Final results of the SAKK 16/00 trial: a randomized phase III trial comparing neoadjuvant chemoradiation to chemotherapy alone in stage IIIA/N2 non-small cell lung cancer (NSCLC).

Aim: One standard option in the treatment of stage IIIA/N2 NSCLC is neoadjuvant chemotherapy followed by surgery. We investigated in a randomized trial whether the addition of neoadjuvant radiotherapy would improve the outcome. Here we present the final results of this study. Methods: Patients (pts.) with pathologically proven, resectable stage IIIA/N2 NSCLC, performance status 0-1, and adequate organ function were randomized 1:1 to chemoradiation (CRT) with 3 cycles of neoadjuvant chemotherapy (cisplatin 100 mg/m2 and docetaxel 85 mg/m2 d1, q3weeks) followed by accelerated concomitant boost radiotherapy (RT) with 44 Gy in 22 fractions in 3 weeks, or neoadjuvant chemotherapy alone (CT), with subsequent surgery for all pts. The primary endpoint was event-free survival (EFS). Results: 232 pts. were randomized in 23 centers, the median follow-up was 53 months. Two thirds were men, median age was 60 years (range 37-76). Histology was squamous cell in 33%, adenocarcinoma in 43%. Response rate to CRT was 61% vs. 44% with CT. 85% of all pts. underwent surgery, 30-day postoperative mortality was 1%. The rate of complete resection was 91% (CRT) vs. 81% (CT) and the pathological complete remission (pCR) rate was 16% vs. 12%. The median EFS was 13.1 months (95% CI 9.9 - 23.5) for the CRT group vs. 11.8 months (95% CI 8.4 - 15.2) in the CT arm (p 0.665). The median overall survival (OS) with CRT was 37.1 months (95% CI 22.6 -50), with CT 26.1 months ( 95% CI 26.1 - 52.1, p 0.938). The local failure rate was 23% in both arms. In the CT arm 12 pts. were given postoperative radiotherapy (PORT) for R1 resection, 6 pts. received PORT in violation of the protocol. Pts. with a pCR, mediastinal downstaging to ypN0/1 and complete resection had a better outcome. Toxicity of chemotherapy was substantial, especially febrile neutropenia was common, whereas RT was well tolerated. Conclusions: This is the first completed phase III trial to evaluate the role of induction chemoradiotherapy and surgery, in comparison to neoadjuvant CT alone followed by surgery. RT was active, it increased response, complete resection and pCR rates. However, this failed to translate into an improvement of local control, EFS or OS. Notably, surgery after induction treatment was safe, including pneumonectomy. The overall survival rates of our neoadjuvant regimen are very encouraging, especially for a multicenter setting. Disclosure: M. Pless: Advisory Board for Sanofi; R. Cathomas: Advisory Board Sanofi D.C. Betticher: Advisory Board Sanofi. All other authors have declared no conflicts of interest.

Formato da onda do jato ureteral ao estudo Doppler espectral: comparação interobservadores. Estudo prospectivo em crianças assintomáticas

OBJETIVO: Diagnóstico precoce de distúrbios miccionais pode diminuir as repercussões sociais e psicológicas e evitar lesões renais. O jato ureteral pode ser avaliado por estudo Doppler, método que apresenta boa associação com dados clínicos dos pacientes no que diz respeito ao diagnóstico de disfunção miccional. O objetivo deste estudo é avaliar a concordância interobservadores entre os tipos de jato ureteral. MATERIAIS E MÉTODOS: Estudo prospectivo de concordância interobservadores. Um total de 41 pacientes foi examinado sequencialmente por dois médicos ultrassonografistas. Para cada paciente, três curvas dopplerfluxométricas foram obtidas de jatos consecutivos de cada ureter. O número de picos em cada curva foi observado e classificado. A velocidade máxima do maior pico de cada onda foi observada. Coeficientes kappa (κ) foram calculados. RESULTADOS: A concordância interobservadores foi moderada (κ = 0,48; intervalo de confiança 95%: 0,36-0,60). O padrão platô foi o mais frequente. As velocidades máximas dos ureteres, medidas pelos dois observadores, foram de 32,37 cm/s e 35,63 cm/s, respectivamente. CONCLUSÃO: O exame das curvas dopplerfluxométricas do jato ureteral é método que demonstrou moderada concordância interobservadores.

