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2. A phase II open label trial evaluating safety and efficacy of a telomerase peptide vaccination in patients with advanced hepatocellular carcinoma

Author

Ayuso Carmen, Barget Nathalie, N'Kontchou Gisele, Korangy Firouzeh, Forner Alejandro, Greten Tim F, Ormandy Lars A, Manns Michael P, Beaugrand Michel, and Bruix Jordi

Subjects
Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Abstract Background The sole effective option for patients with advanced HCC is sorafenib and there is an urgent need to develop new therapeutic approaches. Immunotherapy is a promising option that deserves major investigation. In this open label, single arm clinical trial, we analyzed the effect of a low dose cyclophosphamide treatment in combination with a telomerase peptide (GV1001) vaccination in patients with advanced HCC. Methods 40 patients with advanced HCC were treated with 300 mg/m2 cyclophosphamide on day -3 followed by GM-CSF + GV1001 vaccinations on days 1, 3, 5, 8, 15, 22, 36 followed by 4-weekly injections. Primary endpoint of this phase II trial was tumor response; secondary endpoints evaluated were TTP, TTSP, PFS, OS, safety and immune responses. Results None of the patients had a complete or partial response to treatment, 17 patients (45.9%) demonstrated a stable disease six months after initiation of treatment. The median TTP was 57.0 days; the median TTSP was estimated to be 358.0 days. Cyclophosphamide, GV1001 and GM-CSF treatment were well tolerated and most adverse events, which were of grade 1 or 2, were generally related to the injection procedure and injection site reactions. GV1001 treatment resulted in a decrease in CD4+CD25+Foxp3+ regulatory T cells; however, no GV1001 specific immune responses were detected after vaccination. Conclusions Low dose cyclophosphamide treatment followed by GV1001 vaccinations did not show antitumor efficacy as per tumor response and time to progression. Further studies are needed to analyze the effect of a combined chemo-immunotherapy to treat patients with HCC. Trial registration NCT00444782

Published
2010
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3. OS-110 ARMCENVIN: multibipolar radiofrequency ablation of HCC using intratumourous versus extratumourous “no-touch” techniques. French multicentric randomized controlled trial (NCT 01008657)

Author

Seror, Olivier, primary, N'Kontchou, Gisele, additional, Rode, Agnès, additional, Merle, Philippe, additional, Aubé, Christophe, additional, Oberti, Frédéric, additional, Vilgrain, Valerie, additional, Bouattour, Mohamed, additional, Trillaud, Hervé, additional, Blanc, Jean-Frédéric, additional, Guiu, Boris, additional, Pageaux, Georges-Philippe, additional, Chevallier, Patrick, additional, Tran, Albert, additional, Portal, Jean-Jacques, additional, Nault, Jean Charles, additional, Sutter, Olivier, additional, Ganne-Carrié, Nathalie, additional, Nahon, Pierre, additional, and Vicaut, Eric, additional

Published
2024
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4. Early hepatocellular carcinoma detection using magnetic resonance imaging is cost-effective in high-risk patients with cirrhosis

