Off-label use of cetuximab plus sorafenib and panitumumab plus regorafenib to personalize therapy for a patient with V600E BRAF-mutant metastatic colon cancer

References

• Wilhelm SM, Carter C, Tang L, Wilkie D, McNabola A, Rong H, et al. BAY 43-9006 exhibits broad spectrum oral antitumor activity and targets the RAF/MEK/ERK pathway and receptor tyrosine kinases involved in tumor progression and angiogenesis. Cancer Res 2004; 64:7099 - 109; http://dx.doi.org/10.1158/0008-5472.CAN-04-1443; PMID: 15466206
   PubMed Web of Science ®Google Scholar
• Wilhelm SM, Adnane L, Newell P, Villanueva A, Llovet JM, Lynch M. Preclinical overview of sorafenib, a multikinase inhibitor that targets both Raf and VEGF and PDGF receptor tyrosine kinase signaling. Mol Cancer Ther 2008; 7:3129 - 40; http://dx.doi.org/10.1158/1535-7163.MCT-08-0013; PMID: 18852116
   PubMed Web of Science ®Google Scholar
• Adjei AA. Blocking oncogenic Ras signaling for cancer therapy. J Natl Cancer Inst 2001; 93:1062 - 74; http://dx.doi.org/10.1093/jnci/93.14.1062; PMID: 11459867
   PubMed Web of Science ®Google Scholar
• Davies H, Bignell GR, Cox C, Stephens P, Edkins S, Clegg S, et al. Mutations of the BRAF gene in human cancer. Nature 2002; 417:949 - 54; http://dx.doi.org/10.1038/nature00766; PMID: 12068308
   PubMed Web of Science ®Google Scholar
• Di Nicolantonio F, Martini M, Molinari F, Sartore-Bianchi A, Arena S, Saletti P, et al. Wild-type BRAF is required for response to panitumumab or cetuximab in metastatic colorectal cancer. J Clin Oncol 2008; 26:5705 - 12; http://dx.doi.org/10.1200/JCO.2008.18.0786; PMID: 19001320
   PubMed Web of Science ®Google Scholar
• Roth AD, Tejpar S, Delorenzi M, Yan P, Fiocca R, Klingbiel D, et al. Prognostic role of KRAS and BRAF in stage II and III resected colon cancer: results of the translational study on the PETACC-3, EORTC 40993, SAKK 60-00 trial. J Clin Oncol 2010; 28:466 - 74; http://dx.doi.org/10.1200/JCO.2009.23.3452; PMID: 20008640
   PubMed Web of Science ®Google Scholar
• Richman SD, Seymour MT, Chambers P, Elliott F, Daly CL, Meade AM, et al. KRAS and BRAF mutations in advanced colorectal cancer are associated with poor prognosis but do not preclude benefit from oxaliplatin or irinotecan: results from the MRC FOCUS trial. J Clin Oncol 2009; 27:5931 - 7; http://dx.doi.org/10.1200/JCO.2009.22.4295; PMID: 19884549
   PubMed Web of Science ®Google Scholar
• Prahallad A, Sun C, Huang S, Di Nicolantonio F, Salazar R, Zecchin D, et al. Unresponsiveness of colon cancer to BRAF(V600E) inhibition through feedback activation of EGFR. Nature 2012; 483:100 - 3; http://dx.doi.org/10.1038/nature10868; PMID: 22281684
   PubMed Web of Science ®Google Scholar
• Downward J. Targeting RAS signalling pathways in cancer therapy. Nat Rev Cancer 2003; 3:11 - 22; http://dx.doi.org/10.1038/nrc969; PMID: 12509763
   PubMed Web of Science ®Google Scholar
• Hilger RA, Scheulen ME, Strumberg D. The Ras-Raf-MEK-ERK pathway in the treatment of cancer. Onkologie 2002; 25:511 - 8; http://dx.doi.org/10.1159/000068621; PMID: 12566895
   PubMed Web of Science ®Google Scholar
