Neural Transformers for Intraductal Papillary Mucosal Neoplasms (IPMN) Classification in MRI images.

Early detection of precancerous cysts or neoplasms, i.e., Intraductal Papillary Mucosal Neoplasms (IPMN), in pancreas is a challenging and complex task, and it may lead to a more favourable outcome. Once detected, grading IPMNs accurately is also necessary, since low-risk IPMNs can be under surveillance program, while high-risk IPMNs have to be surgically resected before they turn into cancer. Current standards (Fukuoka and others) for IPMN classification show significant intra- and inter-operator variability, beside being error-prone, making a proper diagnosis unreliable. The established progress in artificial intelligence, through the deep learning paradigm, may provide a key tool for an effective support to medical decision for pancreatic cancer. In this work, we follow this trend, by proposing a novel AI-based IPMN classifier that leverages the recent success of transformer networks in generalizing across a wide variety of tasks, including vision ones. We specifically show that our transformer-based model exploits pre-training better than standard convolutional neural networks, thus supporting the sought architectural universalism of transformers in vision, including the medical image domain and it allows for a better interpretation of the obtained results.

Nab-paclitaxel/gemcitabine combination is more effective than gemcitabine alone in locally advanced, unresectable pancreatic cancer - A GISCAD phase II randomized trial.

BACKGROUND: The role of combination chemotherapy has not yet been established in unresectable locally advanced pancreatic cancer (LAPC) lacking dedicated randomized trials. METHODS: This phase II trial tested the efficacy of Nab-paclitaxel (NAB-P)/Gemcitabine (G) versus G alone. Patients were randomized, 1:1 to G 1000 mg/m2 on days 1, 8 and 15 every 28 days versus NAB-P 125 mg/m2 on days 1, 8 and 15 every 28 days plus G 1000 mg/m2 on days 1, 8 and 15 every 28 days. Disease progression rate after three cycles of chemotherapy was the primary end-point. Progression-free survival (PFS), overall survival (OS) and response rate were secondary end-points. FINDINGS: A total of124 patients were enrolled. The study showed a reduction of a progressive disease from 45.6% with G to 25.4% with NAB-P/G (P = 0.01) at 3 months. Noteworthy, at 6 months in the G arm, 35.6% of patients present a metastatic spread versus 20.8% in the NAB/G arm. The response rate was 5.3% in the G arm and 27% in the NAB/G arm. Median PFS was 4 months for the G arm and 7 months for the NAB-P/G arm. Median OS was 10.6 in the G arm and 12.7 months in the NAB-P/G arm. One patient died during treatment with G due to a stroke. INTERPRETATION: NAB-P/G reduced the rate of LAPC patients progressing after three cycles of chemotherapy compared with G, especially in terms of distant relapses. It positively affects PFS. To the best of our knowledge, this is the first randomized trial providing evidence that combination chemotherapy is superior to gemcitabine alone in this setting. CLINICALTRIALS. GOV IDENTIFIER: NCT02043730.

Trifluridine/tipiracil in patients with metastatic gastroesophageal junction cancer: a subgroup analysis from the phase 3 TAGS study.

BACKGROUND: Patients with advanced gastroesophageal junction cancer (GEJC) have poor survival outcomes, and GEJC-specific data from trials evaluating agents in gastric cancers (GCs) as a whole are lacking. Trifluridine/tipiracil (FTD/TPI) was approved for previously treated metastatic GC or GEJC (mGC/mGEJC) based on results of the phase 3 TAGS trial. Subgroup analyses by primary tumor type (GC or GEJC) in TAGS are reported here. METHODS: Pa tients with mGC/mGEJC treated with ≥ 2 prior chemotherapy regimens were randomized (2:1) to receive FTD/TPI or placebo, plus best supportive care. A pre-planned sub-analysis was performed to evaluate efficacy and safety outcomes by primary tumor type (GEJC or GC). RESULTS: Of 507 randomized patients, 145 (29%) had GEJC and 360 (71%) had GC as the primary disease site. Baseline characteristics were generally similar between the GEJC and GC subgroups, except that more patients in the GEJC subgroup had received ≥ 3 prior regimens (72 vs. 59% in the GC subgroup). Survival benefit with FTD/TPI was observed in both subgroups. The overall survival hazard ratio for FTD/TPI vs placebo was 0.75 (95% CI 0.50-1.11) and 0.67 (95% CI 0.52-0.87) in the GEJC and GC subgroups, respectively. Grade ≥ 3 adverse events of any cause were reported in 75 (77%) and 192 (81%) FTD/TPI-treated patients in the GEJC and GC subgroups, respectively. No new safety concerns were noted with FTD/TPI. CONCLUSION: As in patients with GC, FTD/TPI showed an efficacy benefit in patients with GEJC in the TAGS trial, along with demonstrating a manageable safety profile.

