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FOLFIRI & Cetuximab
FOLFIRI & Cetuximab: FOLinic acid (Leucovorin), Fluorouracil, IRInotecan, Cetuximab
Regimen
| FDA-recommended dose |
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy | |
|---|---|---|---|---|---|
Van Cutsem et al. 2009 (CRYSTAL)
|
2004-07 to 2005-11 | Phase 3 (E-RT-esc) | FOLFIRI | Superior OS1 (secondary endpoint) Median OS: 23.5 vs 19.5 mo (HR 0.81, 95% CI 0.69-0.94) | |
| Heinemann et al. 2014 (FIRE-3) | 2007-2012 | Phase 3 (E-switch-ooc) | FOLFIRI & Bevacizumab | Did not meet primary endpoint of ORR |
1Reported efficacy for CRYSTAL is based on the 2012 pooled update and is only for KRAS wild-type tumors.
Biomarker eligibility criteria
- CRYSTAL: none
- FIRE-3: Wild-type KRAS, Wild-type NRAS
Chemotherapy
- Leucovorin (Folinic acid) 400 mg/m2 IV over 2 hours once on day 1, given second, 1 hour after completion of cetuximab, with irinotecan
- Fluorouracil (5-FU) 400 mg/m2 IV bolus once on day 1, then 2400 mg/m2 IV continuous infusion over 46 hours, given third (total dose per cycle: 2800 mg/m2)
- Irinotecan (Camptosar) 180 mg/m2 IV over 30 to 90 minutes once on day 1, given second, 1 hour after completion of cetuximab, with leucovorin
Targeted therapy
- Cetuximab (Erbitux) as follows, given first and completed at least 1 hour before FOLFIRI begins:
- Cycle 1: 400 mg/m2 IV over 2 hours once on day 1, then 250 mg/m2 IV over 60 minutes once on day 8
- Cycle 2 onwards: 250 mg/m2 IV over 60 minutes once per day on days 1 & 8
14-day cycles
References
- CRYSTAL: Van Cutsem E, Köhne CH, Hitre E, Zaluski J, Chang Chien CR, Makhson A, D'Haens G, Pintér T, Lim R, Bodoky G, Roh JK, Folprecht G, Ruff P, Stroh C, Tejpar S, Schlichting M, Nippgen J, Rougier P. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med. 2009 Apr 2;360(14):1408-17. link to original article contains dosing details in manuscript PubMed NCT00154102
- Update: Van Cutsem E, Köhne CH, Láng I, Folprecht G, Nowacki MP, Cascinu S, Shchepotin I, Maurel J, Cunningham D, Tejpar S, Schlichting M, Zubel A, Celik I, Rougier P, Ciardiello F. Cetuximab plus irinotecan, fluorouracil, and leucovorin as first-line treatment for metastatic colorectal cancer: updated analysis of overall survival according to tumor KRAS and BRAF mutation status. J Clin Oncol. 2011 May 20;29(15):2011-9. Epub 2011 Apr 18. link to original article contains dosing details in manuscript PubMed
- Pooled update: Bokemeyer C, Van Cutsem E, Rougier P, Ciardiello F, Heeger S, Schlichting M, Celik I, Köhne CH. Addition of cetuximab to chemotherapy as first-line treatment for KRAS wild-type metastatic colorectal cancer: Pooled analysis of the CRYSTAL and OPUS randomised clinical trials. Eur J Cancer. 2012 Jul;48(10):1466-75. Epub 2012 Mar 23. link to original article PubMed
- Biomarker analysis: Van Cutsem E, Lenz HJ, Köhne CH, Heinemann V, Tejpar S, Melezínek I, Beier F, Stroh C, Rougier P, van Krieken JH, Ciardiello F. Fluorouracil, leucovorin, and irinotecan plus cetuximab treatment and RAS mutations in colorectal cancer. J Clin Oncol. 2015 Mar 1;33(7):692-700. Epub 2015 Jan 20. link to original article PubMed
- FIRE-3: Heinemann V, von Weikersthal LF, Decker T, Kiani A, Vehling-Kaiser U, Al-Batran SE, Heintges T, Lerchenmüller C, Kahl C, Seipelt G, Kullmann F, Stauch M, Scheithauer W, Hielscher J, Scholz M, Müller S, Link H, Niederle N, Rost A, Höffkes HG, Moehler M, Lindig RU, Modest DP, Rossius L, Kirchner T, Jung A, Stintzing S. FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer (FIRE-3): a randomised, open-label, phase 3 trial. Lancet Oncol. 2014 Sep;15(10):1065-75. Epub 2014 Jul 31. link to original article PubMed NCT00433927