Impact of second-line cetuximab-containing therapy in patients with KRAS wild-type metastatic colorectal cancer: Results from the ITACa randomized clinical trial

Alessandro Passardi, Emanuela Scarpi, Fabio Gelsomino, Maria Angela Palladino, Andrea Casadei Gardini, Daniele Turci, Vincenzo Emanuele Chiuri, Claudia Mucciarini, Davide Tassinari, Angela Ragazzini, Giovanni Luca Frassineti, Martina Valgiusti, Paola Ulivi, Dino Amadori

Research output: Contribution to journalArticlepeer-review

Abstract

The ITACa trial was designed to define the role of cetuximab (Cet) and bevacizumab (Bev) in combination with standard chemotherapy (CT, FOLFIRI or FOLFOX4) as first- and second-line treatment in metastatic colorectal cancer. All patients with WT KRAS tumors who had been enrolled in the first-line trial were randomized onto two independent second-line trials: CT or CT + Cet (study 2A) and CT + Bev or CT + Bev + Cet (study 2B). Patients with mutated KRAS were not eligible for randomization and were treated with CT alone (study 2A) or CT + Bev (study 2B). The primary endpoint was progression-free survival (PFS). 48 and 56 KRAS WT patients were randomized while 31 and 40 KRAS mutated patients were treated without randomization. Study 2A: median PFS was 3.4 (95%CI 2.3-4.6) and 6.2 (95%CI 4.3-7.8) months for the CT and CT + Cet arms, respectively, with a hazard ratio (HR) = 0.64 (95%CI 0.35-1.16, p = 0.144). Study 2B: median PFS was 7.7 (95%CI 4.1-10.1) and 4.9 (95%CI 3.2-7.0) months for CT + Bev and CT + Cet + Bev arms, respectively, with a HR = 1.31 (95%CI 0.76-2.26, p = 0.330). Notwithstanding limitations due to the small sample size, among patients with WT KRAS the addition of Cet to second-line CT increased PFS, whereas the addition of Cet to CT + Bev was associated with worse PFS.

Original languageEnglish
Article number10426
JournalScientific Reports
Volume7
Issue number1
DOIs
Publication statusPublished - Dec 1 2017

ASJC Scopus subject areas

  • General

Fingerprint Dive into the research topics of 'Impact of second-line cetuximab-containing therapy in patients with KRAS wild-type metastatic colorectal cancer: Results from the ITACa randomized clinical trial'. Together they form a unique fingerprint.

Cite this