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1.
Per Med ; 17(2): 83-87, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-32157952

RESUMO

Sorafenib is acknowledged as the standard therapy for advanced hepatocellular carcinoma (HCC) but in the clinical practice the treatment of these patients is extremely complex and needs to be personalized. New evidence suggests that surgical resection-based multimodal treatments may improve outcome in these patients. There is no strong evidence supporting the ability of sorafenib in downstage HCC before surgery. We presented a case of a 53-year-old man with well-compensated HCV-cirrhosis complicated with HCC and neoplastic portal vein thrombosis. The patient was treated initially with sorafenib with optimal radiological and serological response and subsequently with liver resection. Pathological examination showed necrotic portal thrombosis and massive necrosis of a metastatic regional node confirming radiological evidence. This finding suggests that sorafenib exhibits a potential to downstage advanced HCC which is not irrelevant. A possible combination of different modalities has to be considered in the view of a personalized medicine.


Assuntos
Carcinoma Hepatocelular/tratamento farmacológico , Neoplasias Hepáticas/tratamento farmacológico , Sorafenibe/administração & dosagem , Trombose Venosa/tratamento farmacológico , Carcinoma Hepatocelular/complicações , Carcinoma Hepatocelular/patologia , Carcinoma Hepatocelular/cirurgia , Hepatectomia , Humanos , Neoplasias Hepáticas/complicações , Neoplasias Hepáticas/patologia , Neoplasias Hepáticas/cirurgia , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Veia Porta/efeitos dos fármacos , Veia Porta/patologia , Sorafenibe/uso terapêutico , Resultado do Tratamento , Trombose Venosa/patologia
2.
Hepatology ; 72(6): 2206-2218, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-32064645

RESUMO

Treatment allocation is extremely complex in patients with hepatocellular carcinoma (HCC) because this neoplasm arises, in most cases, in patients with cirrhosis and additional comorbidities. The "stage hierarchy" approach, which involves linking each stage (or substage) of the disease to a specific treatment, has become the main proposed treatment strategy for the clinical management of HCC, particularly in the West. The Barcelona Clinic Liver Cancer (BCLC) scheme serves as the main example of the application of this strategy. In an attempt to increase the plasticity of the "stage hierarchy" approach as well as its adaptability to the requirements of real-world clinical practice, the latest versions of European and American guidelines have introduced certain relevant elements of flexibility, which were not intrinsic to the original BCLC scheme. These elements are as follows: the "treatment stage migration" strategy, which allows moving to another treatment (generally the one that is associated with the subsequent stage) if the approach linked with the current stage proves to be unfeasible, and the "treatment stage alternative" approach, which proposes further therapeutic options for each BCLC-defined stage. In regard to most of the solid cancers, another potential strategy is to consider the treatment decision to be hierarchically dictated by the efficacy of each therapy with complete or partial independence from the tumor stage. This concept of "therapeutic hierarchy" has been historically endorsed by the Asia-Pacific treatment algorithm as well as by the recent Italian multisociety guidelines. The present review provides a critical analysis of the different conceptual approaches to HCC management, highlighting their advantages and disadvantages and focusing on the remarkable differences between the stage-guided and the hierarchical strategies.


Assuntos
Carcinoma Hepatocelular/terapia , Procedimentos Clínicos/tendências , Neoplasias Hepáticas/terapia , Oncologia/tendências , Guias de Prática Clínica como Assunto , Carcinoma Hepatocelular/diagnóstico , Carcinoma Hepatocelular/mortalidade , Regras de Decisão Clínica , Procedimentos Clínicos/normas , Humanos , Neoplasias Hepáticas/diagnóstico , Neoplasias Hepáticas/mortalidade , Oncologia/métodos , Oncologia/normas , Estadiamento de Neoplasias , Seleção de Pacientes , Prognóstico , Medição de Risco/métodos , Medição de Risco/normas , Resultado do Tratamento
3.
Hepatology ; 68(4): 1232-1244, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-30048016

