Introdução a regressão logística exata

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Prospective Study of Cetuximab, Carboplatin, and Radiation Therapy for Patients With Locally Advanced Head and Neck Squamous Cell Cancer Unfit for Cisplatin

Purpose: To report on the outcomes of a novel treatment regimen for patients with locally advanced head and neck squamous cell carcinoma who were fit for curative treatment but not fit for cisplatin

iPrevent®: a tailored, web-based, decision support tool for breast cancer risk assessment and management

We aimed to develop a user-centered, web-based, decision support tool for breast cancer risk assessment and personalized risk management. Using a novel model choice algorithm, iPrevent® selects one of two validated breast cancer risk estimation models (IBIS or BOADICEA), based on risk factor data entered by the user. Resulting risk estimates are presented in simple language and graphic formats for easy comprehension. iPrevent® then presents risk-adapted, evidence-based, guideline-endorsed management options. Development was an iterative process with regular feedback from multidisciplinary experts and consumers. To verify iPrevent®, risk factor data for 127 cases derived from the Australian Breast Cancer Family Study were entered into iPrevent®, IBIS (v7.02), and BOADICEA (v3.0). Consistency of the model chosen by iPrevent® (i.e., IBIS or BOADICEA) with the programmed iPrevent® model choice algorithm was assessed. Estimated breast cancer risks from iPrevent® were compared with those attained directly from the chosen risk assessment model (IBIS or BOADICEA). Risk management interventions displayed by iPrevent® were assessed for appropriateness. Risk estimation model choice was 100% consistent with the programmed iPrevent®logic. Discrepant 10-year and residual lifetime risk estimates of >1% were found for 1 and 4 cases, respectively, none was clinically significant (maximal variation 1.4%). Risk management interventions suggested by iPrevent® were 100% appropriate. iPrevent® successfully integrates the IBIS and BOADICEA risk assessment models into a decision support tool that provides evidence-based, risk-adapted risk management advice. This may help to facilitate precision breast cancer prevention discussions between women and their healthcare providers

Immune checkpoint inhibitor therapy for advanced cutaneous squamous cell carcinoma in Australia: A retrospective real world cohort study

Objectives: To review the outcomes of immune checkpoint inhibitor (ICI) treatment of advanced cutaneous squamous cell carcinoma (CSCC) outside clinical trials. Study design: Retrospective observational study; review of patient records in fifteen Australian institutions. Setting, participants: All Australian adults with locally advanced or metastatic CSCC not amenable to curative surgery or radiotherapy treated with ICIs, 5 May 2017 – 23 May 2022, through a cemiplimab compassionate access scheme (Therapeutic Goods Administration Special Access Scheme) or who personally covered the cost of pembrolizumab prior to the start of the access scheme. Main outcome measures: Best overall response rate (ORR) according to standardised assessment criteria using the hierarchy: Response Evaluation Criteria in Solid Tumors (RECIST 1.1), the modified World Health Organization clinical response criteria, and the Positron Emission Tomography Response Criteria (PERCIST 1.0); overall and progression-free survival. Results: A total of 286 people with advanced CSCC received ICI therapy during May 2017 – May 2022 (cemiplimab, 270; pembrolizumab, 16). Their median age was 75.2 years (range, 39.3–97.5 years) and 232 were men (81%); median follow-up time was 12.2 months (interquartile range, 5.5–20.5 months). Eighty-eight people (31%) were immunocompromised, 27 had autoimmune disease, and 59 of 277 (21%) had ECOG performance scores of 2 or 3. The ORR was 60% (166 of 278 evaluable patients): complete responses were recorded for 74 (27%) and partial responses for 92 patients (33%). Twelve-month overall survival was 78% (95% confidence interval [CI], 72–83%); progression-free survival was 65% (95% CI, 58–70%). Poorer ECOG performance status was associated with poorer overall survival (per unit: adjusted hazard ratio [aHR], 3.0; 95% CI, 2.0–4.3) and progression-free survival (aHR, 2.4; 95% CI, 1.8–3.3), as was being immunocompromised (overall: aHR, 1.8; 95% CI, 1.1–3.0; progression-free: aHR, 1.8; 95% CI, 1.2–2.7). Fifty-five people (19%) reported immune-related adverse events of grade 2 or higher; there were no treatment-related deaths. Conclusion: In our retrospective study, the effectiveness and toxicity of ICI therapy were similar to those determined in clinical trials. Our findings suggest that ICIs could be effective and well tolerated by people with advanced CSCC who are ineligible for clinical trials

