Cetuximab plus FOLFIRINOX (ERBIRINOX) as first-line treatment for unresectable metastatic colorectal cancer: A phase II trial

Oncologist

Volumn 16, Issue 11, 2011, Pages 1557-1564

  Assenat, Eric ^a   Desseigne, Francoise ^b   Thezenas, Simon ^a   Viret, Frédéric ^c   Mineur, Laurent ^d   Kramar, Andrew ^a   Samalin, Emmanuelle ^a   Portales, Fabienne ^a   Bibeau, Frédéric ^a   Crapez Lopez, Evelyne ^a   Bleuse, Jean Pierre ^a   Ychou, Marc ^a  

^a CENTRE VAL D AURELLE   (France)

^b CENTRE LÉON BÉRARD   (France)

^c Department of Hematology   (France)

^d Sainte Catherine Institute   (France)

Author keywords

[No Author keywords available]

Indexed keywords

CETUXIMAB; FLUOROURACIL; FOLINIC ACID; IRINOTECAN; OXALIPLATIN;

ABDOMINAL PAIN; ACNE; ADULT; AGED; ANOREXIA; ARTICLE; ASTHENIA; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL EVALUATION; COLORECTAL CANCER; CONSTIPATION; CONTINUOUS INFUSION; DIARRHEA; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG SAFETY; FEBRILE NEUTROPENIA; FEMALE; GENE MUTATION; HUMAN; INOPERABLE CANCER; MALE; METASTASIS POTENTIAL; MULTIPLE CYCLE TREATMENT; NAIL DISEASE; NAUSEA AND VOMITING; NEUROPATHY; NEUTROPENIA; ONCOGENE K RAS; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; SIDE EFFECT; SKIN TOXICITY; SURVIVAL RATE; THROMBOCYTOPENIA; TREATMENT DURATION; TREATMENT RESPONSE;

ADULT; AGED; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAMPTOTHECIN; COLORECTAL NEOPLASMS; DISEASE PROGRESSION; DISEASE-FREE SURVIVAL; DRUG ADMINISTRATION SCHEDULE; FEMALE; FLUOROURACIL; HUMANS; LEUCOVORIN; MALE; MIDDLE AGED; NEOPLASM METASTASIS; ORGANOPLATINUM COMPOUNDS; SURVIVAL RATE;

EID: 82355190597     PISSN: 10837159     EISSN: 1549490X     Source Type: Journal    
DOI: 10.1634/theoncologist.2011-0141     Document Type: Article

References (27)

