Folfox4 plus cetuximab administered weekly or every second week in the first-line treatment of patients with kras wild-type metastatic colorectal cancer: A randomized phase ii cecog study

Annals of Oncology

Volumn 24, Issue 7, 2013, Pages 1769-1777

  Brodowicz, T ^a,b   Ciuleanu, T E ^c   Radosavljevic, D ^d   Shacham Shmueli, E ^e   Vrbanec, D ^f   Plate, S ^g   Mrsic Krmpotic, Z ^h   Dank, M ⁱ   Purkalne, G ^j   Messinger, D ^k   Zielinski, C C ^a,b  

^a MEDICAL UNIVERSITY OF VIENNA   (Austria)

^b Comprehensive Cancer Centre ^*  (Australia)

^c THE ONCOLOGY INSTITUTE PROF DR ION CHIRICUTA   (Romania)

^d INSTITUTE FOR ONCOLOGY AND RADIOLOGY OF SERBIA   (Serbia)

^e TEL AVIV SOURASKY MEDICAL CENTER   (Israel)

^f KBC Zagreb   (Croatia)

^g Latvian Centre of Oncology   (Latvia)

^h SESTRE MILOSRDNICE UNIVERSITY HOSPITAL   (Croatia)

ⁱ SEMMELWEIS UNIVERSITY   (Hungary)

^j PAULS STRADINS CLINICAL UNIVERSITY HOSPITAL   (Latvia)

^k IST GmbH   (Germany)

more..

Author keywords

Cetuximab every second week; Folfox4; Kras wild type; Metastatic colorectal cancer

Indexed keywords

CETUXIMAB; FLUOROURACIL; FOLINIC ACID; K RAS PROTEIN; OXALIPLATIN;

ACNE; ARTICLE; BRONCHOPNEUMONIA; CANCER ADJUVANT THERAPY; CANCER COMBINATION CHEMOTHERAPY; CANCER CONTROL; CANCER IMMUNOTHERAPY; CANCER RADIOTHERAPY; CANCER SURGERY; CHEMOTHERAPY INDUCED NAUSEA AND VOMITING; COLORECTAL CARCINOMA; CONTINUOUS INFUSION; CONTROLLED STUDY; DEEP VEIN THROMBOSIS; DEHYDRATION; DERMATITIS; DIARRHEA; DOSAGE SCHEDULE COMPARISON; DOSE RESPONSE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG ERUPTION; DRUG FATALITY; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG WITHDRAWAL; FALLING; FATIGUE; FEVER; GASTROINTESTINAL DISEASE; HUMAN; HYPERGLYCEMIA; HYPOMAGNESEMIA; HYPOTENSION; INFUSION RELATED REACTION; METASTATIC COLORECTAL CANCER; MONOTHERAPY; MULTIPLE CYCLE TREATMENT; NAIL DISEASE; NEUROTOXICITY; NEUTROPENIA; ONCOGENE K RAS; OVERALL SURVIVAL; PERIPHERAL NEUROPATHY; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SKIN DISEASE; SKIN MANIFESTATION; THROMBOCYTOPENIA; TREATMENT OUTCOME; WILD TYPE;

CETUXIMAB EVERY SECOND WEEK; FOLFOX4; KRAS WILD-TYPE; METASTATIC COLORECTAL CANCER;

ADENOCARCINOMA; ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; COLORECTAL NEOPLASMS; DISEASE-FREE SURVIVAL; DRUG ADMINISTRATION SCHEDULE; FEMALE; FLUOROURACIL; GENOTYPE; HUMANS; KAPLAN-MEIER ESTIMATE; LEUCOVORIN; LIVER NEOPLASMS; MALE; MIDDLE AGED; ORGANOPLATINUM COMPOUNDS; PROPORTIONAL HAZARDS MODELS; PROTO-ONCOGENE PROTEINS; RAS PROTEINS; TREATMENT OUTCOME;

EID: 84882798781     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdt116     Document Type: Article

References (38)