Which is the best communication strategy, based on anti-tobacco ads, to impress teenagers? A multicenter cross-sectional study.

BACKGROUND: Well-planned mass-media campaigns can increase health literacy and raise awareness about the consequences of tobacco use. This study aims to evaluate the emotions and opinions of adolescents about several anti-tobacco spots delivered by the mass media over the world. STUDY DESIGN: Cross-sectional study. METHODS: The study was conducted in Italy in 2016-2017 among students aged 13-17 years. Students expressed their emotions and opinions about seven anti-tobacco spots from all over the world on different topics and styles. RESULTS: 499 students attended. The video "Sponge" was found to be the most impressive (30.2%) and what they would have chosen if they had been responsible for campaign launched by the Minister of Health (40.5%). The "Icons" spot ranged second, with 19.2% and 17.4%, respectively. CONCLUSIONS: In summary, this study showed that the communication strategies most effective, according to the students interviewed, are those that give clear messages with a scientific profile or that discover the false stereotypes, as in the video "Icons". However, further research is needed to investigate the effectiveness of TV campaigns against smoking, in terms of habits and knowledge in young people.

Management of patients with early-stage colon cancer: guidelines of the Italian Medical Oncology Association.

About 75% of colorectal cancers are diagnosed as early stage, in which radical surgery is achievable. In the last decade, in Italy, the overall incidence of colorectal cancer has remained stable, while mortality gradually decreased, which is attributable to early diagnosis and improved medical, surgical and locoregional treatments. The Italian Medical Oncology Association formulated guidelines to manage early-stage colon cancer, including screening, diagnosis, treatment and follow-up, which we herein present.

Interleukin-6 receptor blocking with intravenous tocilizumab in COVID-19 severe acute respiratory distress syndrome: A retrospective case-control survival analysis of 128 patients.

In cases of COVID-19 acute respiratory distress syndrome, an excessive host inflammatory response has been reported, with elevated serum interleukin-6 levels. In this multicenter retrospective cohort study we included adult patients with COVID-19, need of respiratory support, and elevated C-reactive protein who received intravenous tocilizumab in addition to standard of care. Control patients not receiving tocilizumab were matched for sex, age and respiratory support. We selected survival as the primary endpoint, along with need for invasive ventilation, thrombosis, hemorrhage, and infections as secondary endpoints at 30 days. We included 64 patients with COVID-19 in the tocilizumab group and 64 matched controls. At baseline the tocilizumab group had longer symptom duration (13 ± 5 vs. 9 ± 5 days) and received hydroxychloroquine more often than controls (100% vs. 81%). The mortality rate was similar between groups (27% with tocilizumab vs. 38%) and at multivariable analysis risk of death was not significantly influenced by tocilizumab (hazard ratio 0.61, 95% confidence interval 0.33-1.15), while being associated with the use at baseline of non invasive mechanical or invasive ventilation, and the presence of comorbidities. Among secondary outcomes, tocilizumab was associated with a lower probability of requiring invasive ventilation (hazard ratio 0.36, 95% confidence interval 0.16-0.83; P = 0.017) but not with the risk of thrombosis, bleeding, or infections. The use of intravenous tocilizumab was not associated with changes in 30-day mortality in patients with COVID-19 severe respiratory impairment. Among the secondary outcomes there was less use of invasive ventilation in the tocilizumab group.

Vitamin D plus epigallocatechin gallate: a novel promising approach for uterine myomas.