Intervenções farmacológicas para prevenção de nefropatia induzida por contraste : uma aplicação do método do tamanho ótimo da informação corrigido para heterogeneidade a fim de determinar se as evidências de uma metanálise são definitivas e conclusivas

Objetivo: O número necessário de participantes em uma metanálise (i.e. tamanho da informação) deve ser pelo menos do mesmo tamanho que um ensaio clínico com poder adequado e deve ser corrigido para heterogeneidade (tamanho ótimo da informação corrigido para heterogeneidade - TOIH). Análises seqüenciais podem reduzir o risco de erro aleatório devido aos múltiplos testes aplicados, avaliando se a metanálise atinge o tamanho da informação através dos limites de monitorização. Isso é análogo aos limites seqüenciais de monitorização de um estudo individual. Aplicamos este método para avaliar se as evidências das intervenções farmacológicas para prevenção de nefropatia induzida por contraste (NIC) são conclusivas e definitivas. Fonte de dados: MEDLINE e referências de revisões sistemáticas prévias. Seleção de estudos: Incluímos ensaios clínicos randomizados (ECR), controlados por placebo, que avaliaram a eficácia de uma intervenção farmacológica para prevenção de NIC. Extração de dados: Qualidade dos estudos, características das intervenções e incidência de NIC. Resultados: Incluímos 51 artigos (40 estudos com N-acetilcisteína, 5 estudos com teofilina, 4 estudos com dopamina, 3 estudos com fenoldopam e 2 estudos com furosemida) e realizamos 5 metanálises separadas (uma para cada intervenção). A maioria dos estudos era de baixa qualidade metodológica (40,4% eram duplo-cego, 25% tinham sigilo da lista de alocação e 15,4% reportaram análise com intenção de tratar). Para cada uma das 5 metanálises, estimamos o tamanho da informação (TOIH) considerando um poder de 90%, alfa de 1%, e uma redução de risco relativo de 30%. Monitoramos os resultados dessas metanálises gerando uma análise interina após a inclusão de cada um dos estudos, avaliando os resultados usando análise seqüencial com os limites de Lan- DeMets. Nenhuma das metanálises cumulativas alcançou o tamanho da informação necessário ou cruzou os limites de monitorização. Conclusões: As metanálises dos estudos avaliando as intervenções farmacológicas para prevenção de NIC não conseguiram atingir o tamanho de informação necessário para obtermos uma resposta confiável e conclusiva. Mais estudos com tamanho de amostra maior e de melhor qualidade metodológica são necessários.Background and Objective: The required number of participants in a meta-analysis (i.e. information size) should be at least as large as an adequately powered single trial and must be corrected for heterogeneity (heterogeneity corrected optimal information size - HOIS). Trial sequential analysis (TSA) may reduce risk of random errors due to repetitive testing of accumulating data by evaluating meta-analyses not reaching the information size with monitoring boundaries. This is analogous to sequential monitoring boundaries in a single trial. We applied this method to evaluate if the evidence for pharmacological interventions to prevent contrast-induced nephropathy (CIN) is reliable and conclusive. Data Sources: MEDLINE and references from previous systematic reviews. Study Selection: We included placebo-controlled randomized trials (RCT) evaluating the efficacy of a pharmacological interventions for the prevention of CIN. Data Extraction: Quality of trials, characteristics of the interventions and incidence of CIN. Results: We included 51 Trials (40 trials with N-acetylcysteine, 5 trials with theophylline, 4 trials with dopamine, 3 trials with fenoldopam and 2 trials with furosemide) and conducted 5 separate meta-analysis (one for each pharmacological intervention). Most trials were of low methodological quality (40.4% were double-blind, 25% had allocation concealment and 15.4% reported as intention-to-treat). For each of the 5 meta-analysis, we estimated the required information size (HOIS) considering 90% statistical power, alpha of 1% and a 30% relative risk reduction. We monitored the results of these meta-analyses by generating interim cumulative meta-analyses after each included trial and evaluated their results using TSA with Lan-DeMets monitoring. None of the cumulative meta-analysis reached the information size or crossed the monitoring boundaries. Conclusions: The meta-analysis of trials evaluating pharmacological interventions for the prevention of CIN fail to meet the minimal required sample size to provide a reliable and conclusive answer. Further trials with larger sample sizes and with higher methodological quality are required in this field

Introdução a regressão logística exata

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