{"id":1771,"date":"2004-10-01T01:00:00","date_gmt":"2004-10-01T00:00:00","guid":{"rendered":"https:\/\/angh.net\/abstracts\/essai-randomise-octreotide-retard-vs-placebo-pour-le-traitement-palliatif-du-carcinome-hepatocellulaire-chc-resultats-preliminaires-de-lessai-choc-ffcd-angh-2001-01\/"},"modified":"2018-10-20T18:39:34","modified_gmt":"2018-10-20T16:39:34","slug":"essai-randomise-octreotide-retard-vs-placebo-pour-le-traitement-palliatif-du-carcinome-hepatocellulaire-chc-resultats-preliminaires-de-lessai-choc-ffcd-angh-2001-01","status":"publish","type":"post","link":"https:\/\/angh.net\/abstracts\/essai-randomise-octreotide-retard-vs-placebo-pour-le-traitement-palliatif-du-carcinome-hepatocellulaire-chc-resultats-preliminaires-de-lessai-choc-ffcd-angh-2001-01\/","title":{"rendered":"ESSAI RANDOMISE OCTREOTIDE-RETARD VS PLACEBO POUR LE TRAITEMENT PALLIATIF DU CARCINOME HEPATOCELLULAIRE (CHC) : RESULTATS PRELIMINAIRES DE L\u2019ESSAI CHOC FFCD-ANGH 2001-01"},"content":{"rendered":"

2004<\/strong><\/p>\n

JC. BARBARE (Compi\u00e8gne), C. GIRAULT, F. BONNETAIN (FFCD).<\/em><\/p>\n

H\u00e9patologie <\/strong>– \u00a02004-09-14 –\u00a0CO –<\/p>\n

________________________________<\/p>\n

L\u2019effet anti-tumoral des d\u00e9riv\u00e9s de la somatostatine constat\u00e9 chez l\u2019animal et au cours des tumeurs endocrines, la pr\u00e9sence de r\u00e9cepteurs de la somatostatine dans des CHC, et un essai randomis\u00e9 positif (Kouroumalis E et al. Gut 1998;42:442-47.) ont conduit \u00e0 mener cette \u00e9tude afin d\u2019\u00e9valuer l\u2019effet de l\u2019octr\u00e9otide-retard sur la dur\u00e9e de survie des malades atteints de CHC en situation palliative.
\nLes crit\u00e8res d\u2019inclusion \u00e9taient les suivants : CHC prouv\u00e9 par histologie ou selon les crit\u00e8res non-invasifs dits \u00ab de Barcelone \u00bb, et malade non \u00e9ligible pour un traitement chirurgical, par destruction percutan\u00e9e ou par chimioembolisation, ou CHC r\u00e9cidivant apr\u00e8s un traitement sp\u00e9cifique. Les crit\u00e8res de non-inclusion \u00e9taient les suivants : hypoglyc\u00e9mie, diab\u00e8te mal \u00e9quilibr\u00e9, maladie extra-h\u00e9patique mena\u00e7ant la vie, score du CLIP > 3, cr\u00e9atinin\u00e9mie > 120 \u00b5mol\/L, TP < 50 %, nombre de plaquettes < 50.000 \/mm3, lithiase v\u00e9siculaire symptomatique. Les malades inclus ont \u00e9t\u00e9 r\u00e9partis par randomisation centralis\u00e9e en 2 groupes : toutes les 4 semaines, ceux du groupe trait\u00e9 ont re\u00e7u un injection IM de 30 mg de Sandostatine-LP\u00d2 et ceux du groupe contr\u00f4le ont re\u00e7u une injection IM de placebo. Il a \u00e9t\u00e9 fait une stratification selon le centre, le score du CLIP, l\u2019existence ou non d\u2019ant\u00e9c\u00e9dent d\u2019h\u00e9morragie digestive et\/ou la pr\u00e9sence de VO grade 2. Les malades avaient un bilan clinique et biologique toutes les 4 semaines et un scanner pour \u00e9valuation de la masse tumorale 3 et 6 mois apr\u00e8s l\u2019inclusion. Le crit\u00e8re principal de jugement \u00e9tait la dur\u00e9e de survie globale.
\nDe juillet 2002 \u00e0 octobre 2003, 272 malades ont \u00e9t\u00e9 inclus, 137 dans le bras octr\u00e9otide-retard et 135 dans le bras placebo. Soixante dix-neuf centres ont inclus des malades ; la participation de l\u2019ANGH a repr\u00e9sent\u00e9 67 % des centres actifs et 51 % des inclusions ; les 2 groupes de malades n\u2019\u00e9taient pas diff\u00e9rents pour l\u2019\u00e2ge (m = 68 [38-87] ans), le score du CLIP (0 : 6 %, 1 : 28 % ; 2-3 : 63 %), l\u2019existence d\u2019une cirrhose (67 %), l\u2019\u00e9tiologie de la cirrhose (alcool : 72 %), la classe de Child-Pugh (A : 51 %, B : 18 %, C : 1 %), le score OMS (0 : 27 %, 1 : 40 %, 2 : 15 %, 3 : 2 %), l\u2019existence d\u2019une thrombose portale (22 %) ou de m\u00e9tastases (18 %). Un effet ind\u00e9sirable consid\u00e9r\u00e9 comme possiblement li\u00e9 au traitement (hypoglyc\u00e9mie) n\u2019a \u00e9t\u00e9 observ\u00e9 \u00e0 ce jour que chez un malade (0,7 %) ; il n\u2019a en particulier pas \u00e9t\u00e9 constat\u00e9 de cas de chol\u00e9cystite ou de complication locale du fait des injections IM.
\nIl vient d\u2019\u00eatre proc\u00e9d\u00e9 \u00e0 l\u2019analyse interm\u00e9diaire pr\u00e9vue par le protocole ; la m\u00e9diane de survie de l\u2019ensemble des malades inclus est de 6,9 mois (5,1 \u2013 8,1). Les r\u00e9sultats ont \u00e9t\u00e9 soumis \u00e0 un comit\u00e9 d\u2019experts ind\u00e9pendants de l\u2019\u00e9tude, qui a recommand\u00e9 de ne plus inclure de nouveaux malades et de continuer \u00e0 suivre et traiter les malades non d\u00e9c\u00e9d\u00e9s jusqu\u2019\u00e0 la date de point finale fix\u00e9e au 15 octobre 2004.
\nEn conclusion : l\u2019ANGH reste tr\u00e8s active dans la recherche clinique ; le nombre de malades atteints de CHC pouvant entrer dans les essais th\u00e9rapeutiques est important ; la classification du CLIP est robuste ; les injections IM d\u2019octr\u00e9otide-retard semblent bien tol\u00e9r\u00e9es chez ces malades ; quelque soit le r\u00e9sultat d\u00e9finitif de l\u2019essai CHOC, il faut pr\u00e9parer le suivant.
\nPromoteur de l\u2019\u00e9tude : NOVARTIS<\/p>\n","protected":false},"excerpt":{"rendered":"