OBJECTIVE: Uterine myomas are the most common benign tumors in females. Most myomas are asymptomatic and require no intervention or further investigations; however, almost a third of women with myomas will require a therapy. Treatment options include pharmacological approaches or surgery, and depend on symptomatology, size, number and desire for future pregnancy. Minimally invasive procedures or alternative medical treatments for handling myomas are preferred, when possible, to the radical abdominal surgery. Vitamin D and epigallocatechin gallate (EGCG) recently proved effective in the management of these benign tumors. Our aim was to verify the effect of combined oral vitamin D and EGCG supplementation in symptomatic women with myomas. PATIENTS AND METHODS: Symptomatic women with myomas were enrolled in this pilot study and divided in two groups: one group treated daily with two tablets of 25 µg vitamin D + 150 mg EGCG + 5 mg vitamin B6, for 4 months; the other group received no treatment (control), for the same period. Volume, number of myomas as well as severity of symptoms (SS) and quality of life (QoL) were analyzed. RESULTS: The total myoma volume significantly decreased by 34.7% in the treated group, whereas it increased by 6.9% in the control group. An improvement in the QoL of women treated with vitamin D, EGCG and vitamin B6 was reported along with a reduction of the SS. CONCLUSIONS: The combined supplementation of vitamin D and EGCG seems to be an optimal approach for the management of myomas and correlated symptoms. For the first time, we showed the cooperative effectiveness as a promising and novel treatment for myomas.

Gambling in nursing students of the University of Palermo.

INTRODUCTION: Gambling disorder is recognized as a psychiatric disorder. It is shown that the prevalence of pathological gambling is on the rise among university students, especially involving students attending the nursing degree course. The aim of the study was to estimate the prevalence of gambling's problem and to analyze the associated factors in the population of nursing students at the University of Palermo. MATERIAL AND METHODS: It's a cross-sectional study. In April 2019, a self-administered, anonymous and voluntary questionnaire was provided to students who attend daily lessons of the 3-years nursing degree course of University of Palermo, after they gave informed consent. The questionnaire investigates on socio-demographic information, year of study, the perception of the economic and health status, alcohol use disorders and gambling problems. RESULTS: The average age of the sample is 22.0 years (standard deviation ±4.3), 67.6% of the interviewees are women. The analysis shows that the risk to be "Player at risk/Moderate gambling problems/Serious game problems" is significantly associated with the following independent variables: male gender (aOR 5.15); "Do you live with your family? No" (aOR 2.98); "perceived health status: low" (aOR 2.51); "Risky consumption of alcohol: At Risk" (aOR 3.40). CONCLUSIONS: It is important to develop an effective gambling prevention program that will reduce the risk that youths will develop gambling problems. Participation in the prevention program significantly improves youths' attitudes and knowledge regarding gambling activities.

Why nursing students have sex without condom? A study in the university of Palermo.

AIMS: Evaluation of the knowledge and behavioral risks related to sexually transmitted infections (STIs) among the student population of the degree course in nursing at the University of Palermo. MATERIAL AND METHODS: An anonymous online a survey was provided to students that investigate to socio-demographic information, sexual habits and the level of knowledge of the STIs. Multivariable logistic regression was performed, considering it as a dependent variable "Do you permanently have unprotected sex (without a condom)? Yes", in order to evaluate the role of the variables of the questionnaire. Results are expressed as adjusted Odds Ratio (aOR). RESULTS: The sample size consists of 405. The average age of the sample is 21.65 years (standard deviation±3.24). The analysis shows that the risk of having permanently unprotected sex (without condom) is significantly associated with the following variables: "Are you engaged or single? Engaged" (aOR 3.24, 95% CI 1.66 - 6.33); "Sexual orientation. Homosexual or Bisexual (aOR 4.45, 95% CI 1.30 - 15.29); "Have you occasionally had unprotected sex (without a condom)? Yes" (aOR 5.09, 95% CI 2.69 - 9.62); "How would you define your knowledge of sexually transmitted diseases? Good" (aOR 2.07, 95% CI 1.05 - 4.08); "How would you define your knowledge about contraceptive methods? Good" (aOR 2.51, 95% CI 1.23 - 5.15); "Have you or have you ever had a sexually transmitted disease? Yes (aOR 4.43, 95% CI 1.71 - 11.53); "Do you know that men can also undergo HPV vaccination? Yes" (aOR 2.57, 95% CI 1.03 - 6.40); "Age. As the unit increase" (aOR 1.14, 95% CI 1.02 - 1.26). CONCLUSIONS: These results highlight the importance of involving university students in programs aimed at improving the knowledge in terms of STIs and increase of Sexual and reproductive health. Further, because STIs prevention is based mainly on human behavior, tailored intervention is needed especially because behavior change remains a complex challenge.

