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Background: The American Case Manager Association defines Case Management, in Lifestyle Medicine perspective, a collaborative practice between all the actors involved in the care process. The goal of this review was to evaluate the Nurse Case Manager role in Type 2 Diabetes patients, analyzing the quali/quan-titative data related to Nurse Case Management programs in Lifestyle Medicine view. Study design and Methods: Three independent operators were involved in two distinct phases, applying the Prisma method, specifics PICOS and research strategies from PubMed and Cinahl. The first part integrated a Cochrane systematic review on the Specialist Nurses in Diabetes Mellitus, while the second part evaluated the Nurse Case Manager interventions in Lifestyle Medicine view. Results: The first part includes 13 studies and the second 6. The glycemic control was improved in the Nurse Case Manager groups in Lifestyle Medicine perspective. Good results were appreciated in secondary outcomes: lipid profile, Body Mass Index, quality of life and stress management. The results for the management of self-care and adherence to Lifestyle Medicine programs are encouraging. Conclusions: It emerged unequivocally that, taking care and supporting the diabetic subject, leads to significant benefits in the general health and to reduction of possible complications. After the Covid-19 Pandemic, the Nurse Case Manager Lifestyle Medicine could represent a valid alternative of health management for the improvement of care in Type 2 Diabetic patients.
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COVID-19 , Gerentes de Casos , Diabetes Mellitus Tipo 2 , Diabetes Mellitus Tipo 2/terapia , Humanos , Estilo de Vida , Pandemias , Qualidade de VidaRESUMO
BACKGROUND: Oxaliplatin-based adjuvant chemotherapy is the standard treatment of high-risk colon cancer (CC). A shorter duration (3 months) can achieve a similar outcome [in terms of relapse-free survival (RFS)] to a longer duration. This study reports the overall survival (OS) analysis of the three or six colon adjuvant (TOSCA) phase III study. It assessed different adjuvant chemotherapy durations in patients with resected high-risk stage II and stage III CC. MATERIAL AND METHODS: TOSCA was an open-label, phase III, multicentre, non-inferiority trial conducted in 130 Italian centres. Patients were randomly assigned, in a 1 : 1 ratio, to receive 3 months of standard doses of FOLFOX/CAPOX, or 6 months of FOLFOX/CAPOX. Patients with histologically confirmed high-risk stage II and III CC were included, with RFS being the primary end point. OS was a secondary end point. RESULTS: From June 2007 to March 2013, 3759 patients were accrued. At a median follow-up of 7 years, the hazard ratio (HR) for RFS of the 3-month versus 6-month arms was 1.13; 95% confidence interval (CI) 0.99-1.29, P for non-inferiority = 0.380, P for superiority = 0.068, crossing the non-inferiority limit of 1.20. This result did not allow us to reject the null hypothesis of the inferiority of the 3-month arm. The HR for OS of the 3-month versus 6-month arms was 1.09 (95% CI 0.93-1.26, P for superiority = 0.288). At the last follow-up analysis, the absolute OS difference between arms was <1%. CONCLUSIONS: The present analysis of the TOSCA trial does not indicate any significant difference in OS between the treatment groups. The extra benefit provided by the longer treatment should be balanced against the extra toxicity of more prolonged therapy. The trial is registered with ClinicalTrials.gov, registration number: NCT0064660.
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Fluoruracila , Recidiva Local de Neoplasia , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Capecitabina/uso terapêutico , Quimioterapia Adjuvante , Intervalo Livre de Doença , Fluoruracila/efeitos adversos , Humanos , Itália , Recidiva Local de Neoplasia/patologia , Estadiamento de NeoplasiasRESUMO
BACKGROUND: Healthcare acquired infections (HAIs) represent a significant burden for hospitalized patients in terms of mortality, morbidity, length of stay and costs. Also cause medical liability and medical malpractice litigation. METHODS: Specific keywords combinations were analitically searched in PubMed and Scopus databases. Publications concerning medical liability, medical malpractice and litigation issues were reviewed. RESULTS: The authors outlined the healthcare workers and healthcare settings mandatory duties in consideration of the Italian law. In case of infections occurred in hospital environment the patients must demonstrate the guilty nature of the physicians and healthcare settings, the existence of a harm and causal connection. Physicians and healthcare facilities defence is mainly based on demonstration that protocols and aseptic measures were adopted scrupulously applying the up to date scientific knowledge. CONCLUSIONS: HAI are a complex issue which need a multitask strategy and a surveillance system to control the phenomenon and help physicians and healthcare facilities to reduce malpractice litigation.
