Exercise and cancer: a position statement from the Spanish Society of Medical Oncology.

Due to improvements in the number of cancer survivors and survival time, there is a growing interest in healthy behaviors, such as physical activity (PA), and their potential impact on cancer- and non-cancer-related morbidity in individuals with cancer. Commissioned by the Spanish Society of Medical Oncology (SEOM), in this review, we sought to distill the most recent evidence on this topic, focusing on the mechanisms that underpin the effects of PA on cancer, the role of PA in cancer prevention and in the prognosis of cancer and practical recommendations for clinicians regarding PA counseling. Despite the available information, the introduction of exercise programs into the global management of cancer patients remains a challenge with several areas of uncertainty. Among others, the most effective behavioral interventions to achieve long-term changes in a patient's lifestyle and the optimal intensity and duration of PA should be defined with more precision in future studies.

SEOM clinical guidelines in advanced and recurrent breast cancer (2018).

Although the metastasic breast cancer is still an incurable disease, recent advances have increased significantly the time to progression and the overall survival. However, too much information has been produced in the last 2 years, so a well-based guideline is a valuable document in treatment decision making. The SEOM guidelines are intended to make evidence-based recommendations on how to manage patients with advanced and recurrent breast cancer to achieve the best patient outcomes based on a rational use of the currently available therapies. To assign a level of certainty and a grade of recommendation the United States Preventive Services Task Force guidelines methodology was selected as reference.

[Quantification of changes in the external morphology of the back by means of surface topography based on structured light in idiopathic scoliosis in adolescents after a year of treatment with orthopedic corse]. / Cuantificación de cambios en la morfología externa de la espalda mediante topografía de superficie basada en luz estructurada en la escoliosis idiopática del adolescente tras un año de tratamiento con corsé ortopédico.

BACKGROUND: To quantify the morphological changes in the surface of the back of adolescents with idiopathic scoliosis as a result of treatment with braces and to correlate them with radiographic changes. MATERIAL AND METHODS: An analytical, cohort, prospective study on a sample of 31 adolescents with idiopathic scoliosis. We divided them into two groups: eleven treated with braces and twenty without them. Quantification of the deformity was performed on two separate occasions with an interval of one year using three systems: 1) angle of trunk rotation (scoliometer); 2) surface topography; 3) full spine X-rays. RESULTS: No statistically significant differences were detected between the initial and final assessment of the topographic and radiographic variables in the group with braces. In the untreated group, only in measures with the scoliometer significant differences were registered. A positive correlation was found between the Cobb angle difference of the main curve with two topographic variables that quantify the asymmetry in the axial and coronal plane, respectively. DISCUSSION: In following patients with scoliosis treated with braces, we should consider and evaluate not only radiographic parameters such as the Cobb angle, but also clinical and topographic parameters that quantify the external deformity of the back, as there is a clinical-radiographic discrepancy amply demonstrated in the literature. The improvement of the external shape of the back is a very important factor for the patient, and can influence a better completion of the orthopedic treatment. In our study, the scoliotic curve and external deformity of the back remained stable during the follow-up period in both treated and untreated patients.

ANTECEDENTES: Cuantificar los cambios morfológicos producidos en la superficie de la espalda de adolescentes con escoliosis idiopática como resultado del tratamiento mediante corsé y correlacionarlos con las variaciones radiográficas. MATERIAL Y MÉTODOS: Estudio analítico, de cohortes, prospectivo, sobre una muestra de 31 adolescentes con escoliosis idiopática divididos en dos grupos: 11 con tratamiento mediante corsé y 20 sin corsé. Se realizó una cuantificación de la deformidad en dos ocasiones separadas entre sí por un intervalo de un año mediante tres sistemas: 1) ángulo de rotación del tronco (escoliómetro); 2) topografía de superficie; 3) radiografía simple de raquis completo. RESULTADOS: No se detectaron diferencias estadísticamente significativas entre la valoración inicial y final de las variables topográficas y radiográficas en el grupo con corsé. En el grupo no tratado, sólo hubo diferencias significativas para las medidas del escoliómetro. Se encontró una correlación positiva entre la diferencia del ángulo de Cobb de la curva principal con la de dos variables topográficas que cuantifican la asimetría en el plano axial y en el coronal, respectivamente. DISCUSIÓN: En el seguimiento de pacientes con escoliosis tratados con corsé, se deben tener en cuenta y valorar no sólo parámetros radiográficos como el ángulo de Cobb, sino también parámetros clínicos y topográficos que cuantifiquen la deformidad externa de la espalda, ya que existe una discrepancia clínico-radiográfica demostrada de manera amplia en la literatura. La mejoría de la forma externa de la espalda es un factor muy importante para el paciente y es lo que va a percibir fundamentalmente, lo que puede influir en una mejor cumplimentación del tratamiento ortopédico. En nuestro estudio, la curva escoliótica, así como la deformidad externa de la espalda, se mantuvo estable en el período de seguimiento tanto en los pacientes tratados con corsé como en los no tratados.

