Treatment of advanced hepatocellular carcinoma with long-acting octreotide: A phase III multicentre,randomised, double blind placebo-controlled study |
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| Authors: | Jean-Claude Barbare Olivier Bouché Franck Bonnetain Laetitia Dahan Catherine Lombard-Bohas Roger Faroux Jean-Luc Raoul Stéphane Cattan Alain Lemoine Jean-Frédéric Blanc Jean-Pierre Bronowicki Jean-Pierre Zarski Sophie Cazorla Dany Gargot Thierry Thevenot Emmanuel Diaz Anne Bastie Thomas Aparicio Laurent Bedenne |
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| Institution: | 1. Fédération Francophone de Cancérologie Digestive, Association Nationale des Hépato-Gastroentérologues des Hôpitaux Généraux, France;2. Délégation à la Recherche Clinique et à l’Innovation, Centre Hospitalier, Universitaire Amiens Nord, 1 Place Victor Pauchet, 80054 Amiens Cedex, France;3. Service d’Hépatogastroentérologie, CHRU Reims, France;4. Biostatistics and Methodological Unit of Fédération Francophone de Cancérologie Digestive, Institut National de la Santé et de la Recherche Médicale U866, Dijon, France;5. Service d’Hépatogastroentérologie et Oncologie Digestive, CHRU AP-HM La Timone, Université de la Méditerranée, Marseille, France;6. Service d’Hépatogastroentérologie, CHRU Lyon, France;7. Service d’Hépatogastroentérologie, CH La Roche sur Yon, France;8. Centre Régional de Lutte Contre le Cancer Eugène Marquis, Rennes, France;9. European University in Brittany, France;10. Service d’Hépatogastroentérologie, CHRU Lille, France;11. Service d’Hépatogastroentérologie, CH Nevers, France;12. Service d’Hépatogastroentérologie, CHRU Bordeaux Saint André, France;13. Service d’Hépatogastroentérologie, CHRU Vandoeuvre les Nancy, France;14. Service d’Hépatogastroentérologie, CHU Grenoble, France;15. Service d’Hépatogastroentérologie, CHRU Bordeaux Pessac, France;p. Service d’Hépatogastroentérologie, CH Blois, France;q. Service d’Hépatologie, CHU Besançon, France;r. Service de Gastroentérologie, CH Béthune, France;s. Novartis Pharma, 2-4 rue Lionel Terray, 92506 Rueil Malmaison, France;t. Service d’Hépatogastroentérologie, CHU AP-HP Bichat, Paris, France;u. Fédération Francophone de Cancérologie Digestive, Institut National de la Santé’ et de la Recherche Médicale U866, Dijon, France;1. Department of rheumatology, CHRU Jean-Minjoz, 2, boulevard Fleming, 25030 Besançon, France;2. Department of hepatology, CHRU Jean-Minjoz, 2, boulevard Fleming, 25030 Besançon, France;1. Department of Biology, College of Natural Sciences (RINS) and Applied Life Science (BK21 plus), Gyeongsang National University, Jinju 660-701, Republic of Korea;2. Center of Excellence in Genomic Medicine and Research (CEGMR), King Abdulaziz University, Jeddah 21589, Saudi Arabia;1. Department of Pharmaceutical Sciences and Technology, Institute of Chemical Technology (Elite status), N.P. Marg, Matunga (East), Mumbai 400019, India;2. Department of Biochemistry and Virology, National Institute for Research in Reproductive Health (ICMR), J.M. Street, Parel, Mumbai 400012, India;1. Service d’hépatologie et de soins intensifs digestifs, hôpital Jean-Minjoz, 25030 Besançon cedex, France;2. Service de gastro-entérologie, hôpital Jean-Minjoz, 25030 Besançon cedex, France;3. Département d’information médical, hôpital Jean-Minjoz, 25030 Besançon cedex, France |
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| Abstract: | BackgroundA previous study reported a significant survival benefit for octreotide compared with no treatment in patients with advanced hepatocellular carcinoma (HCC). This was investigated further in this multicentre study.Patients and methodsTwo hundred and seventy two patients with HCC who were ineligible for curative treatments or had relapsed following potentially curative therapies were randomised to receive long-acting octreotide, 30 mg as an intramuscular injection once every 4 weeks for up to 2 years, or placebo.ResultsAt the time of the final analysis, median overall survival (OS) was 6.53 months (95% confidence interval CI], 4.8–8.3) for octreotide versus 7.03 months (95% CI, 5.43–8.53) for placebo (p = 0.34). Progression-free survival (p = 0.26) also did not differ significantly between the two treatment groups. No objective responses were achieved in the octreotide group but 33% of patients achieved disease stabilisation for a mean time of 5.5 months (95% CI, 1.1–9.9). The median time until definitive global health score deterioration (according to QLQ-C30) was 2.3 months (95% CI, 1.4–3.7) in the octreotide and 4 months (95% CI, 2.2–5.7) in the placebo group (p = 0.09). There were four objective responses in the placebo group. Octreotide was well tolerated; seven patients reported severe adverse events possibly related to octreotide and there were no cases of haematoma or cholecystitis.ConclusionsIn patients with advanced HCC, octreotide has a favourable safety profile but does not improve OS and could have a negative impact on quality of life. |
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