Cetuximab in the treatment of patients with colorectal cancer

Expert Opinion on Biological Therapy

Volumn 11, Issue 7, 2011, Pages 937-949

  Garrett, Christopher R ^a   Eng, Cathy ^a  

^a UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

Author keywords

BRAF mutation; cetuximab; colorectal cancer; EGFR; KRAS mutation

Indexed keywords

AMPHIREGULIN; B RAF KINASE; BEVACIZUMAB; BIOLOGICAL MARKER; CAPECITABINE; CETUXIMAB; CLINDAMYCIN; DOXYCYCLINE; EPIDERMAL GROWTH FACTOR RECEPTOR; EPIREGULIN; FLUOROURACIL; FOLINIC ACID; IRINOTECAN; K RAS PROTEIN; OXALIPLATIN; PANITUMUMAB; PHOSPHATIDYLINOSITOL 3 KINASE; PHOSPHATIDYLINOSITOL 3,4,5 TRISPHOSPHATE 3 PHOSPHATASE; STEROID;

ANAPHYLAXIS; ARTICLE; BOLUS INJECTION; CANCER ADJUVANT THERAPY; CANCER COMBINATION CHEMOTHERAPY; CANCER SURGERY; CANCER SURVIVAL; COLORECTAL CANCER; DISEASE FREE SURVIVAL; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG HALF LIFE; DRUG HYPERSENSITIVITY; DRUG INDUCED DISEASE; DRUG INTERMITTENT THERAPY; DRUG MECHANISM; DRUG POTENTIATION; DRUG SAFETY; GENE DOSAGE; GENE EXPRESSION; GENE MUTATION; HUMAN; HYPERTRICHOSIS; HYPOMAGNESEMIA; METASTASIS; MONOTHERAPY; OVERALL SURVIVAL; PARONYCHIA; PROGRESSION FREE SURVIVAL; RASH; SIGNAL TRANSDUCTION; TREATMENT RESPONSE;

ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAMPTOTHECIN; COLORECTAL NEOPLASMS; DISEASE-FREE SURVIVAL; EVIDENCE-BASED MEDICINE; HUMANS; INDIVIDUALIZED MEDICINE; MUTATION; PROTO-ONCOGENE PROTEINS; RAS PROTEINS; RECEPTOR, EPIDERMAL GROWTH FACTOR; SURVIVAL RATE; TIME FACTORS; TREATMENT OUTCOME; TUMOR MARKERS, BIOLOGICAL;

EID: 79958043820     PISSN: 14712598     EISSN: None     Source Type: Journal    
DOI: 10.1517/14712598.2011.582464     Document Type: Article

References (86)