Proceso de enfermería, estudio de familia de adolescente embarazada en atención primaria de salud / Nursing process, primary health care study on the family of a pregnant teenager / Processo de enfermagem, estudo de família de adolescente grávida em atenção primária de saúde

Resumen Introducción: En Chile persiste el embarazo adolescente, sin embargo, no se sistematiza la evidencia de las intervenciones realizadas, ni cómo, desde la Atención Primaria el personal de enfermería desempeña un rol fundamental en la atención de las familias para mejorar la salud de todos sus miembros. Objetivo: Elaborar un estudio de familia de acuerdo con las directrices del proceso enfermero enmarcado en el modelo de atención integral de salud familiar y comunitaria. Método: Desarrollo de estudio de familia con enfoque en el proceso de enfermería. Caso índice embarazada adolescente que presenta riesgo tras la aplicación de la pauta de Riesgo Psicosocial-Evaluación Psicosocial Abreviada en el control de ingreso de embarazo en el marco del programa Chile Crece Contigo. Desarrollo: Aplicación de instrumentos de valoración familiar mediante visita domiciliaria integral, realización de proceso enfermero e intervención mediante programa educativo. Registro en ficha electrónica, elaboración de informe para seguimiento del caso por parte del equipo; evaluación de proceso, estructura y resultado para posteriormente evaluar los objetivos a corto plazo planteados en el proceso enfermero. Conclusiones: En el contexto del modelo de atención integral de salud familiar y comunitaria, el estudio de familia se vuelve fundamental para la comprensión holística de la familia como unidad funcional de la sociedad. Mas, es el uso de la sistematización del Proceso de Enfermería, lo que permite una identificación de la problemática de la familia y su intervención para disminuir el riesgo psicosocial de una embarazada adolescente.

Abstract Introduction: In Chile, teenage pregnancies are still occuring, but the evidence regarding the interventions, including those from family-focussed nursing in primary health care, is not systematized. Objective: To carry out a family study following the phases of the nursing process under the family and community health integral attention model framework. Method: Family study following the nursing process. The index case is a pregnant teenager who, as reflected by the Pauta de Riesgo Psicosocial-Evaluación de Riesgo Psicosocial instrument from the Chile Crece Contigo program, was found to be at risk. Development: Family assessment instruments were applied during home visits. Following the nursing process, the intervention was based on an educational program. An electronic record was registered. A follow up inform on the case was elaborated. The process, structure, and primary results were assessed to support the evaluation of the short term objectives set out in the nursing process. Conclusions: Within the context of the family and community health integral attention model, the family study becomes fundamental in order to holistically understand the family as a functional unit of society. Therefore, the systematization of the nursing process allows a better identification of the problems within the family - in this case a teenage pregnancy, and thus the development of better approaches to reduce the related psychosocial risks.

Resumo Introdução: No Chile persiste a gravidez adolescente, porém, não se sistematiza a evidência das intervenções realizadas, nem o como, desde a Atenção Primária o pessoal de enfermagem desempenha um papel fundamental na atenção das famílias para melhorar a saúde de todos seus membros. Objetivo: Elaborar um estudo de família conforme às diretrizes do processo enfermeiro enquadrado no modelo de atenção integral de saúde familiar e comunitária. Método: Desenvolvimento de estudo de família com enfoque no processo de enfermagem. O caso de índice gravidez adolescente que apresenta risco depois da aplicação da Pauta de Riesgo Psicosocial-Evaluación Psicosocial Abreviada no controle de ingresso de gravidez no marco do programa Chile Crece Contigo. Desenvolvimento: Aplicação de instrumentos de valoração familiar mediante visita domiciliar integral, realização de processo enfermeiro e intervenção mediante programa educativo. Registro em ficha eletrônica, elaboração de relatório para seguimento do caso por parte da equipe; avaliação de processo, estrutura e resultado para posteriormente avaliar os objetivos a curto prazo levantados no processo de enfermagem. Conclusões: No contexto do modelo de atenção integral de saúde familiar e comunitária, o estudo de família torna-se fundamental para a compreensão holística da família como unidade funcional da sociedade. Mas, é o uso da sistematização do Processo de Enfermagem, o que permite uma identificação da problemática da família e sua intervenção para diminuir o risco psicossocial de uma grávida adolescente.

Efficacy and Safety of Trifluridine/Tipiracil Treatment in Patients With Metastatic Gastric Cancer Who Had Undergone Gastrectomy: Subgroup Analyses of a Randomized Clinical Trial.

IMPORTANCE: Trifluridine/tipiracil (FTD/TPI) treatment has shown clinical benefit in patients with pretreated metastatic gastric cancer or gastroesophageal junction cancer (mGC/GEJC). Patients who have undergone gastrectomy constitute a significant proportion of patients with mGC/GEJC. OBJECTIVE: To assess the efficacy and safety of FTD/TPI among patients with previously treated mGC/GEJC who had or had not undergone gastrectomy. DESIGN, SETTING, AND PARTICIPANTS: This preplanned subgroup analysis of TAGS (TAS-102 Gastric Study), a phase 3, randomized, placebo-controlled, clinical trial included patients with mGC/GEJC who had received at least 2 previous chemotherapy regimens, and was conducted at 110 academic hospitals in 17 countries in Europe, Asia, and North America, with enrollment between February 24, 2016, and January 5, 2018; the data cutoff was March 31, 2018. INTERVENTIONS: Patients were randomized 2:1 to receive oral FTD/TPI 35 mg/m2 twice daily or placebo twice daily with best supportive care on days 1 through 5 and days 8 through 12 of each 28-day treatment cycle. MAIN OUTCOMES AND MEASURES: The primary end point was overall survival. This subgroup analysis was conducted to examine potential trends and was not powered for statistical significance. Efficacy and safety end points were evaluated in the subgroups. RESULTS: Of 507 randomized patients (369 [72.8%] male; mean [SD] age, 62.5 [10.5] years), 221 (43.6%) had undergone gastrectomy (147 randomized to FTD/TPI and 74 to placebo) and 286 (56.4%) had not undergone gastrectomy (190 randomized to FTD/TPI and 96 to placebo). In the gastrectomy subgroup, the overall survival hazard ratio (HR) in the FTD/TPI group vs placebo group was 0.57 (95% CI, 0.41-0.79), and the progression-free survival HR was 0.48 (95% CI, 0.35-0.65). In the no gastrectomy subgroup, the overall survival HR in the FTD/TPI group vs placebo group was 0.80 (95% CI, 0.60-1.06), and the progression-free survival HR was 0.65 (95% CI, 0.49-0.85). Among FTD/TPI-treated patients, grade 3 or higher adverse events of any cause occurred in 122 of 145 patients (84.1%) in the gastrectomy subgroup and 145 of 190 (76.3%) in the no gastrectomy subgroup: 64 (44.1%) in the gastrectomy subgroup and 50 (26.3%) in the no gastrectomy subgroup had grade 3 or higher neutropenia, 31 (21.4%) in the gastrectomy subgroup and 33 (17.4%) in the no gastrectomy subgroup had grade 3 or higher anemia, and 21 (14.5%) in the gastrectomy subgroup and 10 (5.3%) in the no gastrectomy subgroup hD grade 3 or higher leukopenia. In the gastrectomy subgroup, 94 (64.8%) had dosing modifications because of adverse events vs 101 (53.2%) in the no gastrectomy subgroup; 15 (10.3%) in the gastrectomy group and 28 (14.7%) in the no gastrectomy group discontinued treatment because of adverse events. Treatment exposure was similar between groups. CONCLUSIONS AND RELEVANCE: The FTD/TPI treatment was tolerable and provided efficacy benefits among patients with pretreated mGC/GEJC regardless of previous gastrectomy. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02500043.

Smoking behaviour among nursing students: attitudes toward smoking cessation.

INTRODUCTION: The purpose of the study was to assess tobacco smoking habits among nursing students and how these are influenced by family members and cohabitants. METHODS: Cross-sectional study. An anonymous paper questionnaire was administered to nursing students of the three-year course of the University of Palermo. Adjusted Odds Ratio (aOR) are presented. RESULTS: 301 nursing students (63.12 % female) completed the questionnaire (response rate 61.17%). The average age of the sample is 21.88 years (SD ± 2.80). Considering as a dependent variable: "I currently smoke", the statistically significant independent variables associated are: "Male gender" (aOR 2.09), "Single" (aOR 2.06), "Second year of study of the degree course in nursing" (aOR 0.46), "Third year of study of the degree course in nursing" (aOR 0.43), "Don't think that warnings and pictures on cigarette packs can help stop smoking" (aOR 6.38), "Mother smoked in the past" (aOR 2.25) and "Brother or sister smoked in the past" (aOR 5.50). CONCLUSIONS: Students and graduate nurses need to be aware of current knowledge in the smoking cessation field and they have an influential role in modifying patient behavior in order to assist them to smoking cessation.

Digital epidemiology: assessment of measles infection through Google Trends mechanism in Italy.

