The safety of monoclonal antibodies for treatment of colorectal cancer

References

• Stintzing S. Management of colorectal cancer. F1000Prime Rep. 2014;4(6):108.
   Google Scholar
• Jain RK. Normalizing tumor vasculature with anti-angiogenic therapy: a new paradigm for combination therapy. Nat Med. 2001;7(9):987–989.
   PubMed Web of Science ®Google Scholar
• Bergers G, Benjamin LE. Tumorigenesis and the angiogenic switch. Nat Rev Cancer. 2003;3(6):401–410.
   PubMed Web of Science ®Google Scholar
• Allegra CJ, Rumble RB, Hamilton SR, et al. Extended RAS gene mutation testing in metastatic colorectal carcinoma to predict response to anti-epidermal growth factor receptor monoclonal antibody therapy: American Society of Clinical Oncology Provisional Clinical Opinion Update 2015. J Clin Oncol. 2016;34(2):179–185.
   PubMed Web of Science ®Google Scholar
• 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(8):1166–1169.
   PubMed Web of Science ®Google Scholar
• Lievre A, Bachet J-B, Le Corre D, et al. KRAS mutation status is predictive of response to cetuximab therapy in colorectal cancer. Cancer Res. 2006;66(8):3992–3995.
   PubMed Web of Science ®Google Scholar
• Kirstein MM, Lange A, Prenzler A, et al. Targeted therapies in metastatic colorectal cancer: a systematic review and assessment of currently available data. Oncologist. 2014 Nov;19(11):1156–1168.
   PubMed Web of Science ®Google Scholar
• Hurwitz H, Fehrenbacher L, Novotny W, et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med. 2004;350(23):2335–2342.
   PubMed Web of Science ®Google Scholar
• Saltz LB, Cox JV, Blanke C, et al Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. N Engl J Med. 2000;343(13):905–914.
   PubMed Web of Science ®Google Scholar
• 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 randomized trial. Lancet. 2000;355(9212):1041–1047.
   PubMed Web of Science ®Google Scholar
• Passardi A, Nanni O, Tassinari D, et al. Effectiveness of bevacizumab added to standard chemotherapy in metastatic colorectal cancer: final results for first-line treatment from the ITACa randomized clinical trial. Ann Oncol. 2015 Jun;26(6):1201–1207.
   PubMed Web of Science ®Google Scholar
• Hurwitz HI, Tebbutt NC, Kabbinavar F, et al. Efficacy and safety of bevacizumab in metastatic colorectal cancer: pooled analysis from seven randomized controlled trials. Oncologist. 2013;18(9):1004–1012.
   PubMed Web of Science ®Google Scholar
• Saltz LB, Clarke S, Díaz-Rubio E, et al. Bevacizumab in combination with oxaliplatin-based chemotherapy as first-line therapy in metastatic colorectal cancer: a randomized phase III study. J Clin Oncol. 2008;26(12):2013–2019.
   PubMed Web of Science ®Google Scholar
• Hochster HS, Hart LL, Ramanathan RK, et al. Safety and efficacy of oxaliplatin and fluoropyrimidine regimens with or without bevacizumab as first-line treatment of metastatic colorectal cancer: results of the TREE Study. J Clin Oncol. 2008;26(21):3523–3529.
   PubMed Web of Science ®Google Scholar
• Lenz HJ, Niedzwiecki D, Innocenti F, et al. CALGB/SWOG 80405: phase III trial of irinotecan/5-FU/leucovorin (FOLFIRI) or oxaliplatin/5-FU/leucovorin (mFOLFOX6) with bevacizumab (BV) or cetuximab (CET) for patients with expanded ras analyses untreated metastatic adenocarcinoma of the colon or rectum (MCRC). Abstract 5010. Ann Oncol. 2014;25(suppl 4):v1–v41. doi:10.1093/annonc/mdu438.13. Oral presentation at the European Society of Medical Oncology congress 2014.
   Google Scholar
• Heinemann V, Von Weikersthal LF, Decker T, et al. FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer (FIRE-3): a randomised, open-label, phase 3 trial. Lancet Oncol. 2014;15(10):1065–1075.
   PubMed Web of Science ®Google Scholar
• Bennouna J, Sastre J, Arnold D, et al. Continuation of bevacizumab after first progression in metastatic colorectal cancer (ML18147): a randomised phase 3 trial. Lancet Oncol. 2013 Jan;14(1):29–37.
