Cetuximab plus FOLFOX6 or FOLFIRI in metastatic colorectal cancer: Cecog trial

World Journal of Gastroenterology

Volumn 16, Issue 25, 2010, Pages 3133-3143

  Ocvirk, Janja ^a   Brodowicz, Thomas ^b   Wrba, Fritz ^b   Ciuleanu, Tudor E ^c   Kurteva, Galina ^d   Beslija, Semir ^e   Koza, Ivan ^f   Pápai, Zsuzsanna ^g   Messinger, Diethelm ^h   Yilmaz, Ugur ⁱ   Faluhelyi, Zsolt ^j   Yalcin, Suayib ^k   Papamichael, Demetris ^l   Wenczl, Miklós ^m   Mrsic Krmpotic, Zrinka ⁿ   Shacham Shmueli, Einat ^o   Vrbanec, Damir ^p   Esser, Regina ^q   Scheithauer, Werner ^b   Zielinski, Christoph C ^b  

^a INSTITUTE OF ONCOLOGY   (Slovenia)

^b MEDICAL UNIVERSITY OF VIENNA   (Austria)

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

^d Specialized Hospital for Active Treatment in Oncology   (Bulgaria)

^e UNIVERSITY OF SARAJEVO   (Bosnia and Herzegovina)

^f CANCER RESEARCH INSTITUTE   (Slovakia)

^g AEK Onkologiai Osztaly   (Hungary)

^h IST GmbH   (Germany)

ⁱ DOKUZ EYLUL UNIVERSITY   (Turkey)

^j Veszprem County Hospital   (Hungary)

^k HACETTEPE UNIVERSITY   (Turkey)

^l Bank of Cyprus Group Oncology Centre   (Cyprus)

^m Markusovszky Teaching Hospital   (Hungary)

ⁿ SESTRE MILOSRDNICE UNIVERSITY HOSPITAL   (Croatia)

^o TEL AVIV SOURASKY MEDICAL CENTER   (Israel)

^p KBC Zagreb   (Croatia)

^q MERCK KGAA   (Germany)

more..

Author keywords

5 fluorouracil folinic acid and irinotecan; 5 fluorouracil folinic acid and oxaliplatin; Cetuximab; KRAS; Metastatic colorectal cancer

Indexed keywords

CETUXIMAB; DNA; EPIDERMAL GROWTH FACTOR RECEPTOR; FLUOROURACIL; FOLINIC ACID; IRINOTECAN; K RAS PROTEIN; OXALIPLATIN; ANTINEOPLASTIC AGENT; CAMPTOTHECIN; KRAS PROTEIN, HUMAN; MONOCLONAL ANTIBODY; ONCOPROTEIN; PLATINUM COMPLEX; RAS PROTEIN;

ACNE; ACUTE HEART INFARCTION; ACUTE RESPIRATORY FAILURE; ADULT; ADVANCED CANCER; AGED; ANAPHYLAXIS; ANGINA PECTORIS; ARTICLE; BOLUS INJECTION; BRONCHOSPASM; BRONCHUS OBSTRUCTION; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CHILL; CLINICAL TRIAL; CLONUS; COLORECTAL CANCER; COMPUTER ASSISTED TOMOGRAPHY; CONTINUOUS INFUSION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CONVULSION; CYANOSIS; DEHYDRATION; DIARRHEA; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DRY SKIN; DYSPNEA; EPILEPSY; ERYSIPELAS; ERYTHEMA; FACE EDEMA; FEMALE; FOLLICULITIS; FOLLOW UP; GENE EXPRESSION; GENE MUTATION; HEART FAILURE; HUMAN; HYPERPYREXIA; HYPERTRICHOSIS; HYPOTENSION; HYPOXIA; MAJOR CLINICAL STUDY; MALE; METASTASIS; MUCOSA INFLAMMATION; MULTICENTER STUDY; NAIL DISEASE; NAIL INFECTION; NEUTROPENIA; NUCLEAR MAGNETIC RESONANCE IMAGING; ONCOGENE K RAS; OPEN STUDY; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PARONYCHIA; PATIENT COMPLIANCE; PERIPHERAL NEUROPATHY; PHASE 2 CLINICAL TRIAL; PROGRESSION FREE SURVIVAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RASH; REAL TIME POLYMERASE CHAIN REACTION; RESPIRATORY DISTRESS; RESPIRATORY FAILURE; SHOCK; SIDE EFFECT; SUDDEN DEATH; SURVIVAL RATE; SYNCOPE; THROMBOCYTOPENIA; TREATMENT DURATION; TREATMENT RESPONSE; ANALOGS AND DERIVATIVES; COLORECTAL NEOPLASMS; DISEASE FREE SURVIVAL; GENETICS; KAPLAN MEIER METHOD; MIDDLE AGED; PATHOLOGY; TREATMENT OUTCOME;

