{"id":40722,"date":"2026-10-20T13:56:44","date_gmt":"2026-10-20T11:56:44","guid":{"rendered":"https:\/\/www.hellocare.com\/blog\/?page_id=40722"},"modified":"2026-10-20T14:08:33","modified_gmt":"2026-10-20T12:08:33","slug":"cancer-du-sein-re-positif-her2-negatif-lessentiel-sur-letude-serena-6","status":"publish","type":"page","link":"https:\/\/www.hellocare.com\/blog\/cancer-du-sein-re-positif-her2-negatif-lessentiel-sur-letude-serena-6\/","title":{"rendered":"Cancer du sein RE-positif\/HER2-n\u00e9gatif\u00a0: l\u2019essentiel sur l\u2019\u00e9tude SERENA-6"},"content":{"rendered":"<link rel=\"preconnect\" href=\"https:\/\/fonts.googleapis.com\">\n<link rel=\"preconnect\" href=\"https:\/\/fonts.gstatic.com\" crossorigin>\n<link href=\"https:\/\/fonts.googleapis.com\/css2?family=Outfit:wght@400;500;700;800&#038;display=swap\" rel=\"stylesheet\">\n<style>\n.art-s6{max-width:760px;margin:0 auto;color:#111;font-family:'Outfit',sans-serif;font-size:18px;line-height:1.75}\n.art-s6 *{font-family:'Outfit',sans-serif}\n.art-s6-banner{background:#772432;color:#fff;border-radius:28px;padding:72px 64px 56px;margin:0 0 48px;min-height:420px;display:flex;flex-direction:column;justify-content:space-between;gap:56px}\n.art-s6-banner h1{margin:0;color:#fff;font-size:52px;line-height:1.12;font-weight:800;letter-spacing:-.01em;max-width:660px}\n.art-s6-banner img{display:block;width:190px;height:auto}\n.art-s6 h2{font-size:26px;font-weight:700;line-height:1.3;margin:48px 0 14px;padding:0;border:0;color:#111}\n.art-s6 h2 sup{font-size:.55em;font-weight:400;vertical-align:super}\n.art-s6 p{margin:0 0 18px}\n.art-s6 sup,.art-s6 sub{font-size:.7em;line-height:0}\n.art-s6 ul,.art-s6 ol{margin:0 0 22px;padding-left:22px}\n.art-s6 li{margin:0 0 8px;padding-left:4px}\n.art-s6 strong{font-weight:700}\n.art-s6-fig{margin:40px 0 0}\n.art-s6-fig img{display:block;width:100%;height:auto}\n.art-s6 .refs{font-size:16px;line-height:1.6}\n.art-s6 .refs a{color:#111;text-decoration:underline;text-underline-offset:3px}\n.art-s6 .refs a:hover{text-decoration:none}\n@media (max-width:640px){\n.art-s6{font-size:16px}\n.art-s6-banner{border-radius:20px;padding:44px 24px 36px;min-height:300px;gap:40px;margin-bottom:36px}\n.art-s6-banner h1{font-size:32px}\n.art-s6-banner img{width:140px}\n.art-s6 h2{font-size:22px;margin-top:40px}\n}\n<\/style>\n<div class=\"art-s6\">\n<div class=\"art-s6-banner\">\n<h1>Cancer du sein RE-positif\/HER2-n\u00e9gatif : l\u2019essentiel sur l\u2019\u00e9tude SERENA-6<\/h1>\n<p><img class=\"lazyload\" decoding=\"async\" src=\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%272560%27%20height%3D%27445%27%20viewBox%3D%270%200%202560%20445%27%3E%3Crect%20width%3D%272560%27%20height%3D%27445%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\" data-orig-src=\"https:\/\/www.hellocare.com\/blog\/wp-content\/uploads\/2026\/10\/LogoHellocare_WHite-1-scaled.png\" alt=\"Hellocare\">\n<\/div>\n<h2>Introduction<sup>1,2<\/sup><\/h2>\n<p>Les cancers du sein m\u00e9tastatiques sont majoritairement hormonod\u00e9pendants. Les cellules tumorales captent les hormones via les r\u00e9cepteurs aux \u0153strog\u00e8nes pr\u00e9sents \u00e0 leur surface. Ces interactions entra\u00eenent une stimulation de l\u2019expansion du cancer.<\/p>\n<p>L\u2019association d\u2019un inhibiteur d\u2019aromatase avec un inhibiteur de la prolif\u00e9ration cellulaire (CDK4\/6) repr\u00e9sente la th\u00e9rapie standard pour ce type de cancer. Les patients porteurs de mutations sur le g\u00e8ne codant les r\u00e9cepteurs aux \u0153strog\u00e8nes (ESR1) d\u00e9veloppent une r\u00e9sistance aux traitements anti-aromatases, ce qui peut entra\u00eener une r\u00e9-\u00e9volution du cancer. Ces mutations surviennent chez moins de 5 % des patients en d\u00e9but de th\u00e9rapie, et chez 40 % en cours de 1<sup>re<\/sup> ligne de traitement, lors de la progression de la maladie.