The evolving role of monoclonal antibodies in colorectal cancer: Early presumptions and impact on clinical trial development

Oncologist

Volumn 15, Issue 1, 2010, Pages 73-84

  Eng, Cathy ^a  

^a UNIVERSITY OF TEXAS   (United States)

Author keywords

Bevacizumab; Cetuximab; Colorectal; EGFR; Panitumumab; VEGF

Indexed keywords

B RAF KINASE; BEVACIZUMAB; BIOLOGICAL MARKER; CAPECITABINE; CELECOXIB; CETUXIMAB; EPIDERMAL GROWTH FACTOR RECEPTOR KINASE INHIBITOR; FLUOROURACIL; FOLINIC ACID; IRINOTECAN; K RAS PROTEIN; MOLECULAR MARKER; OXALIPLATIN; PANITUMUMAB; PLACEBO; VASCULOTROPIN INHIBITOR;

CANCER COMBINATION CHEMOTHERAPY; CLINICAL TRIAL; COLORECTAL CANCER; DIGESTIVE SYSTEM PERFORATION; DISEASE COURSE; DISEASE SEVERITY; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG INTERMITTENT THERAPY; DRUG WITHDRAWAL; FOOD AND DRUG ADMINISTRATION; GENE MUTATION; HEALTH CARE COST; HEALTH CARE SYSTEM; HUMAN; HYPERTENSION; METASTASIS; MULTIPLE CYCLE TREATMENT; OUTCOME ASSESSMENT; PATIENT CARE; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; REVIEW; SURVIVAL RATE; THROMBOSIS; TREATMENT INDICATION; TREATMENT RESPONSE; VENOUS THROMBOEMBOLISM; WILD TYPE; WOUND HEALING IMPAIRMENT;

ANGIOGENESIS INHIBITORS; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAMPTOTHECIN; CHEMOTHERAPY, ADJUVANT; CLINICAL TRIALS AS TOPIC; COLORECTAL NEOPLASMS; GENETIC MARKERS; HUMANS; MUTATION; PROGNOSIS; PROTO-ONCOGENE PROTEINS; PROTO-ONCOGENE PROTEINS B-RAF; RAS PROTEINS; RECEPTOR, EPIDERMAL GROWTH FACTOR; TUMOR MARKERS, BIOLOGICAL; VASCULAR ENDOTHELIAL GROWTH FACTOR A;

EID: 75649089748     PISSN: 10837159     EISSN: 1549490X     Source Type: Journal    
DOI: 10.1634/theoncologist.2009-0167     Document Type: Review

References (74)