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Infecção Hospitalar/epidemiologia , Responsabilidade Legal , Imperícia/legislação & jurisprudência , Hospitalização/legislação & jurisprudência , Humanos , Itália , Tempo de Internação , Médicos/legislação & jurisprudênciaRESUMO
On the subject of vaccination, owing to complex issues connected to vaccine refusal and vaccine hesitancy, the pharmacist is seen as a professional figure in the health sector who is qualified to improve social accountability with the aim of increasing the consent. In order to provide accurate information, Law no. 119/2007 has confirmed the central role of the pharmacist in the promotion of prophylactic vaccination, explicitly stating under art. 2 that the Ministry will be able to count on the collaboration of pharmacists as well as general practitioners and paediatricians. Pharmacists are pinpointed as new professional figures who could assist the national health service in its vaccine awareness and administration campaigns. Art. 5 comma 1 of Law no.119/2017 states that to meet vaccine goals, each Region will be able to allow vaccines to be booked through the Italian booking system (CUP) and administered free-of-charge in authorized pharmacies.
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Promoção da Saúde/métodos , Assistência Farmacêutica/organização & administração , Farmacêuticos/organização & administração , Vacinação/métodos , Comportamento Cooperativo , Educação em Saúde/métodos , Humanos , Itália , Programas Nacionais de Saúde/organização & administração , Papel Profissional , Recusa de Vacinação/psicologia , Vacinas/administração & dosagemRESUMO
Since the Expanded Program on Immunization was proposed by the World Health Organization in 1981, it has been promptly adopted by Vietnam as one of the country's national priority programs. In 1986, Vietnam achieved some remarkable goals, including polio-free status and the elimination of neonatal tetanus. At the same time, however, barriers and difficulties have also emerged. This article aims to provide an overview of both achievements and barriers to the implementation of the program and proposes some solutions.
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Vacinação/estatística & dados numéricos , Atenção à Saúde/estatística & dados numéricos , Países em Desenvolvimento/estatística & dados numéricos , Educação em Saúde , Pessoal de Saúde/educação , Acessibilidade aos Serviços de Saúde/estatística & dados numéricos , Disparidades em Assistência à Saúde/estatística & dados numéricos , Humanos , Imunização , Programas de Imunização/economia , Programas de Imunização/estatística & dados numéricos , Esquemas de Imunização , Sarampo/epidemiologia , Sarampo/prevenção & controle , Morbidade/tendências , Cobertura Vacinal/estatística & dados numéricos , Recusa de Vacinação/psicologia , Recusa de Vacinação/estatística & dados numéricos , Doenças Preveníveis por Vacina/epidemiologia , Vietnã/epidemiologiaRESUMO
INTRODUCTION: Energy drinks represent an emerging health problem among young people. Energy drinks generally refer to a class of beverages containing sugars and various combinations of bioactive ingredients such as caffeine, taurine etc. Also the mix of energy drinks with alcohol is fairly frequent among young people and could be associated with dangerous effects. METHODS: In 2016-2017, a cross-sectional study was conducted in 1581 students attending eight high school in the Marche Region. Data were collected via an anonymous self-administered questionnaire. RESULTS: The 27.7% of students use energy drinks and the majority, corresponding with the 93.0%, are aware of the main ingredients contained in energy drinks. The main activities for which young people use these drinks are: sport, leisure, pleasure, study. Young people who admit to using alcohol mixed with energy drinks more than 4 times a month are an alarming fact. CONCLUSIONS: This research confirms that energy drinks are used more by young males and especially by those who practice sports. Furthermore, the use these beverages to increase the concentration in the study and to be more brilliant in free time, is confirmed.