RESUMO

Prognostic assessment of patients with hepatocellular carcinoma (HCC) at the time of diagnosis remains controversial and becomes even more complex at the time of restaging when new variables need to be considered. The aim of the current study was to evaluate the prognostic utility of restaging patients before proceeding with additional therapies for HCC. Two independent Italian prospective databases were used to identify 1,196 (training cohort) and 648 (validation cohort) consecutive patients with HCC treated over the same study period (2008-2015) who had complete restaging before decisions about additional therapies. The performance of the Italian Liver Cancer (ITA.LI.CA) prognostic score at restaging was compared with that of the Barcelona Clinic Liver Cancer, Hong Kong Liver Cancer, and Cancer of the Liver Italian Program systems. A multivariable Cox survival analysis was performed to identify baseline, restaging, or dynamic variables that were able to improve the predictive performance of the prognostic systems. At restaging, 35.3% of patients maintained stable disease; most patients were either down-staged by treatment (27.2%) or had disease progression (37.5%). The ITA.LI.CA scoring system at restaging demonstrated the best prognostic performance in both the training and validation cohorts (c-index 0.707 and 0.722, respectively) among all systems examined. On multivariable analysis, several variables improved the prognostic ability of the ITA.LI.CA score at restaging, including progressive disease after the first treatment, Model for End-Stage Liver Disease at restaging, and choice of nonsurgical treatment as additional therapy. A new ITA.LI.CA restaging model was created that demonstrated high discriminative power in both the training and validation cohorts (c-index 0.753 and 0.745, respectively). CONCLUSION: Although the ITA.LI.CA score demonstrated the best prognostic performance at restaging, other variables should be considered to improve the prognostic assessment of patients at the time of deciding additional therapies for HCC.


Assuntos
Carcinoma Hepatocelular/patologia , Carcinoma Hepatocelular/terapia , Tomada de Decisão Clínica/métodos , Progressão da Doença , Estadiamento de Neoplasias/métodos , Idoso , Análise de Variância , Carcinoma Hepatocelular/mortalidade , Ablação por Cateter , Estudos de Coortes , Bases de Dados Factuais , Intervalo Livre de Doença , Feminino , Hepatectomia/métodos , Humanos , Infusões Intra-Arteriais , Itália , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Invasividade Neoplásica/patologia , Prognóstico , Reprodutibilidade dos Testes , Estudos Retrospectivos , Medição de Risco , Sorafenibe/uso terapêutico , Estatísticas não Paramétricas , Análise de Sobrevida
4.
Liver Transpl ; 21(10): 1250-8, 2015 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-26183802

RESUMO

The lifetime utility of liver transplantation (LT) in patients with hepatocellular carcinoma (HCC) is still controversial. The aim of this study was to ascertain when LT is cost-effective for HCC patients, with a view to proposing new transplant selection criteria. The study involved a real cohort of potentially transplantable Italian HCC patients (n = 2419 selected from the Italian Liver Cancer group database) who received nontransplant therapies. A non-LT survival analysis was conducted, the direct costs of therapies were calculated, and a Markov model was used to compute the cost utility of LT over non-LT therapies in Italian and US cost scenarios. Post-LT survival was calculated using the alpha-fetoprotein (AFP) model on the basis of AFP values and radiological size and number of nodules. The primary endpoint was the net health benefit (NHB), defined as LT survival benefit in quality-adjusted life years minus incremental costs (US $)/willingness to pay. The calculated median cost of non-LT therapies per patient was US $53,042 in Italy and US $62,827 in the United States. On Monte Carlo simulation, the NHB of LT was always positive for AFP model values ≤ 3 and always negative for values > 7 in both countries. A multivariate model showed that nontumor variables (patient's age, Child-Turcotte-Pugh [CTP] class, and alternative therapies) had the potential to shift the AFP model threshold of LT cost-ineffectiveness from 3 to 7. LT proved always cost-effective for HCC patients with AFP model values ≤ 3, whereas the cost-ineffectiveness threshold ranged between 3 and 7 using nontumor variables.


Assuntos
Carcinoma Hepatocelular/sangue , Carcinoma Hepatocelular/cirurgia , Técnicas de Apoio para a Decisão , Neoplasias Hepáticas/sangue , Neoplasias Hepáticas/cirurgia , Transplante de Fígado , Seleção de Pacientes , alfa-Fetoproteínas/análise , Idoso , Carcinoma Hepatocelular/economia , Carcinoma Hepatocelular/mortalidade , Carcinoma Hepatocelular/patologia , Análise Custo-Benefício , Bases de Dados Factuais , Feminino , Custos de Cuidados de Saúde , Humanos , Itália , Neoplasias Hepáticas/economia , Neoplasias Hepáticas/mortalidade , Neoplasias Hepáticas/patologia , Transplante de Fígado/efeitos adversos , Transplante de Fígado/economia , Transplante de Fígado/mortalidade , Masculino , Cadeias de Markov , Pessoa de Meia-Idade , Modelos Econômicos , Método de Monte Carlo , Análise Multivariada , Valor Preditivo dos Testes , Modelos de Riscos Proporcionais , Anos de Vida Ajustados por Qualidade de Vida , Estudos Retrospectivos , Análise de Sobrevida , Fatores de Tempo , Resultado do Tratamento , Carga Tumoral , Estados Unidos
5.
Liver Transpl ; 20(9): 1021-8, 2014 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-24809799

