Patient profiles as an aim to optimize selection in the second line setting: the role of aflibercept.

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.

[Lipid lowering treatment of severe hypertriglyceridemia with acute pancreatitis caused by everolimus in a patient with a neuroendocrine tumor]. / Tratamiento hipolipemiante de la pancreatitis aguda secundaria a hipertrigliceridemia severa por everolimus en un paciente con tumor neuroendocrino.

Everolimus is an mTOR inhibitor, approved as a treatment for cancer and as an immunosuppressant agent in solid organ transplantation; it frequently produces toxic metabolic effects, particularly of the most severe kind. Its use can cause hyperglycemia, hypercholesterolemia and hypertriglyceridemia; thus, metabolic values should be monitored regularly to prevent these adverse events. We present the case of a woman with an intestinal neuroendocrine tumor who developed two episodes of acute pancreatitis, secondary to severe hypertriglyceridemia caused by everolimus. After treatment with fibrates and omega-3, triglyceride levels returned to baseline, without developing new metabolic or digestive complications. Targeted levels of triglyceride for cancer patients treated with everolimus, should be below 500 or 300 mg/dL, depending on whether life expectancy is less or longer than one year, respectively.

New clinical trials regulation in Spain: analysis of royal decree 1090/2015.

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.

[Evaluation through the EORTC questionnaires of long-term quality of life in patients with breast cancer in initial stages]. / Evaluación de la calidad de vida a largo plazo en pacientes con cáncer de mama en estadios iniciales mediante los cuestionarios de la EORTC.

BASIS: The objective of the present work is to evaluate the quality of life of a group of patients with breast cancer after a long follow-up time. METHODS: 104 patients with breast cancer in initial stages, of a total of 125 to whom the questionnaire was sent, have completed the general questionnaire QLQ-C30 and the module of the breast QLQ-BR23 of the EORTC in 2001, five years after their diagnosis. A subgroup of 48 patients had completed these questionnaires in 1996. The scorings of quality of life and the differences among the measurements of 2001 and 1996 have been evaluated, and groups organized according to the stage, the type of treatment, and the surgery have been compared. RESULTS: The scorings of quality of life are appropriate and similar in both periods (1996 and 2001). There are alterations in the sexual function and concern over the future. The differences between the type of surgery focus on the corporal image. There are not significant differences in the analyses according to the stage or according to the type of treatment. CONCLUSIONS: The scorings of quality of life indicate that the situation of these patients is satisfactory. The differences in the type of surgery are similar to the ones observed in the literature.