Integrating anti-EGFR therapies in metastatic colorectal cancer

Journal of Gastrointestinal Oncology

Volumn 4, Issue 3, 2013, Pages 285-298

  Haraldsdottir, Sigurdis ^a   Bekaii Saab, Tanios ^a  

^a OHIO STATE UNIVERSITY   (United States)

Author keywords

Cetuximab; Epidermal growth factor inhibitors (EGFR inhibitor); KRAS; Metastatic colorectal cancer (mCRC); Panitumumab; Targeted therapy

Indexed keywords

BEVACIZUMAB; CAPECITABINE; CETUXIMAB; DOXYCYCLINE; EPIDERMAL GROWTH FACTOR RECEPTOR; EPIDERMAL GROWTH FACTOR RECEPTOR KINASE INHIBITOR; FLUOROURACIL; FOLINIC ACID; HYDROCORTISONE; IRINOTECAN; OXALIPLATIN; PANITUMUMAB; SUNSCREEN; VASCULOTROPIN INHIBITOR;

ACNE; ANOREXIA; ANTIANGIOGENIC ACTIVITY; ANTIBODY DEPENDENT CELLULAR CYTOTOXICITY; APOPTOSIS; CANCER INHIBITION; CANCER RESISTANCE; CELL CYCLE ARREST; CHEMOTHERAPY INDUCED EMESIS; COLORECTAL CANCER; DEHYDRATION; DIARRHEA; DISEASE FREE SURVIVAL; DOSAGE SCHEDULE COMPARISON; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG ERUPTION; DRUG HALF LIFE; DRUG HYPERSENSITIVITY; DRUG WITHDRAWAL; ELECTROLYTE DISTURBANCE; ERYTHEMA; FATIGUE; FEBRILE NEUTROPENIA; GASTROINTESTINAL TOXICITY; GENE MUTATION; HUMAN; HYPOKALEMIA; HYPOMAGNESEMIA; INFUSION RELATED REACTION; LIVER METASTASIS; LOADING DRUG DOSE; LUNG EMBOLISM; METASTASIS INHIBITION; METASTATIC COLORECTAL CANCER; MOLECULARLY TARGETED THERAPY; MUCOSA INFLAMMATION; NAIL; NAUSEA; NEUTROPENIA; ONCOGENE K RAS; OVERALL SURVIVAL; PARONYCHIA; PROGRESSION FREE SURVIVAL; RASH; REVIEW; SIDE EFFECT; SKIN EXFOLIATION; SKIN PRURITUS; SKIN TOXICITY; SURVIVAL RATE; UNSPECIFIED SIDE EFFECT;

EID: 84995743870     PISSN: 20786891     EISSN: 2219679X     Source Type: Journal    
DOI: 10.3978/j.issn.2078-6891.2013.028     Document Type: Review

References (82)