Laparoscopic Roux-en-Y gastric bypass in patients over the age of 60 years

The prevalence of obesity is increasing even in older patients. Bariatric surgery is often considered more risky in this group, and not necessarily associated with the same benefits as in younger patients. In France, guidelines recommend to assess indication for surgery based on comorbidities and physiological age.

Reprodutibilidade do volume de membros fetais pela ultrassonografia tridimensional utilizando o método XI VOCAL

OBJETIVO: Avaliar a reprodutibilidade do volume do braço e coxa fetais aferido pela ultrassonografia tridimensional utilizando o método eXtended Imaging Virtual Organ Computer-aided AnaLysis (XI VOCAL). MATERIAIS E MÉTODOS: Realizou-se estudo de reprodutibilidade com 43 fetos normais entre 20 e 37 semanas. Para o cálculo do volume do braço e coxa fetais utilizou-se o método XI VOCAL com delimitação de 10 planos consecutivos. Para o cálculo da variabilidade interobservador, um examinador realizou uma medida do volume do braço e coxa dos 43 fetos, enquanto um segundo examinador, sem o conhecimento prévio dos resultados do primeiro examinador, realizou uma segunda medida dos mesmos volumes. Utilizaram-se, para os cálculos estatísticos, o coeficiente de correlação intraclasse (ricc), gráficos de Bland-Altman e teste t-Student pareado (p). RESULTADOS: Observou-se alta reprodutibilidade interobservador. Para o volume do braço, obtiveram-se ricc = 0,996 (intervalo de confiança [IC] 95%: 0,992; 0,998) e média das diferenças = 0,13 ± 1,29% (95% limites de concordância: -2,54; +2,54%). Para o volume da coxa, obtiveram-se ricc = 0,997 (IC 95%: 0,995; 0,999) e média das diferenças = 0,24 ± 7,60% (95% limites de concordância: -7,6; +7,6%). CONCLUSÃO: O volume do braço e coxa fetais aferido pela ultrassonografia tridimensional utilizando o método XI VOCAL apresentou elevada reprodutibilidade interobservador.

Avaluació d’un programa de prevenció de luxacions i subluxacions d’espatlla en el judo

Aquest projecte està encarat a avaluar un protocol de prevenció de luxacions i subluxacions d’espatlla en el judo. L’objectiu principal és el de reduir el nombre de luxacions i subluxacions d’espatlla en judokes de categories compreses entre les categories cadet i absoluta millorant paràmetres com la força, la elasticitat muscular, la propiocepció, l’alimentació i la condició física dels esportistes. Aquest serà un estudi experimental amb dos grups, on el Centre de Tecnificació del Bages un realitzarà el protocol objecte d’estudi i el grup de la Federació Catalana de Judo i D.A seguiran amb la seva activitat habitual. Cada grup estarà format per 37 esportistes amb un risc alfa de 0.05 i un risc beta inferior al 0.2, amb una taxa de pèrdua de seguiment d’un 10%. Aquest protocol de prevenció pot ser útil en la nostre comunitat, però no té perquè ser-ho en altres països o regions depenent del tipus de judo que es realitza a cada lloc. Abans de començar amb l’actuació del protocol es realitzaran avaluacions biomecàniques per conèixer l’estat dels esportistes i poder actuar analíticament on més ho necessiti cada integrant de l’estudi.