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Bebidas Energéticas/efeitos adversos , Instituições Acadêmicas , Estudantes/psicologia , Adolescente , Cafeína , Estudos Transversais , Feminino , Humanos , Masculino , Inquéritos e QuestionáriosRESUMO
INTRODUCTION: The primary consumers of energy drinks were athletes, to combat fatigue, but in reality, thanks to their fast expansion and economic growth, young adults and teenagers represent the new target market. Consumption of energy drinks by both recreational and competitive athletes has increased dramatically in recent years, though they are often unaware of what is being ingested, believing to improve their physical and psychological performance. The literature shows contradictions about the capacity of energy drinks to enhance psychophysical results. In relation to probable adverse effects induced by the irregular consumption of energy drinks, which in several cases are not so clear, we decided to investigate the possible relationship between the intake of energy drinks and the presence of mental and physical stress in young people and athletes. METHODS: Two experimental sessions, separated at least by 1 week, according to a randomized cross-over design, following this protocol were conducted: in the first session a mental and physical stress was conducted without the consumption of energy drinks, the second after energy drinks consumption. BAI (Beck Anxiety Inventory) and BDI (Beck Depression Inventory II) test have been used to test the mental stress, and a "cycle ergometer test" to test the physical stress. RESULTS: BAI and BDI tests results showed that before the consumption of energy drinks, subjects are considered in the range of "minimal level of anxiety", (10 and 60 percentiles) and do not report a level of depression. After the energy drinks consumption, a "mild level of anxiety" has been recorded, and the BDI showed a case with a pathological profile. The physical test recorded a small increase in the maximum heart rate was verified with the intake of an energetic beverage. CONCLUSIONS: The stimulating effect of Energy Drinks EDs on nervous system and cardiovascular system, must be checked and studied in deeper detail, because it may represent a risk for the health of young athletes.
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Depressão/induzido quimicamente , Bebidas Energéticas/efeitos adversos , Estresse Psicológico/induzido quimicamente , Adolescente , Adulto , Feminino , Frequência Cardíaca/efeitos dos fármacos , Humanos , Masculino , Projetos Piloto , Adulto JovemRESUMO
The phenomenon of "vaccine hesitancy" has only been studied for a few years, and this attitude is becoming a serious threat that can frustrate the efforts of recent years that have led to the achievement of relevant scientific advances to human health. The paper analyzes the possible causes, the scope of the phenomenon and its consequences, trying to identify the most effective actions to resolve this trend.
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Movimento contra Vacinação , Aceitação pelo Paciente de Cuidados de Saúde , Saúde Pública , Movimento contra Vacinação/estatística & dados numéricos , Promoção da Saúde , Humanos , InternetRESUMO
BACKGROUND: The economic crisis in Italy has led to profound changes in resource management not only at the macro level but also for individual families, causing substantial changes in different habits of Italians. STUDY DESIGN: The purpose of this research was to conduct a study on changes in family eating habits potentially triggered by the economic crisis was conducted in an area of the Marche Region in central Italy. METHODS: The research was conducted in the period 2016 - 2017 by administering a specific and anonymous questionnaire. RESULTS: The interviewed people has reduced its food consumption. In particular, analyzing the results for the animal protein food group, there has been a reduction in purchase of beef, and an increase in that of pork. Overall fish consumption has decreased by 44%, with a decrease in the purchase of fresh fish, and an increase in that of canned fish products. Finally, consumers have reduced their purchases of fresh and canned legumes, fresh vegetables, and fresh fruit. CONCLUSION: The economic crisis seems to have changed the eating habits and food-related lifestyle choices of the subjects studied, especially in the urban area affected by the deeper economic depression. These changes are likely to have permanent social consequences, and deserve to be analyzed also in smaller territories in order to better understand the dynamics of individual choices and the social framework.
