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Boulin M.,University Hospital | Boulin M.,University of Burgundy | Ciboulet A.,University Hospital | Guiu B.,University of Burgundy | And 21 more authors.
Digestive and Liver Disease | Year: 2011

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 were randomised in the control group. The two groups were comparable with respect to their baseline characteristics. The objective response rate according to the EASL criteria was 62% (95% CI 35-88) in the amiodarone group and 50% (95% CI 24-76) in the control group. At 1 and 2 years, survival rates were 77% (95% CI 44-92) and 52% (95% CI 22-75) in the amiodarone group, and 57% (95% CI 28-78) and 40% (95% CI 15-65) in the control group, respectively. There was no difference between the two groups in terms of toxicity. Conclusions: The results of this study suggest that lipiodol transarterial chemoembolisation with anthracycline and amiodarone was safe but did not increase survival compared with lipiodol transarterial chemoembolisation with anthracycline alone in patients with hepatocellular carcinoma. © 2011 Editrice Gastroenterologica Italiana S.r.l.


Boulin M.,University Hospital | Boulin M.,University of Burgundy | Adam H.,University Hospital | Guiu B.,University of Burgundy | And 17 more authors.
Digestive and Liver Disease | Year: 2014

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 regression model. The robustness of the final model was confirmed using bootstrapping (500 replications). Results: 124 patients were included, median age was 67 years and 90% were male; 22 patients (18%) experienced severe TACE-related toxicity. Factors that independently predicted severe TACE-related toxicity in multivariate analysis were total tumour size (OR, 1.15cm-1; 95%CI, 1.04-1.26; p=0.01), and high serum AST levels (OR, 1.10 per 10IU/l; 95%CI, 1.01-1.21; p=0.04). The results were confirmed by bootstrapping. Conclusions: Total tumour size and high serum AST levels were predictive factors of severe TACE-related toxicity in this hospital-based series of patients with unresectable HCC. © 2014 Editrice Gastroenterologica Italiana S.r.l.


Guiu B.,Montpellier University | Schmitt A.,Georges Francois Leclerc Anticancer Center | Reinhardt S.,CeloNova | Fohlen A.,University of Caen Lower Normandy | And 5 more authors.
Journal of Vascular and Interventional Radiology | Year: 2015

Purpose To present in vitro loading and release characteristics of idarubicin with ONCOZENE (CeloNova BioSciences, Inc, San Antonio, Texas) drug-eluting embolic (DEE) agents and in vivo pharmacokinetics data after transarterial chemoembolization with idarubicin-loaded ONCOZENE DEE agents in patients with hepatocellular carcinoma. Materials and Methods Loading efficacy of idarubicin with ONCOZENE DEE agents 100 μm and DC Bead (Biocompatibles UK Ltd, Farnham, United Kingdom) DEE agents 100-300 μm was monitored at 10, 20, and 30 minutes loading time by high-pressure liquid chromatography. A T-apparatus was used to monitor the release of idarubicin from the two types of DEE agents over 12 hours. Clinical and 24-hour pharmacokinetics data were recorded after transarterial chemoembolization with idarubicin-loaded ONCOZENE DEE agents in four patients with unresectable hepatocellular carcinoma. Results Idarubicin loading in ONCOZENE DEE agents was > 99% at 10 minutes. Time to reach 75% of the release plateau level was 37 minutes ± 6 for DC Bead DEE agents and 170 minutes ± 19 for ONCOZENE DEE agents both loaded with idarubicin 10 mg/mL. After transarterial chemoembolization with idarubicin-loaded ONCOZENE DEE agents, three partial responses and one complete response were observed with only two asymptomatic grade 3 biologic adverse events. Median time to maximum concentration for idarubicin in patients was 10 minutes, and mean maximum concentration was 4.9 μg/L ± 1.7. Mean area under the concentration-time curve from 0-24 hours was equal to 29.5 μg.h/L ± 20.5. Conclusions ONCOZENE DEE agents show promising results with very fast loading ability, a favorable in vivo pharmacokinetics profile with a sustained release of idarubicin during the first 24 hours, and encouraging safety and responses. Histopathologic and clinical studies are needed to evaluate idarubicin release around the DEE agents in tumor tissue and to confirm safety and efficacy. © 2015 SIR.


Boulin M.,University Hospital | Boulin M.,University of Burgundy | Guiu S.,University of Burgundy | Guiu S.,Georges Francois Leclerc Anticancer Center | And 13 more authors.
Anti-Cancer Drugs | Year: 2011

The aim of this study was to select the best candidate drug for transarterial chemoembolization by in-vitro cytotoxic evaluations of 11 anticancer drugs on three human hepatocellular carcinoma (HCC) cell lines. The SNU-398, HepG2, and SNU-449 human HCC cell lines were exposed for 30 min to 11 concentrations of doxorubicin, epirubicin, idarubicin, mitoxantrone, carboplatin, cisplatin, oxaliplatin, 5-fluorouracil, gemcitabine, mitomycin C, or paclitaxel. Cytotoxicity was measured using a quantitative colorimetric assay. For each drug and cell line, we calculated the drug concentration that caused 90% cell death (IC90). To enable comparisons of drugs with different concentration ranges, we computed the cytotoxic index (CyI) as the ratio of maximal drug concentration of more than IC90. Parameters were estimated using nonlinear regression models. Idarubicin was the most active drug on all three cell lines. With SNU-398 cells, the idarubicin CyI was 2.4-fold, 2.5-fold, 57-fold, 148-fold, and more than 58 748-fold higher than the CyIs of mitoxantrone, epirubicin, doxorubicin, gemcitabine, and other drugs, respectively. With HepG2 cells, the idarubicin CyI was 27-fold, 28-fold, 51-fold, and more than 1343-fold higher than the CyIs of doxorubicin, epirubicin, mitoxantrone, and other drugs, respectively. On the resistant SNU-449 cell line, the idarubicin CyI was 2.9-fold and 14-fold higher than the CyIs of paclitaxel and gemcitabine, respectively, the only other drugs effective on this cell line. Among 11 chemotherapeutic agents including doxorubicin, cisplatin, and epirubicin, the most effective on three HCC cell lines was idarubicin. Further clinical investigations are needed to evaluate the safety and efficacy of idarubicin for transarterial chemoembolization in HCC. © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins.


Tixier H.,Georges Francois Leclerc Anticancer Center | Tixier H.,French Institute of Health and Medical Research | Picard A.,Georges Francois Leclerc Anticancer Center | Guiu S.,Georges Francois Leclerc Anticancer Center | And 5 more authors.
Archives of Gynecology and Obstetrics | Year: 2011

Purpose: Secretory carcinoma is a rare form of breast cancer most frequently encountered in children or young adults. Several cases have been described in adults with increased aggressiveness and a risk of metastases. Case report: We report here, in a 30-year-old woman, a case of local relapse and lymph node metastases occurring 16 years after the initial diagnosis of secretory carcinoma. Conclusion: We present the clinical, radiological and pathological findings that led to the diagnosis. © 2010 Springer-Verlag.

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