1. Siegel R, Ward E, Brawley O, et al. Cancer statistics, 2011: the impact of eliminating socioeconomic and racial disparities on premature cancer deaths. CA Cancer J Clin 2011;61:212-36.
2. Gray BN. Colorectal cancer: the natural history of disseminated disease-a review. Aust N Z J Surg 1980;50:643-6.
3. Sanoff HK, Sargent DJ, Campbell ME, et al. Five-year data and prognostic factor analysis of oxaliplatin and irinotecan combinations for advanced colorectal cancer: N9741. J Clin Oncol 2008;26:5721-7.
4. Salomon DS, Brandt R, Ciardiello F, et al. Epidermal growth factor-related peptides and their receptors in human malignancies. Crit Rev Oncol Hematol 1995;19:183-232.
5. Ciardiello F, Tortora G. EGFR antagonists in cancer treatment. N Engl J Med 2008;358:1160-74.
6. Messa C, Russo F, Caruso MG, et al. EGF, TGF-alpha, and EGF-R in human colorectal adenocarcinoma. Acta Oncol 1998;37:285-9.
7. Porebska I, Harlozinska A, Bojarowski T. Expression of the tyrosine kinase activity growth factor receptors (EGFR, ERB B2, ERB B3) in colorectal adenocarcinomas and adenomas. Tumour Biol 2000;21:105-15.
8. 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;92:1331-46.
9. Mayer A, Takimoto M, Fritz E, et al. The prognostic significance of proliferating cell nuclear antigen, epidermal growth factor receptor, and mdr gene expression in colorectal cancer. Cancer 1993;71:2454-60.
10. Spano JP, Lagorce C, Atlan D, et al. Impact of EGFR expression on colorectal cancer patient prognosis and survival. Ann Oncol 2005;16:102-8.
11. Resnick MB, Routhier J, Konkin T, et al. Epidermal growth factor receptor, c-MET, beta-catenin, and p53 expression as prognostic indicators in stage II colon cancer: a tissue microarray study. Clin Cancer Res 2004;10:3069-75.
12. Baselga J. The EGFR as a target for anticancer therapy-- focus on cetuximab. Eur J Cancer 2001;37 Suppl 4:S16-22.
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;360:1408-17.
14. Li S, Schmitz KR, Jeffrey PD, et al. Structural basis for inhibition of the epidermal growth factor receptor by cetuximab. Cancer Cell 2005;7:301-11.
15. 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;25:3712-8.
16. 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 U S A 1986;83:3825-9.
17. Squibb B-M. Erbitux Package Insert. Available online: http://packageinserts.bms.com/pi/pi_erbitux.pdf, Rev March 2013.
18. 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;19:1141-5.
19. Network NCC. NCCN clinical practice guidelines in oncology (NCCN Guidelines): colon cancer. Version 3. 2013. Accessed 04/25/13.
20. Yang XD, Jia XC, Corvalan JR, et al. Eradication of established tumors by a fully human monoclonal antibody to the epidermal growth factor receptor without concomitant chemotherapy. Cancer Res 1999;59:1236-43.
21. Inc. A. Vectibix Package Insert. Available online: http://pi.amgen.com/united_states/vectibix/vectibix_pi.pdf, Rev March 2013.
22. 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;66:3992-5.
23. Brink M, de Goeij AF, Weijenberg MP, et al. K-ras oncogene mutations in sporadic colorectal cancer in The Netherlands Cohort Study. Carcinogenesis 2003;24:703-10.
24. 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.
25. Van Cutsem E, Köhne CH, Láng I, et al. Cetuximab plus irinotecan, fluorouracil, and leucovorin as first-linefor metastatic colorectal cancer: updated analysis of overall survival according to tumor KRAS and BRAF mutation status. J Clin Oncol 2011;29:2011-9.
26. 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;27:663-71.
27. Maughan TS, Adams RA, Smith CG, et al. Addition of cetuximab to oxaliplatin-based first-line combination chemotherapy for treatment of advanced colorectal cancer: results of the randomised phase 3 MRC COIN trial. Lancet 2011;377:2103-14.
28. Tveit KM, Guren T, Glimelius B, et al. Phase III trial of cetuximab with continuous or intermittent fluorouracil, leucovorin, and oxaliplatin (Nordic FLOX) versus FLOX alone in first-line treatment of metastatic colorectal cancer: the NORDIC-VII study. J Clin Oncol 2012;30:1755-62.
29. 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;26:1626-34.
30. Peeters M, Price TJ, Cervantes A, et al. Randomized phase III study of panitumumab with fluorouracil, leucovorin, and irinotecan (FOLFIRI) compared with FOLFIRI alone as second-line treatment in patients with metastatic colorectal cancer. J Clin Oncol 2010;28:4706-13.
31. Douillard JY, Siena S, Cassidy J, et al. Randomized, phase III trial of panitumumab with infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX4) versus FOLFOX4 alone as first-line treatment in patients with previously untreated metastatic colorectal cancer: the PRIME study. J Clin Oncol 2010;28:4697-705.
32. Barber TD, Vogelstein B, Kinzler KW, et al. Somatic mutations of EGFR in colorectal cancers and glioblastomas. N Engl J Med 2004;351:2883.
33. Di Nicolantonio F, Martini M, Molinari F, et al. Wildtype BRAF is required for response to panitumumab or cetuximab in metastatic colorectal cancer. J Clin Oncol 2008;26:5705-12.
