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Therapy Name Cetuximab + Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin
Synonyms Cetuximab + FOLFIRINOX|Cetuximab + FOLFOXIRI
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Cetuximab Erbitux IMC-C225 EGFR Antibody 74 Erbitux (cetuximab) is a monoclonal antibody directed against EGFR, which inhibits signal transduction and cell proliferation (PMID: 28695301). Erbitux (cetuximab) is FDA-approved for use in head and neck squamous cell carcinoma and KRAS wild-type, EGFR-positive colorectal cancer, and in combination with Braftovi (encorafenib) with or without mFOLFOX6 in patients with metastatic colorectal cancer with BRAF V600E (FDA.gov).
Fluorouracil Adrucil 5-FU|5-Fluorouracil Chemotherapy - Antimetabolite 14 Adrucil (fluorouracil) is an antimetabolite chemotherapeutic agent that interferes with DNA and RNA synthesis, thereby preventing cancer cell growth (PMID: 28520376). Adrucil (fluorouracil) is FDA-approved for use in patients with adenocarcinoma of the colon, rectum, breast, stomach, and pancreas (FDA.gov).
Irinotecan Camptosar CPT-11 TOPO1 inhibitor 11 Camptosar (irinotecan) inhibits Topoisomerase-I activity, resulting in inhibition of DNA replication, and potentially leading to cell death and is indicated as a component of first-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic or recurrent colorectal carcinoma (FDA.gov).
Leucovorin Wellcovorin Calcium folinate|Calcium citrovorum factor|folinic acid Chemotherapy - Antimetabolite 14 Wellcovorin (leucovorin) is a metabolite of folate that enhances the efficacy of fluoruracil (PMID: 32490554).
Oxaliplatin Eloxatin Diaminocyclohexane Oxalatoplatinum Chemotherapy - Platinum 7 Eloxatin (oxaliplatin) is comprised of a platinum complex, which causes DNA-platinum cross-links, inhibition of DNA replication and transcription, and cell toxicity, and is FDA approved for colorectal cancer (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
BRAF V600E colorectal cancer no benefit Cetuximab + Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Phase II Actionable In a Phase II trial (FIRE-4.5), the combination of Erbitux (cetuximab) with FOLFOXIRI as first-line therapy did not result in an improved objective response rate (ORR) compared to Avastin (bevacizumab) with FOLFOXIRI, with an ORR of 50.8% (30/59) vs 66.7% (20/30) (P=0.92), a median progression-free survival of 7.6 vs 12.4 months (P=0.003), and a median overall survival of 15.2 vs 22.9 months (P=0.14), respectively, in metastatic colorectal cancer patients harboring BRAF V600E (PMID: 37352476). 37352476

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT01442935 Phase II Bevacizumab + Fluorouracil + Leucovorin + Oxaliplatin Cetuximab + Fluorouracil + Irinotecan + Leucovorin Bevacizumab + Fluorouracil + Irinotecan + Leucovorin Cetuximab + Fluorouracil + Leucovorin + Oxaliplatin Bevacizumab + Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Cetuximab + Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Chemotherapies Associated With Targeted Therapies on the Resection Rate of Hepatic Metastases Completed FRA 0
NCT04034459 Phase II Bevacizumab + Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Cetuximab + Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin FOLFOXIRI Plus Cetuximab vs. FOLFOXIRI Plus Bevacizumab 1st-line in BRAF-mutated mCRC (AIO-KRK-0116) Unknown status DEU 0


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