La notizia arriva dai primi risultati di uno studio clinico di fase II condotto alla Mayo Clinic. La combinazione di brostallicina e cisplatino mostri un’attività antitumorale nelle pazienti pesantemente pre-trattate, dimostrando di allungare la sopravvivenza libera da progressione di oltre tre mesi.
Sono primi risultati incoraggianti, quelli ottenuti da brostallicina in combinazione con cisplatino nel trattamento delle donne con carcinoma metastatico al seno di tipo triplo negativo, presentati da Cell Therapeutics al San Antonio Breast Cancer Symposium (SABCS) tenutosi negli Stati Uniti. I risultati sono relativi a uno studio clinico di Fase II sponsorizzato da un Cooperative group e condotto alla Mayo Clinic.
Il termine “triplo negativo” è usato per descrivere tumori al seno (generalmente carcinomi duttali invasivi) le cui cellule mancano dei recettori per gli estrogeni e progestinici, e non hanno un eccesso della proteina HER2 sulla loro superficie. Tumori al seno con queste caratteristiche tendono a manifestarsi più spesso nelle donne più giovani e nelle donne afro-americane. Il carcinoma al seno di tipo triplo-negativo tende a crescere e diffondersi più rapidamente della maggior parte degli altri tipi di tumore al seno, e poiché alle cellule tumorali mancano questi recettori, né la terapia ormonale, né farmaci che colpiscono l’HER2 sono trattamenti efficaci (ma la chemioterapia può essere ancora utile, se necessario). Tra il 10% e il 20% dei tumori al seno è di tipo triplo negativo.
Il trial ha arruolato donne con diagnosi confermata di malattia metastatica e carcinoma al seno del sottotipo triplo negativo. Al momento dell’analisi dei dati, 48 donne erano state arruolate nello studio e 47 sono state valutate per l’efficacia. Circa la metà delle pazienti aveva ricevuto da due a quattro regimi precedenti di chemioterapia per malattia metastatica.
In questo studio, i pazienti hanno ricevuto cisplatino al giorno 1, brostallicina al giorno 2, e GCSF o GCSF- pegilato al giorno 3, con il ciclo ripetuto ogni 21 giorni. La brostallicina è un ligando sintetico di seconda generazione del solco minore del DNA che ha dimostrato una potente attività antitumorale, e si è dimostrata sinergica sia in associazione agli agenti citotossici standard, sia in associazione a nuove terapie mirate, nei modelli tumorali preclinici sperimentali.
L’endpoint primario dello studio era di 3 mesi di sopravvivenza libera da progressione (PFS). Gli endpoint secondari includevano invece il tasso di risposta complessiva (ORR), la durata della risposta, la sopravvivenza libera da progressione a 6 mesi, la sopravvivenza globale (OS) e la sicurezza. I principali risultati indicano che 10 su 47 pazienti valutabili (21%) hanno ottenuto una risposta tumorale confermata, e nove donne hanno avuto una risposta parziale (PR) e un paziente una risposta confermata (CR). Nonostante la popolazione fosse pesantemente pretrattata, inoltre la sopravvivenza libera da progressione a 3 mesi è stata del 51% e la PFS a 6 mesi è attualmente del 26%. La durata mediana di risposta è stata di 3,4 mesi, il tempo mediano di progressione è stato di 3,2 mesi. Gli eventi avversi sono stati per lo più di natura ematologica (74,5%) e in linea con gli altri trattamenti in quest’area.
Gli autori hanno concluso che in questo studio la combinazione di brostallicina e cisplatino ha mostrato una promettente attività nelle pazienti con carcinoma metastatico mammario di tipo triplo negativo pesantemente pre-trattati e ha raggiunto il suo endpoint primario confrontandosi favorevolmente agli altri studi clinici di Fase II in questa malattia. I risultati finali di questo studio dovrebbero essere presentati al meeting annuale dell’American Society of Clinical Oncology 2013. Uno studio randomizzato di Fase II di follow-up è inoltre in sviluppo.
Fonte: “Quotidianosanità.it” – 21 dicembre 2012
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