• Davies H, Bignell GR, Cox C, Stephens P, Edkins S, Clegg S, et al. Mutations of the BRAF gene in human cancer. Nature 2002; 417:949 - 54; http://dx.doi.org/10.1038/nature00766; PMID: 12068308
   PubMed Web of Science ®Google Scholar
• Lang L. FDA approves sorafenib for patients with inoperable liver cancer. Gastroenterology 2008; 134:379; http://dx.doi.org/10.1053/j.gastro.2007.12.037; PMID: 18242200
   PubMed Web of Science ®Google Scholar
• Kane RC, Farrell AT, Saber H, Tang S, Williams G, Jee JM, et al. Sorafenib for the treatment of advanced renal cell carcinoma. Clin Cancer Res 2006; 12:7271 - 8; http://dx.doi.org/10.1158/1078-0432.CCR-06-1249; PMID: 17189398
   PubMed Web of Science ®Google Scholar
• Joudeh J, Allen JE, Das A, Prabhu V, Farbaniec M, Adler J, et al. Novel antineoplastics targeting genetic changes in colorectal cancer. Adv Exp Med Biol 2013; 779:1 - 34; http://dx.doi.org/10.1007/978-1-4614-6176-0_1; PMID: 23288633
   PubMed Web of Science ®Google Scholar
• Plastaras JP, Kim SH, Liu YY, Dicker DT, Dorsey JF, McDonough J, et al. Cell cycle dependent and schedule-dependent antitumor effects of sorafenib combined with radiation. Cancer Res 2007; 67:9443 - 54; http://dx.doi.org/10.1158/0008-5472.CAN-07-1473; PMID: 17909054
   PubMed Web of Science ®Google Scholar
• Moore M, Hirte HW, Siu L, Oza A, Hotte SJ, Petrenciuc O, et al. Phase I study to determine the safety and pharmacokinetics of the novel Raf kinase and VEGFR inhibitor BAY 43-9006, administered for 28 days on/7 days off in patients with advanced, refractory solid tumors. Ann Oncol 2005; 16:1688 - 94; http://dx.doi.org/10.1093/annonc/mdi310; PMID: 16006586
   PubMed Web of Science ®Google Scholar
• Kupsch P, Henning BF, Passarge K, Richly H, Wiesemann K, Hilger RA, et al. Results of a phase I trial of sorafenib (BAY 43-9006) in combination with oxaliplatin in patients with refractory solid tumors, including colorectal cancer. Clin Colorectal Cancer 2005; 5:188 - 96; http://dx.doi.org/10.3816/CCC.2005.n.030; PMID: 16197622
   PubMedGoogle Scholar
• Penland SK, Goldberg RM. Combining anti-VEGF approaches with oxaliplatin in advanced colorectal cancer. Clin Colorectal Cancer 2004; 4:Suppl 2 S74 - 80; http://dx.doi.org/10.3816/CCC.2004.s.012; PMID: 15479483
   PubMedGoogle Scholar
• Heim M, Scharifi M, Zisowsky J, Jaehde U, Voliotis D, Seeber S, et al. The Raf kinase inhibitor BAY 43-9006 reduces cellular uptake of platinum compounds and cytotoxicity in human colorectal carcinoma cell lines. Anticancer Drugs 2005; 16:129 - 36; http://dx.doi.org/10.1097/00001813-200502000-00003; PMID: 15655409
   PubMed Web of Science ®Google Scholar
• Ricci MS, Kim SH, Ogi K, Plastaras JP, Ling J, Wang W, et al. Reduction of TRAIL-induced Mcl-1 and cIAP2 by c-Myc or sorafenib sensitizes resistant human cancer cells to TRAIL-induced death. Cancer Cell 2007; 12:66 - 80; http://dx.doi.org/10.1016/j.ccr.2007.05.006; PMID: 17613437
   PubMed Web of Science ®Google Scholar
• Ratain MJ, Eisen T, Stadler WM, et al. Final findings from a Phase II, placebo controlled, randomized discontinuation trial (RDT) of sorafenib (BAY 43-9006) in patients with advanced renal cell carcinoma (RCC). Proc Am Assoc Cancer Res 2005; 23:388s