1. Cunningham D, Humblet Y, Siena S et al. Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. N Engl J Med 2004; 351: 337-345.
2. Goldstein NS, Armin M. Epidermal growth factor receptor immunohistochemical reactivity in patients with American Joint Committee on Cancer Stage IV colon adenocarcinoma: implications for a standardized scoring system. Cancer 2001; 92: 1331-1346.
3. Sunada H, Magun BE, Mendelsohn J et al. Monoclonal antibody against epidermal growth factor receptor is internalized without stimulating receptor phosphorylation. Proc Natl Acad Sci USA 1986; 83: 3825-3829.
4. Fan Z, Lu Y, Wu X et al. Antibody-induced epidermal growth factor receptor dimerization mediates inhibition of autocrine proliferation of A431 squamous carcinoma cells. J Biol Chem 1994; 269: 27595-27602.
5. Li S, Schmitz KR, Jeffrey PD et al. Structural basis for inhibition of the epidermal growth factor receptor by cetuximab. Cancer Cell 2005; 7: 301-311.
6. Huang SM, Bock JM, Harari PM. Epidermal growth factor receptor blockade with C225 modulates proliferation, apoptosis, and radiosensitivity in squamous cell carcinomas of the head and neck. Cancer Res 1999; 59: 1935-1940.
7. Perrotte P, Matsumoto T, Inoue K et al. Anti-epidermal growth factor receptor antibody C225 inhibits angiogenesis in human transitional cell carcinoma growing orthotopically in nude mice. Clin Cancer Res 1999; 5: 257-265.
8. Kawaguchi Y, Kono K, Mimura K et al. Cetuximab induce antibody-dependent cellular cytotoxicity against EGFR-expressing esophageal squamous cell carcinoma. Int J Cancer 2007; 120: 781-787.
9. Fan Z, Masui H, Altas I et al. Blockade of epidermal growth factor receptor function by bivalent and monovalent fragments of 225 anti-epidermal growth factor receptor monoclonal antibodies. Cancer Res 1993; 53: 4322-4328.
10. Van Cutsem E, Kohne CH, Hitre E et al. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med 2009; 360: 1408-1417.
11. Van Cutsem E, Kohne CH, Lang I et al. 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; 29: 2011-2019.
12. 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.
13. Bokemeyer C, Bondarenko I, Hartmann JT et al. Efficacy according to biomarker status of cetuximab plus FOLFOX-4 as first-line treatment for metastatic colorectal cancer: the OPUS study. Ann Oncol 2011; 22: 1535-1546.
14. Ocvirk J, Brodowicz T, Wrba F et al. Cetuximab plus FOLFOX6 or FOLFIRI in metastatic colorectal cancer: CECOG trial. World J Gastroenterol 2010; 16: 3133-3143.
15. Nolting A, Fox FE, Kovar A. Clinical drug development of cetuximab, a monoclonal antibody. In Meibohm B (ed). Pharmacokinetics and Pharmacodynamics of Biotech Drugs: Principles and Case Studies In Drug Development. Weinheim, Germany: Wiley VCH Verlag GmbH & Co. KGaA 2006; 353-371.
16. Baselga J, Pfister D, Cooper MR et al. Phase I studies of anti-epidermal growth factor receptor chimeric antibody C225 alone and in combination with cisplatin. J Clin Oncol 2000; 18: 904-914.
17. Tan AR, Moore DF, Hidalgo M et al. Pharmacokinetics of cetuximab after administration of escalating single dosing and weekly fixed dosing in patients with solid tumors. Clin Cancer Res 2006; 12: 6517-6522.
18. Fracasso PM, Burris H, 3rd, Arquette MA et al. A phase 1 escalating single-dose and weekly fixed-dose study of cetuximab: pharmacokinetic and pharmacodynamic rationale for dosing. Clin Cancer Res 2007; 13: 986-993.
19. Tabernero J, Ciardiello F, Rivera F et al. Cetuximab administered once every second week to patients with metastatic colorectal cancer: a two-part pharmacokinetic/pharmacodynamic phase I dose-escalation study. Ann Oncol 2010; 21: 1537-1545.