AGED; ANTIBODIES, MONOCLONAL; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAMPTOTHECIN; COLORECTAL NEOPLASMS; DISEASE-FREE SURVIVAL; FEMALE; FLUOROURACIL; HUMANS; KAPLAN-MEIER ESTIMATE; LEUCOVORIN; MALE; MIDDLE AGED; NEOPLASM METASTASIS; ORGANOPLATINUM COMPOUNDS; PROTO-ONCOGENE PROTEINS; RAS PROTEINS; TREATMENT OUTCOME;

EID: 77954372574     PISSN: 10079327     EISSN: None     Source Type: Journal    
DOI: 10.3748/wjg.v16.i25.3133     Document Type: Article

References (32)

1. Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin 2005; 55: 74-108
2. Thirion P, Michiels S, Pignon JP, Buyse M, Braud AC, Carlson RW, O'Connell M, Sargent P, Piedbois P. Modulation of fluorouracil by leucovorin in patients with advanced colorectal cancer: an updated meta-analysis. J Clin Oncol 2004; 22: 3766-3775
3. Jemal A, Clegg LX, Ward E, Ries LA, Wu X, Jamison PM, Wingo PA, Howe HL, Anderson RN, Edwards BK. Annual report to the nation on the status of cancer, 1975-2001, with a special feature regarding survival. Cancer 2004; 101: 3-27
4. Borner MM, Castiglione M, Bacchi M, Weber W, Herrmann R, Fey MF, Pagani O, Leyvraz S, Morant R, Pestalozzi B, Hanselmann S, Goldhirsch A. The impact of adding low-dose leucovorin to monthly 5-fluorouracil in advanced colorectal carcinoma: results of a phase III trial. Swiss Group for Clinical Cancer Research (SAKK). Ann Oncol 1998; 9: 535-541
5. Poon MA, O'Connell MJ, Moertel CG, Wieand HS, Cullinan SA, Everson LK, Krook JE, Mailliard JA, Laurie JA, Tschetter LK. Biochemical modulation of fluorouracil: evidence of significant improvement of survival and quality of life in patients with advanced colorectal carcinoma. J Clin Oncol 1989; 7: 1407-1418
6. de Gramont A, Figer A, Seymour M, Homerin M, Hmissi A, Cassidy J, Boni C, Cortes-Funes H, Cervantes A, Freyer G, Papamichael D, Le Bail N, Louvet C, Hendler D, de Braud F, Wilson C, Morvan F, Bonetti A. Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer. J Clin Oncol 2000; 18: 2938-2947
7. Giacchetti S, Perpoint B, Zidani R, Le Bail N, Faggiuolo R, Focan C, Chollet P, Llory JF, Letourneau Y, Coudert B, Bertheaut-Cvitkovic F, Larregain-Fournier D, Le Rol A, Walter S, Adam R, Misset JL, Lévi F. Phase III multicenter randomized trial of oxaliplatin added to chronomodulated fluorouracil-leucovorin as first-line treatment of metastatic colorectal cancer. J Clin Oncol 2000; 18: 136-147
8. Douillard JY, Cunningham D, Roth AD, Navarro M, James RD, Karasek P, Jandik P, Iveson T, Carmichael J, Alakl M, Gruia G, Awad L, Rougier P. Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomized trial. Lancet 2000; 355: 1041-1047
9. Saltz LB, Cox JV, Blanke C, Rosen LS, Fehrenbacher L, Moore MJ, Maroun JA, Ackland SP, Locker PK, Pirotta N, Elfring GL, Miller LL. Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan Study Group. N Engl J Med 2000; 343: 905-914
10. Goldstein NI, Prewett M, Zuklys K, Rockwell P, Mendelsohn J. Biological efficacy of a chimeric antibody to the epidermal growth factor receptor in a human tumor xenograft model. Clin Cancer Res 1995; 1: 1311-1318
11. Li S, Schmitz KR, Jeffrey PD, Wiltzius JJ, Kussie P, Ferguson KM. Structural basis for inhibition of the epidermal growth factor receptor by cetuximab. Cancer Cell 2005; 7: 301-311
12. Cunningham D, Humblet Y, Siena S, Khayat D, Bleiberg H, Santoro A, Bets D, Mueser M, Harstrick A, Verslype C, Chau I, Van Cutsem E. Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. N Engl J Med 2004; 351: 337-345
13. 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; 360: 1408-1417
14. Bokemeyer C, Bondarenko I, Makhson A, Hartmann JT, Aparicio J, de Braud F, Donea S, Ludwig H, Schuch G, Stroh C, Loos AH, Zubel A, Koralewski P. Fluorouracil, leucovorin, and oxaliplatin with and without cetuximab in the firstline treatment of metastatic colorectal cancer. J Clin Oncol 2009; 27: 663-671
