Phase III Study with FOLFIRI + Cetuximab Versus FOLFIRI + Cetuximab Followed by Cetuximab Alone in RAS and BRAF WT mCRC

Abstract

The optimal duration and intensity of first-line therapy in metastatic colorectal cancer patients once they have achieved an objective response is controversial. In a molecularly selected RAS and BRAF wild-type (wt) population, this concern is amplified. Once disease control has been achieved with a combination therapy including an anti-EGFR antibody, further exposure both to cytotoxic drugs and targeted therapy might result only in increased toxicity. In unresectable metastatic RAS and BRAF wt colorectal cancer patients, a deintensified therapy could represent a valuable option that might preserve quality of life. We designed a study to compare FOLFIRI/cetuximab to FOLFIRI/cetuximab for eight cycles followed by cetuximab alone in first-line treatment of RAS and BRAF (wt) metastatic colorectal cancer patients.

Keywords::

• cetuximab
• colorectal cancer
• de-escalation therapy
• RAS and BRAF wild-type

Trial registration

Clinicaltrials.gov NCT02484833

Financial & competing interests disclosure

The study is partially supported by an unrestricted grant provided by Merck. Merck KGaA reviewed the manuscript for medical accuracy only before journal submission. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Additional information

Funding

The study is partially supported by an unrestricted grant provided by Merck. Merck KGaA reviewed the manuscript for medical accuracy only before journal submission. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.