Repercussões da cicatriz uterina resultante de cesariana prévia na dopplervelocimetria das artérias uterinas entre 26 e 32 semanas

OBJETIVO: Avaliar as repercussões da cicatriz uterina na dopplervelocimetria das artérias uterinas, entre 26 e 32 semanas, em gestantes primíparas com uma cesariana prévia, considerando quando esta foi realizada fora (cesárea eletiva) ou durante o trabalho de parto. MATERIAIS E MÉTODOS: Estudo prospectivo transversal em 45 gestantes, divididas em três grupos: 17 gestantes com cicatriz prévia resultante de cesariana eletiva (grupo A); 14 gestantes com uma cicatriz prévia oriunda de cesariana executada em trabalho de parto (grupo B); 14 gestantes cujo único parto anterior foi realizado por via vaginal (grupo C). A dopplervelocimetria das artérias uterinas foi realizada pela via abdominal. Foram calculados as médias, medianas e desvios-padrão (DP) para cada grupo em estudo. Em relação ao índice de pulsatilidade, a comparação dos grupos foi conduzida pelo teste não paramétrico de Kruskal-Wallis. RESULTADOS: Os valores médios do índice de pulsatilidade no grupo A variaram de 0,60 a 1,60 (média: 0,90; DP: 0,29), no grupo B, de 0,53 a 1,43 (média: 0,87; DP: 0,24), e no grupo C, de 0,65 a 1,65 (média: 1,01; DP: 0,37); p = 0,6329. CONCLUSÃO: Não houve repercussões da cicatriz de cesariana prévia na dopplervelocimetria das artérias uterinas avaliadas de 26 a 32 semanas de gestação.

Anàlisi de la incidència del sistema de joc en la creació de situacions de superioritat numèrica en el futbol amb el juvenil “A” del Futbol Club Barcelona

El present treball es centra en l’estudi de les situacions de superioritat numèrica generades al llarg de la temporada 2013-2014 de l’equip Juvenil A del Futbol Club Barcelona. L’objectiu principal d’aquest treball és esbrinar quina incidència té el sistema de joc 1-4-3-3 en la creació d’aquestes situacions ofensives en el joc de l’equip. Per tal d’enregistrar múltiples situacions de joc i diferenciar la seva complexitat, s’han establert tres variables d’estudi: la zona del camp on es crea la superioritat numèrica (dividint el camp en 12 zones), el tipus de superioritat produïda (2 contra 1, 3 contra 1, 3 contra 2, 4 contra 2 i 4 contra 3), i la freqüència d’interacció dels jugadors en les situacions de superioritat en relació al networking (jugadors que intervenen en les situacions de superioritat per tal de poder establir relacions entre posicions del sistema de joc 1-4-3-3). El mètode utilitzat és notacional (ja que s’enregistra la freqüència en què succeeix un fenomen a partir d’unes taules creades especialment per l’enregistrament de dades), on fent ús de la proposta de Gréhaigne (2001) s’analitzen 8 partits al llarg de la temporada 2013-2014. Els resultats obtinguts mostren que es produeixen més superioritats a les zones 4 i 6 (20,37% respectivament), seguides de les zones 7 (14,81%) i 5 (13,89%). El major tipus de superioritat ha estat el 2 contra 1 (48,15%) seguit del 3 contra 2 (39,81%). La interacció més freqüent entre jugadors en les situacions de 2 contra 1 ha estat: lateral dret i central dret (26,92%) i lateral esquerre i central esquerre (21,15%). En les situacions de tres jugadors (3 contra 1) ha estat: entre el central dret, central esquerre i el pivot (28,57%) i entre el central dret, el lateral dret i el pivot (28,75%). En les situacions de 3 contra 2: lateral dret, l’interior dret i l’extrem dret (18,60%) i entre el central esquerre, el lateral esquerre i l’interior esquerre (18,60%). Pel que fa a les situacions de 4 contra 2 no se n’ha produït cap, i les de 4 contra 3 hi ha una igualtat entre diverses posicions(16,67%), però no s’observen dades molt significatives en quan a la intervenció, excepte la posició del pivot que intervé en gairebé totes. Aquestes dades, s’assimilen al que diuen Sans i Frattarola (2009) sobre el fet que en la zona d’inici es creen més situacions de superioritat que en la zona de progressió i finalització. També Castelo (1999) aporta un estudi sobre els percentatges d’aportacions ofensives dels jugadors en funció de l’espai i la demarcació, però tot i que en aquest cas no ho compara amb situacions de superioritat numèrica, les dades extretes son interessants per la comparativa amb l’estudi que es presenta.