Author

Nahon, Pierre, Asselah, Tarik, Guyader, Dominique, Pol, Stanislas, Fontaine, Hélène, Pageaux, Georges-Philippe, De Lédinghen, Victor, Ouzan, Denis, Zoulim, Fabien, Roulot, Dominique, Tran, Albert, Bronowicki, Jean-Pierre, Decaensi, Thomas, Riachi, Ghassan, Calès, Paul, Péron, Jean-Marie, Alric, Laurent, Bourlière, Marc, Mathurin, Philippe, Dharancy, Sebastien, Blanc, Jean-Frédéric, Abergel, Armand, Chazouillères, Olivier, Mallat, Ariane, Grangé, Jean-Didier, Attali, Pierre, d’Alteroche, Louis, Wartelle, Claire, Dao, Thông, Thabut, Dominique, Pilette, Christophe, Silvain, Christine, Christidis, Christos, Nguyen-Khac, Eric, Bernard-Chabert, Brigitte, Hillaire, Sophie, Di Martino, Vincent, Bonnet, Delphine, Payssan-Sicart, Virginie, Pomes, Chloe, Bailly, François, Beaudoin, Marjolaine, Giboz, Dominique, Hartig-Lavie, Kerstin, Maynard, Marianne, Billaud, Eric, Boutoille, David, Cavellec, Morane, Cheraud-Carpentier, Marjorie, Hubert, Isabelle, Benhida, Jaouad, Lannes, Adrien, Lunel, Françoise, Oberti, Frédéric, Boyer, Nathalie, Giuily, Nathalie, Castelnau, Corinne, Scoazec, Giovanna, Chibah, Aziza, Keser, Sylvie, Bonardi, Karim, Vallet-Pichard, Anaïs, Sogni, Philippe, Foucher, Juliette, Hiriart, Jean-Baptiste, Wilson, Amy, Shili, Sarah, Chermak, Faiza, Ansaldi, Christelle, Ben Amara, Nisserine, Chouquet, Laëtitia, De Luca, Emilie, Oules, Valérie, Anty, Rodolphe, Gelsi, Eve, Truchi, Régine, Luckina, Elena, Messaoudi, Nadia, Moussali, Joseph, De Dieuleveult, Barbara, Labarriere, Damien, Poter, Pascal, Si Ahmed, Si Nafa, Grando-Lemaire, Véronique, Bourcier, Valérie, Brulé, Séverine, Stalhberger, Thomas, Jezequel, Caroline, Brener, Audrey, Laligant, Anne, Rabot, Aline, Renard, Isabelle, Baumert, Thomas F., Dofföel, Michel, Mutter, Catherine, Simo-Noumbissie, Pauline, Razi, Esma, Barraud, Hélène, Bensenane, Mouni, Nani, Abdelbasset, Hassani-Nani, Sarah, Bernard, Marie-Albertine, Bismuth, Michael, Caillo, Ludovic, Faure, Stéphanie, Ripault, Marie Pierre, Bureau, Christophe, Peron, Jean Marie, Robic, Marie Angèle, Tarallo, Léa, Faure, Marine, Froissart, Bruno, Hilleret, Marie-Noelle, Zarski, Jean-Pierre, Goria, Odile, Grard, Victorien, Montialoux, Hélène, François, Muriel, Ouedraogo, Christian, Pauleau, Christelle, Varault, Anne, Andreani, Tony, Angoulevant, Bénédicte, Chevance, Azeline, Serfaty, Lawrence, Antonini, Teresa, Coilly, Audrey, Duclos Vallée, Jean-Charles, Tateo, Mariagrazia, Bonny, Corinne, Brigitte, Chanteranne, Lamblin, Géraldine, Muti, Léon, Babouri, Abdenour, Filipe, Virginie, Barrault, Camille, Costes, Laurent, Hagège, Hervé, Merbah, Soraya, Carrier, Paul, Debette-Gratien, Maryline, Jacques, Jérémie, Lassailly, Guillaume, Artu, Florent, Canva, Valérie, Dharancy, Sébastien, Louvet, Alexandre, Latournerie, Marianne, Bardou, Marc, Mouillot, Thomas, Bacq, Yannick, Barbereau, Didier, Nicolas, Charlotte, Chevalier, Caroline, Archambeaud, Isabelle, Habes, Sarah, Botta-Fridlund, Danièle, Saillard, Eric, Lafrance, Marie-Josée, Cacoub, Patrice, Carrat, Fabrice, Carrieri, Patrizia, Delarocque-Astagneau, Elisabeth, De Ledinghen, Victor, Dorival, Céline, Dubuisson, Jean, Housset, Chantal, Larrey, Dominique, Marcellin, Patrick, Pawlotsky, Jean-Michel, Petrov-Sanchez, Ventzislava, Vaux, Sophie, Wittkop, Linda, Yazdanpanah, Yazdan, Zucman-Rossi, Jessica, Ganne-Carrié, Nathalie, Chaffaut, Cendrine, Moreno, Christophe, Moirand, Romain, Carbonell, Nicolas, Duclos-Vallée, Jean-Charles, de Ledinghen, Victor, Ozenne, Violaine, Henrion, Jean, Perlemuter, Gabriel, Amiot, Xavier, Chevret, Sylvie, Najean, Marie, Layese, Richard, Zarca, Kevin, Segar, Laeticia Blampain, Cagnot, Carole, N’Kontchou, Gisèle, Ronot, Maxime, Audureau, Etienne, and Durand-Zaleski, Isabelle