INTRODUCTION: The primary aim of this study is to evaluate the temporal correlation between Google Trends and the data on measles infection arising from the conventional surveillance system, reported by the Istituto Superiore di Sanità's (ISS) bulletin. Moreover, this study is also aimed at forecasting the trends of the reported infectious diseases cases over time. MATERIAL AND METHODS: The reported cases of measles were selected from January 2013 until October 2018. The data on Internet searches have been obtained from Google Trends; the research data referred to the first 48 weeks of year 2017 have been aggregated on a weekly basis. The search volume provided by Google Trends has a relative nature and is calculated as a percentage of query related to a specific term in connection with a determined place and time-frame. The statistical analyses have been performed by using the Spearman's rank correlation coefficient (rho). The statistical significance level for such analyses has been fixed in 0.05. OUTCOMES: We have observed a strong correlation at a lag of 0 to -4 weeks (rho > 0.70) with the cases reported by ISS with the strongest correlation at a lag of -3 weeks (rho > 0.80 both for measles than for the symptoms of the measles). The database containing monthly data has shown a moderate correlation at a lag of -1 to +1 months and a strongest correlation at a lag of -1 (rho = 0.6152 for measles and rho = 0.5039 for symptoms of the measles). CONCLUSIONS: The surveillance systems based on Google Trends have a potential role in public health in order to provide near real-time indicators of the spread of infectious diseases. Therefore the huge potential of this approach could be used in the immediate future as a support of the traditional surveillance systems.

Sexual and reproductive health risk behaviours among Palermo university students: results from an online survey.

AIM: Evaluation of the knowledge and behavioral risks related to sexually transmitted infections (STIs) among the students at the University of Palermo. MATERIALS AND METHODS: Cross-sectional study. An anonymous online questionnaire has been submitted to the students of Palermo University. Survey investigates to socio-demographic information, sexual habits and the level of knowledge of the STIs. RESULT: The sample consists of 539 students; average age 22.65 (± 2.95). The risk to have unprotected occasional sexual intercourse is related to the following circumstances: the homosexual or bisexual status, the male gender, the age of the occurrence of the first sexual intercourse, that is at 17 year or earlier and the circumstance to have contracted a sexually transmitted infection during life. CONCLUSION: It is necessary to implement sexual education programs aimed at improving the knowledge in terms of STIs and increase of sexual and reproductive health. The findings presented should be interpreted with a degree of caution. Future studies are needed to assess the effectiveness and cost of education programs.

Trifluridine/tipiracil versus placebo in patients with heavily pretreated metastatic gastric cancer (TAGS): a randomised, double-blind, placebo-controlled, phase 3 trial.

BACKGROUND: Trifluridine/tipiracil showed activity and was well tolerated in a phase 2 study of pretreated patients with advanced gastric cancer done in Japan. We investigated whether the treatment was efficacious compared with placebo in a global population. METHODS: TAGS was a randomised, double-blind, placebo-controlled, phase 3 trial done in 110 academic hospitals in 17 countries. Patients aged 18 years or older with histologically confirmed, non-resectable, metastatic gastric adenocarcinoma (including adenocarcinoma of the gastroesophageal junction) as defined by the American Joint Committee on Cancer staging classification (7th edition) who had received at least two previous chemotherapy regimens and had experienced radiological disease progression were eligible for inclusion. Patients were randomly assigned (2:1) via dynamic randomisation from a centralised interactive voice-response system to receive either oral trifluridine/tipiracil (35 mg/m2 twice daily on days 1-5 and days 8-12 every 28 days) plus best supportive care or placebo plus best supportive care. Participants were allocated to groups by study-site personnel. Randomisation was stratified by region (Japan vs rest of world), ECOG performance status (0 vs 1), and previous treatment with ramucirumab (yes vs no). Both patients and investigators were masked to treatment allocation. The primary endpoint was overall survival. Efficacy was assessed in the intention-to-treat population and safety in all patients who received at least one dose of treatment. This trial is registered with ClinicalTrials.gov, number NCT02500043. The trial, including follow-up of all participants, has been completed. FINDINGS: Between Feb 24, 2016, and Jan 5, 2018, 507 patients were enrolled and randomly assigned, 337 to the trifluridine/tipiracil group and 170 to the placebo group. Median overall survival was 5·7 months (95% CI 4·8-6·2) in the trifluridine/tipiracil group and 3·6 months (3·1-4·1) in the placebo group (hazard ratio 0·69 [95% CI 0·56-0·85]; one-sided p=0·00029, two-sided p=0·00058). Grade 3 or worse adverse events of any cause occurred in 267 (80%) patients in the trifluridine/tipiracil group and 97 (58%) in the placebo group. The most frequent grade 3 or worse adverse events of any cause were neutropenia (n=114 [34%]) and anaemia (n=64 [19%]) in the trifluridine/tipiracil group and abdominal pain (n=15 [9%]) and general deterioration of physical health (n=15 [9%]) in the placebo group. Serious adverse events of any cause were reported in 143 (43%) patients in the trifluridine/tipiracil group and 70 (42%) in the placebo group. One treatment-related death was reported in each group (because of cardiopulmonary arrest in the trifluridine/tipiracil group and because of toxic hepatitis in the placebo group). INTERPRETATION: Trifluridine/tipiracil significantly improved overall survival compared with placebo and was well tolerated in this heavily pretreated population of patients with advanced gastric cancer. Trifluridine/tipiracil could be a new treatment option in this population who represent a high unmet medical need. FUNDING: Taiho Oncology and Taiho Pharmaceutical.

