RESUMEN
Colorectal cancer is the second leading cause of cancer-related death worldwide. For metastatic colorectal cancer (mCRC) patients, it is recommended, as first-line treatment, chemotherapy (CT) based on doublet cytotoxic combinations of fluorouracil, leucovorin, and irinotecan (FOLFIRI) and fluorouracil, leucovorin, and oxaliplatin (FOLFOX). In addition to CT, biological (targeted agents) are indicated in the first-line treatment, unless contraindicated. In this context, most of mCRC patients are likely to progress and to change from first line to second line treatment when they develop resistance to first-line treatment options. It is in this second line setting where Aflibercept offers an alternative and effective therapeutic option, thought its specific mechanism of action for different patient's profile: RAS mutant, RAS wild-type (wt), BRAF mutant, potentially resectable and elderly patients. In this paper, a panel of experienced oncologists specialized in the management of mCRC experts have reviewed and selected scientific evidence focused on Aflibercept as an alternative treatment.
Asunto(s)
Inhibidores de la Angiogénesis/uso terapéutico , Neoplasias Colorrectales/tratamiento farmacológico , Sustitución de Medicamentos , Receptores de Factores de Crecimiento Endotelial Vascular/uso terapéutico , Proteínas Recombinantes de Fusión/uso terapéutico , Factores de Edad , Antineoplásicos Inmunológicos/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Bevacizumab/uso terapéutico , Camptotecina/análogos & derivados , Camptotecina/uso terapéutico , Ensayos Clínicos Fase III como Asunto , Neoplasias Colorrectales/genética , Neoplasias Colorrectales/patología , Fluorouracilo/uso terapéutico , Genes ras , Humanos , Leucovorina/uso terapéutico , Neoplasias Hepáticas/secundario , Neoplasias Hepáticas/cirugía , Neoplasias Pulmonares/secundario , Neoplasias Pulmonares/cirugía , Mutación , Neovascularización Patológica/tratamiento farmacológico , Compuestos Organoplatinos/uso terapéutico , Proteínas Proto-Oncogénicas B-raf/genética , Factor A de Crecimiento Endotelial Vascular/antagonistas & inhibidoresAsunto(s)
Oncología Médica , Neoplasias/complicaciones , Sistema de Registros/estadística & datos numéricos , Sociedades Médicas , Trombosis de la Vena/etiología , Antineoplásicos/efectos adversos , Cisplatino/efectos adversos , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto , España , Trombosis de la Vena/tratamiento farmacológicoRESUMEN
The coming into force of Directive 2001/20/EC represented a step forward in harmonising clinical trial regulation in European countries, guaranteeing a uniform protection of subjects participating in clinical research across Europe. However, it led to a disproportionate increase in the bureaucratization, and thus, it became evident that procedures needed to be simplified without detriment to patient's safety. Thus, Regulation 536/2014, that repealed Directive 2001/20/EC, with the aim of decreasing the growing bureaucratization and stimulating clinical research in Europe, established simplified procedures, such as regulating a common procedure for authorising trials in Europe, the institution of strict assessment timelines, or the definition of new concepts, such as "low-intervention clinical trial". The legal form of a Regulation allowed the norm to be directly applied to Member States without the need for transposition. By means of the new Royal Decree, the national legislation is adapted to make the application of the regulation feasible and it allows the development of the aspects that the Regulation leaves to national legislation. Both documents seek to stimulate clinical research with medicinal products to foster knowledge, facilitate transparency, and reinforce subjects' safety. This will surely be the case, but with this revision, we will look at the novelties and key aspects that are most relevant to investigators and we will analyse the consequences for all parties involved in clinical research.
Asunto(s)
Ensayos Clínicos como Asunto/legislación & jurisprudencia , Regulación Gubernamental , Humanos , EspañaRESUMEN
Minerals content (Fe, Ca, Mn, Mg, Na, K, Zn and Cu) of the leaves of Paraguayan yerba mate (Ilex paraguariensis, S.H.) as well as of commercial products has been determined by atomic absorption spectrophotometry. Considerable amounts of iron and calcium and remarkably high content of magnesium and potassium have been found both in the leaves and in the commercial products. Highly significant difference between the Fe content of the leaves and that of the commercial products has been found. Also, highly significant difference has been found between the Fe and Ca content of the higher quality-greater sale reputed commercial products and that of the lower quality-smaller sale reputed ones. Seasonal and soil linked variations are also presented. The nutritional and quality control significance of these findings for the MERCOSUR (Southern South America Economical Community) are discussed.