1. Boyle P, Ferlay J. Cancer incidence and mortality in Europe, 2004. Ann Oncol 2005;16:481-488.
2. O'Connell JB, Maggard MA, Ko CY. Colon cancer survival rates with the new American Joint Committee on Cancer sixth edition staging. J Natl Cancer Inst 2004;96:1420-1425.
3. Adam R, Delvart V, Pascal G et al. Rescue sur-gery for unresectable colorectal liver metastases downstaged by chemotherapy: A model to predict long-term survival. Ann Surg 2004;240:644-657; discussion 657-658.
4. Grothey A, Sargent D, Goldberg RM et al. Survival of patients with advanced colorectal cancer improves with the availability of fluorouracil-leu-covorin, irinotecan, and oxaliplatin in the course of treatment. J Clin Oncol 2004;22:1209-1214.
5. Tournigand C, André T, Achille E et al. FOL-FIRI followed by FOLFOX6 or the reverse se-quence in advanced colorectal cancer: A randomized GERCOR study. J Clin Oncol 2004; 22:229-237.
6. Ychou M, Conroy T, Seitz JF et al. An open phase I study assessing the feasibility of the triple combination: Oxaliplatin plus irinotecan plus leu-covorin/5-fluorouracil every 2 weeks in patients with advanced solid tumors. Ann Oncol 2003;14: 481-489.
7. Ychou M, Viret F, Kramar A et al. Tritherapy with fluorouracil/leucovorin, irinotecan and oxaliplatin (FOLFIRINOX): A phase II study in colorectal cancer patients with non-resectable liver metastases. Cancer Chemother Pharmacol 2008; 62:195-201.
8. Masi G, Allegrini G, Cupini S et al. First-line treatment of metastatic colorectal cancer with irino-tecan, oxaliplatin and 5-fluorouracil/leucovorin (FOLFOXIRI): Results of a phase II study with a simplified biweekly schedule. Ann Oncol 2004;15: 1766-1772.
9. Falcone A, Ricci S, Brunetti I et al. Phase III trial of infusional fluorouracil, leucovorin, oxali-platin, and irinotecan (FOLFOXIRI) compared with infusional fluorouracil, leucovorin, and iri-notecan (FOLFIRI) as first-line treatment for metastatic colorectal cancer: The Gruppo Onco-logico Nord Ovest. J Clin Oncol 2007;25:1670-1676.
10. Rivoire M, Thezenas C, Rebischung F et al. Preliminary results of a randomized phase II trial comparing standard bi-therapy versus three intensi-fied chemotherapy regimens as treatment for pa-tients with non resectable liver metastases from colorectal cancer (LMCRC) (METHEP). J Clin Oncol 2008;26(15 suppl):Abstract 4075.
11. Wu X, Fan Z, Masui H et al. Apoptosis in-duced by an anti-epidermal growth factor receptor monoclonal antibody in a human colorectal carcinoma cell line and its delay by insulin. J Clin Invest 1995;95:1897-1905.
12. Cunningham D, Humblet Y, Siena S et al. Cetuximab monotherapy and cetuximab plus irinote-can in irinotecanrefractory metastatic colorectal cancer. N Engl J Med 2004;351:337-345.
13. Van Cutsem E, Köhne CH, Hitre E et al. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med 2009; 360:1408-1417.
14. 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: 663-671.
15. Tabernero J, Van Cutsem E, Déaz-Rubio E et al. Phase II trial of cetuximab in combination with fluorouracil, leucovorin, and oxaliplatin in the first-line treatment of metastatic colorectal cancer. J Clin Oncol 2007;25:5225-5232.
16. Arnold D, Höhler T, Dittrich C et al. Cetux-imab in combination with weekly 5-fluorouracil/ folinic acid and oxaliplatin (FUFOX) in untreated patients with advanced colorectal cancer: A phase Ib/II study of the AIO GI Group. Ann Oncol 2008; 19:1442-1449.
17. Folprecht G, Lutz MP, Schôffski P et al. Ce-tuximab and irinotecan/5-fluorouracil/folinic acid is a safe combination for the first-line treatment of patients with epidermal growth factor receptor ex-pressing metastatic colorectal carcinoma. Ann Oncol 2006;17:450-456.
18. Folprecht G, Gruenberger T, Bechstein WO et al. Tumour response and secondary resectability of colorectal liver metastases following neoadjuvant chemotherapy with cetuximab: The CELIM ran-domised phase 2 trial. Lancet Oncol 2010;11:38-47.
19. Masi G, Loupakis F, Salvatore L et al. Bevacizumab with FOLFOXIRI (irinotecan, oxaliplatin, fluorouracil, and folinate) as first-line treatment for metastatic colorectal cancer: A phase 2 trial. Lancet Oncol 2010;11:845-852.
20. De Roock W, Piessevaux H, De Schutter J et al. KRAS wild-type state predicts survival and is associated to early radiological response in met-astatic colorectal cancer treated with cetuximab. Ann Oncol 2008;19:508-515.
21. Di Fiore F, Blanchard F, Charbonnier F et al. Clinical relevance of KRAS mutation detection in metastatic colorectal cancer treated by cetuximab plus chemotherapy. Br J Cancer 2007;96:1166-1169.
22. Lièvre A, Bachet JB, Boige V et al. KRAS mutations as an independent prognostic factor in patients with advanced colorectal cancer treated with cetuximab. J Clin Oncol 2008;26:374-379.
23. Yen LC, Uen YH, Wu DC et al. Activating KRAS mutations and overexpression of epidermal growth factor receptor as independent predictors in metastatic colorectal cancer patients treated with cetuximab. Ann Surg 2010;251:254-260.
24. Normanno N, Tejpar S, Morgillo F et al. Im-plications for KRAS status and EGFR-targeted therapies in metastatic CRC. Nat Rev Clin Oncol 2009;6:519-527.
25. Masi G, Marcucci L, Loupakis F et al. First-line 5-fluorouracil/folinic acid, oxaliplatin and iri-notecan (FOLFOXIRI) does not impair the feasibility and the activity of second line treatments in metastatic colorectal cancer. Ann Oncol 2006; 17:1249-1254.
26. Masi G, Loupakis F, Pollina L et al. Long-term outcome of initially unresectable metastatic colorectal cancer patients treated with 5-fluoroura-cil/leucovorin, oxaliplatin, and irinotecan (FOL-FOXIRI) followed by radical surgery of metastases. Ann Surg 2009;249:420-425.
27. Allen PJ, Kemeny N, Jarnagin W et al. Impor-tance of response to neoadjuvant chemotherapy in pa-tients undergoing resection of synchronous colorectal liver metastases. J Gastrointest Surg 2003;7:109-115;discussion 116-117.