Active immunization status against measles, mumps, rubella, hepatitis B in internationally adopted children, surveyed at the university hospital of Palermo, Sicily.

INTRODUCTION: The internationally adopted child is a fragile subject who often shows an incomplete health documentation, which hinders the complete assessment of health status. MATERIALS AND METHODS: Between January 2010 and June 2016, at the University Hospital "AOUP P. Giaccone" of Palermo, we reviewed the health documentations of 111 children recently arrived in Italy following the conclusion of the international adoption procedure. 62.2% of the children were male, of various nationalities and with an average age of 7 years (± 3.4). This study aims to detect, in the observed sample, the reliability of the vaccinal documentation and the real acquired immunization. We intend to estimate the presence of IgG against Measles, Mumps, Rubella and Hepatitis B viruses. RESULTS: Percentages of subjects with a complete correspondence between documentation attesting the successful vaccination and the effective immunization were: 78% for measles, 66% for mumps, 84% for rubella, 71% for hepatitis B. Percentages of subjects without vaccinal documentation but with positive evidence of IgG were: 50% for measles, 38% for mumps, 71% for rubella, 50% for hepatitis B. CONCLUSIONS: The partial correspondence found between vaccinations performed and real immune status can be attributed to several reasons: poor reliability of the received health documentation, the complex economic situation of the health services in the countries of origin, the incorrect vaccines storage or the administration beyond the expiration date, the poor immunological response due to concomitant diseases or severe malnutrition, the probable non-administration of the expected booster dose. Particular attention needs to be paid to this population, which may represent a risk group susceptible to vaccine-preventable diseases.

Management of metastatic colorectal cancer patients: guidelines of the Italian Medical Oncology Association (AIOM).

In the past 15 years, the outcome for patients with metastatic colorectal cancer has substantially improved owing to the availability of new cytotoxic and biological agents along with many significant advances in molecular selection, the use of personalised therapy and locoregional treatment, a more widespread sharing of specific professional experiences (multidisciplinary teams with oncologists, surgeons, radiotherapists, radiologists, biologists and pathologists), and the adoption of patient-centred healthcare strategies. The Italian Medical Oncology Association (AIOM) has developed evidence-based recommendations to help oncologists and all professionals involved in the management of patients with metastatic colorectal cancer in their daily clinical practice.

Significance of neutrophil-to-lymphocyte ratio in Western advanced EGFR-mutated non-small cell lung cancer receiving a targeted therapy.

PURPOSE: Lung cancer is one of the leading causes of cancer-related death worldwide and, although targeted therapy with tyrosine kinase inhibitors has dramatically improved the rates of response and survival in advanced EGFR-mutated adenocarcinoma, the overall outcome remains unsatisfactory. Therefore, new prognostic factors, preferably simple, inexpensive, and easy to reproduce on a large scale, are needed. We performed a retrospective analysis of our database including 63 western Caucasian patients with advanced EGFR-mutated lung adenocarcinoma and receiving gefitinib, erlotinib, or afatinib as first- or second-line therapy. Several studies demonstrated a strong link between elevated neutrophil-to-lymphocyte ratio (NLR) and poor prognosis both in early and advanced stages of non-small-cell lung cancer (NSCLC). METHODS: From January 2011 to December 2015, 63 consecutive elegible patients with advanced EGFR-mutated NSCLC were included in this analysis from 5 institutions. The NLR was derived from the absolute neutrophil and the absolute lymphocyte counts of a full blood count and the cutoff value was determined according to the mean NLR level. RESULTS: Despite the small sample analyzed, we found that NLR has a prognostic role for progression-free survival (PFS) and overall survival (OS), reaching a statistically significant difference with a better PFS and OS in the lower NLR group. CONCLUSIONS: Pretreatment NLR seems to represent a reliable, simple, and easy to reproduce laboratory tool to predict outcome and response to cancer therapies in this setting of Western Caucasian patients with EGFR-mutated NSCLC.