1. 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.
2. 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.
3. Jonker DJ, O'Callaghan CJ, Karapetis CS et al. Cetuximab for the treatment of colorectal cancer. N Engl J Med 2007;357:2040 -2048.
4. 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.
5. Zhang W, Gordon M, Schultheis A et al. Two immunoglobulin G fragment C receptor polymorphisms associated with clinical outcome of EGFR-expressing metastatic colorectal cancer patients treated with single agent cetuximab. J Clin Oncol 2006;24(## suppl):3028.
6. Kabbinavar F, Zurlo A, Irl C et al. Bevacizumab improves outcomes of patients with metastatic colorectal cancer (mCRC) treated with 5-fluorouracil based regimens irrespective of baseline risk. Oncology 2008;75:215-223.
7. Grothey A, Sugrue MM, Purdie DM et al. Bevacizumab beyond first pro-gression is associated with prolonged overall survival in metastatic colorectal cancer: Results from a large observational cohort study (BRiTE). J Clin Oncol 2008;26:5326 -5334.
8. Scappaticci FA, Skillings JR, Holden SN et al. Arterial thrombotic events in patients with metastatic carcinoma treated with chemotherapy and bevacizumab. J Natl Cancer Inst 2007;99:1232-1239.
9. Nalluri SR, Chu D, Keresztes R et al. Risk of venous thromboembolism with the angiogenesis inhibitor bevacizumab in cancer patients: A metaanalysis. JAMA 2008;300:2277-2285.
10. Kopetz S, Hoff PM, Morris JS et al. Phase II trial of infusional fluorouracil, irinotecan, and bevacizumab for metastatic colorectal cancer: Efficacy and circulating angiogenic biomarkers associated with therapeutic resistance. J Clin Oncol [Epub ahead of print] PMID 20008624.
11. Kocakova I, Spelda S, Kocak I et al. Phase I/II study of capecitabine plus irinotecan (XELIRI) in combination with bevacizumab as first-line therapy for metastatic colorectal cancer. Klin Onkol 2009;22:73-76.
12. Bendell JC, Fernando N, MorseMet al. A phase II study of oxaliplatin (O), capecitabine (CAP), and bevacizumab (BV) in the treatment of metastatic colorectal cancer. J Clin Oncol 2006;24(18 suppl):3541.
13. 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.
14. Colucci G, Gebbia V, Paoletti G et al. Phase III randomized trial of FOLFIRI versus FOLFOX4 in the treatment of advanced colorectal cancer: A multicenter study of the Gruppo Oncologico Dell'Italia Meridionale. J Clin Oncol 2005;23:4866-4875.
15. Cassidy J, Clarke S, Diaz-Rubio E et al. Randomized phase III study of capecitabine plus oxaliplatin compared with fluorouracil/folinic acid plus oxaliplatin as first-line therapy for metastatic colorectal cancer. J Clin Oncol 2008;26:2006 -2012.
16. Saltz LB, Clarke S, Diaz-Rubio E et al. Bevacizumab in combination with oxaliplatin-based chemotherapy as first-line therapy in metastatic colorectal cancer:Arandomized phase III study. J Clin Oncol 2008;26:2013-2019.
17. Fuchs CS, Marshall J, Mitchell E et al. Randomized, controlled trial of irinotecan plus infusional, bolus, or oral fluoropyrimidines in first-line treatment of metastatic colorectal cancer: Results from the BICC-C study. J Clin Oncol 2007;25:4779-4786.
18. Fuchs CS, Marshall J, Barrueco J. Randomized, controlled trial of irinotecan plus infusional, bolus, or oral fluoropyrimidines in first-line treatment of metastatic colorectal cancer: Updated results from the BICC-C study. J Clin Oncol 2008;26:689-690.
19. Giantonio BJ, Catalano PJ, Meropol NJ et al. Bevacizumab in combination with oxaliplatin, fluorouracil, and leucovorin (FOLFOX4) for previously treated metastatic colorectal cancer: Results from the Eastern Cooperative Oncology Group Study E3200. J Clin Oncol 2007;25:1539-1544.
20. Arnold D, Reinacher-Schick A, Müller L et al. Bevacizumab (Bev) beyond progression (BP) in combination with second-line chemotherapy (CT) after failure of a Bev containing first-line CT in patients (pts) with metastatic colorectal cancer (mCRC). Preliminary baseline and safety analysis from the AIO 0504/AGMT phase III study [abstract 469]. Proc Gastrointest Cancer Symp 2008.
21. Wilke H, Glynne-Jones R, Thaler J et al. Cetuximab plus irinotecan in heavily pretreated metastatic colorectal cancer progressing on irinotecan: MABEL study. J Clin Oncol 2008;26:5335-5343.
22. Sobrero AF, Maurel J, Fehrenbacher L et al. EPIC: Phase III trial of cetuximab plus irinotecan after fluoropyrimidine and oxaliplatin failure in patients with metastatic colorectal cancer. J Clin Oncol 2008;26:2311-2319.
23. Au H, Karapetis CS, O'Callaghan CJ et al. Health-related quality of life in patients with advanced colorectal cancer treated with cetuximab: Overall and KRAS-specific results of the NCIC CTG and AGITG CO.17 trial. J Clin Oncol 2009;27:1822-1828.
24. Erbitux® (Cetuximab) [package insert]. ImClone Systems Incorporated, New York, NY and Bristol-Myers Squibb Company, Princeton, NJ, 2007.