   PubMed Web of Science ®Google Scholar
• Tabernero J, Yoshino T, Cohn AL, et al. Ramucirumab versus placebo in combination with second-line FOLFIRI in patients with metastatic colorectal carcinoma that progressed during or after first-line therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine (RAISE): a randomised, double-blind, multicentre, phase 3 study. Lancet Oncol. 2015 May;16(5):499–508.
   PubMed Web of Science ®Google Scholar
• National Cancer Institute. FDA approval for Ramucirumab [Internet]. 2014. [updated 2015 Apr 30; cited 2016 Feb 20]. Available from: http://www.cancer.gov/about-cancer/treatment/drugs/fda-ramucirumab
   Google Scholar
• Van Cutsem E, Tabernero J, Lakomy R, et al. Addition of aflibercept to fluorouracil, leucovorin, and irinotecan improves survival in a phase III randomized trial in patients with metastatic colorectal cancer previously treated with an oxaliplatin-based regimen. J Clin Oncol. 2012;30(28):3499–3506.
   PubMed Web of Science ®Google Scholar
• Galizia G, Lieto E, De Vita F, et al. Cetuximab, a chimeric human mouse anti-epidermal growth factor receptor monoclonal antibody, in the treatment of human colorectal cancer. Oncogene. 2007;26(25):3654–3660.
   PubMed Web of Science ®Google Scholar
• Van Cutsem E, Köhne CH, Hitre EN, et al. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med. 2009;360(14):1408–1417.
   PubMed Web of Science ®Google Scholar
• 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;22(7):1535–1546.
   PubMed Web of Science ®Google Scholar
• 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(9783):2103–2114.
   PubMed Web of Science ®Google Scholar
• 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(15):1755–1762.
   PubMed Web of Science ®Google Scholar
• Jonker DJ, O’Callaghan CJ, Karapetis CS, et al. Cetuximab for the treatment of colorectal cancer. N Engl J Med. 2007;357(20):2040–2048.
   PubMed Web of Science ®Google Scholar
• 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(13):1658–1664.
   PubMed Web of Science ®Google Scholar
• 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(10):1626–1634.
   PubMed Web of Science ®Google Scholar
• Douillard JY, Siena S, Cassidy J, et al. Final results from PRIME: randomized phase III study of panitumumab with FOLFOX4 for first-line treatment of metastatic colorectal cancer. Ann Oncol. 2014 Jul;25(7):1346–1355.
   PubMed Web of Science ®Google Scholar
• Douillard JY, Oliner KS, Siena S, et al. Panitumumab-FOLFOX4 treatment and RAS mutations in colorectal cancer. N Engl J Med. 2013;369(11):1023–1034.
   PubMed Web of Science ®Google Scholar
• Price TJ, Peeters M, Kim TW, et al. Panitumumab versus cetuximab in patients with chemotherapy-refractory wild-type KRAS exon 2 metastatic colorectal cancer: a randomised, multicentre, open-label, non-inferiority phase 3 study. Lancet Oncol. 2014;15(6):569–579.
   PubMed Web of Science ®Google Scholar
• Adams GP, Weiner LM. Monoclonal antibody therapy of cancer. Nat Biotechnol. 2005;23(9):1147–1157.
   PubMed Web of Science ®Google Scholar
• FDA 1.14.2.3, final labeling text, bevacizumab, dosage and administration, metastatic colorectal cancer (2.2) [Internet]. 2004. [revised 2009 May; cited 2016 Feb 23]. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125085s0169lbl.pdf
   Google Scholar
• FDA, U.S. Food and Drug Administration. FDA news release, P04-23. FDA approves first angiogenesis inhibitor to treat colorectal cancer [Internet]. 2004 [updated 2013 Mar 29; cited 2016 Feb 24]. Available from: http://www.fda.gov/newsevents/newsroom/pressannouncements/2004/ucm108252.htm
   Google Scholar
• Mould DR, Sweeney KR. The pharmacokinetics and pharmacodynamics of monoclonal antibodies–mechanistic modeling applied to drug development. Curr Opin Drug Discov Devel. 2007;10(1):84–96.
   PubMed Web of Science ®Google Scholar
• Dimmeler S, Zeiher AM. Endothelial cell apoptosis in angiogenesis and vessel regression. Circ Res. 2000;87(6):434–439.
   PubMed Web of Science ®Google Scholar
• Eskens FA, Verweij J. The clinical toxicity profile of vascular endothelial growth factor (VEGF) and vascular endothelial growth factor receptor (VEGFR) targeting angiogenesis inhibitors; a review. Eur J Cancer. 2006;42(18):3127–3139.