34. 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;23:1803-10.
35. Hecht JR, Mitchell E, Neubauer MA, et al. Lack of correlation between epidermal growth factor receptor status and response to Panitumumab monotherapy in metastatic colorectal cancer. Clin Cancer Res 2010;16:2205-13.
36. Jiang Z, Li C, Li F, et al. EGFR gene copy number as a prognostic marker in colorectal cancer patients treated with cetuximab or panitumumab: a systematic review and meta analysis. PLoS One 2013;8:e56205.
37. Linardou H, Dahabreh IJ, Kanaloupiti D, et al. Assessment of somatic k-RAS mutations as a mechanism associated with resistance to EGFR-targeted agents: a systematic review and meta-analysis of studies in advanced non-smallcell lung cancer and metastatic colorectal cancer. Lancet Oncol 2008;9:962-72.
38. Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group. Recommendations from the EGAPP Working Group: can testing of tumor tissue for mutations in EGFR pathway downstream effector genes in patients with metastatic colorectal cancer improve health outcomes by guiding decisions regarding anti-EGFR therapy?. Genet Med 2013;15:517-27.
39. Han CB, Li F, Ma JT, et al. Concordant KRAS mutations in primary and metastatic colorectal cancer tissue specimens: a meta-analysis and systematic review. Cancer Invest 2012;30:741-7.
40. Jonker DJ, O'Callaghan CJ, Karapetis CS, et al. Cetuximab for the treatment of colorectal cancer. N Engl J Med 2007;357:2040-8.
41. 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;25:1658-64.
42. Cunningham D, Humblet Y, Siena S, et al. Cetuximab monotherapy and cetuximab plus irinotecan in irinotecanrefractory metastatic colorectal cancer. N Engl J Med 2004;351:337-45.
43. Langer C, Kopit J, Awad M, et al. Analysis of K-RAS mutations in patients with metastatic colorectal cancer receiving cetuximab in combination with irinotecan: results from the EPIC trial. Ann Oncol 2008;19:133.
44. Taieb J, Maughan TS, Bokemeyer C, et al. Cetuximab combined with infusional 5-fluorouracil/folinic acid (5- FU/FA) and oxaliplatin in metastatic colorectal cancer (mCRC): a pooled analysis of COIN and OPUS study data. J Clin Oncol 2012;30:abstr 3574.
45. Schmoll HJ, Van Cutsem E, Stein A et al. ESMO Consensus Guidelines for management of patients with colon and rectal cancer. A personalized approach to clinical decision making. Ann Oncol 2012;23:2479-516.
46. Oliner K, Douillard J, Siena S, et al. Analysis of KRAS/ NRAS and BRAF mutations in the phase III PRIME study of panitumumab (pmab) plus FOLFOX versus FOLFOX as first-line treatment (tx) for metastatic colorectal cancer (mCRC). Available online: http://www.asco.org/sites/www.asco.org/files/abstract_115136.pdf, 2013.
47. Saltz LB, Lenz HJ, Kindler HL, et al. Randomized phase II trial of cetuximab, bevacizumab, and irinotecan compared with cetuximab and bevacizumab alone inirinotecan-refractory colorectal cancer: the BOND-2 study. J Clin Oncol 2007;25:4557-61.
48. Tol J, Koopman M, Cats A, et al. Chemotherapy, bevacizumab, and cetuximab in metastatic colorectal cancer. N Engl J Med 2009;360:563-72.
49. Hecht JR, Mitchell E, Chidiac T, et al. A randomized phase IIIB trial of chemotherapy, bevacizumab, and panitumumab compared with chemotherapy and bevacizumab alone for metastatic colorectal cancer. J Clin Oncol 2009;27:672-80.
50. Alberts SR, Sargent DJ, Nair S, et al. Effect of oxaliplatin, fluorouracil, and leucovorin with or without cetuximab on survival among patients with resected stage III colon cancer: a randomized trial. JAMA 2012;307:1383-93.
51. Schwartzberg L, Rivera F, Karthaus M, et al. PEAK (study 20070509): A randomized phase II study of mFOLFOX6 with either panitumumab (pmab) or bevacizumab (bev) as first-line treatment (tx) in patients (pts) with unresectable wild type (WT) KRAS metastatic colorectal cancer (mCRC). J Clin Oncol 2012;30:abstr 446.
52. Hecht J, Cohn A, Dakhil S, et al. SPIRITT (study 20060141): A randomized phase II study of FOLFIRI with either panitumumab (pmab) or bevacizumab (bev) as second-line treatment (tx) in patients (pts) with wild-type (WT) KRAS metastatic colorectal cancer (mCRC). J Clin Oncol 2012;30:abstr 454.
53. Venook AP, Blanke CD, Niedzwiecki D, et al. Revisiting the Cancer and Leukemia Group B/Southwest Oncology Group 80405 Trial: a phase III trial of chemotherapy and biologic agents for patients with untreated advanced colorectal adenocarcinoma. Clin Colorectal Cancer 2007;6:536-8.
54. ClinicalTrials.gov. 5-FU, folinic acid and irinotecan (FOLFIRI) plus cetuximab versus FOLFIRI plus bevacizumab in first line treatment colorectal cancer (CRC). Available online: http://clinicaltrials.gov/ct2/show/NCT00433927, Accessed 05/08/2013.
55. Haraldsdottir S, Rose JS, Wu C, et al. A single institutional experience with panitumumab in metastatic colorectal cancer. Journal of Cancer Therapy 2012;3:948-55.