   Google Scholar
• Abou-Alfa GK, Schwartz L, Ricci S, et al. Phase II study of BAY 43-9006 in patients with advanced hepatocellular carcinoma (HCC). Eur J Cancer 2004; 2:16; http://dx.doi.org/10.1016/S1359-6349(04)80050-8
   Google Scholar
• Gulhati P, Zaytseva YY, Valentino JD, Stevens PD, Kim JT, Sasazuki T, et al. Sorafenib enhances the therapeutic efficacy of rapamycin in colorectal cancers harboring oncogenic KRAS and PIK3CA. Carcinogenesis 2012; 33:1782 - 90; http://dx.doi.org/10.1093/carcin/bgs203; PMID: 22696593
   PubMed Web of Science ®Google Scholar
• Strumberg D, Richly H, Hilger RA, Schleucher N, Korfee S, Tewes M, et al. Phase I clinical and pharmacokinetic study of the Novel Raf kinase and vascular endothelial growth factor receptor inhibitor BAY 43-9006 in patients with advanced refractory solid tumors. J Clin Oncol 2005; 23:965 - 72; http://dx.doi.org/10.1200/JCO.2005.06.124; PMID: 15613696
   PubMed Web of Science ®Google Scholar
• Awada A, Hendlisz A, Gil T, Bartholomeus S, Mano M, de Valeriola D, et al. Phase I safety and pharmacokinetics of BAY 43-9006 administered for 21 days on/7 days off in patients with advanced, refractory solid tumours. Br J Cancer 2005; 92:1855 - 61; http://dx.doi.org/10.1038/sj.bjc.6602584; PMID: 15870716
   PubMed Web of Science ®Google Scholar
• Clark JW, Eder JP, Ryan D, Lathia C, Lenz HJ. Safety and pharmacokinetics of the dual action Raf kinase and vascular endothelial growth factor receptor inhibitor, BAY 43-9006, in patients with advanced, refractory solid tumors. Clin Cancer Res 2005; 11:5472 - 80; http://dx.doi.org/10.1158/1078-0432.CCR-04-2658; PMID: 16061863
   PubMed Web of Science ®Google Scholar
• BAY 43-9006 Plus Cetuximab to Treat Colorectal Cancer. Identifier: NCT00326495. Available online at http://clinicaltrials.gov/ct2/show/NCT00326495? Accessed 5/1/13.
   Google Scholar
• Galal KM, Khaled Z, Mourad AM. Role of cetuximab and sorafenib in treatment of metastatic colorectal cancer. Indian J Cancer 2011; 48:47 - 54; http://dx.doi.org/10.4103/0019-509X.75825; PMID: 21248446
   PubMed Web of Science ®Google Scholar
• Safety Study of PLX4032 in patients with Solid Tumors. Identifier No. -NCT00405587. Available online at http://www.clinicaltrials.gov/ct2/show/NCT00405587. Accessed 5/1/13
   Google Scholar
• Safety and Efficacy Study of BMS-908662 Alone or in Combination With Cetuximab in Subjects With K-RAS or B-RAF Mutation Positive Advanced or Metastatic Colorectal Cancer. Identifier No. - NCT01086267. Available online at http://clinicaltrials.gov/show/NCT01086267. Accessed 5/1/13.
   Google Scholar
• Schwartz GK, Robertson S, Shen A, et al. A phase I study of XL281, a selective oral RAF kinase inhibitor, in patients (Pts) with advanced solid tumors. J Clin Oncol 2009; 27:15s
   Web of Science ®Google Scholar
• King AJ, Patrick DR, Batorsky RS, Ho ML, Do HT, Zhang SY, et al. Demonstration of a genetic therapeutic index for tumors expressing oncogenic BRAF by the kinase inhibitor SB-590885. Cancer Res 2006; 66:11100 - 5; http://dx.doi.org/10.1158/0008-5472.CAN-06-2554; PMID: 17145850
   PubMed Web of Science ®Google Scholar