Efficacy and safety of a biomarker-driven cetuximab-based treatment regimen over 3 treatment lines in mCRC patients with RAS/BRAF wild type tumors at start of first line: The CAPRI 2 GOIM trial

• Published in: Frontiers in oncology Vol. 13; p. 1069370
• Main Authors: Martini, Giulia, Ciardiello, Davide, Napolitano, Stefania, Martinelli, Erika, Troiani, Teresa, Latiano, Tiziana Pia, Avallone, Antonio, Normanno, Nicola, Di Maio, Massimo, Maiello, Evaristo, Ciardiello, Fortunato
• Format: Journal Article
• Language: English
• Published: Switzerland Frontiers Media S.A 13-02-2023
• Subjects: biomarker; cetuximab; colorectal cancer; EGFR; liquid biopsy; Oncology; cetuximab; colorectal cancer; biomarker; EGFR; liquid biopsy
• ISSN: 2234-943X; 2234-943X
• DOI: 10.3389/fonc.2023.1069370

Monoclonal antibodies targeting EGFR such as cetuximab or panitumumab represent a major step forward in the treatment of
wild type (WT) metastatic colorectal cancer (mCRC). Unfortunately, primary and acquired resistance mechanisms occur, with a huge percentage of patients succumbing to the disease. In the last years,
mutation has been identified as the main molecular driver that determine resistance to anti-EGFR monoclonal antibodies. Liquid biopsy analysis allows to a dynamic and longitudinal assessment of mutational status during mCRC disease and has provided important information on the use of anti-EGFR drugs beyond progression or as rechallenge strategy in patients with
WT tumors.
The phase II CAPRI 2 GOIM trial investigates the efficacy and safety of a bio-marker-driven cetuximab-based treatment regimen over 3 treatment lines in mCRC patients with
WT tumors at start of first line.
The aim of the study is to identify patients with
WT tumors defined as "addicted" to an-anti EGFR based treatment along three lines of therapy. Moreover, the trial will evaluate the activity of cetuximab re-introduction in combination with irinotecan as 3
line therapy as rechallenge for patients that will be treated in second line with FOLFOX plus bevacizumab, having a
mutant disease at progression after FOLFIRI plus cetuximab first line. A novel characteristic of this program is that the therapeutic algorithm will be defined at each treatment decision (
) in a prospective fashion in each patient by a liquid biopsy assessment of
status by a comprehensive 324 genes Foundation One Liquid assay (Foundation/Roche).
EudraCT Number: 2020-003008-15, ClinicalTrials.gov identifier: NCT05312398.