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La Società Europea di Radiologia Interventistica inserisce il primo paziente nel nuovo registro SIR Spheres® (microsfere di resina con ittrio-90)


News provided by

Sirtex Medical Europe

Jan 20, 2015, 02:00 ET

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Sirtex Logo (PRNewsFoto/Sirtex)
Sirtex Logo (PRNewsFoto/Sirtex)

BONN, Germania, January 20, 2015 /PRNewswire/ --

La Società Europea di Radiologia Cardiovascolare ed Interventistica (CIRSE) ha varato il Registro CIRSE per la Terapia con SIR-Spheres (CIRT)  

Il nuovo registro raccoglierà i dati dei pazienti affetti da tumori al fegato inoperabili trattati con le SIR-Spheres®, microsfere di resina con ittrio-90, presso gli ospedali specializzati di tutta l'Europa.  

Il CIRSE ha annunciato di aver inserito il primo paziente all'interno di un nuovo registro creato per raccogliere informazioni sui soggetti affetti da tumori al fegato inoperabili trattati con le microsfere SIR-Spheres di resina con ittrio-90, la forma più comune e diffusa di Radioterapia Interna Selettiva (o SIRT). Il Registro CIRSE per la Terapia con SIR-Spheres (CIRT) è stato sviluppato dalla Società in collaborazione con Sirtex Medical Limited, il produttore delle microsfere SIR-Spheres di resina con ittrio-90.

     (Logo: http://photos.prnewswire.com/prnh/20150119/724485 )

"Il CIRSE è lieto di aver creato il registro CIRT, che crediamo sarà di grande aiuto ai medici nell'amministrare la terapia con SIR-Spheres allo scopo di ottenere informazioni approfondite sui pazienti colpiti da tumori inoperabili al fegato, che di certo trarranno beneficio da questo trattamento" ha dichiarato il Professor José Ignacio Bilbao, parlando a nome del CIRSE in quanto Direttore del Comitato Direttivo del CIRT. "Il nostro obiettivo è raccogliere nel nuovo registro CIRT dati su oltre 500 pazienti l'anno da oltre 20 strutture ospedaliere specialistiche europee," ha aggiunto il Professor Bilbao, che è inoltre Primario di Radiologia Interventistica presso la Clinica Universitaria di Navarra a Pamplona, Spagna.

"Sirtex è certa che il registro onnicomprensivo sulle microsfere SIR-Spheres appena inaugurato dal CIRSE aiuterà i futuri processi clinici decisionali, fornendo ai radiologi interventisti nuove e approfondite informazioni sui pazienti che hanno più probabilità di trarre beneficio da questo tipo di trattamento. Pensiamo che questo possa essere un passo importante per aumentare le speranze di guarigione per i pazienti con tumori epatici inoperabili," ha dichiarato Nigel Lange, CEO di Sirtex Medical Europe GmbH.

Le microsfere SIR-Spheres di resina con ittrio-90, prodotto di punta di Sirtex Medical Limited, è l'unico prodotto utilizzato nella Radioterapia Interna Selettiva (SIRT) a essere raccomandato all'interno delle più recenti linee guida cliniche promulgate dalla Società Europea di Oncologia Medica (ESMO) per il trattamento del carcinoma metastatico del colon-retto (mCRC).[1]

Nell'aprile del 2013, Sirtex ha annunciato di aver concluso il reclutamento di pazienti per il SIRFLOX, uno studio clinico randomizzato su un campione di 500 pazienti che ha confrontato l'impiego delle microsfere SIR-Spheres di resina con ittrio-90 in combinazione con l'attuale trattamento chemioterapico di prima linea con la sola chemioterapia di prima linea su pazienti con mCRC inoperabili recentemente diagnosticati, quindi molto prima rispetto all'attuale paradigma terapeutico. I dati ottenuti dal SIRFLOX sono attesi per la fine del 2015.

Informazioni sulle microsfere SIR-Spheres di resina con ittrio-90  

Le microsfere SIR-Spheres di resina con ittrio-90 sono uno strumento medico utilizzato nell'oncologia interventistica (conosciuta anche come SIRT o radioembolizzazione), una tecnologia comprovata per il trattamento dei tumori epatici inoperabili che irradia dosi considerevoli e mirate di radiazioni direttamente nel cancro. Con un trattamento mini-invasivo, attraverso un catetere, vengono inoculate direttamente nel fegato milioni di microsfere SIR-Spheres, che colpiscono in modo selettivo i tumori con una dose di radiazioni interne fino a quaranta volte superiore rispetto alla normale radioterapia, senza danneggiare il tessuto epatico sano circostante.

Prodotte da Sirtex Medical Limited, le microsfere SIR-Spheres hanno ottenuto l'approvazione dell'Unione Europea (con il Marchio CE) e di molti altri Paesi per il loro utilizzo nel trattamento dei tumori del fegato impossibili da rimuovere attraverso interventi chirurgici. Sono attualmente disponibili in oltre 700 centri di trattamento, e finora in tutto il mondo sono state fornite oltre 45.000 dosi di microsfere SIR-Spheres.

®SIR-Spheres è un marchio registrato di Sirtex SIR-Spheres Pty Ltd.

Riferimenti  

(1) Van Cutsem E, Cervantes A, Nordlinger B, Arnold D per conto del Gruppo di Lavoro per le Linee Guida dell'ESMO.  Carcinoma metastatico del colon-retto: Linee Guida Cliniche ESMO per la diagnosi, il trattamento e la post-terapia.  Ann Oncol 2014; 25 (Suppl 3): iii1-iii9.

# 975-E-0115

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