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Clinical Trial
. 2025 Jun 27;56(1):141.
doi: 10.1007/s12029-025-01260-6.

Final Results of ERBIMOX: A Randomized Phase II Study of Modified FOLFOX7 With or Without Cetuximab as First-Line Treatment for KRAS Wild-type Metastatic Colorectal Cancer

Karin Potthoff  1 , Norbert Marschner  2 , Lothar Müller  3 , Stephan Sahm  4 , Christian Lerchenmüller  5 , Reinhard Depenbusch  6 , Emil Boller  7 , Beate Niemeier  2 , Ute Zirrgiebel  2 , Hans Tesch  8
Affiliations
Clinical Trial

Final Results of ERBIMOX: A Randomized Phase II Study of Modified FOLFOX7 With or Without Cetuximab as First-Line Treatment for KRAS Wild-type Metastatic Colorectal Cancer

Karin Potthoff et al. J Gastrointest Cancer. .

Abstract

Background: The combination of FOLFOX/FOLFIRI with an EGFR-antibody (cetuximab/panitumumab) is a first-line standard for RAS wild-type metastatic colorectal cancer (mCRC). The OPTIMOX stop-and-go regimen, which reduces oxaliplatin-induced neuropathy, and fluorouracil/folinic acid (FU/FA) were standard maintenance-therapies in the pre-antibody era. Whether an EGFR-antibody adds value to the OPTIMOX strategy in the RAS wild-type setting remains unknown.

Methods: In the open-label, randomized, multicenter phase II ERBIMOX trial, patients with KRAS wild-type mCRC received either first-line induction-therapy with 8 cycles of mFOLFOX7 followed by maintenance-therapy with FU/FA (OPTIMOX arm) or mFOLFOX7 + cetuximab followed by FU/FA + cetuximab (ERBIMOX arm). Primary objective was to demonstrate superiority of additional cetuximab to mFOLFOX7 during induction/maintenance-therapy. Primary endpoint was objective response rate (ORR). Secondary endpoints included progression-free survival (PFS), overall survival (OS) and safety. The trial is registered at EudraCT (No.2006-002744-28).

Results: From 2006-2011, 138 patients with KRAS wild-type mCRC from 23 German sites were randomly assigned to either OPTIMOX (N = 63) or ERBIMOX (N = 75). ORR numerically favored the ERBIMOX arm (64.0% vs. 54.0%, P = 0.3071). Median PFS (ERBIMOX vs. OPTIMOX) was 9.6 vs. 8.8 months (P = 0.7612), median OS 25.6 vs. 30.9 months (P = 0.5821). Most common grade 3/4 adverse events (AEs) were skin reactions (21.9% vs. 2.1%) and gastrointestinal disorders (13.5% vs. 9.5%). No cetuximab-related deaths occurred.

Conclusion: In treatment-naïve KRAS wild-type mCRC, adding cetuximab to mFOLFOX7 resulted in numerically higher ORR than mFOLFOX alone, but no statistically significant differences in ORR, PFS or OS; probably because of the premature stop due to poor recruitment. The safety profile was as expected, with few discontinuations.

Keywords: KRAS mutation status; Cetuximab; First-line therapy; Metastatic colorectal cancer; Modified FOLFOX7.

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Conflict of interest statement

Declarations. Competing interests: The authors declare no competing interests concerning the topic of this publication. Outside of the published work, the institutions of LM, SS, CL, RD and HT received remuneration for the documentation of patient data; NM declares stock ownership and upper management responsibility (iOMEDICO); SS declares stock ownership (Merck); HT declares stock ownership (CHOP GmbH, VISION MED GmbH, Care and Coach GmbH).

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References

    1. Duan B, Zhao Y, Bai J, Wang J, Duan X, Luo X, Zhang R, et al. Colorectal cancer: an overview. In: Morgado-Diaz JA, editor. Gastrointestinal cancers. Brisbane: Exon Publications; 2022. http://www.ncbi.nlm.nih.gov/books/NBK586003/ .
    1. Van Cutsem E, Cervantes A, Nordlinger B, et al. Metastatic colorectal cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol Off J Eur Soc Med Oncol. 2014;25(Suppl 3):iii1-9. https://doi.org/10.1093/annonc/mdu260 . - DOI
    1. De Falco V, Napolitano S, Roselló S, et al. How we treat metastatic colorectal cancer. ESMO Open. 2020;4:e000813. https://doi.org/10.1136/esmoopen-2020-000813 . - DOI - PubMed - PMC
    1. Tournigand C, Cervantes A, Figer A, et al. OPTIMOX1: A Randomized Study of FOLFOX4 or FOLFOX7 With Oxaliplatin in a Stop-and-Go Fashion in Advanced Colorectal Cancer—A GERCOR Study. J Clin Oncol. 2006;24:394–400. https://doi.org/10.1200/JCO.2005.03.0106 . - DOI - PubMed
    1. Bokemeyer C, Bondarenko I, Makhson A, et al. Fluorouracil, Leucovorin, and Oxaliplatin With and Without Cetuximab in the First-Line Treatment of Metastatic Colorectal Cancer. J Clin Oncol. 2009;27:663–71. https://doi.org/10.1200/JCO.2008.20.8397 . - DOI - PubMed

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