The risk factors for fractures and trabecular bone-score value in patients with endogenous Cushing's syndrome.

In a cohort study of 182 consecutive patients with active endogenous Cushing's syndrome, the only predictor of fracture occurrence after adjustment for age, gender bone mineral density (BMD) and trabecular bone score (TBS) was 24-h urinary free cortisol (24hUFC) levels with a threshold of 1472 nmol/24 h (odds ratio, 3.00 (95 % confidence interval (CI), 1.52-5.92); p = 0.002). INTRODUCTION: The aim was to estimate the risk factors for fracture in subjects with endogenous Cushing's syndrome (CS) and to evaluate the value of the TBS in these patients. METHODS: All enrolled patients with CS (n = 182) were interviewed in relation to low-traumatic fractures and underwent lateral X-ray imaging from T4 to L5. BMD measurements were performed using a DXA Prodigy device (GEHC Lunar, Madison, Wisconsin, USA). The TBS was derived retrospectively from existing BMD scans, blinded to clinical outcome, using TBS iNsight software v2.1 (Medimaps, Merignac, France). Urinary free cortisol (24hUFC) was measured by immunochemiluminescence assay (reference range, 60-413 nmol/24 h). RESULTS: Among enrolled patients with CS (149 females; 33 males; mean age, 37.8 years (95 % confidence interval, 34.2-39.1); 24hUFC, 2370 nmol/24 h (2087-2632), fractures were confirmed in 81 (44.5 %) patients, with 70 suffering from vertebral fractures, which were multiple in 53 cases; 24 patients reported non-vertebral fractures. The mean spine TBS was 1.207 (1.187-1.228), and TBS Z-score was -1.86 (-2.07 to -1.65); area under the curve (AUC) was used to predict fracture (mean spine TBS) = 0.548 (95 % CI, 0.454-0.641)). In the final regression model, the only predictor of fracture occurrence was 24hUFC levels (p = 0.001), with an increase of 1.041 (95 % CI, 1.019-1.063), calculated for every 100 nmol/24-h cortisol elevation (AUC (24hUFC) = 0.705 (95 % CI, 0.629-0.782)). CONCLUSIONS: Young patients with CS have a low TBS. However, the only predictor of low traumatic fracture is the severity of the disease itself, indicated by high 24hUFC levels.

Chronic disease management programmes for adults with asthma (intervention Review)