   PubMed Web of Science ®Google Scholar
• Shen BQ, Lee DY, Zioncheck TF. Vascular endothelial growth factor governs endothelial nitric-oxide synthase expression via a KDR/Flk-1 receptor and a protein kinase C signaling pathway. J Biol Chem. 1999;274(46):33057–33063.
   PubMed Web of Science ®Google Scholar
• An MM, Zou Z, Shen H, et al. Incidence and risk of significantly raised blood pressure in cancer patients treated with bevacizumab: an updated meta-analysis. Eur J Clin Pharmacol. 2010;66(8):813–821.
   PubMed Web of Science ®Google Scholar
• Cunningham D, Lang I, Marcuello E, et al. Bevacizumab plus capecitabine versus capecitabine alone in elderly patients with previously untreated metastatic colorectal cancer (AVEX): an open-label, randomised phase 3 trial. Lancet Oncol. 2013;14(11):1077–1085.
   PubMed Web of Science ®Google Scholar
• Kozloff M, Yood MU, Berlin J, et al. Clinical outcomes associated with bevacizumab-containing treatment of metastatic colorectal cancer: the BRiTE observational cohort study. Oncologist. 2009;14(9):862–870.
   PubMed Web of Science ®Google Scholar
• Zhu X, Wu S, Dahut WL, et al. Risks of proteinuria and hypertension with bevacizumab, an antibody against vascular endothelial growth factor: systematic review and meta-analysis. Am J Kidney Dis. 2007;49(2):186–193.
   PubMed Web of Science ®Google Scholar
• Wu S, Kim C, Baer L, et al. Bevacizumab increases risk for severe proteinuria in cancer patients. J Am Soc Nephrol. 2010;21(8):1381–1389.
   PubMed Web of Science ®Google Scholar
• Porta C, Cosmai L, Gallieni M, et al. Renal effects of targeted anticancer therapies. Nat Rev Nephrol. 2015;11(6):354–370.
   PubMed Web of Science ®Google Scholar
• Kabbinavar FF, Hurwitz HI, Yi J, et al. Addition of bevacizumab to fluorouracil-based first-line treatment of metastatic colorectal cancer: pooled analysis of cohorts of older patients from two randomized clinical trials. J Clin Oncol. 2009;27(2):199–205.
   PubMed Web of Science ®Google Scholar
• Tebbutt NC, Wilson K, Gebski VJ, et al. Capecitabine, bevacizumab, and mitomycin in first-line treatment of metastatic colorectal cancer: results of the Australasian gastrointestinal trials group randomized phase III MAX study. J Clin Oncol. 2010;28(19):3191–3198.
   PubMed Web of Science ®Google Scholar
• Scappaticci FA, Skillings JR, Holden SN, et al. Arterial thromboembolic events in patients with metastatic carcinoma treated with chemotherapy and bevacizumab. J Natl Cancer Inst. 2007;99(16):1232–1239.
   PubMed Web of Science ®Google Scholar
• Elice F, Rodeghiero F, Falanga A, et al. Thrombosis associated with angiogenesis inhibitors. Best Pract Res Clin Haematol. 2009;22:115–128.
   PubMed Web of Science ®Google Scholar
• Hurwitz HI, Saltz LB, Van Cutsem E, et al. Venous thromboembolic events with chemotherapy plus bevacizumab: a pooled analysis of patients in randomized phase II and III studies. J Clin Oncol. 2011;29(13):1757–1764.
   PubMed Web of Science ®Google Scholar
• Leighl NB, Bennouna J, Yi J, et al. Bleeding events in bevacizumab-treated cancer patients who received full-dose anticoagulation and remained on study. Br J Cancer. 2011;104(3):413–418.
   PubMed Web of Science ®Google Scholar
• Elice F, Rodeghiero F. Side effects of anti-angiogenic drugs. Thromb Res. 2012;129(Suppl 1):S50–3.
   PubMed Web of Science ®Google Scholar
• Kabbinavar FF, Flynn PJ, Kozloff M, et al. Gastrointestinal perforation associated with bevacizumab use in metastatic colorectal cancer: results from a large treatment observational cohort study. Eur J Cancer. 2012;48(8):1126–1132.
   PubMed Web of Science ®Google Scholar
• Hapani S, Chu D, Wu S, et al. Risk of gastrointestinal perforation in patients with cancer treated with bevacizumab: a meta-analysis. Lancet Oncol. 2009;10(6):559–568.