Published
2022
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5. Impact of cirrhosis aetiology on incidence and prognosis of hepatocellular carcinoma diagnosed during surveillance

Author

Ganne-Carrié, Nathalie, Chaffaut, Cendrine, Archambeaud, Isabelle, d’Alteroche, Louis, Oberti, Frédéric, Roulot, Dominique, Moreno, Christophe, Louvet, Alexandre, Dao, Thông, Moirand, Romain, Goria, Odile, Nguyen-Khac, Eric, Carbonell, Nicolas, Duclos-Vallée, Jean-Charles, Pol, Stanislas, de Ledinghen, Victor, Ozenne, Violaine, Henrion, Jean, Péron, Jean-Marie, Tran, Albert, Perlemuter, Gabriel, Amiot, Xavier, Zarski, Jean-Pierre, Chevret, Sylvie, Nahon, Pierre, Asselah, Tarik, Guyader, Dominique, Fontaine, Hélène, Pageaux, Georges-Philippe, De Lédinghen, Victor, Ouzan, Denis, Zoulim, Fabien, Bronowicki, Jean-Pierre, Decaens, Thomas, Riachi, Ghassan, Calès, Paul, Alric, Laurent, Bourlière, Marc, Mathurin, Philippe, Dharancy, Sebastien, Blanc, Jean-Frédéric, Abergel, Armand, Chazouillères, Olivier, Mallat, Ariane, Grangé, Jean-Didier, Attali, Pierre, Wartelle, Claire, Thabut, Dominique, Pilette, Christophe, Silvain, Christine, Christidis, Christos, Bernard-Chabert, Brigitte, Hillaire, Sophie, Di Martino, Vincent, N’Kontchou, Gisèle, Layese, Richard, and Audureau, Etienne

Published
2021
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6. Upfront multi‐bipolar radiofrequency ablation for HCC in transplant‐eligible cirrhotic patients with salvage transplantation in case of recurrence.

Author

Boros, Carina, Sutter, Olivier, Cauchy, François, Ganne‐Carrié, Nathalie, Nahon, Pierre, N'kontchou, Gisele, Ziol, Marianne, Grando, Véronique, Demory, Alix, Blaise, Lorraine, Dondero, Fédérica, Durand, François, Soubrane, Olivier, Lesurtel, Mickael, Laurent, Alexis, Seror, Oliver, and Nault, Jean Charles

Subjects
CATHETER ablation, OVERALL survival, LIVER failure, ALCOHOL drinking, HEPATOCELLULAR carcinoma
Abstract

Introduction: We aim to assess the long‐term outcomes of percutaneous multi‐bipolar radiofrequency (mbpRFA) as the first treatment for hepatocellular carcinoma (HCC) in transplant‐eligible cirrhotic patients, followed by salvage transplantation for intrahepatic distant tumour recurrence or liver failure. Materials and Methods: We included transplant‐eligible patients with cirrhosis and a first diagnosis of HCC within Milan criteria treated by upfront mbp RFA. Transplantability was defined by age <70 years, social support, absence of significant comorbidities, no active alcohol use and no recent extrahepatic cancer. Baseline variables were correlated with outcomes using the Kaplan‐Meier and Cox models. Results: Among 435 patients with HCC, 172 were considered as transplantable with HCCs >2 cm (53%), uninodular (87%) and AFP >100 ng/mL (13%). Median overall survival was 87 months, with 75% of patients alive at 3 years, 61% at 5 years and 43% at 10 years. Age (p =.003) and MELD>10 (p =.01) were associated with the risk of death. Recurrence occurred in 118 patients within Milan criteria in 81% of cases. Local recurrence was observed in 24.5% of cases at 10 years and distant recurrence rates were observed in 69% at 10 years. After local recurrence, 69% of patients were still alive at 10 years. At the first tumour recurrence, 75 patients (65%) were considered transplantable. Forty‐one patients underwent transplantation, mainly for distant intrahepatic tumour recurrence. The overall 5‐year survival post‐transplantation was 72%, with a tumour recurrence of 2.4%. Conclusion: Upfront multi‐bipolar RFA for a first diagnosis of early HCC on cirrhosis coupled with salvage liver transplantation had a favourable intention‐to‐treat long‐term prognosis, allowing for spare grafts. [ABSTRACT FROM AUTHOR]

