Naslov
FOLFOX4 plus cetuximab administered weekly or every second week in the first-line treatment of patients with KRAS wild-type metastatic colorectal cancer: a randomized phase II CECOG study

Autori
Brodowicz, T. ; Ciuleanu, T.E. ; Radosavljević, D. ; Shacham-Shmueli, E. ; Vrbanec, Damir ; Plate, S. ; Mrsić-Krmpotić, Z. ; Dank, M. ; Purkalne, G. ; Messinger, D. ; Zielinski, C.C.

Izvornik
Annals of oncology (0923-7534) 24 (2013), 7; 1769-1777

Vrsta, podvrsta i kategorija rada
Radovi u časopisima, članak, znanstveni

Ključne riječi
colorectal cancer; FOLFOX4; cetuximab

Sažetak
This randomized phase II study investigated first-line chemotherapy plus cetuximab administered every second week in KRAS wild-type metastatic colorectal cancer. Patients received FOLFOX4 plus either standard weekly cetuximab (arm 1) or cetuximab (500 mg/m2) every second week (arm 2), until disease progression or unacceptable toxicity. Primary end point was the objective response rate (ORR). Progression-free survival (PFS), overall survival (OS), disease control rate (DCR) and safety were also investigated. The study was not powered to establish non-inferiority, but aimed at the estimation of treatment differences. Of 152 randomized eligible patients, 75 were treated in arm 1 and 77 in arm 2 ; ORRs [53% versus 62%, odds ratio 1.40, 95% confidence interval (CI) 0.74–2.66], PFS [median 9.5 versus 9.2 months, hazard ratio (HR) 0.92, 95% CI 0.63–1.34], OS (median 25.8 versus 23.0 months, HR 0.86, 95% CI 0.56–1.30) and DCR (87%) were comparable. HRs adjusted for baseline factors were 1.01 and 0.99 for PFS and OS, respectively. Frequencies of grade 3/4 adverse events in arms 1 versus 2 were similar: most common were neutropenia (28% versus 34%) and rash (15% versus 17%). Activity and safety of FOLFOX4 plus either cetuximab administered weekly or every second week were similar.

Izvorni jezik
Engleski

Znanstvena područja
Kliničke medicinske znanosti

POVEZANOST RADA