RESUMEN
Some patients use complementary medicine. We present a patient with Hodgkin's lymphoma, scanned with 18F-FDG PET/CT for evaluation of response after chemotherapy, who was self-administering mistletoe as a homeopathic medicine product. The careful review of the images of the entire scan and patient collaboration in anamnesis were crucial to avoid a false positive result. A review of the published scientific data on the effects of mistletoe is also presented.
Asunto(s)
Antineoplásicos Fitogénicos/efectos adversos , Radioisótopos de Flúor/análisis , Fluorodesoxiglucosa F18/análisis , Enfermedad de Hodgkin/diagnóstico por imagen , Ganglios Linfáticos/diagnóstico por imagen , Materia Medica/efectos adversos , Fitoterapia/efectos adversos , Tomografía Computarizada por Tomografía de Emisión de Positrones , Radiofármacos/análisis , Proteínas Inactivadoras de Ribosomas Tipo 2/efectos adversos , Toxinas Biológicas/efectos adversos , Viscum album/efectos adversos , Adulto , Antineoplásicos Fitogénicos/administración & dosificación , Antineoplásicos Fitogénicos/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Bleomicina/administración & dosificación , Dacarbazina/administración & dosificación , Doxorrubicina/administración & dosificación , Femenino , Enfermedad de Hodgkin/tratamiento farmacológico , Humanos , Inyecciones Subcutáneas , Ganglios Linfáticos/efectos de los fármacos , Estadificación de Neoplasias , Proteínas Inactivadoras de Ribosomas Tipo 2/administración & dosificación , Proteínas Inactivadoras de Ribosomas Tipo 2/uso terapéutico , Automedicación , Grasa Subcutánea/diagnóstico por imagen , Grasa Subcutánea/metabolismo , Toxinas Biológicas/administración & dosificación , Toxinas Biológicas/uso terapéutico , Vinblastina/administración & dosificaciónRESUMEN
Phase I oncology clinical trials are designed to identify the optimal dose that will be recommended for phase II trials. This dose is typically defined as the dose associated with a certain probability of severe toxicity during the first cycle of treatment, although toxicity is repeatedly measured over cycles on an ordinal scale. We propose a new adaptive dose-finding design using longitudinal measurements of ordinal toxic adverse events, with proportional odds mixed-effect models. Likelihood-based inference is implemented. The optimal dose is then the dose producing a target rate of severe toxicity per cycle. This model can also be used to identify cumulative or late toxicities. The performances of this approach were compared with those of the continual reassessment method in a simulation study. Operating characteristics were evaluated in terms of correct identification of the target dose, distribution of the doses allocated and power to detect trends in the risk of toxicities over time. This approach was also used to reanalyse data from a phase I oncology trial. Use of a proportional odds mixed-effect model appears to be feasible in phase I dose-finding trials, increases the ability of selecting the correct dose and provides a tool to detect cumulative effects.
Asunto(s)
Antineoplásicos/administración & dosificación , Ensayos Clínicos Fase I como Asunto/métodos , Funciones de Verosimilitud , Estudios Longitudinales , Dosis Máxima Tolerada , Modelos Estadísticos , Adulto , Antineoplásicos/toxicidad , Simulación por Computador , Humanos , Neoplasias/tratamiento farmacológico , Preparaciones de Plantas/administración & dosificación , Preparaciones de Plantas/efectos adversos , Proteínas Inactivadoras de Ribosomas Tipo 2/administración & dosificación , Proteínas Inactivadoras de Ribosomas Tipo 2/efectos adversos , Toxinas Biológicas/administración & dosificación , Toxinas Biológicas/efectos adversosRESUMEN
Safety of aviscumine by subcutaneous route was assessed in patients with advanced cancer refractory to chemotherapy. Patients with progressive disease received escalating doses twice weekly. Treatment of the accrued 26 patients (10 colorectal cancer (CRC), 6 soft tissue sarcoma (STS), 5 melanoma (MM), 5 others) was well tolerated without substance-related grade 3 or 4 toxicities. Grade 1/2 toxicities were predominantly injection site reactions. Aviscumine lacked dose-limiting toxicity (DLT) up to a maximal dose of 10 ng/kg. An increase of interleukin-1 beta and interferon-gamma from baseline was seen in the patient's plasma between the 1st and 11th injection. Highest release of both cytokines was in the dose range of 4-5.9 ng/kg. Interferon-gamma was not detected after doses higher than 6 ng/kg. Eight patients (5 CRC, 1 MM, 1 STS, 1 RCC) had disease stabilisation for 79-250 days (median122 days) associated with an increase of interleukin (IL)-1 beta and interferon (IFN)-gamma. Aviscumine was well tolerated and appeared to possess clinical activity at a biologically active dose between 4 and 6 ng/kg.