Idarubicin-loaded beads for chemoembolisation of hepatocellular carcinoma: results of the IDASPHERE phase I trial

SummaryBackground A phase I dose-escalation trial of transarterial chemoembolisation (TACE) with idarubicin-loaded beads was performed in cirrhotic patients with hepatocellular carcinoma (HCC). Aim To estimate the maximum-tolerated dose (MTD) and to assess safety, efficacy, pharmacokinetics and quality of life. Methods Patients received a single TACE session with injection of 2 mL drug-eluting beads (DEBs; DC Bead 300–500 μm) loaded with idarubicin. The idarubicin dose was escalated according to a modified continuous reassessment method. MTD was defined as the dose level closest to that causing dose-limiting toxicity (DLT) in 20% of patients. Results Twenty-one patients were enrolled, inclu…

A 30-Year, Population-Based Study Shows Improved Management and Prognosis of Hepatocellular Carcinoma

Background & Aims Little is known about the impact of changes in the management of hepatocellular carcinoma (HCC) over time. We assessed trends in the pattern of care and in prognosis at a population level. Methods Data on diagnostic conditions, treatment, and prognosis from 1976–2005 were collected by the population-based digestive cancer registry of Burgundy (France). A nonconditional logistic regression was used to identify factors associated with treatment for cure. A multivariate relative survival analysis was also performed. Results The context of HCC diagnosis has changed; the proportion of asymptomatic patients increased from 5.6% (1976–1985) to 37.2% (1996–2005). The proportion of …

Suspicious liver nodule in chronic liver disease: Usefulness of a second biopsy

International audience; Purpose: To assess the usefulness of a second biopsy when the first one was inconclusive in patients with a liver nodule found during the follow-up for chronic liver disease.Materials and methods: Among 381 patients (544 nodules) included in a prospective study designed to evaluate the accuracy of imaging for the diagnosis of small hepatocellular carcinoma (HCC) in chronic liver disease, 254 nodules were biopsied. The following histological results were considered as conclusive: HCC, dysplastic or regenerative nodule, and other identified tumors (benign or malignant). For nodules with inconclusive results (e.g. fibrosis or no definite focal lesion), a second biopsy w…

LO3 : Safety and efficacy of the combination daclatasvir-sofosbuvir in HCV genotype 1-mono-infected patients from the french observational cohort ANRS CO22 hepather

International audience; no abstract

Randomised controlled trial of lipiodol transarterial chemoembolisation with or without amiodarone for unresectable hepatocellular carcinoma.

Abstract Background There is no consensus about the most effective method for transarterial chemoembolisation of hepatocellular carcinoma. Aim The aim of this phase II trial was to compare the efficacy and toxicity of lipiodol transarterial chemoembolisation with amiodarone in association with pirarubicin or doxorubicin versus lipiodol transarterial chemoembolisation with anthracycline alone in a control group. Methods Patients with unresectable hepatocellular carcinoma and Child-Pugh A/B7 were considered eligible for the trial. transarterial chemoembolisation was repeated every 6 weeks for a maximum of 4 sessions. Results Thirteen patients were randomised in the amiodarone group, and 14 we…

Impact pronostique de la concentration de 3-hydroxymyristate sur la survie des patients atteints de cirrhose alcoolique ou virale

Etat de la question Le role de l’endotoxemie liee a la translocation bacterienne sur l’aggravation de la cirrhose fait l’objet de nombreuses etudes, mais son impact sur la mortalite au cours de la cirrhose est mal connu. Le but de ce travail etait d’etudier l’impact de la concentration sanguine de 3-hydroxymyristate (3-HM) total (composant specifique des lipopolysaccharides, endotoxine), sur le risque de deces et de complications des malades cirrhotiques. Materiel et methodes Au total, 593 patients atteints de cirrhose alcoolique ou virale, sans carcinome hepatocellulaire ont ete inclus entre 2008 et 2012 dans six centres hospitalo-universitaires francais. Le dosage de 3-HM total, libre et …

Predictive factors of transarterial chemoembolisation toxicity in unresectable hepatocellular carcinoma

Abstract Background Transarterial chemoembolisation (TACE) is an effective treatment for unresectable hepatocellular carcinoma (HCC), but can cause severe toxicity. Aim To identify predictive factors of severe TACE-related toxicity in patients with unresectable HCC. Methods All HCC patients who underwent TACE at the Dijon University Hospital between 2008 and 2011 were included in this retrospective study. Severe TACE-related toxicity was defined as the occurrence of any adverse event grade ≥4, or any adverse event that caused a prolongation of hospitalisation of >8 days, or any additional hospitalisation within 1 month after TACE. Factors predicting toxicity were identified using a logistic…

Risk factors for Coronavirus Disease 2019 (COVID-19) severity and mortality among solid cancer patients and impact of the disease on anticancer treatment: A French nationwide cohort study (GCO-002 CACOVID-19).

