Dataset Information


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

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.

PROVIDER: S-EPMC5585399 | BioStudies |

REPOSITORIES: biostudies

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