Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer

New England Journal of Medicine

Volumn 360, Issue 14, 2009, Pages 1408-1417

  Van Cutsem, Eric ^a   Köhne, Claus Henning ^c   Hitre, Erika ^f   Zaluski, Jerzy ⁱ   Chien, Chung Rong Chang ^j   Makhson, Anatoly ^k   D'Haens, Geert ^b   Pintér, Tamás ^g   Lim, Robert ^l   Bodoky, György ^h   Roh, Jae Kyung ^m   Folprecht, Gunnar ^d   Ruff, Paul ⁿ   Stroh, Christopher ^e   Tejpar, Sabine ^a   Schlichting, Michael ^e   Nippgen, Johannes ^e   Rougier, Philippe ^o  

^a UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^b IMELDA HOSPITAL   (Belgium)

^c KLINIKUM OLDENBURG   (Germany)

^d UNIVERSITY HOSPITAL CARL GUSTAV CARUS   (Germany)

^e MERCK KGAA   (Germany)

^f NATIONAL INSTITUTE OF ONCOLOGY   (Hungary)

^g Petz Aladár County Teaching Hospital   (Hungary)

^h Szent Laszlo Hospital   (Hungary)

ⁱ GREATER POLAND CANCER CENTRE   (Poland)

^j CHANG GUNG MEMORIAL HOSPITAL   (Taiwan)

^k Moscow City Oncology Clinical Hospital 62   (Russian Federation)

^l NATIONAL UNIVERSITY HOSPITAL   (Singapore)

^m Yonsei University College of Medicine   (South Korea)

ⁿ UNIVERSITY OF THE WITWATERSRAND   (South Africa)

^o HÔPITAL AMBROISE PARÉ   (France)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CETUXIMAB; EPIDERMAL GROWTH FACTOR RECEPTOR; FLUOROURACIL; FOLINIC ACID; IRINOTECAN; ANTINEOPLASTIC AGENT; CAMPTOTHECIN; DRUG DERIVATIVE; IFL PROTOCOL; MONOCLONAL ANTIBODY;

ADULT; AGED; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER GROWTH; CANCER SURVIVAL; CLINICAL TRIAL; COLORECTAL CANCER; CONTINUOUS INFUSION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DERMATITIS; DERMATITIS ACNEIFORM; DIARRHEA; DISEASE SEVERITY; DRUG EFFECT; DRUG EFFICACY; DRUG ERUPTION; DRUG RESPONSE; DRUG SAFETY; FATIGUE; FEMALE; HUMAN; INJECTION SITE REACTION; LEUKOPENIA; MAJOR CLINICAL STUDY; MALE; METASTASIS; MULTICENTER STUDY; MUTATION; NEUTROPENIA; ONCOGENE K RAS; OVERALL SURVIVAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; RISK REDUCTION; SINGLE DRUG DOSE; SKIN MANIFESTATION; TREATMENT OUTCOME; VOMITING; WILD TYPE; COLORECTAL TUMOR; COMPARATIVE STUDY; DISEASE COURSE; DRUG ANTAGONISM; GENETICS; KAPLAN MEIER METHOD; MIDDLE AGED; ONCOGENE RAS;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAMPTOTHECIN; COLORECTAL NEOPLASMS; DISEASE PROGRESSION; FEMALE; FLUOROURACIL; GENES, RAS; HUMANS; KAPLAN-MEIERS ESTIMATE; LEUCOVORIN; MALE; MIDDLE AGED; MUTATION; NEOPLASM METASTASIS; RECEPTOR, EPIDERMAL GROWTH FACTOR; YOUNG ADULT;

EID: 63849088630     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa0805019     Document Type: Article

References (34)