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Recessão Econômica , Comportamento Alimentar , Estilo de Vida , Adulto , Comportamento de Escolha , Feminino , Humanos , Itália , Masculino , Pessoa de Meia-Idade , Autorrelato , Adulto JovemRESUMO
BACKGROUND: Ships have long been sites for outbreaks of infectious diseases, particularly gastrointestinal diseases. The ship environment has the potential to facilitate the spread of such diseases, infecting susceptible cohorts of embarked passengers and crew. Gastrointestinal disorders among seafarers are fairly common and usually represent the first or second cause of requests for medical assistance aboard ships in international waters. STUDY DESIGN: The purpose of this study was to evaluate food safety and the level of knowledge among food service personnel on board merchant ships, where food handlers could be a cause of health problems for all crew members. METHODS: An anonymous self-administered questionnaire containing specific questions about food hygiene and safety knowledge was administered. RESULTS: The overall score of correct answers for the food safety aspects tested was 51.77 (SD 3.87) out of 76 points, corresponding to 68.12% of questions answered correctly. Food workers who followed a training course showed higher mean knowledge score (p < 0.05) compared to not-trained workers. The most relevant significant differences (p < 0.05) were noticeable in the personal hygiene, cross-contamination, safe storage, and knowledge of foodborne pathogens sections. CONCLUSION: Food services staff on board cargo ships should be adequately trained and should understand basic and fundamental aspects of food hygiene, related pathologies and sanitation, as they are responsible for the health and wellbeing of many seafarers.
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Inocuidade dos Alimentos , Serviços de Alimentação , Conhecimentos, Atitudes e Prática em Saúde , Navios , Adulto , Feminino , Humanos , Higiene , Masculino , Pessoa de Meia-Idade , Autorrelato , Adulto JovemRESUMO
AIMS: The aim of this research is to verify the presence of Legionella in human dental plaque. METHODS: 65 adult patients not treated with systemic or local antibiotics at least 2 months before the time of sample collection were enrolled for plaque collection between September 2015 and December 2016. A brief questionnaire about lifestyle and health risks was administered. Legionella spp. detection has been executed by semi- nested PCR. RESULTS: 8 out of 65 plaque samples (12.3%) were positive for Legionella spp. As regards health risks and lifestyle aspects, no relevant difference was observed between patients involved in our study, except for two positive patients who have reported a COPD ongoing and a pneumonia in the past. CONCLUSIONS: This study represents a step forward in the knowledge of reservoirs of the microorganism and richness of oral microbiota.
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Placa Dentária/microbiologia , Legionella/isolamento & purificação , Legionelose/epidemiologia , Adulto , Feminino , Humanos , Legionelose/diagnóstico , Estilo de Vida , Masculino , Pessoa de Meia-Idade , Reação em Cadeia da Polimerase , Inquéritos e QuestionáriosRESUMO
Background: Regorafenib and TAS-102 have recently demonstrated statistically significant survival gains in patients with refractory metastatic colorectal cancer (mCRC). Life expectancy ≥12 weeks was an inclusion criterion in registrative trials, and the identification of proper clinical selection tools for the daily use of these drugs in heavily pre-treated patients is needed to improve the cost-benefit ratio. We aimed at building a nomogram able to predict death probability within 12 weeks from the date of assessment of refractory mCRC. Patients and methods: Four hundred eleven refractory mCRC patients with ECOG performance status (PS) ≤2 receiving regorafenib, TAS-102 or other treatments were used as developing set. Putative prognostic variables were selected using a random forest model and included in a binary logistic model from which the nomogram was developed. The nomogram was externally validated and its performance was evaluated by examining calibration (how close predictions were to the actual outcome) and discriminative ability (Harrell C index) both on developing (internal validation) and validating (external validation) sets. Results: Four variables were selected and included in the nomogram: PS (P < 0.0001), primary tumor resection (P = 0.027), LDH value (P = 0.0001) and peritoneal involvement (P = 0.081). In the developing set, the nomogram discriminative ability was high (C = 0.778), and was confirmed in the validating set (C = 0.778), where the overall outcome was better as a consequence of the enrichment in patients receiving regorafenib or TAS-102 (46% versus 34%; P < 0.0001). Conclusions: Our nomogram may be a useful tool to predict the probability of death within 12 weeks in patients with refractory mCRC. Based on four easy-to-collect variables, the 'Colon Life' nomogram and free app for smartphones may improve mCRC patients' selection for later-line therapies and assist researchers for the enrollment in clinical trials in this setting.
