective clinical study was designed. Between December 2005 and December 2007, 22 patients were included, all of whom had an histological and/or radiological diagnosis of progressive or recurrent primary brain tumor, classified as high-grade malignant glioblastoma (n=6), diffuse brain stem glioma (n=6), ependymoblastoma (n=5), low-grade glioma (n=4), or thalamic tumor (n=1); life expectancy of at least 4 weeks; and a Karnofsky or Lansky Performance Status score of ≥50. Nimotuzumab was administered on a 100 mg weekly intravenous infusion schedule for 6 to 8 weeks, followed by a bi-weekly maintenance phase, as long as there was no deterioration in the patient's functional capacity. Therapeutic protocols were followed for administration as monotherapy or in combination with chemotherapy and/or radiotherapy. All patients received clinical and imaging follow-up. Results Nimotuzumab was well tolerated in all therapeutic modalities, even with prolonged exposure. A minority of patients reported slight or moderate adverse events, such as vomiting, mucositis and chills, as classified by the Common Terminology Criteria for Adverse Events (CTCAE). The disease was controlled in 64% (14/22) of patients; 6-month and 1-year survival rates were 82% and 64%, respectively; average survival was 20.3 months and median survival, 19 months. Recovery of neurological functions and improvement in general status were notable in patients who attained control of the disease. Conclusions As used in this study, nimotuzumab demonstrated a broad safety profile, making it acceptable for chronic use, and implied clinical benefits in terms of increased survival and improved functional status in these patients, compared to findings described in the literature. These results indicate further studies of this product are warranted.

Alteraciones en las biopsias hepáticas en pacientes de oncopediatría portadores del virus B / Liver biopsy alterations in oncopediatrics patients HBV carriers

Se estudiaron las biopsias hepáticas procedentes de 27 pacientes con enfermedad oncológica y portadores del virus B. Las edades flucturaron entre 2 y 14 años, a todos se les realizó marcadores del virus de la hepatitis B por el método de ELISA. Al momento del diagnóstico 3 eran portadores del virus B y el resto (24 pacientes) resultaron positivos después de iniciado el tratamiento oncoespecífico. Uno de los pacientes además fué positivo para el virus C. Las alteraciones morfológicas halladas fueron hepatitis aguda asintomática en 7 pacientes (incluyendo el portador de B y C). En 17 enfermos se encontró daño mínimo de hepatocitos considerado en relación con el estado de portador y donde además la poliquimioterapia pudiera jugar un papel hepatotóxico. En este grupo hubo 7 biopsias donde también se observó participación con daño mínimo a nivel de espacios porta. En 3 pacientes se consideró el estudio histológico dentro de límites normales. Se determinó la importancia del estudio de los marcadores virales e histología hepática en este grupo de alto riesgo, en el cual es evidente la necesidad de la vacunación para VHB una vez establecido el diagnóstico de su enfermedad de base previo al inicio del tratamiento oncoespecífico

Niveles séricos de alfa-fetoproteína en la población cubana. Valores normales y en neoplasias malignas de la infancia / Serum alpha-fetoprotein levels in the Cuban population. Normal values and values in the course of malignant neoplasms in infancy

Se estudiaron los niveles séricos de alfa-fetoproteina en 133 individuos normales de la población cubana, mediante una técnica de radioinmunoanálisis. Los valores normales mostraban tendencia a aumentar a medida que aumentaba la edad de los individuos estudiados. Al analizar sueros de niños con algunas enfermedades malignas, se encontraron concentraciones elevadas de alfa-fetoproteína en los sueros de algunos pacientes con retinoblastomas, tumores embrionarios y seminomas. En el estudio evolutivo de uno de los pacientes, se encontró buena correlación clínica con la variación de los niveles séricos de alfa-fetoproteína(AU)