20. Martin-Martorell P, Rosello S, Rodriguez-Braun E et al. Biweekly cetuximab and irinotecan in advanced colorectal cancer patients progressing after at least one previous line of chemotherapy: results of a phase II single institution trial. Br J Cancer 2008; 99: 455-458.
21. Pfeiffer P, Nielsen D, Bjerregaard J et al. Biweekly cetuximab and irinotecan as third-line therapy in patients with advanced colorectal cancer after failure to irinotecan, oxaliplatin and 5-fluorouracil. Ann Oncol 2008; 19: 1141-1145.
22. Shitara K, Yuki S, Yoshida M et al. Phase II study of combination chemotherapy with biweekly cetuximab and irinotecan for wild-type KRAS metastatic colorectal cancer refractory to irinotecan, oxaliplatin, and fluoropyrimidines. Invest New Drugs 2012; 30: 787-793.
23. Kang MJ, Hong YS, Kim KP et al. Biweekly cetuximab plus irinotecan as secondline chemotherapy for patients with irinotecan-refractory and KRAS wild-type metastatic colorectal cancer according to epidermal growth factor receptor expression status. Invest New Drugs 2012; 30: 1607-1613.
24. Jensen BV, Schou JV, Johannesen HH et al. Cetuximab every second week with irinotecan in patients with metastatic colorectal cancer refractory to 5-FU, oxaliplatin, and irinotecan: KRAS mutation status and efficacy. J Clin Oncol 2010; 28: 7s, (supp;abstr 3573).
25. Bouchahda M, Macarulla T, Liedo G et al. Feasibility of cetuximab given with a simplified schedule every 2 weeks in advanced colorectal cancer: a multicenter, retrospective analysis. Med Oncol 2011; 28(Suppl 1): S253-S258.
26. Roca JM, Alonso V, Pericay C et al. Cetuximab given every 2 weeks plus irinotecan is an active and safe option for previously treated patients with metastatic colorectal cancer. Chemotherapy 2010; 56: 142-146.
27. 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.
28. Lievre 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.
29. De Roock W, Piessevaux H, De Schutter J et al. KRAS wild-type state predicts survival and is associated to early radiological response in metastatic colorectal cancer treated with cetuximab. Ann Oncol 2008; 19: 508-515.
30. Karapetis CS, Khambata-Ford S, Jonker DJ et al. K-ras mutations and benefit from cetuximab in advanced colorectal cancer. N Engl J Med 2008; 359: 1757-1765.
31. Agresti A. Categorical Data Analysis. Hoboken, New Jersey: John Wiley & Sons, 2002.
32. Klein J, Moeschberger M. Survival Analysis. New York: Springer-Verlag, 1997.
33. Chung KY, Shia J, Kemeny NE et al. Cetuximab shows activity in colorectal cancer patients with tumors that do not express the epidermal growth factor receptor by immunohistochemistry. J Clin Oncol 2005; 23: 1803-1810.
34. Lenz HJ, Van Cutsem E, Khambata-Ford S et al. Multicenter phase II and translational study of cetuximab in metastatic colorectal carcinoma refractory to irinotecan, oxaliplatin, and fluoropyrimidines. J Clin Oncol 2006; 24: 4914-4921.
35. Wierzbicki R, Jonker DJ, Moore MJ et al. A phase II, multicenter study of cetuximab monotherapy in patients with refractory, metastatic colorectal carcinoma with absent epidermal growth factor receptor immunostaining. Invest New Drugs 2011; 29: 167-174.
36. Richman SD, Seymour MT, Chambers P et al. KRAS and BRAF mutations in advanced colorectal cancer are associated with poor prognosis but do not preclude benefit from oxaliplatin or irinotecan: results from the MRC FOCUS trial. J Clin Oncol 2009; 27: 5931-5937.
37. Tol J, Dijkstra JR, Klomp M et al. Markers for EGFR pathway activation as predictor of outcome in metastatic colorectal cancer patients treated with or without cetuximab. Eur J Cancer 2010; 46: 1997-2009.
38. Di Nicolantonio F, Martini M, Molinari F et al. Wild-type BRAF is required for response to panitumumab or cetuximab in metastatic colorectal cancer. J Clin Oncol 2008; 26: 5705-5712.