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.

Kidney Transplantation From a Donor With Sickle Cell Disease.

In the United States, >100 000 patients are waiting for a kidney transplant. Given the paucity of organs available for transplant, expansion of eligibility criteria for deceased donation is of substantial interest. Sickle cell disease (SCD) is viewed as a contraindication to kidney donation, perhaps because SCD substantially alters renal structure and function and thus has the potential to adversely affect multiple physiological processes of the kidney. To our knowledge, transplantation from a donor with SCD has never been described in the literature. In this paper, we report the successful transplantation of two kidneys from a 37-year-old woman with SCD who died from an intracranial hemorrhage. Nearly 4 mo after transplant, both recipients are doing well and are off dialysis. The extent to which kidneys from donors with SCD can be safely transplanted with acceptable outcomes is unknown; however, this report should provide support for the careful expansion of kidneys from donors with SCD without evidence of renal dysfunction and with normal tissue architecture on preimplantation biopsies.

Cost analysis of skeletal-related events in Spanish patients with bone metastases from solid tumours.

PURPOSE: To estimate the cost per skeletal-related event (SRE) in patients with bone metastases secondary to solid tumours in the Spanish healthcare setting. METHODS: Patients diagnosed with bone metastases secondary to breast, prostate or lung cancer were included in this multicentre, observational study. SREs are defined as pathologic fracture (vertebral and non-vertebral fracture), radiation to bone, spinal cord compression or surgery to bone. Health resource utilisation associated with these events (inpatient stays, outpatient, emergency room and home health visits, nursing home stays and procedures) were collected retrospectively for all SREs that occurred in the 97 days prior to enrolment and prospectively during follow-up. Unit costs were obtained from the 2010 eSalud healthcare costs database. RESULTS: A total of 93 Spanish patients with solid tumours were included (31 had breast cancer, 21 prostate cancer and 41 lung cancer), contributing a total of 143 SREs to this cost analysis. Inpatient stays (between 9.0 and 29.9 days of mean length of stay per inpatient stay by SRE type) and outpatient visits (between 1.7 and 6.4 mean visits per SRE type) were the most frequently reported types of health resources utilised. The mean cost per SRE was between 2,377.79 (radiation to bone) and 7,902.62 (spinal cord compression). CONCLUSION: SREs are associated with a significant consumption of healthcare resources that generate a substantial economic burden for the Spanish healthcare system.

Cost-effectiveness analysis of docetaxel (Taxotere) vs. 5-fluorouracil in combined therapy in the initial phases of breast cancer.

INTRODUCTION: The randomised controlled trial BCIRG001 has recently demonstrated that docetaxel in combination with doxorubicin and cyclophosphamide (TAC) has better efficacy than the standard treatment (FAC, i.e., 5-fluorouracil, doxorubicin and cyclophosphamide) in the adjuvant treatment of patients with node-positive breast cancer. The cost-effectiveness of TAC vs. FAC in the Spanish setting is analysed. PATIENTS AND METHODS: Clinical outcomes from trial BCIRG001 were combined with Spanish costs and longterm efficacy of FAC and TAC extrapolated up to 5 years by means of a Markov model. Results are shown as cost per life year gained (C/LYG) and cost per quality-adjusted life year (C/QALY). Costs and effects were discounted at a rate of 3%. RESULTS: Mean survival was 17.8 and 16.5 years for TAC and FAC, with total costs of euro14,611 and euro11,586, respectively. The results of the cost-effectiveness analysis showed that TAC achieves a C/LYG and a C/QALY of only euro2345 and euro2631, respectively. Sensitivity analysis confirmed the robustness of the results. CONCLUSIONS: Combined therapy based on docetaxel (TAC) is not only an effective option, but also presents a favourable cost-effectiveness ratio, clearly below the Spanish efficiency threshold in all the scenarios considered.