BACKGROUND: The burden of asthma on patients and healthcare systems is substantial. Interventions have been developed to overcome difficulties in asthma management. These include chronic disease management programmes, which are more than simple patient education, encompassing a set of coherent interventions that centre on the patients' needs, encouraging the co-ordination and integration of health services provided by a variety of healthcare professionals, and emphasising patient self-management as well as patient education. OBJECTIVES: To evaluate the effectiveness of chronic disease management programmes for adults with asthma. SEARCH METHODS: Cochrane Central Register of Controlled Trials (CENTRAL), Cochrane Effective Practice and Organisation of Care (EPOC) Group Specialised Register, MEDLINE (MEDLINE In-Process and Other Non-Indexed Citations), EMBASE, CINAHL, and PsycINFO were searched up to June 2014. We also handsearched selected journals from 2000 to 2012 and scanned reference lists of relevant reviews. SELECTION CRITERIA: We included individual or cluster-randomised controlled trials, non-randomised controlled trials, and controlled before-after studies comparing chronic disease management programmes with usual care in adults over 16 years of age with a diagnosis of asthma. The chronic disease management programmes had to satisfy at least the following five criteria: an organisational component targeting patients; an organisational component targeting healthcare professionals or the healthcare system, or both; patient education or self-management support, or both; active involvement of two or more healthcare professionals in patient care; a minimum duration of three months. DATA COLLECTION AND ANALYSIS: After an initial screen of the titles, two review authors working independently assessed the studies for eligibility and study quality; they also extracted the data. We contacted authors to obtain missing information and additional data, where necessary. We pooled results using the random-effects model and reported the pooled mean or standardised mean differences (SMDs). MAIN RESULTS: A total of 20 studies including 81,746 patients (median 129.5) were included in this review, with a follow-up ranging from 3 to more than 12 months. Patients' mean age was 42.5 years, 60% were female, and their asthma was mostly rated as moderate to severe. Overall the studies were of moderate to low methodological quality, because of limitations in their design and the wide confidence intervals for certain results.Compared with usual care, chronic disease management programmes resulted in improvements in asthma-specific quality of life (SMD 0.22, 95% confidence interval (CI) 0.08 to 0.37), asthma severity scores (SMD 0.18, 95% CI 0.05 to 0.30), and lung function tests (SMD 0.19, 95% CI 0.09 to 0.30). The data for improvement in self-efficacy scores were inconclusive (SMD 0.51, 95% CI -0.08 to 1.11). Results on hospitalisations and emergency department or unscheduled visits could not be combined in a meta-analysis because the data were too heterogeneous; results from the individual studies were inconclusive overall. Only a few studies reported results on asthma exacerbations, days off work or school, use of an action plan, and patient satisfaction. Meta-analyses could not be performed for these outcomes. AUTHORS' CONCLUSIONS: There is moderate to low quality evidence that chronic disease management programmes for adults with asthma can improve asthma-specific quality of life, asthma severity, and lung function tests. Overall, these results provide encouraging evidence of the potential effectiveness of these programmes in adults with asthma when compared with usual care. However, the optimal composition of asthma chronic disease management programmes and their added value, compared with education or self-management alone that is usually offered to patients with asthma, need further investigation.

Arterial Therapies of Non-Colorectal Liver Metastases.

BACKGROUND: The unique situation of the liver with arterial and venous blood supply and the dependency of the tumor on the arterial blood flow make this organ an ideal target for intrahepatic catheter-based therapies. Main forms of treatment are classical bland embolization (TAE) cutting the blood flow to the tumors, chemoembolization (TACE) inducing high chemotherapy concentration in tumors, and radioembolization (TARE) without embolizing effect but very high local radiation. These different forms of therapies are used in different centers with different protocols. This overview summarizes the different forms of treatment, their indications and protocols, possible side effects, and available data in patients with non-colorectal liver tumors. METHODS: A research in PubMed was performed. Mainly clinical controlled trials were reviewed. The search terms were 'embolization liver', 'TAE', 'chemoembolization liver', 'TACE', 'radioembolization liver', and 'TARE' as well as 'chemosaturation' and 'TACP' in the indications 'breast cancer', 'neuroendocrine', and 'melanoma'. All reported studies were analyzed for impact and reported according to their clinical relevance. RESULTS: The main search criteria revealed the following results: 'embolization liver + breast cancer', 122 results, subgroup clinical trials 16; 'chemoembolization liver + breast cancer', 62 results, subgroup clinical trials 11; 'radioembolization liver + breast cancer', 37 results, subgroup clinical trials 3; 'embolization liver + neuroendocrine', 283 results, subgroup clinical trials 20; 'chemoembolization liver + neuroendocrine', 202 results, subgroup clinical trials 9; 'radioembolization liver + neuroendocrine', 64 results, subgroup clinical trials 9; 'embolization liver + melanoma', 79 results, subgroup clinical trials 15; 'chemoembolization liver + melanoma', 60 results, subgroup clinical trials 14; 'radioembolization liver + melanoma', 18 results, subgroup clinical trials 3. The term 'chemosaturation liver' was tested without indication since only few publications exist and provided us with five results and only one clinical trial. CONCLUSION: Despite many years of clinical use and documented efficacy on intra-arterial treatments of the liver, there are still only a few prospective multicenter trials with many different protocols. To guarantee the future use of these efficacious therapies, especially in the light of many systemic or surgical therapies in the treatment of non-colorectal liver metastases, further large randomized trials and transparent guidelines need to be established.

