TAROCCHI GRATIS NEWSLa terapia adiuvante con abemaciclib, a 5 anni, riduce del 32% il rischio di recidiva nel tumore alla mammella in stadio precoce e migliora la sopravvivenza libera da malattia invasiva del 7,6%. Lo dimostrano i risultati a 5 anni di un’analisi predefinita dello studio di fase 3 ‘monarchE’, che ha valutato l’utilizzo di abemaciclib per 2 anni in combinazione con terapia endocrina (Et) rispetto alla sola Et nei pazienti con carcinoma mammario in fase iniziale (Ebc) positivo ai recettori ormonale (Hr+), negativo al recettore del fattore di crescita umano epidermico di tipo 2 (Her2-), linfonodo-positivo, ad alto rischio di recidiva. Questi dati sono stati resi noti in occasione del Congresso 2023 della European Society for Medical Oncology (Esmo), in corso a Madrid.
“Il periodo di 5 anni è un punto di riferimento consolidato per gli studi clinici sul tumore al seno in fase adiuvante e rappresenta una pietra miliare importante per i pazienti e i clinici in questo setting con finalità curativa – spiega Lucia Del Mastro, professore ordinario e direttore della Clinica di Oncologia medica dell’Irccs Ospedale Policlinico San Martino, Università di Genova – I dati a 5 anni di monarchE dimostrano chiaramente un effetto che va oltre il completamento dei 2 anni di trattamento con abemaciclib, con le curve della sopravvivenza libera da malattia invasiva e della sopravvivenza libera da recidiva a distanza che continuano a separarsi, confermando la fiducia nel ruolo di abemaciclib in aggiunta alla terapia endocrina nel setting adiuvante per i pazienti ad alto rischio di recidiva”.
“I benefici ottenuti da abemaciclib in aggiunta alla terapia endocrina tendono a protrarsi anche dopo la fine del trattamento, che dura 2 anni – afferma Valentina Guarneri, direttore dell’Oncologia 2 dell’Istituto oncologico veneto Irccs di Padova e professore ordinario di Oncologia medica all’Università di Padova – L’effetto è molto evidente sulle recidive locali e su quelle a distanza, che sono responsabili della malattia metastatica: evitarle implica non soltanto allungare la sopravvivenza, ma anche aumentare la probabilità di guarigione. L’evoluzione della patologia da stadio iniziale a metastatico infatti ha ripercussioni negative sulla sopravvivenza e sulla qualità di vita dei pazienti. I dati 5 anni dello studio rappresentano un ulteriore passo avanti per portare a guarigione un maggior numero di persone”.
“Nel 2022, in Italia, sono stati stimati 55.700 nuovi casi di carcinoma della mammella, il più frequente in tutta la popolazione – sottolinea Saverio Cinieri, presidente Aiom (Associazione italiana di oncologia medica) – Circa il 15% dei tumori mammari Hr+/Her2- è a rischio aumentato di sviluppare metastasi. E’ importante che la ricerca metta a disposizione terapie molto efficaci come abemaciclib che appartiene alla classe degli inibitori delle cicline chinasi dipendenti, che agiscono selettivamente bloccando due proteine, Cdk4 e Cdk6, in grado di aumentare la velocità con cui le cellule tumorali della mammella crescono e si dividono”.
I dati presentati – si legge in una nota – comprendono i risultati di un’analisi predefinita al follow-up mediano di 4,5 anni. Tutti i pazienti hanno completato il trattamento con abemaciclib e più dell’80% è stato seguito per almeno 2 anni dopo il termine. Nella popolazione intent-to-treat (Itt), il rischio di sviluppare la malattia invasiva si è ridotto del 32%. Inoltre, questo miglioramento è stato osservato anche nella sopravvivenza libera da recidiva a distanza (Drfs) con abemaciclib, con la riduzione del rischio di recidiva a distanza o di morte del 32,5%. Il beneficio assoluto a 5 anni della sopravvivenza libera da malattia invasiva (Idfs) e della Drfs è incrementato rispetto ai tassi registrati precedentemente a 2, 3 e 4 anni, raggiungendo oggi il 7,6% e 6,7% rispettivamente. In questa analisi dei risultati a 5 anni, le curve Kaplan-Meier continuano a separarsi, confermando un beneficio sostenuto oltre il periodo di trattamento di 2 anni. I risultati di Idfs e Drfs della coorte 1 hanno dimostrato risultati coerenti con quelli della popolazione Itt. Come precedentemente riportato, il beneficio di Idfs e Drfs è stato riscontrato in tutti i sottogruppi.
Mentre i dati di sopravvivenza globale restano immaturi, nel braccio con abemaciclib sono stati osservati meno decessi (208 pazienti su 2.808, 7,4%) rispetto al braccio di controllo (234 pazienti su 2.829, 8,3%). Circa il doppio dei pazienti trattati con la sola terapia endocrina (269) ha sviluppato e sta vivendo con la malattia metastatica rispetto a quelli trattati con abemaciclib (138). Non sono stati rilevati nuovi segnali di sicurezza e i risultati globali sono coerenti con il profilo di sicurezza consolidato di abemaciclib. Gli eventi avversi (Aes) più frequenti sono stati diarrea, neutropenia e fatigue nel braccio con abemaciclib più Et, e artralgia, vampate e fatigue nel braccio con la sola terapia endocrina.
Infine – prosegue la nota – è stata presentata un’analisi che dimostra che la riduzione del dosaggio non ha compromesso l’efficacia di abemaciclib nello studio monarchE, il che è coerente con i risultati già pubblicati di abemaciclib nel setting metastatico. La riduzione del dosaggio, se necessaria, può risultare una strategia efficace per gestire gli effetti collaterali e perseguire l’obiettivo di massimizzare l’aderenza alla terapia nei 2 anni di trattamento con abemaciclib per il tumore del seno precoce ad alto rischio.
Secondo Globocan, il tumore del seno ha superato quello del polmone come tumore più comunemente diagnosticato in tutto il mondo. La stima di 2,3 milioni di nuovi casi indica che una diagnosi di tumore su 8 è stata di carcinoma mammario nel 2020. Con circa 685mila decessi nel 2020, il tumore del seno è la quinta causa di morte per cancro a livello mondiale. Si stima che negli Stati Uniti le nuove diagnosi saranno più di 300mila nel 2023. Il tumore del seno è la seconda causa di morte per cancro nelle donne negli Stati Uniti. Si stima che il 90% dei tumori del seno venga diagnosticato in fase iniziale. Circa il 70% dei casi di tumore del seno risulta del sottotipo Hr+, Her2. Nonostante la prognosi del tumore del seno precoce Hr+, Her2- sia generalmente favorevole, i pazienti ad alto rischio sono 3 volte più esposti a sviluppare la recidiva rispetto a quelli a basso rischio, e nella maggior parte si tratta di malattia metastatica incurabile. Questi pazienti presentano un rischio maggiore di recidiva nei primi 2 anni di terapia endocrina.CONTINUA A LEGGERE SU TAROCCHI GRATIS
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