1. Jemal A, Siegel R, Xu J, Ward E. Cancer statistics, 2010. CA Cancer J Clin 2010;60:277-300
2. Jemal A, Siegel R, Xu J, Ward E. Declining death rates reflect progress against cancer. PLoS One 2010;5(3):e9584
3. Jemal A, Bray F, Center MM, et al. Global cancer statistics. CA Cancer J Clin 2011;61:69-90
4. GLOBOCAN 2008 World Health Organization International Agency for Research on Cancer. Available from: http://globocan.iarc.fr/ [Accessed 14 February 2011]
5. Goldberg RM. Lessons learned from the edrecolomab story: how a checkered past became a checkered flag for monoclonal antibodies in colorectal cancer therapy. Onkologie 2005;28:311-12
6. Carpenter G. The biochemistry and physiology of the receptor-kinase for epidermal growth factor. Mol Cell Endocrinol 1983;31:1-19 (Pubitemid 13066937)
7. Salomon DS, Brandt R, Ciardiello F, Normanno N. Epidermal growth factor-related peptides and their receptors in human malignancies. Crit Rev Oncol Hematol 1995;19:183-232
8. Mendelsohn J, Baselga J. Status of epidermal growth factor receptor antagonists in the biology and treatment of cancer. J Clin Oncol 2003;21:2787-99 (Pubitemid 46606324)
9. Mendelsohn J, Baselga J. Epidermal growth factor receptor targeting in cancer. Semin Oncol 2006;33:369-85 (Pubitemid 44142736)
10. Lockhart AC, Berlin JD. The epidermal growth factor receptor as a target for colorectal cancer therapy. Semin Oncol 2005;32:432
11. Steele RJ, Kelly P, Ellul B, Eremin O. Epidermal growth factor receptor expression in colorectal cancer. Br J Surg 1990;77:1352-4
12. Kluftinger AM, Robinson BW, Quenville NF, et al. Correlation of epidermal growth factor receptor and c-erbB2 oncogene product to known prognostic indicators of colorectal cancer. Surg Oncol 1992;1:97-105
13. Sato JD, Kawamoto T, Le AD, et al. Biological effects in vitro of monoclonal antibodies to human epidermal growth factor receptors. Mol Biol Med 1983;1:511-29
14. Kawamoto TK, Sato JD, Le A, et al. Growth stimulation of A431 cells by epidermal growth factor: identification of high-affinity receptors for epidermal growth factor by an anti-receptor monoclonal antibody. Proc Natl Acad Sci USA 1983;80:1337-41 (Pubitemid 13082800)
15. Masui H, Kawamoto T, Sato JD, et al. Growth inhibition of human tumor cells in athymic mice by anti-epidermal growth factor receptor monoclonal antibodies. J Biol Chem 1984;259:7755-60
16. Khazaeli MB, LoBuglio A, Falcey J, et al. Low immunogenicity of a chimeric monoclonal antibody IMC-C225, used to treat epidermal growth factor-receptor positive tumor [abstract]. Pro Am Soc Clin Oncol 2000;19:207
17. Fracasso PM, Burris H III, 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;13:986-93 (Pubitemid 46340377)
18. Mendelsohn J. Blockade of receptors for growth factors: an anticancer therapy. Clin Cancer Res 2000;6:747-53
19. Prewett M, Hooper A, Bassi R, et al. Enhanced antitumor activity of anti-epidermal growth factor receptor monoclonal antibody IMC-C225 in combination with irinotecan (CPT-11) against human colorectal tumor xenografts. Clin Cancer Res 2002;8:994-1003 (Pubitemid 34517632)
20. Prewett M, Deevi DS, Bassi R, et al. Tumors established with cell lines selected for oxaliplatin resistance respond to oxaliplatin if combined with cetuximab. Clin Cancer Res 2007;13:7432-40
21. 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;18:904-14 (Pubitemid 30106623)
22. Pippas AW, Lenz HJ, Mayer RJ, et al. Analysis of EGFR status in metastatic colorectal cancer patients treated with cetuximab monotherapy [abstract]. J Clin Oncol 2005;23:3595
23. Saltz L, Rubin M, Hochster H, et al. Cetuximab plus irinotecan is active in irinotecan-refractory colorectal cancer that expresses epidermal growth factor receptor [abstract]. Proc Am Soc Clin Oncol 2001;20:7