1. Global cancer statistics, 2002. CA Cancer J Clin 2005;55:74-108.
2. Douillard JY, Cunningham D, Roth AD, et al. Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial. Lancet 2000;355:1041-1047 [Erratum, Lancet 2000;355:1372.] (Pubitemid 30162806)
3. Saltz LB, Cox JV, Blanke C, et al. Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. N Engl J Med 2000;343:905-914
4. Goldberg RM, Sargent DJ, Morton RF, et al. A randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer. J Clin Oncol 2004;22:23-30.
5. Van Cutsem E, Geboes K. The multidisciplinary management of gastrointestinal cancer. The integration of cytotoxics and biologicals in the treatment of metastatic colorectal cancer. Best Pract Res Clin Gastroenterol 2007;21:1089-1108
6. 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
7. 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
8. Folprecht G, Lutz MP, Schöffski P, et al. Cetuximab and irinotecan/5-fluorouracil/ folinic acid is a safe combination for the first-line treatment of patients with epidermal growth factor receptor expressing metastatic colorectal carcinoma. Ann Oncol 2006;17:450-456
9. Rougier P, Raoul J-L, Van Laethem J-L, et al. Cetuximab + FOLFIRI as first-line treatment for metastatic colorectal CA. J Clin Oncol 2004;22:Suppl:248s. abstract.
10. Tabernero J, Van Cutsem E, Diaz-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
11. Bokemeyer C, Staroslawska E, Makhson A, et al. Cetuximab plus 5FU/FA/ oxaliplatin (FOLFOX4) in the first-line treatment of metastatic colorectal cancer (mCRC): a large-scale phase II study, OPUS. Eur J Cancer Suppl 2007;5:236. abstract.
12. Arnold D, Höhler T, Dittrich C, et al. Cetuximab 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
13. 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
14. 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
15. 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
16. Lièvre A, Bachet JB, Le Corre D, et al. KRAS mutation status is predictive of response to cetuximab therapy in colorectal cancer. Cancer Res 2006;66:3992-3995
17. Cervantes A, Macarulla T, Martinelli E, et al. Correlation of KRAS status (wild type [wt] vs. mutant [mt]) with efficacy to first-line cetuximab in a study of cetuximab single agent followed by cetuximab + FOLFIRI in patients (pts) with metastatic colorectal cancer (mCRC). J Clin Oncol 2008;26:Suppl:210s. abstract.
18. Van Cutsem E, Peeters M, Siena S, et al. Open-label phase III trial of panitumumab plus best supportive care compared with best supportive care alone in patients with chemotherapy-refractory metastatic colorectal cancer. J Clin Oncol 2007;25:1658-1664
19. Amado RG, Wolf M, Peeters M, et al. Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer. J Clin Oncol 2008;26:1626-1634
20. Tournigand C, André T, Achille E, et al. FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study. J Clin Oncol 2004;22:229-237
21. Chen CY, Shiesh SC, Wu SJ. Rapid detection of K-ras mutations in bile by peptide nucleic acid-mediated PCR clamping and melting curve analysis: comparison with restriction fragment length polymorphism analysis. Clin Chem 2004;50:481-489 (Pubitemid 38297296)
22. Simeonov A, Nikiforov TT. Single nucleotide polymorphism genotyping using short, fluorescently labeled locked nucleic acid (LNA) probes and fluorescence polarization detection. Nucleic Acids Res 2002;30(17):e91.
23. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958;53:457-481
24. Collett D. Modelling survival data in medical research. 2nd ed. Boca Raton, FL: Chapman and Hall, 2003.
25. Fleiss JL. Statistical methods for rates and proportions. 2nd ed. New York: John Wiley, 1981.
26. Food and Drug Administration. Clinical trial endpoints for the approval of cancer drugs and biologics. (Accessed March 9, 2009, at http://www.fda.gov/ CBER/gdlns/clintrialend.pdf.)
27. Schilsky RL. End points in cancer clinical trials and the drug approval process. Clin Cancer Res 2002;8:935-938 (Pubitemid 35177337)
28. 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 (Pubitemid 23080268)
29. Arber N, Shapira I, Ratan J, et al. Activation of c-K-ras mutations in human gastrointestinal tumors. Gastroenterology 2000;118:1045-1050
30. 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;27:663-667
31. Hurwitz H, Fehrenbacher L, Novotny W, et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med 2004;350:2335-2342
32. Saltz LB, Clarke S, Diaz-Rubio E, et al. Bevacizumab in combination with oxal ipla tin-based chemotherapy as first-line therapy in metastatic colorectal cancer: a randomized phase III study. J Clin Oncol 2008;26:2013-2019
33. Khambata-Ford S, Garrett CR, Meropol NJ, et al. 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
34. 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