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(Adnkronos Salute) - Grazie all'innovazione portata dall'oncologia di precisione, è oggi possibile nel tumore del seno posticipare cure aggressive come la chemioterapia. L'identificazione di mutazioni nel gene responsabile della sintesi del recettore degli estrogeni (Esr-1), che ne determinano l'attività anche senza il legame con gli estrogeni, rende possibili nuovi trattamenti mirati del carcinoma della mammella metastatico Er+ Her2-. La nuova molecola elacestrant, il primo degradatore selettivo del recettore degli estrogeni (Serd) attivo per via orale, riduce il rischio di progressione della malattia o di morte del 45% rispetto alla terapia endocrina 'convenzionale'. I benefici maggiori sono per le pazienti che presentano una mutazione nel gene recettore degli estrogeni (Esr1) e che hanno già ricevuto una prima linea di terapia antiormonale. "Un risultato molto interessante per un gruppo di pazienti che presenta un bisogno terapeutico nuovo, determinato dalla emergenza di un nuovo meccanismo di resistenza alla terapia antiormonale. Il nostro auspicio è che la terapia divenga presto disponibile anche in Italia per rappresentare una ulteriore opzione di trattamento. Rappresenta una grande innovazione in quanto, al momento, non vi sono trattamenti alternativi in grado di ritardare o limitare l'impiego di chemioterapici nelle pazienti in progressione di malattia dopo trattamento con inibitori delle chinasi ciclino-dipendenti e ormonoterapia". E' quanto affermato oggi dal presidente della Fondazione per la medicina personalizzata (Fmp) Paolo Marchetti, a Roma durante una conferenza stampa realizzata grazie al contributo non condizionante di Menarini Stemline."Il carcinoma mammario è estremamente complesso e viene classificato in diversi sottotipi istologici, rendendo necessario un approccio personalizzato - commenta Marchetti - In un quadro clinico-patologico così variegato, la neoplasia può presentare un decorso clinico molto variabile. In particolare, proprio per l'introduzione di nuovi trattamenti attivi, osserviamo la comparsa di meccanismi di resistenza che non si evidenziavano in precedenza. La chemioterapia, per quanto sia spesso un trattamento imprescindibile dopo le cicline, presenta tuttavia effetti collaterali che le pazienti soffrono molto. In questo contesto si inserisce elacestrant, che ha dimostrato un'efficacia superiore rispetto all'attuale standard di cura nelle pazienti non solo ormonoresistenti, ma ciclino-resistenti". "Le peculiarità della terapia sono rappresentate anche dall'alta tollerabilità e dalla facilità di somministrazione - aggiunge Giuseppe Curigliano, direttore Divisione Sviluppo di nuovi farmaci all'Istituto europeo di oncologia di Milano e professore di Oncologia medica all'Università Statale di Milano - Elacestrant è, infatti, il primo orale degradatore selettivo del recettore degli estrogeni alfa (Er-a) e svolge un'attività contro le mutazioni del gene Esr1. Queste rappresentano un meccanismo di resistenza abbastanza comune dopo trattamenti prolungati con terapie antiormonali convenzionali nei tumori del seno Er-positivi e l'acquisizione delle mutazioni ha un impatto fortemente sfavorevole in termini sia di sopravvivenza libera da progressione che globale. I minori effetti collaterali e l'assunzione orale quotidiana di elacestrant sono poi due elementi che favoriscono l'aderenza terapeutica e contribuiscono al mantenimento della qualità di vita"."Sono più di 2.200 le donne che solo in Italia ogni anno potrebbero giovare dei benefici del nuovo trattamento con elacestrant - sostiene Saverio Cinieri, presidente Fondazione Aiom - Associazione italiana di oncologia medica - E' possibile che vi sia una tendenza all'incremento di questo numero già abbastanza rilevante. Infatti, le mutazioni di Esr1, che rappresentano il bersaglio molecolare della molecola, possono raggiungere il 40% dei casi di carcinoma del seno Er+, Her2-. Per individuare le potenziali pazienti da alcuni anni gli specialisti hanno a disposizione non solo la biopsia tissutale, ma, come importante innovazione, anche la biopsia liquida. Si tratta di un'analisi del sangue che valuta il Dna tumorale circolante ed è un esame utile ai fini sia diagnostici che prognostici. Inoltre, può fornire informazioni anche sulla possibile risposta ad ulteriori trattamenti oncologici con terapie a bersaglio molecolare".Il test "ha dei grandi vantaggi e importanti potenzialità non solo per l'intero sistema sanitario nazionale, ma anche per il singolo paziente - sottolinea Antonella Iadanza, Patient Advocate di Fondazione IncontraDonna - In particolare, sono apprezzate la poca invasività del test e la precisione nel migliorare la selezione delle terapie da parte degli specialisti. E' fondamentale quindi che tutti, anche le istituzioni, capiscano l'importanza di garantire a tutte le pazienti l'accesso alla migliore terapia, in termini di efficacia, ma anche di qualità di vita. IncontraDonna, da sempre molto attiva nel campo del tumore metastatico del seno, conferma dunque il suo impegno per l'equità delle cure e il diritto alla salute. Il test viene utilizzato non solo per il carcinoma mammario, ma anche per quello del colon-retto, nel melanoma e nel tumore polmonare. Per questi motivi il ricorso alla biopsia liquida deve essere incentivato e favorito in tutte le strutture sanitarie della nostra Penisola".Elacestrant è stato già approvato dall'ente regolatorio statunitense Fda e da quello europeo Ema, riporta una nota. "E' l'unica soluzione terapeutica raccomandata nel sottogruppo di pazienti resistenti a cicline con mutazioni Esr1 - evidenzia Marchetti - In particolare, in quelle in cui si osserva una progressione con le terapie precedenti, ma che non traggono risultati ottimali dalla somministrazione dei farmaci attualmente disponibili. Il trattamento è innovativo in quanto nella popolazione luminale Her2-negativa che ha il massimo bisogno terapeutico a causa delle mutazioni di Esr1 è il primo Serd orale che ha dimostrato efficacia nelle pazienti cicline-resistenti, il primo prescrivibile su un test di biopsia liquida e non sulle più invasive biopsie tissutali". "Elacestrant - conclude il presidente Fmp - risponde ad un bisogno terapeutico che prima della introduzione dei trattamenti con agenti antiormonali associati agli inibitori delle chinasi ciclino-dipendenti non era noto e presenta un valore terapeutico aggiunto rispetto alle terapie già disponibili. Confidiamo quindi che anche l'Agenzia italiana del farmaco riconosca queste innovazioni e che la terapia sia resa rimborsabile nel nostro Paese quanto prima possibile". di Adnkronos   03-07-2024 - 15:39 Link copiato Commenti Leggi la Netiquette

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