   PubMed Web of Science ®Google Scholar
• Scappaticci FA, Fehrenbacher L, Cartwright T, et al. Surgical wound healing complications in metastatic colorectal cancer patients treated with bevacizumab. J Surg Oncol. 2005;91(3):173–180.
   PubMed Web of Science ®Google Scholar
• Nasti G, Piccirillo MC, Izzo F, et al. Neoadjuvant FOLFIRI+bevacizumab in patients with resectable liver metastases from colorectal cancer: a phase 2 trial. Br J Cancer. 2013;108(8):1566–1570.
   PubMed Web of Science ®Google Scholar
• Seet RC, Rabinstein AA. Clinical features and outcomes of posterior reversible encephalopathy syndrome following bevacizumab treatment. QJM. 2012;105(1):69–75.
   PubMed Web of Science ®Google Scholar
• Hinchey J, Chaves C, Appignani B, et al. A reversible posterior leukoencephalopathy syndrome. N Engl J Med. 1996;334(8):494–500.
   PubMed Web of Science ®Google Scholar
• Mukherjee P, McKinstry RC. Reversible posterior leukoencephalopathy syndrome: evaluation with diffusion-tensor MR imaging. Radiology. 2001;219(3):756–765.
   PubMed Web of Science ®Google Scholar
• Ay H, Buonanno FS, Schaefer PW, et al. Posterior leukoencephalopathy without severe hypertension: utility of diffusion-weighted MRI. Neurology. 1998;51(5):1369.
   PubMed Web of Science ®Google Scholar
• 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(11):1109–1117.
   PubMed Web of Science ®Google Scholar
• Commins SP, James HR, Kelly LA, et al. The relevance of tick bites to the production of IgE antibodies to the mammalian oligosaccharide galactose-α-1,3-galactose. J Allergy Clin Immunol. 2011 May;127(5):1286–1293.
   PubMed Web of Science ®Google Scholar
• 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(14):2311–2319.
   PubMed Web of Science ®Google Scholar
• Lenz HJ. Management and preparedness for infusion and hypersensitivity reactions. Oncologist. 2007;12(5):601–609.
   PubMed Web of Science ®Google Scholar
• Potthoff K, Hofheinz R, Hassel JC, et al. Interdisciplinary management of EGFR-inhibitor-induced skin reactions: a German expert opinion. Ann Oncol. 2011;22(3):524–535.
   PubMed Web of Science ®Google Scholar
• Sapadin AN, Fleischmajer R. Tetracyclines: nonantibiotic properties and their clinical implications. J Am Acad Dermatol. 2006;54(2):258–265.
   PubMed Web of Science ®Google Scholar
• 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(4):337–345.
   PubMed Web of Science ®Google Scholar
• Petrelli F, Borgonovo K, Barni S. The predictive role of skin rash with cetuximab and panitumumab in colorectal cancer patients: a systematic review and meta-analysis of published trials. Target Oncol. 2013;8(3):173–181.
   PubMed Web of Science ®Google Scholar
• Schrag D, Chung KY, Flombaum C, et al. Cetuximab therapy and symptomatic hypomagnesemia. J Natl Cancer Inst. 2005;97:1221–1224.
   PubMed Web of Science ®Google Scholar
• Tejpar S, Piessevaux H, Claes K, et al. Magnesium wasting associated with epidermal-growth-factor receptor-targeting antibodies in colorectal cancer: a prospective study. Lancet Oncol. 2007;8(5):387–394.
   PubMed Web of Science ®Google Scholar
• Cao Y, Liao C, Tan A, et al. Meta-analysis of incidence and risk of hypomagnesemia with cetuximab for advanced cancer. Chemotherapy. 2010;56(6):459–465.
   PubMed Web of Science ®Google Scholar
• Moe SM. Disorders involving calcium, phosphorus, and magnesium. Prim Care. 2008;35(2):215–237.
   PubMed Web of Science ®Google Scholar
• Fakih M. Anti-EGFR monoclonal antibody-induced hypomagnesaemia. Lancet Oncol. 2007;8(5):366–367.
   PubMed Web of Science ®Google Scholar
• Whang R, Hampton EM, Whang DD, et al. Magnesium homeostasis and clinical disorders of magnesium deficiency. Ann Pharmacother. 1994;28(2):220–226.
   PubMed Web of Science ®Google Scholar