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Neoplasias Colorretais/tratamento farmacológico , Neoplasias Colorretais/patologia , Análise Custo-Benefício , Nomogramas , Idoso , Colo/efeitos dos fármacos , Colo/patologia , Neoplasias Colorretais/mortalidade , Intervalo Livre de Doença , Combinação de Medicamentos , Feminino , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Metástase Neoplásica , Compostos de Fenilureia/administração & dosagem , Prognóstico , Modelos de Riscos Proporcionais , Piridinas/administração & dosagem , Pirrolidinas , Timina , Trifluridina/administração & dosagem , Uracila/administração & dosagem , Uracila/análogos & derivadosRESUMO
Topical and systemic prophylactic measures, which are administered before the development of epidermal growth factor receptor (EGFR)-related acneiform rash, are appropriate interventions to mitigate the intensity of skin toxicity. We have performed a systematic review and meta-analysis to evaluate whether prophylactic antibiotics may reduce the occurrence and severity of anti-EGFR drug-related skin rashes. A systematic review was performed by searching Medline, Scopus, Embase, CINAHL, LILACS, Web of Science and the Cochrane Library from inception until March 2016 for publications regarding the pre-emptive role of antibiotics for EGFR-induced skin rashes. Fixed- or random-effects meta-analyses, according to heterogeneity, were used to summarize odds ratios of skin toxicity with antibiotic use. Of the 827 citations found in the search, 13 studies comprising 1073 patients were included in the analysis. In 12 studies, patients in the prophylactic antibiotic arms had a lower risk of developing a skin rash (odds ratio 0·53, 95% confidence interval 0·39-0·72, P < 0·01) than patients without antibiotic prophylaxis. In particular, moderate-to-severe toxicities (grades 2-4) were reduced by nearly two-thirds (odds ratio 0·36, 95% confidence interval 0·22-0·60, P < 0·01) in 13 studies. This translated to a 26% absolute difference of high-grade skin rash compared with the control arms (from 50% to 24%). The results of this meta-analysis show that the risk of skin rash after treatment with anti-EGFR agents for solid tumours was significantly lower in patients taking prophylaxis with antibiotics than in those who were not. Therefore, taking pre-emptive tetracyclines for several weeks at the start of anti-EGFR treatment can significantly reduce the incidence and severity of cutaneous acneiform rash.
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Antibioticoprofilaxia , Toxidermias/tratamento farmacológico , Receptores ErbB/antagonistas & inibidores , Exantema/tratamento farmacológico , Anticorpos Monoclonais Humanizados/efeitos adversos , Toxidermias/etiologia , Métodos Epidemiológicos , Exantema/induzido quimicamente , Humanos , Fatores de RiscoRESUMO
Problems related to medical treatment and health literacy are nowadays a considerable difficulty, particularly if awareness of them is low. There is still a lack of information about students understanding of medical recommendations. The aim of this work was to determine the understanding of medical terms among Italian students and to find out if there is any relation between understanding and age, gender, education or parental occupation. The research was realized via questionnaires in the Marche region of Central Italy in 2015. Students were chosen at random from grammar schools, vocational schools and the local university. 387 completed questionnaires were subsequently evaluated. The level of understanding of medical terms among students was quite poor. Most of the terms included in the study were known to only a third of respondents on average. A significant link between the comprehension of medical terms and education level or parental occupation was observed, especially in the terms that are not commonly used. Nevertheless, no relation between knowledge of medical terms and gender was found. This topic, which requires attention, should be investigated because of correct implementation of preventive medicine programs.Key words: medical terms Italian students correct use of medicine risk.