<\/p>\n<p>N\u00e9anmoins, les tumeurs de ces patients restent sensibles aux agents d\u00e9gradant et inhibant le r\u00e9cepteur aux \u0153strog\u00e8nes. De plus, les mutations ESR1 peuvent \u00eatre rep\u00e9r\u00e9es dans le sang des patients par d\u00e9pistage de l\u2019ADN tumoral circulant (ADNtc) avant qu\u2019elles n\u2019entra\u00eenent une r\u00e9-\u00e9volution du cancer. Elles renseignent sur la progression et l\u2019\u00e9volution de la maladie, afin d\u2019en adapter le traitement.<\/p>\n<p>Le camizestrant est un agent d\u00e9gradant et antagoniste du r\u00e9cepteur aux \u0153strog\u00e8nes. L\u2019essai de phase 2 SERENA-2 avait montr\u00e9 une prolongation significative de la survie sans progression (SSP) chez des patients atteints d\u2019un cancer du sein RE-positif \/ HER2-n\u00e9gatif localement avanc\u00e9 ou m\u00e9tastatique, par rapport \u00e0 un autre agent. En parall\u00e8le, l\u2019essai PADA-1 montrait que chez les patients recevant un inhibiteur d\u2019aromatase associ\u00e9 \u00e0 un inhibiteur de CDK4\/6, remplacer l\u2019inhibiteur d\u2019aromatase par un agent d\u00e9gradant du r\u00e9cepteur aux \u0153strog\u00e8nes au moment de la d\u00e9tection d\u2019une mutation ESR1 permettait d\u2019obtenir une survie sans progression significativement plus longue que la poursuite de l\u2019inhibiteur d\u2019aromatase.<\/p>\n<p>Les auteurs ont alors con\u00e7u l\u2019essai SERENA-6 afin de tester l\u2019int\u00e9r\u00eat d\u2019un switch de l\u2019inhibiteur d\u2019aromatase vers le camizestrant chez les patients pr\u00e9sentant une mutation ESR1, et de d\u00e9terminer son efficacit\u00e9 et sa tol\u00e9rance.<\/p>\n<h2>M\u00e9thodologie<sup>2,3<\/sup><\/h2>\n<p>SERENA-6 est un essai de phase III, randomis\u00e9, en double aveugle, guid\u00e9 par le d\u00e9pistage de l\u2019ADNtc, chez des femmes en pr\u00e9-, p\u00e9ri- ou post-m\u00e9nopause et des hommes adultes atteints d\u2019un cancer du sein RE-positif \/ HER2-n\u00e9gatif, localement avanc\u00e9 ou m\u00e9tastatique, pr\u00e9sentant une mutation ESR1 d\u00e9tectable, sans progression de la maladie au cours du traitement de 1<sup>re<\/sup> ligne par un inhibiteur de l\u2019aromatase associ\u00e9 \u00e0 un inhibiteur de CDK4\/6.<\/p>\n<p>Apr\u00e8s randomisation, les patients ont \u00e9t\u00e9 r\u00e9partis en deux groupes :<\/p>\n<ul>\n<li>Switch de l\u2019inhibiteur d\u2019aromatase vers le camizestrant, associ\u00e9 \u00e0 un inhibiteur de CDK4\/6 (n = 157) ;<\/li>\n<li>Poursuite de l\u2019inhibiteur d\u2019aromatase associ\u00e9 \u00e0 un inhibiteur de CDK4\/6 (n = 158).<\/li>\n<\/ul>\n<p>Les facteurs de stratification des patients \u00e9taient :<\/p>\n<ul>\n<li>le site de la maladie (maladie visc\u00e9rale vs non visc\u00e9rale) ;<\/li>\n<li>la d\u00e9tection de la mutation ESR1 ;<\/li>\n<li>le d\u00e9lai entre l\u2019instauration du traitement par inhibiteur de l\u2019aromatase associ\u00e9 \u00e0 un inhibiteur de CDK4\/6 et la randomisation ;<\/li>\n<li>le type d\u2019inhibiteur de CDK4\/6.<\/li>\n<\/ul>\n<p>Le statut ESR1 a \u00e9t\u00e9 \u00e9valu\u00e9 par d\u00e9pistage de l\u2019ADNtc. Sur l\u2019ensemble des mutations identifi\u00e9es, les plus fr\u00e9quentes \u00e9taient <em>D538G<\/em>, <em>Y537S<\/em> et <em>Y537N<\/em>.<\/p>\n<p>Le crit\u00e8re d\u2019\u00e9valuation primaire \u00e9tait la survie sans progression (SSP) \u00e9valu\u00e9e par les investigateurs selon les crit\u00e8res d\u2019\u00e9valuation de la r\u00e9ponse dans les tumeurs solides (RECIST). Les crit\u00e8res secondaires \u00e9taient le d\u00e9lai entre la randomisation et la deuxi\u00e8me progression ou le d\u00e9c\u00e8s (SSP2) et la survie globale (SG).