25. Tabernero J, Van Cutsem E, Díaz-Rubio E et al. Phase II trial of cetuximab in combination with fluorouracil, leucovorin, and oxaliplatin in the firstline treatment of metastatic colorectal cancer. J Clin Oncol 2007;25:5225-5232.
26. Borner M, Koeberle D, Van Moos R et al. Adding cetuximab to capecitabine plus oxaliplatin (XELOX) in first-line treatment of metastatic colorectal cancer: a randomized phase II trial of the Swiss Group for Clinical Cancer Research SAKK. Ann Oncol 2008;19:1288 -1292.
27. Cartwright T, Kuefler P, Cohn A et al. Results of a phase II trial of cetuximab plus capecitabine/irinotecan as first-line therapy for patients with advanced and/or metastatic colorectal cancer. Clin Colorectal Cancer 2008; 7:390 -397.
28. 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.
29. 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: 1408-1417.
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- 671.
31. Van Cutsem E, Rougier P, Kohne CH et al.Ameta-analysis of the CRYSTAL and OPUS studies combining cetuximab with chemotherapy (CT) as 1st-line treatment for patients (pts) with metastatic colorectal cancer (mCRC): Results according to KRAS and BRAF mutation status [abstract 6077]. Presented at the ECCO 15-ESMO 34 European Multidisciplinary Congress, Berlin, Germany, September 20-24, 2009.
32. Maughan T, Adams RA, Smith C et al. Addition of cetuximab to oxaliplatin-based combination chemotherapy (CT) in patients with KRAS wild-type advanced colorectal cancer (ACRC): A randomised superiority trial (MRC COIN). Eur J Cancer Suppl 2009;7:4.
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. Lièvre A, Bachet JB, Le CorreDet al. KRAS mutation status is predictive of response to cetuximab therapy in colorectal cancer. Cancer Res 2006;66: 3992-3995.
35. 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.
36. 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.
37. 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.
38. Karapetis CS, Khambata-Ford S, Jonker DJ et al. K-Ras mutations and benefit from cetuximab in advanced colorectal cancer.NEngl J Med 2008;359: 1757-1765.
39. 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.
40. Douillard J, Siena S, Cassidy J et al. Randomized phase III study of panitumumab with FOLFOX4 compared to FOLFOX4 alone as first line treatment in patients with metastatic colorectal cancer (mCRC): The PRIME trial. Eur J Cancer Suppl 2009;7:6.
41. Peeters M, Price T, Hotko Y et al. Randomized phase III study (20050181) of panitumumab with FOLFIRI compared to FOLFIRI alone as second-line treatment in patients with metastatic colorectal cancer (mCRC). Eur J Cancer Suppl 2009;7:9.
42. 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.
43. Farina A, Moerland E, van Lijnschoten G et al. K-ras and Braf mutation analysis has clinical value in stage III colon carcinoma [abstract 6114]. Eur J Cancer Suppl 2009;7:357.
44. Siena S, Sartore-Bianchi A, Di Nicolantonio F et al. Biomarkers predicting clinical outcome of epidermal growth factor receptor-targeted therapy in metastatic colorectal cancer. J Natl Cancer Inst 2009;101:1308 -1324.
45. 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 -5930.
46. Vukelja S, Richards D, Campos LT et al. Randomized phase II study of perifosine in combination with capecitabine vs. capecitabine alone in patients with second or third line metastatic colon cancer. J Clin Oncol 2009; 27(15 suppl):4081.
47. Garcia A, Rosen L, Cunningham CC et al. Phase 1 study of ARQ 197, a selective inhibitor of the c-Met RTK in patients with metastatic solid tumors reaches recommended phase 2 dose. J Clin Oncol 2007;25(18 suppl): 3525.
48. Kammula US, Kuntz EJ, Francone TD et al. Molecular co-expression of the c-Met oncogene and hepatocyte growth factor in primary colon cancer predicts tumor stage and clinical outcome. Cancer Lett 2007;248:219 -228.
49. Kaulfuss S, Burfeind P, Gaedcke J et al. Dual silencing of insulin-like growth factor-I receptor and epidermal growth factor receptor in colorectal cancer cells is associated with decreased proliferation and enhanced apoptosis. Mol Cancer Ther 2009;8:821- 833.
50. Ciardiello F, Bianco R, DamianoVet al. Angiogenic and antitumor activity of anti-epidermal growth factor receptor C225 monoclonal antibody in combination with vascular endothelial growth factor antisense oligonucleotide in human GEO cancer cells. Clin Cancer Res 2000;6:3739 -3747.
51. Petit AM, Rak J, Hung MC et al. Neutralizing antibodies against epidermal growth factor and ErbB-2/neu receptor tyrosine kinases down-regulate vascular endothelial growth factor production by tumor cells in vitro and in vivo: Angiogenic implications for signal transduction therapy of solid tumors. Am J Pathol 1997;151:1523-1530.