56. Folprecht G, Gruenberger T, Bechstein WO, et al. Tumour response and secondary resectability of colorectal liver metastases following neoadjuvant chemotherapy with cetuximab: the CELIM randomised phase 2 trial. Lancet oncol 2010;11:38-47.
57. Xu J, Ye L, Ren L, et al. A randomized, controlled trial of cetuximab plus chemotherapy for patients with KRAS wild-type unresectable colorectal liver-limited metastasis. ESMO (ed).2012:abstract 1806.
58. Tejpar S, Celik I, Schlichting M, et al. Association of KRAS G13D tumor mutations with outcome in patients with metastatic colorectal cancer treated with first-line chemotherapy with or without cetuximab. J Clin Oncol 2012;30:3570-7.
59. Peeters M, Douillard JY, Van Cutsem E, et al. Mutant KRAS codon 12 and 13 alleles in patients with metastatic colorectal cancer: assessment as prognostic and predictive biomarkers of response to panitumumab. J Clin Oncol 2013;31:759-65.
60. Chen J, Ye Y, Sun H, et al. Association between KRAS codon 13 mutations and clinical response to anti- EGFR treatment in patients with metastatic colorectal cancer: results from a meta-analysis. Cancer Chemother Pharmacol 2013;71:265-72.
61. Metges J, Raoul J, Achour N, et al. PANERB study: panitumumab after cetuximab-based regimen failure. J Clin Oncol 2010;28:e14000.
62. Wadlow RC, Hezel AF, Abrams TA, et al. Panitumumab in patients with KRAS wild-type colorectal cancer after progression on cetuximab. Oncologist 2012;17:14.
63. 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.
64. Lacouture ME, Mitchell EP, Piperdi B, et al. Skin toxicity evaluation protocol with panitumumab (STEPP), a phase II, open-label, randomized trial evaluating the impact of a pre-Emptive Skin treatment regimen on skin toxicities and quality of life in patients with metastatic colorectal cancer. J Clin Oncol 2010;28:1351-7.
65. Peeters M, Van Cutsem E, Berlin J, et al. Safety of panitumumab, a fully human monoclonal antibody against the epidermal growth factor receptor (EGFr), in patients (pts) with metastatic colorectal cancer (mCRC) across clinical trials. J Clin Oncol 2007;25:4138.
66. Peeters M, Siena S, Van Cutsem E, et al. Association of progression-free survival, overall survival, and patientreported outcomes by skin toxicity and KRAS status in patients receiving panitumumab monotherapy. Cancer 2009;115:1544-54.
67. Van Cutsem E, Tejpar S, Vanbeckevoort D, et al. Intrapatient cetuximab dose escalation in metastatic colorectal cancer according to the grade of early skin reactions: the randomized EVEREST study. J Clin Oncol 2012;30:2861-8.
68. Chung CH, Mirakhur B, Chan E, et al. Cetuximabinduced anaphylaxis and IgE specific for galactose-alpha- 1,3-galactose. N Engl J Med 2008;358:1109-17.
69. Samuels Y, Wang Z, Bardelli A, et al. High frequency of mutations of the PIK3CA gene in human cancers. Science 2004;304:554.
70. Sartore-Bianchi A, Martini M, Molinari F, et al. PIK3CAmutations in colorectal cancer are associated with clinical resistance to EGFR-targeted monoclonal antibodies. Cancer Res 2009;69:1851-7.
71. Frattini M, Saletti P, Romagnani E, et al. PTEN loss of expression predicts cetuximab efficacy in metastatic colorectal cancer patients. Br J Cancer 2007;97:1139-45.
72. 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.
73. Perrone F, Lampis A, Orsenigo M, et al. PI3KCA/ PTEN deregulation contributes to impaired responses to cetuximab in metastatic colorectal cancer patients. Ann Oncol 2009;20:84-90.
74. 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.
75. Souglakos J, Philips J, Wang R, et al. Prognostic and predictive value of common mutations for treatment response and survival in patients with metastatic colorectal cancer. Br J Cancer 2009;101:465-72.
76. 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 chemotherapyrefractory metastatic colorectal cancer: a retrospective consortium analysis. Lancet Oncol 2010;11:753-62.
77. Montagut C, Dalmases A, Bellosillo B, et al. Identification of a mutation in the extracellular domain of the Epidermal Growth Factor Receptor conferring cetuximab resistance in colorectal cancer. Nat Med 2012;18:221-3.
78. Misale S, Yaeger R, Hobor S, et al. Emergence of KRAS mutations and acquired resistance to anti-EGFR therapy in colorectal cancer. Nature 2012;486:532-6.
79. Scartozzi M, Mandolesi A, Giampieri R, et al. Insulin-like growth factor 1 expression correlates with clinical outcome in K-RAS wild type colorectal cancer patients treated with cetuximab and irinotecan. Int J Cancer 2010;127:1941-7.
80. Scartozzi M, Mandolesi A, Giampieri R, et al. The role of HER-3 expression in the prediction of clinical outcome for advanced colorectal cancer patients receiving irinotecan and cetuximab. Oncologist 2011;16:53-60.
81. Seiden-Long IM, Brown KR, Shih W, et al. Transcriptional targets of hepatocyte growth factor signaling and Kiras oncogene activation in colorectal cancer. Oncogene 2006;25:91-102.
82. Engelman JA, Zejnullahu K, Mitsudomi T, et al. MET amplification leads to gefitinib resistance in lung cancer by activating ERBB3 signaling. Science 2007;316:1039-43.