15. Lièvre A, Bachet JB, Boige V, Cayre A, Le Corre D, Buc E, Ychou M, Bouché O, Landi B, Louvet C, André T, Bibeau F, Diebold MD, Rougier P, Ducreux M, Tomasic G, Emile JF, Penault-Llorca F, Laurent-Puig P. KRAS mutations as an independent prognostic factor in patients with advanced colorectal cancer treated with cetuximab. J Clin Oncol 2008; 26: 374-379
16. De Roock W, Piessevaux H, De Schutter J, Janssens M, De Hertogh G, Personeni N, Biesmans B, Van Laethem JL, Peeters M, Humblet Y, Van Cutsem E, Tejpar S. 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
17. Di Fiore F, Blanchard F, Charbonnier F, Le Pessot F, Lamy A, Galais MP, Bastit L, Killian A, Sesboüé R, Tuech JJ, Queuniet AM, Paillot B, Sabourin JC, Michot F, Michel P, Frebourg T. Clinical relevance of KRAS mutation detection in metastatic colorectal cancer treated by Cetuximab plus chemotherapy. Br J Cancer 2007; 96: 1166-1169
18. Khambata-Ford S, Garrett CR, Meropol NJ, Basik M, Harbison CT, Wu S, Wong TW, Huang X, Takimoto CH, Godwin AK, Tan BR, Krishnamurthi SS, Burris HA 3rd, Poplin EA, Hidalgo M, Baselga J, Clark EA, Mauro DJ. Expression of epiregulin and amphiregulin and K-ras mutation status predict disease control in metastatic colorectal cancer patients treated with cetuximab. J Clin Oncol 2007; 25: 3230-3237
19. Karapetis CS, Khambata-Ford S, Jonker DJ, O'Callaghan CJ, Tu D, Tebbutt NC, Simes RJ, Chalchal H, Shapiro JD, Robitaille S, Price TJ, Shepherd L, Au HJ, Langer C, Moore MJ, Zalcberg JR. K-ras mutations and benefit from cetuximab in advanced colorectal cancer. N Engl J Med 2008; 359: 1757-1765
20. Malumbres M, Barbacid M. RAS oncogenes: the first 30 years. Nat Rev Cancer 2003; 3: 459-465
21. Hanahan D, Weinberg RA. The hallmarks of cancer. Cell 2000; 100: 57-70
22. Amado RG, Wolf M, Peeters M, Van Cutsem E, Siena S, Freeman DJ, Juan T, Sikorski R, Suggs S, Radinsky R, Patterson SD, Chang DD. Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer. J Clin Oncol 2008; 26: 1626-1634
23. Thelwell N, Millington S, Solinas A, Booth J, Brown T. Mode of action and application of Scorpion primers to mutation detection. Nucleic Acids Res 2000; 28: 3752-3761
24. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958; 53: 457-481
25. Kalbfleisch JD, Prentice RL. The statistical analysis of failure time data. New York: John Wiley & Sons, 1980
26. Van Cutsem E, Lang I, D'haens G, Moiseyenko V, Zaluski J, Folprecht G, Tejpar S, Kisker O, Stroh C, Rougier P. KRAS status and efficacy in the firstline treatment of patients with metastatic colorectal cancer (mCRC) treated with FOLF1R1 with or without cetuximab: The CRYSTAL experience. J Clin Oncol 2008; 26: suppl; abstr 2
27. McLellan EA, Owen RA, Stepniewska KA, Sheffield JP, Lemoine NR. High frequency of K-ras mutations in sporadic colorectal adenomas. Gut 1993; 34: 392-396
28. Richman SD, Seymour MT, Chambers P, Elliott F, Daly CL, Meade AM, Taylor G, Barrett JH, Quirke P. 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
29. Roth AD, Tejpar S, Delorenzi M, Yan P, Fiocca R, Klingbiel D, Dietrich D, Biesmans B, Bodoky G, Barone C, Aranda E, Nordlinger B, Cisar L, Labianca R, Cunningham D, Van Cutsem E, Bosman F. Prognostic role of KRAS and BRAF in stage II and III resected colon cancer: results of the translational study on the PETACC-3, EORTC 40993, SAKK 60-00 trial. J Clin Oncol 2010; 28: 466-474
30. Lenz HJ, Van Cutsem E, Khambata-Ford S, Mayer RJ, Gold P, Stella P, Mirtsching B, Cohn AL, Pippas AW, Azarnia N, Tsuchihashi Z, Mauro DJ, Rowinsky EK. 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
31. Chung KY, Shia J, Kemeny NE, Shah M, Schwartz GK, Tse A, Hamilton A, Pan D, Schrag D, Schwartz L, Klimstra DS, Fridman D, Kelsen DP, Saltz LB. 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
32. Tournigand C, André T, Achille E, Lledo G, Flesh M, Mery- Mignard D, Quinaux E, Couteau C, Buyse M, Ganem G, Landi B, Colin P, Louvet C, de Gramont A. FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study. J Clin Oncol 2004; 22: 229-237