52. Saltz LB, Lenz H, KindlerHLet al. Randomized phase II trial of cetuximab, bevacizumab, and irinotecan compared with cetuximab and bevacizumab alone in irinotecan-refractory colorectal cancer: The BOND-2 study. J Clin Oncol 2007;25:4557- 4561.
53. 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- 680.
54. Berlin J, Posey J, Tchekmedyian S et al. Panitumumab with irinotecan/ leucovorin/5-fluorouracil for first-line treatment of metastatic colorectal cancer. Clin Colorectal Cancer 2007;6:427- 432.
55. Tol J, Koopman M, Cats A et al. Chemotherapy, bevacizumab, and cetuximab in metastatic colorectal cancer. N Engl J Med 2009;360:563-572.
56. Tol J, Nagtegaal ID, Punt CJ. BRAF mutation in metastatic colorectal cancer. N Engl J Med 2009;361:98 -99.
57. Tol J, Dijkstra JR, Vink-Borger ME et al. BRAF mutation is associated with a decreased outcome in patients (pts) with advanced colorectal cancer (ACC) treated with chemotherapy and bevacizumab with or without cetuximab. Eur J Cancer Suppl 2009;7:321.
58. Venook A, Blanke CD, Goldberg RM et al. Assessing the combination of FOLFOX or FOLFIRI with bevacizumab, cetuximab, or both in metastatic colorectal cancer. Comm Oncol 2006;3:593-598.
59. Allegra CJ, Yothers G, O'Connell MJ et al. Initial safety report of NSABP C-08:Arandomized phase III study of modified FOLFOX6 with or without bevacizumab for the adjuvant treatment of patients with stage II or III colon cancer. J Clin Oncol 2009;27:3385-3390.
60. Wolmark N, Yothers G, O'Connell MJ et al. A phase III trial comparing mFOLFOX6 to mFOLFOX6 plus bevacizumab in stage II or III carcinoma of the colon: Results of NSABP Protocol C-08. J Clin Oncol 2009;27(18 suppl):LBA4.
61. ClinicalTrials.gov. Combination Chemotherapy With or Without Bevacizumab in Treating Patients Who Have Had Surgery for Stage II or Stage III Rectal Cancer. ClinicalTrials.gov Identifier: NCT0030628. Available at http://www.cancer.gov/search/SearchClinicalTrials.aspx, accessed July 17, 2009.
62. Hoff P, Clarke S, Cunningham D et al. A three-arm phase III randomized trial of FOLFOX-4 vs. FOLFOX-4 plus bevacizumab vs. XELOX plus bevacizumab in the adjuvant treatment of patients with stage III or high-risk stage II colon cancer: Results of the interim safety analysis of the AVANT trial. Eur J Cancer Suppl 2009;7:324.
63. ClinicalTrials.gov. Oxaliplatin, Leucovorin, and Fluorouracil With and Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer. ClinicalTrials.gov Identifier: NCT00217737. Available at http://www.cancer.gov/search/SearchClinicalTrials.aspx, accessed July 17, 2009.
64. ClinicalTrials.gov. Combination Chemotherapy With or Without Cetuximab in Treating Patients With Stage III Colon Cancer That Was Completely Removed by Surgery. ClinicalTrials.gov Identifier: NCT00265811. Available at http://www.cancer.gov/search/SearchClinicalTrials.aspx, accessed July 17, 2009.
65. Tappenden P, Jones R, Paisley S et al. The cost-effectiveness of bevacizumab in the first-line treatment of metastatic colorectal cancer in England and Wales. Eur J Cancer 2007;43:2487-2494.
66. Tappenden P, Jones R, Paisley S et al. Systemic review and economic evaluation of bevacizumab and cetuximab for the treatment of metastatic colorectal cancer. Health Technol Assess 2007;11:1-128.
67. Jansman FG, Postma MJ, Brouwers JR. Cost considerations in the treatment of colorectal cancer. Pharmacoeconomics 2007;25:537-562.
68. Starling N, Tilden D, White J et al. Cost-effectiveness analysis of cetuximab/irinotecan vs active/best supportive care for the treatment of metastatic colorectal cancer patients who have failed previous chemotherapy treatment. Br J Cancer 2007;96:206 -212.
69. Annemans L, Van Cutsem E, Humblet Y et al. Cost-effectiveness of cetuximab in combination with irinotecan compared with current care in metastatic colorectal cancer after failure on irinotecan: A Belgian analysis. Acta Clin Belg 2007;62:419-425.
70. Shiroiwa T, Fukuda T, Tsutani K. Cost-effectiveness analysis of bevacizumab combined with chemotherapy for the treatment of metastatic colorectal cancer in Japan. Clin Ther 2007;29:2256 -2267.
71. Schrag D, Naughton M, KesselheimAet al. Clinical trial participants' strategies for coping with prescription drug costs: A companion study to CALGB 80405. J Clin Oncol 2009;27(15 suppl):9503.
72. Wong YN, Meropol NJ, SpeierWet al. Cost implications of new treatments for advanced colorectal cancer. Cancer 2009;115:2081-2091.
73. Shankaran V, Bentrem DJ, Mulcahy MF et al. Economic implications of Kras testing in metastatic colorectal cancer (mCRC) [abstract 298]. Presented at the 2009 Gastrointestinal Cancers Symposium (ASCO), San Francisco, CA, January 15-17, 2009.
74. Meropol NJ, Schrag D, Smith TJ et al. American Society of Clinical Oncology Guidance Statement: The cost of cancer care. J Clin Oncol 2009;27: 3868-3874.