2004 JC. BARBARE (Compi\u00e8gne), C. GIRAULT, F. BONNETAIN (FFCD). H\u00e9patologie – \u00a02004-09-14 –\u00a0CO – ________________________________ L\u2019effet anti-tumoral des d\u00e9riv\u00e9s de la somatostatine constat\u00e9 chez l\u2019animal et au cours des tumeurs endocrines, la pr\u00e9sence de r\u00e9cepteurs de la somatostatine dans des CHC, et un essai randomis\u00e9 positif (Kouroumalis E et al. Gut 1998;42:442-47.) ont conduit \u00e0 […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"footnotes":""},"categories":[3],"tags":[15],"class_list":["post-1771","post","type-post","status-publish","format-standard","hentry","category-hepatologie","tag-15"],"yoast_head":"\nESSAI RANDOMISE OCTREOTIDE-RETARD VS PLACEBO POUR LE TRAITEMENT PALLIATIF DU CARCINOME HEPATOCELLULAIRE (CHC) : RESULTATS PRELIMINAIRES DE L\u2019ESSAI CHOC FFCD-ANGH 2001-01 - Abstracts des congr\u00e8s de l'ANGH<\/title>\n<meta name=\"description\" content=\"ANGH R\u00e9sum\u00e9s congr\u00e8s H\u00e9patologie Gastroent\u00e9romogie Hepatology Gastroenterology Etudes cliniques Clinical study\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/angh.net\/abstracts\/essai-randomise-octreotide-retard-vs-placebo-pour-le-traitement-palliatif-du-carcinome-hepatocellulaire-chc-resultats-preliminaires-de-lessai-choc-ffcd-angh-2001-01\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ESSAI RANDOMISE OCTREOTIDE-RETARD VS PLACEBO POUR LE TRAITEMENT PALLIATIF DU CARCINOME HEPATOCELLULAIRE (CHC) : RESULTATS PRELIMINAIRES DE L\u2019ESSAI CHOC FFCD-ANGH 2001-01 - 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