24. Saltz LB, Meropol NJ, Loehrer PJ Sr, et al. Phase II trial of cetuximab in patients with refractory colorectal cancer that expresses the epidermal growth factor receptor. J Clin Oncol 2004;22:1201-8 (Pubitemid 41079832)
25. 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;351:337-45 (Pubitemid 38944402)
26. Alekshun T, Garrett C. Targeted therapies in the treatment of colorectal cancers. Cancer Control 2005;12:105-10 (Pubitemid 40647053)
27. Jonker DJ, O'Callaghan CJ, Karapetis CS, et al. Cetuximab for the treatment of colorectal cancer. N Engl J Med 2007;357:2040-8 (Pubitemid 350106711)
28. 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;359:1757-65
29. Van Cutsem E, Kohne CH, Hitre E, et al. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med 2009;360:1408-17
30. Rougier R, Stroiakovski D, Kohne C, et al. Addition of cetuximab to FOLFIRI in first-line metastatic colorectal cancer (mCRC): updated survival data and influence of KRAS status on outcome in the CRYSTAL study [abstract]. Gastrointestinal Cancers Symposium; 2009. p. 443
31. Van Cutsem E, Lang I, Folprecht G, et al. Cetuximab plus FOLFIRI: final data from the CRYSTAL study on the association of KRAS and BRAF biomarker status with treatment outcome [abstract]. J Clin Oncol 2010;28:3570
32. 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 [Epub ahead of print; doi: 10.1093/annonc/mdq632]
33. Folprecht G, Gruenberger T, Hartmann JT, et al. Cetuximab plus FOLFOX6 or cetuximab plus FOLFIRI as neoadjuvant treatment of nonresectable colorectal liver metastases: a randomized multicenter study (CELIM-study) [abstract]. Gastrointestinal Cancers Symposium; 2009. p. 296
34. Maughan TS, Adams R, Smith CG, et al. Identification of potentially responsive subsets when cetuximab is added to oxaliplatin-fluoropyrimidine chemotherapy in first-line advanced colorectal cancer : mature results of the MRC COIN trial [abstract]. J Clin Oncol 28:3502
35. Tveit K, Guren T, Glimelius B, et al. Randomized phase III study of 5-fluorouracil/folinate/oxaliplatin given continuously or intermittently with or without cetuximab, as first-line treatment of metastatic colorectal cancer: the NORDIC VII study, by the Nordic Colorectal Cancer Biomodulation Group [abstract]. Gastrointestinal Cancers Symposium; 2011. p. 365
36. 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. J Clin Oncol 2010;28(7):1181-9
37. 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(6):1141-5 (Pubitemid 351796340)
38. Alberts SR, Sargent DJ, Smyrk TC, et al. Adjuvant mFOLFOX6 with or without cetuxiumab in KRAS wild-type patients with resected stage III colon cancer: results from NCCTG Intergroup Phase III Trial N0147 [abstract]. J Clin Oncol 2010;28:3507
39. Goldberg RM, Sargent DJ, Thibodeau SN, et al. Adjuvant mFOLFOX6 plus or minus cetuximab in patients with KRAS mutant resected stage III colon cancer: NCCTG Intergroup Phase III Trial N0147 [abstract]. J Clin Oncol 2010;28:3508
40. Trotti A, Colevas AD, Setser A, et al. CTCAE v3.0: development of a comprehensive grading system for the adverse effects of cancer treatment. Semin Radiat Oncol 2003;13(3):176-81 (Pubitemid 36962641)
41. Siena S, Glynne-Jones R, Adenis A, et al. Reduced incidence of infusion-related reactions in metastatic colorectal cancer during treatment with cetuximab plus irinotecan with combined corticosteroid and antihistamine premedication. Cancer 2010;116(7):1827-37
42. O'Neil BH, Allen R, Spigel DR, et al. High incidence of cetuximab-related infusion reactions in Tennessee and North Carolina and the association with atopic history. J Clin Oncol 2007;25:3644-8 (Pubitemid 47372602)
43. Chung CH, Mirakhur B, Chan E, et al. Cetuximab-induced anaphylaxis and IgE specific for galactose-alpha-1,3-galactose. N Engl J Med 2008;358:1109-17 (Pubitemid 351398485)
44. Mitchell EP, Lacouture M, Shearer H, et al. Final STEPP results of prophylacatic versus reactive skin toxicity treatment for panitumumab-related ST in patients with metastatic colorectal cancer [abstract]. J Clin Oncol 2009:27:18s