Background Cancer patients are thought to have an increased risk of developing severe Coronavirus Disease 2019 (COVID-19) infection and of dying from the disease. In this work, predictive factors for COVID-19 severity and mortality in cancer patients were investigated. Patients and Methods In this large nationwide retro-prospective cohort study, we collected data on patients with solid tumours and COVID-19 diagnosed between March 1 and June 11, 2020. The primary endpoint was all-cause mortality and COVID-19 severity, defined as admission to an intensive care unit (ICU) and/or mechanical ventilation and/or death, was one of the secondary endpoints. Results From April 4 to June 11, 2020, 1289…

An explorative study to assess the association between health-related quality of life and the recommended phase II dose in a phase I trial: idarubicin-loaded beads for chemoembolisation of hepatocellular carcinoma

Objectives The objective of this study was to explore the association between health-related quality of life (HRQoL) and the recommended phase 2 dose in a phase I clinical trial according to the Time to HRQoL deterioration approach (TTD). Setting This is a phase I dose-escalation trial of transarterial chemoembolisation (TACE) with idarubicin-loaded beads performed in cirrhotic patients with hepatocellular carcinoma. Patients had to complete the EORTC QLQ-C30 HRQoL questionnaire at baseline and at days 15, 30 and 60 after TACE. Participants Patients aged ≥18 years with HCC unsuitable for curative treatments were evaluated for the study (N=21). Primary and secondary outcome measurements The …

Dans l’hépatite chronique C, les délais entre diagnostic et traitement sont liés à la relation médecins-patients

Une etude epidemiologique menee en 2004 en Cote d’Or et dans le Doubs revelait que parmi 1 251 patients porteurs du VHC, un sur 4 etait traite et un sur 6 ne beneficiait d’aucune prise en charge. Une etude qualitative faite en Bourgogne en 2006-2008 visait a identifier les raisons de l’insuffisance de soins ; 25 medecins ont ete interroges sur leur confrontation a l’infection par le VHC et les difficultes de sa prise en charge, et 27 patients atteints d’hepatite chronique C sur les circonstances du depistage et du diagnostic, l’itineraire de soins, la representation et le vecu de la maladie et du traitement, les relations avec les soignants. L’etude a revele une grande variabilite dans les …

Représentations des professionnels et dépistage des hépatites B et C chez les migrants : une étude qualitative en Côte-d'Or

Les hepatites B et C sont un probleme de sante publique important en France, en particulier chez les migrants. La naissance et un sejour prolonge en pays d’endemie sont des facteurs de risque frequents, surtout pour l’hepatite B. Pourtant ces maladies restent insuffisamment depistees chez les migrants. L’objectif principal de cette etude est d’identifier les representations des professionnels de sante de Cote-d’Or du risque d’infection virale B et C des migrants pour comprendre les freins au depistage et les facteurs le favorisant. Cette etude qualitative par entretiens semi-directifs a ete menee aupres de 23 professionnels de sante et 8 travailleurs sociaux. Les professionnels de sante ont…

Is ribavirin actually useful for Genotype 1 cirrhotic patients who receive DAAs combination? An updated meta-analysis of randomized controlled trials

Prognostic Impact of 3-HM Concentration in Patients with Alcoholic or Viral Cirrhosis

The role of endotoxemia related to intestinal bacterial translocation in worsening liver disease is the subject of many studies, but its impact on cirrhosis mortality has not been well evaluated. In this study, 3-hydroxymyristate (3-HM) (specific lipid of lipopolysaccharides) was directly quantified by an innovative patented assay with the aim of assessing the impact on cirrhosis mortality. The 3-HM concentration was measured in 593 patients with alcoholic or viral cirrhosis in stable clinical condition. A Cox hazards regression model was used to evaluate association between 3-HM and its fractions bound or nor bound to lipoprotein and the mortality. The 3-HM concentration was increased in p…

Evolving epidemiology and antimicrobial resistance in spontaneous bacterial peritonitis: a two-year observational study.

Background Current recommendations for empirical antimicrobial therapy in spontaneous bacterial peritonitis (SBP) are based on quite old trials. Since microbial epidemiology and the management of patients have changed, whether these recommendations are still appropriate must be confirmed. Methods An observational study that exhaustively collected the clinical and biological data associated with positive ascitic fluid cultures was conducted in four French university hospitals in 2010–2011. Results Two hundred and sixty-eight documented positive cultures were observed in 190 cirrhotic patients (median age 61.5 years, 58.5% Child score C). Of these, 57 were classified as confirmed SBP and 140 …