RESUMO

Liver transplantation (LT) is an established treatment for hepatocellular carcinoma (HCC), and sorafenib (SFN) is a validated treatment for patients harboring advanced tumors. It is still not clear whether the combination of the 2 treatments, with SFN used in the neoadjuvant, adjuvant, or recurrence setting, is useful and cost-effective. This article summarizes the present evidence in favor of and against the use of SFN in the setting of LT for HCC, and it also includes the problem of toxicity, particularly when mammalian target of rapamycin inhibitors, which play a central role in regulating cellular growth and proliferation, are used as immunosuppressants. Overall, the data do not support the use of SFN in the pre- or post-LT setting as adjuvant therapy, and additional studies are needed to reach sound conclusions on the topic.


Assuntos
Antineoplásicos/uso terapêutico , Carcinoma Hepatocelular/tratamento farmacológico , Carcinoma Hepatocelular/cirurgia , Neoplasias Hepáticas/tratamento farmacológico , Neoplasias Hepáticas/cirurgia , Transplante de Fígado , Niacinamida/análogos & derivados , Compostos de Fenilureia/uso terapêutico , Antineoplásicos/efeitos adversos , Carcinoma Hepatocelular/patologia , Quimioterapia Adjuvante , Humanos , Imunossupressores/uso terapêutico , Neoplasias Hepáticas/patologia , Transplante de Fígado/efeitos adversos , Terapia Neoadjuvante , Recidiva Local de Neoplasia , Niacinamida/efeitos adversos , Niacinamida/uso terapêutico , Compostos de Fenilureia/efeitos adversos , Fatores de Risco , Sorafenibe , Resultado do Tratamento
7.
Hepatology ; 51(1): 165-73, 2010 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-19877181

RESUMO

UNLABELLED: The role of bridging therapies for patients with hepatocellular carcinoma (HCC) on the waiting list for liver transplantation (LT) remains controversial. There is strong evidence to support the effectiveness of sorafenib in extending the time to progression of HCC. Using a Markov model, we compared two strategies: one using sorafenib as neoadjuvant therapy before LT (Strategy A), and the other using no bridging therapy in the first 6 months (Strategy B). Reference case: T2 HCC patient with compensated cirrhosis. The benefit of sorafenib in delaying time to HCC progression was expressed as the hazard ratio (HR) and taken from recently published randomized trials. The endpoints considered were: survival benefit measured in quality-adjusted life days (QALDs), transplant probability, costs (C) in euro, willingness to pay (WTP), and net health benefit (NHB), where NHB = survival benefit - C/WTP. The calculated WTP of sorafenib in Italy was 346 euro per QALD. Probabilistic sensitivity analysis showed a median survival benefit of 94 QALDs (10% percentile = 38, 90% percentile = 210). In the base-case scenario (HR = 0.47, monthly dropout probability = 5%, median time to LT = 3 months), the gain in LT probability due to sorafenib was 5% and it increased proportionally with increasing median times to LT and decreasing HR. In the cost-benefit analysis, the incremental NHB of Strategy A versus Strategy B was 37 QALDs; it increased as sorafenib HR decreased and when median times to LT were shorter than 6 months, whereas for longer times it gradually dropped, particularly when Strategy B included effective locoregional treatments. CONCLUSION: Sorafenib neoadjuvant therapy is cost-effective by comparison with no therapy for T2-HCC patients waiting for LT, particularly for median times to LT under 6 months.


Assuntos
Antineoplásicos/uso terapêutico , Benzenossulfonatos/uso terapêutico , Carcinoma Hepatocelular/terapia , Piridinas/uso terapêutico , Benzenossulfonatos/toxicidade , Carcinoma Hepatocelular/tratamento farmacológico , Carcinoma Hepatocelular/economia , Análise Custo-Benefício , Humanos , Transplante de Fígado , Cadeias de Markov , Modelos Teóricos , Método de Monte Carlo , Niacinamida/análogos & derivados , Compostos de Fenilureia , Piridinas/toxicidade , Anos de Vida Ajustados por Qualidade de Vida , Sorafenibe , Resultado do Tratamento , Listas de Espera
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