45. Jatoi A, Dakhil SR, Sloan JA, et al. Prophylactic tetracycline does not diminish the severity of epidermal growth factor receptor inhibitor-induced rash: results from the North Central Cancer Treatment Group. Oncologist 2010;15:1016-22
46. Jatoi A, Thrower A, Sloan JA, et al. Does sunscreen prevent epidermal growth factor receptor (EGFR) inhibitor-induced rash? Results of a placebo-controlled trial from the North Central Cancer Treatment Group (N05C4). Oncologist 2010;15(9):1016-22
47. Dueland S, Sauer T, Lund-Johansen F, et al. Epidermal growth factor receptor inhibition induces trichomegaly. Ann Oncol 2005;16(10):1711-12
48. Agero AL, Dusza SW, Benvenuto-Andrade C, et al. Dermatologic side effects associated with the epidermal growth factor receptor inhibitors. J Am Acad Dermatol 2006;55(3):429-37
49. Solomon BM, Jatoi A. Epidermal Growth Factor Receptor (EGFR) Inhibitor-Induced Rash: a Consecutive Patient Series that Illustrates the Need for Rigorous Palliative Trials. J Palliat Med 2011;14:153-6
50. Saltz L, Kies M, Abbruzzese JL, et al. The presence and intensity of the cetuximab-induced acne-like rash predicts increased survival in studies across multiple malignancies [abstract]. Proc Am Soc Clin Oncol 2003;22:817
51. Van Cutsem E, Humblet Y, Gelderblom H, et al. Cetuximab dose-escalation study in patients with metastatic colorectal cancer with no or slight skin reactions on cetuximab standard dose treatment (EVEREST): pharmacokinetic and efficacy data of a randomized study [abstract]. Gastrointestinal Cancers Symposium; 2007. p. 237
52. Schrag D, Chung KY, Flombaum C, Saltz L. Cetuximab therapy and symptomatic hypomagnesemia. J Natl Cancer Inst 2005;97:1221-4 (Pubitemid 41258228)
53. Perrin C, Fabre C, Raoul JL, Boucher E. Behavioral disorders secondary to profound hypomagnesemia in a patient given cetuximab for metastatic colorectal cancer hypomagnesemia due to cetuximab treatment. Acta Oncol 2006;45:1135-6 (Pubitemid 44808503)
54. Wolf FI, Trapani V, Cittadini A, Maier JA. Hypomagnesaemia in oncologic patients: to treat or not to treat? Magnes Res 2009;22:5-9
55. 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;20:1803-10 (Pubitemid 46211358)
56. Barber TD, Vogelstein B, Kinzler KW, Velculescu VE. Somatic mutations of EGFR in colorectal cancers and glioblastomas. N Engl J Med 2004;351:2883 (Pubitemid 40051921)
57. 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;25:3230-7 (Pubitemid 47325606)
58. 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;20:4914-21 (Pubitemid 46630920)
59. Moroni M, Veronese S, Benvenuti S, et al. Gene copy number for epidermal growth factor receptor (EGFR) and clinical response to anti-EGFR treatment in colorectal cancer: a cohort study. Lancet Oncol 2005;6:279-86 (Pubitemid 40590264)
60. Moroni M, Sartore-Bianchi A, Veronese S, Siena S. EGFR FISH in colorectal cancer: what is the current reality? Lancet Oncol 2008;9:402-3 (Pubitemid 351597789)
61. Pao W, Wang TY, Riely GJ, et al. KRAS mutations and primary resistance of lung adenocarcinomas to gefitinib or erlotinib. PLoS Med 2005;2(1):e17
62. Questions and Answers on the Marketing Authorization for Vectibix, London, 20 September 2007, Doc Ref. EMEA/405113/2007. -Available from: http://www.ema.europa.eu/docs/en-GB/ document-library/Medicine-QA/2009/ 12/WC500017035.pdf [Accessed 24 January 2011]
63. Dolgin E. FDA narrows drug label usage. Nature 2009;460(7259):1069
64. De Roock W, Jonker DJ, Di Nicolantonio F, et al. Association of KRAS p.G13D mutation with outcome in patients with chemotherapy-refractory metastatic colorectal cancer treated with cetuximab. JAMA 2010;304:1812-20
65. 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;26:5705-12
