mFOLFOXIRI Plus Cetuximab May Improve Resection Rate in Metastatic Colorectal Cancer

Share this content:
Researchers randomly assigned 143 patients to receive cetuximab plus mFOLFOXIRI followed by cetuximab or bevacizumab maintenance.
Researchers randomly assigned 143 patients to receive cetuximab plus mFOLFOXIRI followed by cetuximab or bevacizumab maintenance.

Modified fluorouracil, oxaliplatin, and irinotecan (mFOLFOXIRI) with cetuximab does not improve progression-free rates (PFR), but may lead to improved surgical resection rates, among some patients with metastatic colorectal cancer (mCRC), according to a study published in JAMA Oncology.1

For the prospective, non-comparative phase 2 MACBETH study ( Identifier: NCT02295930), researchers randomly assigned 143 patients with mCRC to receive 4 months of cetuximab plus mFOLFOXIRI induction every 2 weeks, followed by cetuximab or bevacizumab maintenance therapy.

Of the 143 enrolled patients, 116 patients had RAS and BRAF wild-type mCRC, and were included in the modified intention-to-treat (mITT) population.

After a mean follow-up of 44.0 months, neither study arm reached the primary endpoint of improving the 10-month PFR over standard therapies. The 10-month PFR among patients in the cetuximab maintenance arm was 50.8% (90% CI, 39.5%-62.2%) vs 40.4% (90% CI, 29.4%-52.1%) in the bevacizumab arm.

The overall response rate was 71.6% among the 116 patients in the mITT; the disease control rate was 90.5%. Nearly 76% of patients had early tumor shrinkage.

The most frequently observed grade 3 to 4 adverse events included neutropenia, diarrhea, skin toxic effects, asthenia, stomatitis, and febrile neutropenia.

The authors concluded that although the primary endpoint was not met, “a short induction with mFOLFOXIRI plus cetuximab is feasible as first-line treatment for mCRC and allows achieving impressive activity results in RAS and BRAF wild-type patients, thus emerging as an appealing treatment option especially when a rapid and consistent tumor shrinkage is required.”


  1. Cremolini C, Antoniotti C, Lonardi S, et al. Activity and safety of cetuximab plus modified FOLFOXIRI followed by maintenance with cetuximab or bevacizumab for RAS and BRAF wild-type metastatic colorectal cancer. JAMA Oncol. 2018 Feb 15. doi: 10.1001/jamaoncol.2017.5314 [Epub ahead of print]

Related Resources

You must be a registered member of Cancer Therapy Advisor to post a comment.

Sign Up for Free e-newsletters

Regimen and Drug Listings


Bone Cancer Regimens Drugs
Brain Cancer Regimens Drugs
Breast Cancer Regimens Drugs
Endocrine Cancer Regimens Drugs
Gastrointestinal Cancer Regimens Drugs
Gynecologic Cancer Regimens Drugs
Head and Neck Cancer Regimens Drugs
Hematologic Cancer Regimens Drugs
Lung Cancer Regimens Drugs
Other Cancers Regimens
Prostate Cancer Regimens Drugs
Rare Cancers Regimens
Renal Cell Carcinoma Regimens Drugs
Skin Cancer Regimens Drugs
Urologic Cancers Regimens Drugs