RESUMO
Background: Nimotuzumab is a humanized monoclonal antibody that targets the epidermal growth factor receptor. It was approved in Cuba for the indication of inoperable malignant tumors of the esophagus of epithelial origin. The purpose of this study was to evaluate the safety, overall and progression-free survival, clinical response, and quality of life, in adult patients with inoperable esophageal tumors of epithelial origin treated with nimotuzumab in a practical context. Material and Methods. The number of patients who developed adverse events was determined, and the frequency, seriousness, causality, and severity of these adverse events were determined. It also determined the median of survival and progression-free survival and rates at 12 and 24 months and the quality of life. Results: A total of 111 patients were included. The proportion of serious and related AE with the use of nimotuzumab was 1.3%. Most of the related AEs were mild and moderate, and the most frequent AEs were diarrhea, chills, and tremors. New diagnosed patients who received nimotuzumab concurrent with chemotherapy and radiotherapy reached a median OS of 12.2 months (95% CI, 6.9-17.5) and 12- and 24-month survival rates of 51.0% and 17.0%, respectively. Median PFS was 7.8 months (95% CI, 6.2-9.5), and 12- and 24-month PFS rates were 39.3% and 11.2%, respectively. A favorable evolution of the general state of health (p=0.03) was obtained from the beginning of treatment until month 12, with a significant reduction in the appearance of nausea (p=0.009), insomnia (p=0.04), constipation (p=0.04), eating difficulties (p=0.0006), and choking when swallowing (p=0.0001), but increased in dysphagia (p=0.02). Conclusions: The administration of nimotuzumab was safe in the real-world setting. New diagnosed patients that received nimotuzumab concurrent with chemotherapy and radiotherapy reached a higher overall and progression-free survival and better quality of life than the rest of the patients. Trial registration is RPCEC00000215 (Cuban Registry of Clinical Trials; https://registroclinico.sld.cu/en/home). It is registered prospectively on June 30, 2016.
RESUMO
RESUMEN Introducción: en la literatura biomédica son escasos los reportes sobre el uso de los interferones como tratamiento en el carcinoma epidermoide. En una unidad de atención primaria, en Colón, Matanzas, se implementó el HeberFERON® en este tipo de tumor, con experiencias favorables. Objetivo: describir la efectividad del HeberFERON® en el carcinoma epidermoide. Materiales y métodos: se realizó un estudio observacional, descriptivo en 33 lesiones de carcinoma epidermoide en 29 pacientes. La dosis fue de 7,0 y 10,5 MUI de actividad antiviral, infiltrada de forma perilesional tres veces por semana durante tres semanas. Se realizó el seguimiento clínico de los pacientes antes del tratamiento y a las 16 semanas del inicio del mismo. Las variables fueron: edad, sexo, fototipo de piel, procedencia, localización, tipo clínico, estadio y respuesta clínica al tratamiento. Se consideraron cuatro categorías de respuesta: completa, parcial, enfermedad estable y progresiva. Se incluyó la respuesta objetiva (completa más parcial). Se recogieron los datos en una historia clínica. Se utilizaron los programas Microsoft Excel y SPSS para el procesamiento estadístico. Resultados: el 65,5 % de los pacientes correspondió al sexo masculino. Un 58,6 % son fototipo II y de procedencia urbana. Predominaron las edades entre 61 y 80 años (55,2 %). Hubo respuesta objetiva en 57,6 % (cinco completas y 14 parciales). Las mejores respuestas la mostraron el carcinoma epidermoide queratósico superficial y el noduloulceroso. Conclusiones: la mezcla de interferones fue efectiva en el carcinoma epidermoide en todos los subtipos clínicos, aunque los autores sugieren un segundo ciclo de HeberFERON® o asociarlo con quimioterapia cuando la respuesta no sea completa.
ABSTRACT Introduction: there are few reports in the literature on the use of interferon in the treatment of the squamous cell carcinoma. In a primary care unit in Colon, Matanzas, HeberFERON® was implemented in this type of tumor with favorable experiences. Objective: to describe the effectiveness of HeberFERON® in epidermoid carcinoma. Materials and methods: an observational, descriptive study was conducted in 33 epidermoid carcinoma lesions in 29 patients. The doses were 7.0 and 10.5 MUI of antiviral activity, perilesionally infiltrated three times a week for three weeks. Clinical follow-up of patients was performed before the treatment and at 16 weeks from the beginning of the treatment. The variables were: age, sex, skin phototype, origin; location, clinical type, stage and clinical response to treatment. Four categories of response were considered: complete, partial, stable and progressive disease. The objective response (complete plus partial) was included. Data were collected in a clinical record. The Microsoft Excel and SPSS programs were used for statistical processing. Results: 65.5 % of patients were male. 58.6 % are phototype II and of urban origin. Ages ranging from 61 to 80 years (55.2 %) predominated. There was objective response in 57.6 % (five complete and 14 partials). The superficial keratotic squamous cell carcinoma and the nodular ulcerative one showed the best responses. Conclusions: interferon mixing was effective in all clinical subtypes of epidermoid carcinoma, although the authors suggest a second cycle of HeberFERON® or to associate it with chemotherapy when the response is not complete.
RESUMO
El tumor sólido pseudopapilar del páncreas, conocido también como tumor de Frantz, es una enfermedad rara: neoplasia bien delimitada, de lento crecimiento, no agresiva pero maligna, habitualmente con pronóstico favorable. El tratamiento de elección es quirúrgico. Aunque algunos de ellos son agresivos a nivel local, la mayoría de los pacientes se curan con la resección completa del tumor. Se reportó el caso de una mujer de 30 años, ingresada en el Servicio de Cirugía General del Hospital Universitario Clínico Quirúrgico Comandante Faustino Pérez Hernández, con diagnóstico presuntivo clínico e imagenológico, de tumor pseudopapilar sólido del páncreas, con confirmación histológica tras la resección quirúrgica. Este infrecuente tumor debe ser considerado en el diagnóstico diferencial de los tumores pancreáticos, fundamentalmente en mujeres jóvenes(AU)
The solid pseudo-papillary carcinoma, also known as Frantz´s tumor, is a rare disease. It is a well-defined neoplasia, of low growth, non-aggressive but malignant, usually with a favorable prognosis. The elective treatment is the surgery. Although some of them are locally aggressive, most patients are healed with the complete tumor resection. The authors reported the case of a woman, aged 30 years who entered the Service of General Surgery of the University Hospital Comandante Faustino Pérez Hernández, with a presumptive clinical and imaging diagnosis of pancreas solid pseudo-papillary tumor, histologically confirmed after surgical resection. This infrequent tumor should be taken into account in the differential diagnosis of pancreatic tumors, mainly in young women(AU)