Published
2024
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15. Multibipolar Radiofrequency Ablation for the Treatment of Mass-Forming and Infiltrative Hepatocellular Carcinomas > 5 cm: Long-Term Results

Author

N’Kontchou, Gisele, primary, Nault, Jean-Charles, additional, Sutter, Olivier, additional, Bourcier, Valerie, additional, Coderc, Emmanuelle, additional, Grando, Veronique, additional, Nahon, Pierre, additional, Ganne-Carrié, Nathalie, additional, Diallo, Abou, additional, Sellier, Nicolas, additional, and Seror, Olivier, additional

Published
2018
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17. Multibipolar Radiofrequency Ablation for the Treatment of Mass-Forming and Infiltrative Hepatocellular Carcinomas > 5 cm: Long-Term Results

Author

N’Kontchou, Gisele, Nault, Jean-Charles, Sutter, Olivier, Bourcier, Valerie, Coderc, Emmanuelle, Grando, Veronique, Nahon, Pierre, Ganne-Carrié, Nathalie, Diallo, Abou, Sellier, Nicolas, and Seror, Olivier

Abstract

Aims and Background: Only few patients with cirrhosis and hepatocellular carcinoma (HCC) larger than 5 cm are amenable to resection or straight liver transplantation, and in such circumstances, multibipolar radiofrequency ablation (mbp-RFA) could be a reliable alternative. This study was aimed to assess the long-term outcome in patients treated with mbp-RFA for unresectable HCC > 5 cm. Methods: Eighty-three consecutive patients with cirrhosis (median age 70 years [37–93 years], 67 males, BCLC A/B/C: 54/21/8, 74 naive) with up to three HCCs, the largest > 5 cm in diameter (median: 6.2 cm, 5.1–9 cm, 22 infiltrative forms, 12 with segmental portal invasion of which 10 were infiltrative forms) were treated with mbp-RFA. Overall (OS) and recurrence-free (RFS) survival and their associated predictive factors were assessed. Results: Complete ablation was observed in 78/83 (94%) patients. Thirty-one side effects occurred, including 6 (7%) severe complications. After a median follow-up of 26.1 months (1–112 months), in naive patients the 3- and 5-year OS was 51% (38–62) and 24% (13–36), 63 and 30% for mass-forming and 25 and 6% for infiltrative form, respectively. Infiltrative form (HR: 2.5 [1.33–4.69], p = 0.004) was the only independent OS predictor. In naive patients with mass-forming and infiltrative form, the 3- and 5-year RFS were 47 and 17 and 18 and 18%, respectively. Alpha-fetoprotein (HR: 2.86 [1.32–6.21], p = 0.008), multinodular form (HR: 2.74 [1.4–5.38], p = 0.003) and infiltrative form (HR: 3.43 [1.67–7.01], p = 0.0007) were independent RFS predictors. Conclusions: mbp-RFA offers good OS in inoperable patients with cirrhosis and large HCC, with acceptable safety profile. For infiltrative forms, although mbp-RFA leads to complete responses in more than 80% cases, few only remain tumor progression-free in long-term.

Published
2019
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21. Reply

Author

N'Kontchou, Gisele, primary, Beaugrand, Michel, additional, and Seror, Olivier, additional

Published
2009
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22. A phase II open label trial evaluating safety andefficacy of a telomerase peptide vaccination inpatients with advanced hepatocellular carcinoma.

