RESUMEN
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.
RESUMEN
Se puede pensar que la reflexión moral sobre nuestras actuaciones, en el diagnóstico y tratamiento de los pacientes afectos de enfermedades neoplásicas, es innecesaria, lo cierto es que la existencia de normas y leyes no garantiza la moralidad de individuos y colectivos; por tanto, es necesaria una formación filosófico-moral continua, tan importante como la formación científica y técnica. Si consideramos que el cáncer es la segunda causa de muerte en el mundo occidental, y la primera en la provincia espirituana y que la actividad asistencial sobre esta enfermedad se incrementa día a día, es prudente y necesario tratar de cuestiones morales y éticas en áreas de conocimiento específicas, como la Oncología; ya que los problemas que pueden surgir en la valoración ética de algunas situaciones pueden ser diferentes, dependiendo de si se toman decisiones que afectan a pacientes con enfermedades cancerosas o no. Baste recordar algunas situaciones puntuales de cáncer de mama y embarazo, tratamiento del dolor en pacientes terminales, entre otras(AU)
One can think that the moral reflection on our performances, in the diagnosis and treatment of the patient affections of illnesses neoplásicas, is unnecessary, the certain thing is that the existence of norms and laws don't guarantee the morality of individuals and collective; therefore, it is necessary a continuous philosophical-moral formation, asimportant as the scientific formation and technique. If we consider that the cancer is the second cause of death in the western world, and the first one in the county espirituana and that the assistance activity on this illness is increased day by day, it is wise and necessary to be about moral and ethical questions in specific areas of knowledge, as the Oncology;since the problems that can arise in the ethical valuation of some situations can be different, depending of if they take decisions that affect to patient with cancerous illnesses or nr. it is Enough to remember some punctual situations of Breast cancer and pregnancy, treatment of the pain in terminals, among others(AU)
Asunto(s)
Humanos , Neoplasias/patología , Consentimiento Informado/ética , Experimentación Humana Terapéutica/ética , Ensayo Clínico PragmáticoRESUMEN
Se realizó una investigación de tipo descriptiva, de corte transversal y retrospectiva a 323 enfermos con el diagnóstico de cáncer de mama atendidas en el Servicio de Oncología del Hospital General Camilo Cienfuegos de Sancti Spíritus en el periodo comprendido entre Enero 2008 diciembre 2012. El cáncer de mama apareció con mayor frecuencia en las pacientes mayores de 50 años, representado por el sexo femenino. El mayor número de casos diagnosticados se ubicaron en los estadios iniciales. Al mayor por ciento de la muestra ensayada se le realizaron estudios imagenológico e histológicos respondieron a un diagnóstico sospechoso de malignidad. El tipo histológico más frecuente fue el Carcinoma ductal infiltrante y el mayor numero de tumores fue bien iferenciado. Recibieron tratamiento loco-regional la totalidad de los enfermos y tratamiento hormonal el 99,6 por ciento de los casos. El mayor número de recidivas apareció entre 6 y 12 meses después del tratamiento inicial, correspondiéndose con la etapa III c y estadio IV de la enfermedad. La enfermedadmetastásica tuvo fallo terapéutico en el primer año de tratamiento. Las metástasis a distancia aparecieron con mayor frecuencia en los estadios III. Fallecieron 62 aquejados en este período de tiempo(AU)
Was carried out a descriptive type investigation, of traverse court, retrospective to 323 sick persons with the cancer diagnosis of he/she suckles assisted in the Service of Oncology of the General Hospital Camilo Cienfuegos of Sancti Spíritus in the period understood among January 2003 - January 2008.El cancer of he/she suckles he/she appeared with morefrequency in the patients bigger than 50 years, represented by the feminine sex. The biggest number of diagnosed cases was located in the initial stadiums. To the biggest percent in the rehearsed sample they were carried out studies Imagenológico and histológicos they responded to a suspicious diagnosis of malignancy. The type more frequent histológico was the Carcinoma ductal infiltrante and the adult I number of tumors it was well differentiated.They received treatment loco-regional the entirety of the sick persons and hormonal treatment 99,6 percent of the cases. The biggest number of relapses appeared between 6 and 12 months after the initial treatment, belonging together with the stage III c and stadium IV of the illness. Theillness metastásica had therapeutic failure in the first year of treatment. The metastasis at distance appeared with more frequency in the stadiums III. 62 died in this period of time(AU)
Asunto(s)
Humanos , Neoplasias de la Mama/ultraestructura , Metástasis de la Neoplasia , Epidemiología Descriptiva , Estudios Transversales , Estudios RetrospectivosRESUMEN
Se analizaron 200 pacientes con diagnóstico de cáncer de mama, en un período de 5 años(Enero 2007 a Enero 2012) que fueron diagnosticados y tratados en la consulta especializada de mama en el Servicio de Oncología del Hospital Universitario de Sancti-Spíritus. Se estudiaron los factores pronósticos relacionados con el tumor primario, la presencia de ganglios metastásico, el tratamiento efectuado, el tiempo libre de enfermedad y el tiempo de sobrevida. Se comprobó en nuestra serie el predominio de pacientes con 60 años y más, con localización más frecuente en la mama izquierda, y el cuadrante superior externofue el sitio mamario más afectado. Los factores pronóstico significativos y de mayor relevancia en cuanto al tiempo libre de enfermedad y tiempo de sobrevida fueron: tamaño tumoral, status ganglionar, infiltración periganglionar y la determinación de la hormonodependencia. Se demostró que en la medida que aumenta el tamaño del tumor primario (T)y la afectación ganglionar regional (N), la etapa clínica sea más avanzada y los ganglios axilares en la pieza quirúrgica metastásicos condicionan que exista mayor posibilidad de que ocurra recurrencia tumoral, con una incidencia mayor a presentar metástasis a distancia y que ocurra la muerte en estas pacientes(AU)
200 patients diagnosed with breast cancer were analyzed over a period of 5 years (January2007 to January 2012) who were diagnosed, treated breast specialist at the Department ofOncology, University Hospital of Sancti Spiritus consultation. Prognostic factors related to the primary tumor, presence of metastatic lymph nodes, the treatment performed, the diseasefreetime and survival time were studied. The prevalence of patients aged 60 and older, withmore frequent location in the left breast, and the upper-outer quadrant was found in ourseries was the most affected breast site. The most important and significant in terms ofdisease free survival time and prognostic factors were tumor size, nodal status,periganglionar infiltration and determining hormone dependency. It was shown thatincreasing the size of the primary tumor (T) and regional lymph node involvement (N), themore advanced clinical stage and axillary lymph node metastases in the surgical specimen condition exists greater chance of tumor recurrence occurs with an increased likelihood ofdistant metastasis and death occurs in these patients incidence(AU)