Modified FOLFOXIRI With or Without Cetuximab as Conversion Therapy in Patients with RAS/BRAF Wild-Type Unresectable Liver Metastases Colorectal Cancer: The FOCULM Multicenter Phase II Trial.

ABSTRACT:

Purpose

This trial evaluated the addition of cetuximab to a modified FOLFOXIRI (mFOLFOXIRI: 5-fluorouracil/folinic acid, oxaliplatin, irinotecan) as conversion therapy in a two-group, nonrandomized, multicenter, phase II trial in patients with initially technically unresectable colorectal liver-limited metastases (CLM) and BRAF/RAS wild-type.

Patients and methods

Patients were enrolled to receive cetuximab (500 mg/m² ) plus mFOLFOXIRI (oxaliplatin 85 mg/m² , irinotecan 165 mg/m² , folinic acid 400 mg/m² , 5-fluorouracil 2,800 mg/m² 46-hour infusion, every 2 weeks) (the cetuximab group) or the same regimen of mFOLFOXIRI alone (the control group), in a 2:1 ratio allocation. The primary endpoint was the rate of no evidence

SUBMITTER: Hu H 

PROVIDER: S-EPMC7794191 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature