430 research outputs found
Nivolumab after selective internal radiation therapy for the treatment of hepatocellular carcinoma: a phase 2, single-arm study
Purpose: To evaluate the safety and efficacy of selective internal radiation therapy (SIRT) in combination with a PD-1 inhibitor in patients with unresectable hepatocellular carcinoma (uHCC) and liver-only disease ineligible for chemoembolization.
Patients and methods: NASIR-HCC is a single-arm, multicenter, open-label, phase 2 trial that recruited from 2017 to 2019 patients who were naïve to immunotherapy and had tumors in the BCLC B2 substage (single or multiple tumors beyond the up-to-7 rule), or unilobar tumors with segmental or lobar portal vein invasion (PVI); no extrahepatic spread; and preserved liver function. Patients received SIRT followed 3 weeks later by nivolumab (240 mg every 2 weeks) for up to 24 doses or until disease progression or unacceptable toxicity. Safety was the primary endpoint. Secondary objectives included objective response rate (ORR), time to progression (TTP), and overall survival (OS).
Results: 42 patients received SIRT (31 BCLC-B2, 11 with PVI) and were followed for a median of 22.2 months. 27 patients discontinued and 1 never received Nivolumab. 41 patients had any-grade adverse events (AE) and 21 had serious AEs (SAE). Treatment-related AEs and SAEs grade 3-4 occurred in 8 and 5 patients, respectively. Using RECIST 1.1 criteria, ORR reported by investigators was 41.5% (95% CI 26.3% to 57.9%). Four patients were downstaged to partial hepatectomy. Median TTP was 8.8 months (95% CI 7.0 to 10.5) and median OS was 20.9 months (95% CI 17.7 to 24.1).
Conclusions: The combination of SIRT and nivolumab has shown an acceptable safety profile and signs of antitumor activity in the treatment of patients with uHCC that were fit for SIRT
Câncer e meio ambiente. Tabaco - agrotóxicos - radiações – dieta. Um documento para a Conferência Mundial de Ecologia
Trabalho elaborado como parte de um documento global sobre Saúde e Meio Ambiente da Fundação Oswaldo Cruz
Assessing the impact of COVID-19 on liver cancer management (CERO-19).
BACKGROUND & AIMS: The coronavirus disease 2019 (COVID-19) pandemic has posed unprecedented challenges to healthcare systems and it may have heavily impacted patients with liver cancer (LC). Herein, we evaluated whether the schedule of LC screening or procedures has been interrupted or delayed because of the COVID-19 pandemic. METHODS: An international survey evaluated the impact of the COVID-19 pandemic on clinical practice and clinical trials from March 2020 to June 2020, as the first phase of a multicentre, international, and observational project. The focus was on patients with hepatocellular carcinoma or intrahepatic cholangiocarcinoma, cared for around the world during the first COVID-19 pandemic wave. RESULTS: Ninety-one centres expressed interest to participate and 76 were included in the analysis, from Europe, South America, North America, Asia, and Africa (73.7%, 17.1%, 5.3%, 2.6%, and 1.3% per continent, respectively). Eighty-seven percent of the centres modified their clinical practice: 40.8% the diagnostic procedures, 80.9% the screening programme, 50% cancelled curative and/or palliative treatments for LC, and 41.7% modified the liver transplantation programme. Forty-five out of 69 (65.2%) centres in which clinical trials were running modified their treatments in that setting, but 58.1% were able to recruit new patients. The phone call service was modified in 51.4% of centres which had this service before the COVID-19 pandemic (n = 19/37). CONCLUSIONS: The first wave of the COVID-19 pandemic had a tremendous impact on the routine care of patients with liver cancer. Modifications in screening, diagnostic, and treatment algorithms may have significantly impaired the outcome of patients. Ongoing data collection and future analyses will report the benefits and disadvantages of the strategies implemented, aiding future decision-making. LAY SUMMARY: The coronavirus disease 2019 (COVID-19) pandemic has posed unprecedented challenges to healthcare systems globally. Herein, we assessed the impact of the first wave pandemic on patients with liver cancer and found that routine care for these patients has been majorly disrupted, which could have a significant impact on outcomes
Características da resposta à Aids de secretarias de saúde, no contexto da Política de Incentivo do Ministério da Saúde¹
OBJETIVOS: Analisar a cobertura da Política de Incentivo do Ministério da Saúde para Programas de Aids e as características das ações de prevenção, assistência, gestão e apoio às organizações da sociedade civil induzidas nos Estados e municípios. METODOLOGIA: Os Planos de Ações e Metas de 2006, das 27 Unidades Federadas e de 427 municípios incluídos na Política de Incentivo, foram analisados segundo indicadores estabelecidos para aferir a complexidade e a sustentabilidade das ações induzidas, a inclusão de populações prioritárias e a capacidade de intervenção na epidemia. Informações sobre população e casos de aids registrados foram utilizadas para mensurar a cobertura. RESULTADOS: Os municípios incluídos representaram uma cobertura de 85,2% dos casos de aids do País. Houve uma baixa proporção de secretarias estaduais (48,2%) e municipais (32,6%) de saúde que contemplaram, concomitantemente, ações de prevenção para a população geral e as de maior prevalência da doença, assim como ações para o diagnóstico do HIV, o tratamento de pessoas infectadas e a prevenção da transmissão vertical. Em relação às populações prioritárias, 51,9% dos Estados e 31,1% dos municípios propuseram ações específicas na prevenção e na assistência. Estados (44,4%) e municípios (27,9%) com Planos abrangentes estão mais concentrados no Sudeste e em cidades de grande porte, representando a maioria dos casos de aids do País. CONCLUSÃO: A Política de Incentivo do Ministério da Saúde compreende as regiões de maior ocorrência da aids no Brasil, porém, o perfil da resposta induzida encontra-se parcialmente dissociado das características epidemiológicas da doença no País
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