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Conhecimentos, Atitudes e Prática em Saúde , Estudantes , Feminino , Humanos , Itália , Masculino , Medicina Preventiva , Inquéritos e Questionários , UniversidadesRESUMO
Anti-citrullinated protein antibodies (ACPA) are a family of rheumatoid arthritis (RA)-specific autoantibodies that recognize the amino acid citrulline, resulting from the post-translational modification of arginine. Peptidyl arginine deiminase, the enzyme responsible for citrullination, is present in humans in different isoforms with different tissue distribution, enzymatic activity and target specificity; nonetheless, the number of proteins citrullinated in physiological or pathological conditions is wide, but not every citrullinated protein is a target for antibodies. In pre-RA patients the immune response to citrullinated antigens is initially restricted, expands with time and, after the onset of the disease, is relatively stable. ACPA are heterogeneous in terms of not only fine specificity but also isotype and IgG subclasses usage. This heterogeneity may be relevant for the immunopathogenesis of RA, conditioning the interaction of antibodies with complement and Fc receptors.
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Artrite Reumatoide/imunologia , Autoanticorpos/imunologia , Citrulina/imunologia , Imunoglobulina G/classificação , Ativação do Complemento , Humanos , Hidrolases/metabolismo , Desiminases de Arginina em Proteínas , Receptores Fc/imunologiaAssuntos
Hérnia/complicações , Doenças do Íleo/diagnóstico por imagem , Obstrução Intestinal/diagnóstico por imagem , Ligamento Largo/patologia , Feminino , Herniorrafia , Humanos , Doenças do Íleo/etiologia , Doenças do Íleo/cirurgia , Obstrução Intestinal/etiologia , Obstrução Intestinal/cirurgia , Pessoa de Meia-Idade , Síndrome , Tomografia Computadorizada por Raios XRESUMO
De novo metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) constitutes 10% of recurrent/metastatic (RM) cases. Radiotherapy (RT) has a crucial role in the treatment of locally advanced HNSCC, however its application on RM diseases is still limited. The advent of immune checkpoint inhibitors (ICIs) improves the survival of RM HNSCC, however median overall survival is still limited. Integration of locoregional RT with ICIs in de novo metastatic HNSCC represents a promising treatment option. This perspective aims to explore the role of the combination of locoregional and systemic treatment in improving outcomes for synchronous de novo metastatic HNSCC patients and highlights the principal crucial point in decision making.
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Neoplasias de Cabeça e Pescoço , Carcinoma de Células Escamosas de Cabeça e Pescoço , Humanos , Carcinoma de Células Escamosas de Cabeça e Pescoço/terapia , Carcinoma de Células Escamosas de Cabeça e Pescoço/secundário , Carcinoma de Células Escamosas de Cabeça e Pescoço/radioterapia , Carcinoma de Células Escamosas de Cabeça e Pescoço/mortalidade , Carcinoma de Células Escamosas de Cabeça e Pescoço/patologia , Neoplasias de Cabeça e Pescoço/patologia , Neoplasias de Cabeça e Pescoço/terapia , Metástase Neoplásica , Inibidores de Checkpoint Imunológico/uso terapêutico , Recidiva Local de NeoplasiaRESUMO
BACKGROUND: Polychemotherapy and biological drugs have increased therapeutic options and outcomes of advanced colorectal cancer (CRC). We examined the relation between progression-free survival (PFS), post-progression survival (PPS) and overall survival (OS) in trials of modern (oxaliplatin- and irinotecan-based) chemotherapy alone or with targeted therapies for advanced CRC. We also evaluated surrogacy of PFS and OS. PATIENTS AND METHODS: A PubMed search identified 34 randomized trials. We split the OS, PFS and PPS and evaluated the correlation between OS and either PFS or PPS. RESULTS: The median PPS and PFS were 10.75 and 8.4 months, respectively. For all trials, PPS was strongly associated with OS [regression coefficient (R2)=0.8; Spearman's rank correlation coefficient (r)=0.88], whereas PFS was moderately associated with OS (R2)=0.43; r=0.64). In trials with targeted therapies, the correlation of PPS with OS was 0.88. However, across all trials, correlation between differences in median PFS (ΔPFS) and median OS (ΔOS) is 0.59 (P=0.0007), confirming PFS/OS surrogacy. CONCLUSION: Our findings indicate that in recent first-line, phase III, trials, OS becomes more associated with PPS than PFS. However, improvements in PFS are strongly associated with improvements in OS. In this setting so, PFS may be an appropriate surrogate for OS.