Proceso de enfermería en un estudio de familia de persona adulta mayor en atención primaria de salud / Primary care nursing process in a study on a family with a senior adult / Processo de enfermagem em um estudo de família de pessoas idosas em atenção primária de saúde

Este trabajo tiene la finalidad de aplicar el proceso de enfermería en un estudio de familia a nivel primario de atención a una familia residente en Santiago de Chile. El desarrollo de este estudio de familia nace ante la sospecha de maltrato identificada por un profesional de enfermería durante el control de salud realizado al jefe del hogar. El proceso de enfermería se inicia con la recolección de datos por medio de una revisión de la ficha digital del caso índice, en la segunda etapa se realiza la visita domiciliaria donde se continúa con la etapa de valoración para caracterizar a la familia y su ambiente, análisis del tipo de familia, tareas del desarrollo y etapa del ciclo familiar según Duvall, y funciones familiares. Asimismo, se elabora genograma, ecomapa, círculo familiar, APGAR y test Zarit. Se desarrollan las etapas de diagnóstico, se dio prioridad a un diagnóstico individual y a uno familiar, que correspondieron a la sobrecarga del cuidador y a familia negligente. Posteriormente, se procede a realizar el plan de atención con objetivos a corto, mediano y largo plazo; del mismo modo, se realiza la evaluación de estructura, proceso y resultado, y se analizan los indicadores de resultado de los objetivos a corto plazo. Conclusiones. Se muestra la aplicación del proceso de enfermería en una familia, donde se logra que los implicados alcancen los objetivos planificados; de esta forma, se contribuye a mejorar las problemáticas detectadas y se demuestra la utilidad del uso del proceso de enfermería en el estudio de familia.

In this study the primary care nursing process was applied in a study on a family of Santiago de Chile with a senior adult. The need for this study arose from the suspicion of maltreatment against the head of this family- a situation which was identified by a nursing professional during a health monitoring performed on this person. The nursing process began with the data collection through a review of the digital card of the index case. Then, a home visit was conducted to assess the family and its environment, analyzing the type of family, the development tasks, and the family functions and cycle stage according to Duvall. Also, genogram, ecomap, the family circle, APGAR, and Zarit test were all obtained. A diagnosis of family negligence was concluded. Then, an attention plan was designed with objectives for the short, medium, and long terms. The assessment of structure, process, and result was carried out, and short term result indicators were analyzed. Conclusions: the nursing process was successfully applied on a family achieving the planned objectives, thus showing its potential for other studies with families.

O presente trabalho tem a finalidade de aplicar o processo de enfermagem em um estudo de família a nível primário de atenção a uma família residente em Santiago de Chile. O desenvolvimento deste estudo de família nasce ante a suspeita de maltrato identificada por um profissional de enfermagem durante o controle de saúde realizado ao chefe da família. O processo de enfermagem inicia-se com a coleta de dados por médio de uma revisão da ficha digital do caso índice, na segunda etapa realiza-se a visita domiciliaria onde se continua com a etapa de avaliação para caracterizar à família e seu ambiente, análise do tipo de família, tarefas de desenvolvimento e etapa de ciclo familiar segundo Duvall e funções familiares. Assim mesmo, elabora-se genograma, ecomapa, círculo familiar, APGAR e teste Zarit. Desenvolveram-se as etapas de diagnóstico, deu-se prioridade a um diagnóstico individual e a um familiar, que corresponderam à sobrecarga do cuidador e a família negligente. Posteriormente, procede-se a realizar um plano de atenção com objetivos a curto, mediano e longo prazo, do mesmo modo, realiza-se a avaliação de estrutura, processo e resultado, e se analisaram os indicadores de resultado dos objetivos a curto prazo. Conclusões. Mostra-se a aplicação do processo de enfermagem em uma família, onde se consegue que os implicados atinjam os objetivos planificados, desta forma, se contribui a melhorar as problemáticas detectadas e se demostra a utilidade do uso do processo de enfermagem no estudo de família.