<\/p>\n<figure class=\"art-s6-fig\">\n<img class=\"lazyload\" decoding=\"async\" src=\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%271440%27%20height%3D%271080%27%20viewBox%3D%270%200%201440%201080%27%3E%3Crect%20width%3D%271440%27%20height%3D%271080%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\" data-orig-src=\"https:\/\/www.hellocare.com\/blog\/wp-content\/uploads\/2026\/10\/Schema-etude-SERENA-6-1.png\" alt=\"Sch\u00e9ma de l\u2019\u00e9tude SERENA-6\" loading=\"lazy\"><br \/>\n<\/figure>\n<h2>R\u00e9sultats<sup>2,3<\/sup><\/h2>\n<p>\u00c0 la date du cut-off (28\/11\/2024), la dur\u00e9e m\u00e9diane de suivi \u00e9tait de 12,6 mois depuis la randomisation. Les r\u00e9sultats pr\u00e9sent\u00e9s dans cet article sont ceux obtenus \u00e0 la troisi\u00e8me date de cut-off (02\/01\/2026).<\/p>\n<p>Pour le groupe trait\u00e9 par camizestrant associ\u00e9 \u00e0 l\u2019inhibiteur de CDK4\/6, la survie m\u00e9diane sans progression \u00e9tait de <strong>16,76 mois<\/strong> (IC<sub>95%<\/sub> : 14,72-19,35 mois). Pour le groupe trait\u00e9 par l\u2019inhibiteur de l\u2019aromatase, elle \u00e9tait de <strong>9,23 mois<\/strong> (IC<sub>95%<\/sub> : 7,23-9,66 mois).<\/p>\n<p>Sur les 157 patients du groupe camizestrant, 63,1 % ont connu un \u00e9v\u00e8nement de progression de la maladie, contre 78,5 % des 158 patients du groupe inhibiteur de l\u2019aromatase.<\/p>\n<p>Une r\u00e9duction significative de <strong>55 % du risque de progression de la maladie ou de d\u00e9c\u00e8s<\/strong> a \u00e9t\u00e9 observ\u00e9e dans le groupe trait\u00e9 par camizestrant (HR = 0,45 ; IC<sub>95%<\/sub> : 0,34-0,59 ; <em>p<\/em> &lt; 0,00001).<\/p>\n<h2>Donn\u00e9es de tol\u00e9rance<sup>2,3<\/sup><\/h2>\n<p>Les effets ind\u00e9sirables (EI) rencontr\u00e9s lors de l\u2019essai SERENA-6 \u00e9taient principalement d\u2019ordre h\u00e9matologique, la neutrop\u00e9nie \u00e9tant le plus fr\u00e9quent (54,8 %), suivie de l\u2019an\u00e9mie (17,4 %) et de la leucop\u00e9nie (16,8 %). D\u2019autres EI non h\u00e9matologiques ont \u00e9t\u00e9 rencontr\u00e9s, les plus fr\u00e9quents \u00e9tant la photopsie (20,0 %), l\u2019arthralgie (16,1 %) et la fatigue (15,5 %).<\/p>\n<h2>Conclusion<sup>2,3<\/sup><\/h2>\n<p>L\u2019essai SERENA-6 semble montrer un allongement de la SSP lors d\u2019un switch de l\u2019inhibiteur d\u2019aromatase vers le camizestrant, associ\u00e9 \u00e0 l\u2019inhibiteur de CDK4\/6. Le d\u00e9pistage de l\u2019ADNtc constitue un moyen fiable de conna\u00eetre le statut ESR1 des patients, et donc d\u2019adapter le traitement en cons\u00e9quence.<\/p>\n<h2>R\u00e9f\u00e9rences<\/h2>\n<ol class=\"refs\">\n<li><a href=\"https:\/\/curie.fr\/actualite\/cancer-du-sein-des-preuves-supplementaires-en-faveur-de-lutilisation-clinique-des\" target=\"_blank\" rel=\"noopener\">Institut Curie \u2013 Cancer du sein : des preuves suppl\u00e9mentaires en faveur de l\u2019utilisation clinique des biomarqueurs circulants.<\/a><\/li>\n<li><a href=\"https:\/\/www.nejm.org\/doi\/10.1056\/NEJMoa2502929\" target=\"_blank\" rel=\"noopener\">Bidard FC, et al. First-Line Camizestrant for Emerging ESR1-Mutated Advanced Breast Cancer. <em>N Engl J Med.<\/em> 2025 Aug 7;393(6):569-580.<\/a><\/li>\n<li><a href=\"https:\/\/www.ema.europa.eu\/fr\/documents\/product-information\/etcamah-epar-product-information_fr.pdf\" target=\"_blank\" rel=\"noopener\">R\u00e9sum\u00e9 des caract\u00e9ristiques du produit Camizestrant.<\/a><\/li>\n<\/ol>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Cancer du sein RE-positif\/HER2-n\u00e9gatif : l\u2019essentiel sur l\u2019\u00e9tude SERENA-6 Introduction1,2 Les cancers du sein m\u00e9tastatiques sont majoritairement hormonod\u00e9pendants.<\/p>\n","protected":false},"author":28,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-40722","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO 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