Assuntos
Neoplasias Colorretais/fisiopatologia , Taxa de Sobrevida , Neoplasias Colorretais/mortalidade , Progressão da Doença , Humanos , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: Immune-related adverse events (irAEs) are frequently reported during immune checkpoint inhibitor (ICI) therapy and are associated with long-term outcomes. It is unknown if the irAE occurrence is a valid surrogate of ICIs' efficacy. METHODS: We identified articles reporting the results of randomized trials of experimental ICI therapy in solid tumors with a systematic search. The control arms could be placebo, cytotoxic/targeted therapy, or ICI therapy. We extracted the hazard ratios for overall survival (OS) with the number of OS events per arm and the number and percentages of overall and specific irAEs of grade 1-2 and grade 3-4 per arm. We estimated the treatment effect on the potential surrogate outcome with the odds ratio of the irAE rate between the experimental and the control arm. The statistical analysis consisted of weighted linear regression on a logarithmic scale between treatment effects on irAE rate and treatment effects on OS. RESULTS: Sixty-two randomized trials were included for a total of 79 contrasts and 42 247 patients. The analyses found no significant association between the treatment effects for overall grade 1-2 or grade 3-4 irAE rates or specific (skin, gastrointestinal, endocrine) irAE rates. In the non-small-cell lung cancer (NSCLC) trial subset, we observed a negative association between treatment effects on overall grade 1-2 irAEs and treatment effects on OS in studies with patients selected for programmed death-ligand 1 expression (R2 = 0.55; 95% confidence interval 0.20-0.95; R = -0.69). In the melanoma trial subset, a negative association was shown between treatment effects on gastrointestinal grade 3-4 irAEs and treatment effects on OS in trials without an ICI-based control arm (R2 = 0.77; 95% confidence interval 0.24-0.99; R = -0.89). CONCLUSIONS: We found low-strength correlations between the ICI therapy effects on overall or specific irAE rates and the treatment effects on OS in several cancer types.
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Antineoplásicos , Carcinoma Pulmonar de Células não Pequenas , Neoplasias Pulmonares , Melanoma , Humanos , Inibidores de Checkpoint Imunológico/efeitos adversos , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Neoplasias Pulmonares/tratamento farmacológico , Melanoma/tratamento farmacológico , Antineoplásicos/uso terapêuticoRESUMO
PURPOSE: Anti-epidermal growth factor receptor (EGFR) agents [monoclonal antibodies (MoAbs), tyrosine kinase inhibitors (TKIs)] are targeted therapies used in advanced cancers. Arterial and venous thromboembolic events (ATEs and VTEs excluding catheter-related events) were not investigated with these agents, and the risk of these events is still unknown. PATIENTS AND METHODS: We have carried out a meta-analysis in order to determine the incidence and the relative risk (RR) of VTEs and ATEs associated with these agents. Statistical analyses were conducted to calculate the summary incidence, RRs and 95% confidence intervals (CIs) by using either random effects or fixed effect models according to the heterogeneity of the included studies. RESULTS: A total of 13 studies (7611 patients) was selected for this meta-analysis. The associated RRs of VTEs (11 studies comprising 7073 patients) and ATEs (5 studies consisting of 3030 patients) were 1.32 (95% CI 1.07-1.63; P equals 0.01) and 1.34 (95% CI 0.94-1.9; P equals 0.11) compared with control patients. The analysis of VTEs was also stratified by class of agents: MoAbs (RR 1.34; P equals 0.01) and oral TKIs (RR 1.16; P equals 0.65). CONCLUSION: Anti-EGFR agents are associated with a significant increase in the risk of VTEs. In particular, the risk is significant with cetuximab and panitumumab in settings where these drugs are currently approved.