First line UFT, OXALIPLATIN and ERBITUX combination (TEGAFOX-E) in Elderly (70 years) metastatic colorectal patients: a Phase II I.T.M.O. Study

Nel maggio 2008 è stato avviato uno studio sul carcinoma del colon retto metastatico.

Lo Studio (Protocollo N°01-2008) ha l’obiettivo di valutare l’efficacia e la tollerabilità  della combinazione di UFT, Oxaliplatino ed Erbitux nel trattamento dei pazienti anziani (di età pari e superiore ai 70 anni) affetti da adenocarcinoma del colon-retto metastatico non pretrattati.

Lo studio è stato chiuso anticipatamente al reclutamento nel aprile 2011. Sono stati arruolati 29 dei 53 pazienti previsti da protocollo.

Centri partecipanti :                     Fondazione IRCCS Istituto Nazionale Tumori, MILANO

Az. Ospedaliera Carlo Poma, MANTOVA

Az. Ospedaliera di Desio e Vimercate, DESIO (MB)

Istituto Clinico Humanitas, ROZZANO (MI)

Presidio Ospedaliero di GORGONZOLA (MI)

Istituti Ospitalieri di CREMONA

Ospedale Maggiore della Carità di NOVARA

Riferimento Bibliografico:

  • Lack of KRAS, NRAS, BRAF and TP53 mutations improves outcome of elderly metastatic colorectal cancer patients treated with cetuximab, oxaliplatin and UFT.
    (Di Bartolomeo M, Pietrantonio F, Perrone F, Dotti KF, Lampis A, Bertan C, Beretta E, Rimassa L, Carbone C, Biondani P, Passalacqua R, Pilotti S, Bajetta E; Italian Trials in Medical Oncology Group).
    Target Oncol. 2014 Jun;9(2):155-62. doi: 10.1007/s11523-013-0283-8. Epub 2013 Jul 3.

Abstract

There is conflicting evidence on the predictive role of KRAS status when cetuximab is added to oxaliplatin-based regimens. This study investigated the impact of KRAS, NRAS, BRAF, PI3KCA and TP53 status on outcome of elderly metastatic colorectal cancer patients enrolled in TEGAFOX-E (cetuximab, oxaliplatin and oral uracil/ftorafur–UFT) phase II study. Twenty-eight patients were enrolled and all were evaluable for safety and activity. Twenty-three specimens were analysed for KRAS, BRAF, NRAS, PI3KCA and TP53 mutational status by means of polymerase chain reaction and correlated with objective response, progression-free survival and overall survival. An evident increase of response rate was noted in KRAS/NRAS wild-type cases (70 versus 33%, P = 0.198). KRAS/NRAS wild-type status showed an independent association with a longer progression-free survival (44 versus 9 weeks, P = 0.009). Considering the combined assessment of BRAF, KRAS/NRAS and TP53, a trend towards an increase of response rate was noted in patients without mutations (83 versus 33%, P = 0.063). Moreover, patients with all wild-type genes had significantly longer progression-free survival than patients with any mutation (48 versus 10 weeks, P = 0.007). As a single biomarker, only KRAS/NRAS proteins maintained an independent value for outcome prediction. Patients with KRAS/NRAS, BRAF and TP53 wild-type tumours could derive the maximal benefits from treatment with cetuximab, oxaliplatin and UFT.

PMID: 23821376   [PubMed – indexed for MEDLINE]

Download articolo: Target Oncology 2014