Author

Greten, Tim F., Forner, Alejandro, Korangy, Firouzeh, N'Kontchou, Gisele, Barget, Nathalie, Ayuso, Carmen, Ormandy, Lars A., Manns, Michael P., Beaugrand, Michel, and Bruix, Jordi

Subjects
VACCINATION, CANCER patients, THROMBOTIC thrombocytopenic purpura, IMMUNOTHERAPY, LIVER cancer, T cells, BIOTECHNOLOGY
Abstract

Background: The sole effective option for patients with advanced HCC is sorafenib and there is an urgent need to develop new therapeutic approaches. Immunotherapy is a promising option that deserves major investigation. In this open label, single arm clinical trial, we analyzed the effect of a low dose cyclophosphamide treatment in combination with a telomerase peptide (GV1001) vaccination in patients with advanced HCC. Methods: 40 patients with advanced HCC were treated with 300 mg/m² cyclophosphamide on day -3 followed by GM-CSF + GV1001 vaccinations on days 1, 3, 5, 8, 15, 22, 36 followed by 4-weekly injections. Primary endpoint of this phase II trial was tumor response; secondary endpoints evaluated were TTP, TTSP, PFS, OS, safety and immune responses. Results: None of the patients had a complete or partial response to treatment, 17 patients (45.9%) demonstrated a stable disease six months after initiation of treatment. The median TTP was 57.0 days; the median TTSP was estimated to be 358.0 days. Cyclophosphamide, GV1001 and GM-CSF treatment were well tolerated and most adverse events, which were of grade 1 or 2, were generally related to the injection procedure and injection site reactions. GV1001 treatment resulted in a decrease in CD4+CD25+Foxp3+ regulatory T cells; however, no GV1001 specific immune responses were detected after vaccination. Conclusions: Low dose cyclophosphamide treatment followed by GV1001 vaccinations did not show antitumor efficacy as per tumor response and time to progression. Further studies are needed to analyze the effect of a combined chemo-immunotherapy to treat patients with HCC. Trial registration: NCT00444782. [ABSTRACT FROM AUTHOR]

Published
2010
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23. Reply:.

Author

N'Kontchou, Gisele, Beaugrand, Michel, and Seror, Olivier

Published
2010
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25. Multibipolar Radiofrequency Ablation for the Treatment of Mass-Forming and Infiltrative Hepatocellular Carcinomas > 5 cm: Long-Term Results.

Author

N'Kontchou G, Nault JC, Sutter O, Bourcier V, Coderc E, Grando V, Nahon P, Ganne-Carrié N, Diallo A, Sellier N, and Seror O

Abstract

Aims and Background: Only few patients with cirrhosis and hepatocellular carcinoma (HCC) larger than 5 cm are amenable to resection or straight liver transplantation, and in such circumstances, multibipolar radiofrequency ablation (mbp-RFA) could be a reliable alternative. This study was aimed to assess the long-term outcome in patients treated with mbp-RFA for unresectable HCC > 5 cm., Methods: Eighty-three consecutive patients with cirrhosis (median age 70 years [37-93 years], 67 males, BCLC A/B/C: 54/21/8, 74 naive) with up to three HCCs, the largest > 5 cm in diameter (median: 6.2 cm, 5.1-9 cm, 22 infiltrative forms, 12 with segmental portal invasion of which 10 were infiltrative forms) were treated with mbp-RFA. Overall (OS) and recurrence-free (RFS) survival and their associated predictive factors were assessed., Results: Complete ablation was observed in 78/83 (94%) patients. Thirty-one side effects occurred, including 6 (7%) severe complications. After a median follow-up of 26.1 months (1-112 months), in naive patients the 3- and 5-year OS was 51% (38-62) and 24% (13-36), 63 and 30% for mass-forming and 25 and 6% for infiltrative form, respectively. Infiltrative form (HR: 2.5 [1.33-4.69], p = 0.004) was the only independent OS predictor. In naive patients with mass-forming and infiltrative form, the 3- and 5-year RFS were 47 and 17 and 18 and 18%, respectively. Alpha-fetoprotein (HR: 2.86 [1.32-6.21], p = 0.008), multinodular form (HR: 2.74 [1.4-5.38], p = 0.003) and infiltrative form (HR: 3.43 [1.67-7.01], p = 0.0007) were independent RFS predictors., Conclusions: mbp-RFA offers good OS in inoperable patients with cirrhosis and large HCC, with acceptable safety profile. For infiltrative forms, although mbp-RFA leads to complete responses in more than 80% cases, few only remain tumor progression-free in long-term.

Published
2019
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