{"id":21869,"date":"2026-10-22T11:57:33","date_gmt":"2026-10-22T11:57:33","guid":{"rendered":"https:\/\/veilles-affaires-sociales.fr\/?p=21869"},"modified":"2026-10-22T11:57:33","modified_gmt":"2026-10-22T11:57:33","slug":"rapport-europeen-public-devaluation-epar-pour-les-medicaments-a-usage-humain-taxotere-docetaxel-date-dautorisation-27-11-1995-revision-53-statut-autorise-titre-tr","status":"publish","type":"post","link":"https:\/\/veilles-affaires-sociales.fr\/?p=21869","title":{"rendered":"Rapport europ\u00e9en public d\u2019\u00e9valuation (EPAR) pour les m\u00e9dicaments \u00e0 usage humain : Taxotere, doc\u00e9taxel, Date d\u2019autorisation : 27\/11\/1995, R\u00e9vision : 53, Statut : Autoris\u00e9\u00a0(titre traduit en fran\u00e7ais par l&rsquo;IA)"},"content":{"rendered":"<p>Le document pr\u00e9sente Taxotere, un m\u00e9dicament anticanc\u00e9reux dont la substance active est le doc\u00e9taxel, appartenant \u00e0 la classe des taxanes. Il pr\u00e9cise les principales indications th\u00e9rapeutiques et les modalit\u00e9s d\u2019utilisation, informations pertinentes pour le suivi des pratiques de chimioth\u00e9rapie et de l\u2019acc\u00e8s aux traitements anticanc\u00e9reux.<\/p>\n<p>Taxotere est indiqu\u00e9 dans plusieurs cancers : cancer du sein, cancer bronchique non \u00e0 petites cellules, cancer de la prostate m\u00e9tastatique, ad\u00e9nocarcinome gastrique m\u00e9tastatique et cancers de la t\u00eate et du cou localement avanc\u00e9s. Pour le cancer du sein, il peut \u00eatre utilis\u00e9 seul apr\u00e8s \u00e9chec d\u2019autres traitements, ou en association avec d\u2019autres m\u00e9dicaments anticanc\u00e9reux (doxorubicine, cyclophosphamide, trastuzumab ou cap\u00e9citabine), soit en premi\u00e8re ligne, soit apr\u00e8s \u00e9chec de traitements ant\u00e9rieurs, selon le type et le stade du cancer. Dans le cancer bronchique non \u00e0 petites cellules, Taxotere peut \u00eatre administr\u00e9 seul apr\u00e8s \u00e9chec d\u2019autres traitements, ou en association avec le cisplatine chez des patients n\u2019ayant pas encore \u00e9t\u00e9 trait\u00e9s.<\/p>\n<p>Pour le cancer de la prostate m\u00e9tastatique, il est utilis\u00e9 en association avec la prednisone ou la prednisolone lorsque la maladie est r\u00e9sistante \u00e0 la castration (cancer de la prostate r\u00e9sistant \u00e0 la castration) et peut aussi \u00eatre associ\u00e9 \u00e0 un traitement de privation androg\u00e9nique lorsque l\u2019hormonoth\u00e9rapie reste efficace (cancer de la prostate hormonosensible). Dans l\u2019ad\u00e9nocarcinome gastrique m\u00e9tastatique, chez des patients na\u00effs de traitement, Taxotere est prescrit en association avec le cisplatine et le 5-fluorouracile. Dans les cancers de la t\u00eate et du cou localement avanc\u00e9s, il est utilis\u00e9 l\u00e0 encore en association avec cisplatine et 5-fluorouracile.<\/p>\n<p>Le m\u00e9dicament est soumis \u00e0 prescription obligatoire et son utilisation est r\u00e9serv\u00e9e \u00e0 des unit\u00e9s sp\u00e9cialis\u00e9es dans l\u2019administration de chimioth\u00e9rapies, sous la surveillance de m\u00e9decins qualifi\u00e9s en chimioth\u00e9rapie, ce qui implique un encadrement hospitalier sp\u00e9cialis\u00e9. Le sch\u00e9ma d\u2019administration standard est une perfusion intraveineuse d\u2019une dur\u00e9e d\u2019une heure, renouvel\u00e9e toutes les trois semaines. La dose, la dur\u00e9e du traitement et les associations th\u00e9rapeutiques d\u00e9pendent du type de cancer et des caract\u00e9ristiques anthropom\u00e9triques du patient (poids, taille). Un traitement cortico\u00efde, de type dexam\u00e9thasone, doit \u00eatre administr\u00e9 en pr\u00e9m\u00e9dication \u00e0 partir de la veille de la perfusion de Taxotere. En cas d\u2019effets ind\u00e9sirables, une r\u00e9duction de dose, une interruption ou un arr\u00eat du traitement peuvent \u00eatre n\u00e9cessaires.<\/p>\n<p>Le m\u00e9canisme d\u2019action d\u00e9crit repose sur le blocage de la d\u00e9sorganisation du \u00ab squelette \u00bb interne des cellules (microtubules), ce qui emp\u00eache leur division et conduit \u00e0 leur mort. Le document souligne que, du fait de son action sur les cellules en division, Taxotere touche aussi des cellules non canc\u00e9reuses, notamment les cellules sanguines, pouvant entra\u00eener des effets ind\u00e9sirables h\u00e9matologiques, ce qui constitue un enjeu pour la surveillance de la tol\u00e9rance et la gestion des risques en onco-h\u00e9matologie.<\/p>\n<p>L\u2019efficacit\u00e9 et la tol\u00e9rance de Taxotere ont \u00e9t\u00e9 \u00e9valu\u00e9es dans de larges populations de patients, avec plus de 4 000 patients atteints de cancer du sein, environ 2 000 atteints de cancer bronchique non \u00e0 petites cellules, environ 2 700 atteints de cancer de la prostate, 457 pr\u00e9sentant un ad\u00e9nocarcinome gastrique et 897 atteints de cancers de la t\u00eate et du cou. Ces volumes d\u2019inclusion indiquent un niveau important de donn\u00e9es cliniques disponibles, sans toutefois que le document ne d\u00e9taille les r\u00e9sultats d\u2019efficacit\u00e9 ou de s\u00e9curit\u00e9. Aucun pays, autorit\u00e9 publique ou organisme de r\u00e9gulation sp\u00e9cifique n\u2019est mentionn\u00e9, mais le cadre pr\u00e9sent\u00e9 (prescription obligatoire, administration en milieu sp\u00e9cialis\u00e9, surveillance m\u00e9dicale \u00e9troite) renvoie aux standards de prise en charge hospitali\u00e8re de la chimioth\u00e9rapie et \u00e0 des exigences de comp\u00e9tence et de s\u00e9curit\u00e9 pouvant int\u00e9resser le suivi des politiques de lutte contre le cancer. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l&rsquo;IA)\u00a0\u200b<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/taxotere\" target=\"_blank\" class=\"feedzy-rss-link-icon\">Lire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Le document pr\u00e9sente Taxotere, un m\u00e9dicament anticanc\u00e9reux dont la substance active est le doc\u00e9taxel, appartenant \u00e0 la classe des taxanes. Il pr\u00e9cise les principales indications th\u00e9rapeutiques et les modalit\u00e9s d\u2019utilisation, [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":17698,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[7],"tags":[257,227,226],"class_list":["post-21869","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicaments-et-produits-de-sante","tag-ema","tag-ia","tag-sources-etrangeres"],"_links":{"self":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21869","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=21869"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21869\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/media\/17698"}],"wp:attachment":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=21869"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21869"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21869"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}