66. Laurent-Puig P, Cayre A, Manceau G, et al. Analysis of PTEN, BRAF, and EGFR status in determining benefit from cetuximab therapy in wild-type KRAS metastatic colon cancer. J Clin Oncol 2009;27:5924-30
67. Rizzo S, Bronte G, Fanale D, et al. Prognostic versus predictive molecular biomarkers in colorectal cancer: is KRAS and BRAF wild type status required for anti-EGFR therapy? Cancer Treat Rev 2010;36:56-61
68. Loupakis F, Pollina L, Stasi I, et al. PTEN expression and KRAS mutations on primary tumors and metastases in the prediction of benefit from cetuximab plus irinotecan for patients with metastatic colorectal cancer. J Clin Oncol 2009;27:2622-9
69. Hsu CP, Kao TY, Chang WL, et al. Clinical significance of tumor suppressor PTEN in colorectal carcinoma. Eur J Surg Oncol 2011;37:140-7
70. Ogino S, Nosho K, Kirkner GJ, et al. PIK3CA mutation is associated with poor prognosis among patients with curatively resected colon cancer. J Clin Oncol 2009;27(9):1477-84
71. Sartore-Bianchi A, Martini M, Molinari F, et al. PIK3CA mutations in colorectal cancer are associated with clinical resistance to EGFR-targeted monoclonal antibodies. Cancer Res 2009;69:1851-7
72. Prenen H, De Schutter J, Jacobs B, et al. PIK3CA mutations are not a major determinant of resistance to the epidermal growth factor receptor inhibitor cetuximab in metastatic colorectal cancer. Clin Cancer Res 2009;15:3184-8
73. De Roock W, Claes B, Bernasconi D, et al. Effects of KRAS, BRAF, NRAS, and PIK3CA mutations on the efficacy of cetuximab plus chemotherapy in chemotherapy-refractory metastatic colorectal cancer: a retrospective consortium analysis. Lancet Oncol 2010;11(8):753-62
74. Power DG, Shah MA, Asmis TR, et al. Safety and efficacy of panitumumab following cetuximab: retrospective review of the Memorial Sloan-Kettering experience. Invest New Drugs 2010;28:353-60
75. Saif MW, Kaley K, Chu E, Copur MS. Safety and efficacy of panitumumab therapy after progression with cetuximab: experience at two institutions. Clin Colorectal Cancer 2010;9:315-18
76. Jansman FG, Postma MJ, Brouwers JR. Cost considerations in the treatment of colorectal cancer. Pharmacoeconomics 2007;25:537-62 (Pubitemid 47048039)
77. Schrag D. The price tag on progress-chemotherapy for colorectal cancer. N Engl J Med 2004;351:317-19 (Pubitemid 38944397)
78. Rothenberg ML, LaFleur B, Levy DE, et al. Randomized phase II trial of the clinical and biological effects of two dose levels of gefitinib in patients with recurrent colorectal adenocarcinoma. J Clin Oncol 2005;23:9265-74
79. Townsley CA, Major P, Siu LL, et al. Phase II study of erlotinib (OSI-774) in patients with metastatic colorectal cancer. Br J Cancer 2006;94:1136-43
80. Zhang W, Gordon M, Schultheis AM, et al. FCGR2A and FCGR3A polymorphisms associated with clinical outcome of epidermal growth factor receptor expressing metastatic colorectal cancer patients treated with single-agent cetuximab. J Clin Oncol 2007;25:3712-18 (Pubitemid 47372612)
81. Tol J, Koopman M, Cats A, et al. Chemotherapy, bevacizumab, and cetuximab in metastatic colorectal cancer. N Engl J Med 2009;360(6):563-72
82. Cappuzzo F, Finocchiaro G, Rossi E, et al. EGFR FISH assay predicts for response to cetuximab in chemotherapy refractory colorectal cancer patients. Ann Oncol 2008;19:717-23 (Pubitemid 351461042)
83. Sartore-Bianchi A, Moroni M, Veronese S, et al. Epidermal growth factor receptor gene copy number and clinical outcome of metastatic colorectal cancer treated with panitumumab. J Clin Oncol 2007;25(22):3238-45 (Pubitemid 47325607)
84. 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;26:374-9 (Pubitemid 351171687)
85. 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;19:508-15 (Pubitemid 351325672)
86. Finocchiaro G, Cappuzzo F, Janne PA, et al. EGFR, HER2 and Kras as predictive factors for cetuximab sensitivity in colorectal cancer [abstract]. J Clin Oncol 2007;18s:4021