Sentiment de finitude de vie et de coping chez le patient face à l'annonce d'un cancer digestif étude descriptive correlationnelle

Problématique. Le cancer digestif est une maladie qui s'accompagne de nombreux décès. L'annonce d'un tel diagnostic engendre une crise existentielle composée d'un sentiment de finitude de la vie. Des réactions psychosociales accompagnent cette mauvaise nouvelle. Un concept particulier appelé le transitoriness est omniprésent. La personne lutte pour continuer à vivre. Elle adopte des stratégies de coping pour s'ajuster aux difficultés imposées par ce sentiment de finitude de vie. But. Décrire le niveau de sentiment de finitude de vie et les stratégies de coping utilisées face à l'annonce du diagnostic d'un cancer digestif et explorer la présence d'associations entre les variables. Méthode. Cette étude descriptive corrélationnelle a été conduite auprès de 40 personnes hospitalisées pour une intervention chirurgicale, recrutées selon un échantillonnage de convenance. Le protocole de recherche a été avalisé par le comité cantonal d'éthique. Les données ont été recueillies par un formulaire de données sociodémographiques et de santé ainsi que deux instruments de mesure : le SEKT (Subjektive Einschätzung von Krankheitssituation und Todesnähe) a permis de mesurer le sentiment de finitude de vie et le JCS (Jalowiec Coping Scale) a été employé pour recueillir les stratégies de coping. Les deux instruments de mesure n'étant pas disponibles en français, une procédure de traduction et retraduction a été effectuée et avalisée par un comité d'expert. Des analyses descriptives et corrélationnelles ont été réalisées. Résultats. L'échantillon est composé majoritairement d'hommes (51%), âgés entre 56- 74 ans (52,5%), mariés (45%) et avec enfants âgés de plus de 20 ans (60%). Il apparaît une forte proportion de personnes d'une autre nationalité (40%) que la suisse et avec une formation obligatoire (40%). Le sentiment de finitude de vie est présent: 62% réalisent que le cancer représente une menace pour leur vie. Les préoccupations autour de la mort sont « quelquefois » présentes (32,5%). Les personnes se sentent « un peu » à « proche » de la mort et le score total de la proximité est de M = 3,37 (ĒT= 1,77 ; rang: 0-8). Le style de coping privilégié est l'optimisme (M = 2,10), puis l'indépendance (M = 1,95) et l'affrontement de la situation (M =1,80). Aucune relation entre le sentiment de finitude de vie et le score total de coping n'apparaît, si ce n'est une probabilité p< 0,08 entre le sentiment de finitude de vie et les styles de coping expression des émotions et indépendance. La relation entre le sentiment de finitude de vie et la variable sociodémographique la nationalité présente une probabilité marginale (p= 0,058). Certains facteurs sociodémographiques influencent l'utilisation des différentes stratégies de coping : affrontement de la situation (p= 0,0007), coping palliatif (p= 0,0449) et niveau de formation; optimisme et genre (p= 0,0424) ; expression des émotions et âge (p= 0,045); indépendance et nationalité (p= 0,0319); soutien social et nombre d'enfants (p= 0,0016). Conclusion. Les professionnels de la santé doivent être sensibilisés aux spécificités du transitoriness et aux facteurs influençant l'utilisation de stratégies de coping efficaces afin de détecter les personnes vulnérables et de cibler leurs interventions de soins pour diminuer le risque de détresse et son impact sur la qualité de vie du patient.