Cetuximab plus FOLFOX-4 for fully resected stage III colon carcinoma: scientific background and the ongoing PETACC-8 trial

References

• Ferlay J, Bray F, Pisani P et al. GLOBOCAN 2002. Cancer Incidence, Mortality and Prevalence Worldwide. IARC CancerBase.5, Version 2.0. IARC Press, Lyon, France (2004).
   Google Scholar
• Boyle P, Ferlay J. Cancer incidence and mortality in Europe, 2004. Ann. Oncol.16, 481–488 (2005).
   PubMed Web of Science ®Google Scholar
• Skibber JM, Minsky BD, Hoff PM. Cancer of the colon. In: Cancer Principles and Practice of Oncology (6th Edition). DeVita VT, Hellman S, Rosenberg SA (Eds). Lippincott Williams & Wilkins, PA, USA, 1217 (2001).
   Google Scholar
• Arnold D, Schmoll HJ. (Neo-)adjuvant treatments in colorectal cancer. Ann. Oncol.16, ii133–ii140 (2005).
   PubMedGoogle Scholar
• Andre T, Boni C, Mounedji-Boudiaf L et al. Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer. N. Engl. J. Med.350, 2343–2351 (2004).
   PubMed Web of Science ®Google Scholar
• Kuebler JP, Wieand HS, O’Connell MJ et al. Oxaliplatin combined with weekly bolus fluorouracil and leucovorin as surgical adjuvant chemotherapy for stage II and III colon cancer: results from NSABP C-07. J. Clin. Oncol.25, 2198–2204 (2007).
   PubMed Web of Science ®Google Scholar
• Wong SF. Cetuximab: an epidermal growth factor receptor monoclonal antibody for the treatment of colorectal cancer. Clin. Ther.27, 684–694 (2005).
   PubMed Web of Science ®Google Scholar
• Jennis A, Polikoff J, Mitchell E et al. Erbitux (cetuximab) plus FOLFOX for Colorectal Cancer (EXPLORE): preliminary efficacy analysis of a randomized Phase III trial. Proc. Am. Soc. Clin. Oncol.23 (2005) (Abstract 3574).
   Google Scholar
• Venook A, Niedzwiecki D, Hollis D et al. Phase III study of irinotecan/5FU/LV (FOLFIRI) or oxaliplatin/5FU/LV (FOLFOX) (±) cetuximab for patients (pts) with untreated metastatic adenocarcinoma of the colon or rectum (MCRC): CALGB 80203 preliminary results. Proc. Am. Soc. Clin. Oncol.24, (2006) (Abstract 3509).
   Google Scholar
• André T, Tabernero J, van Cutsem E et al. Phase II study with cetuximab plus FOLFOX-4 in first-line setting for epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer (mCRC): final results. Presented at: 2007 Gastrointestinal Cancers Symposium. Orlando, FL, USA 19 Januray–21 January, Abstract 334 (2007).
   Google Scholar
• Colucci G, Giuliani F, Mattioli R et al. FOLFOX-4 + cetuximab in untreated patients with advanced colorectal cancer. A Phase II study of the Gruppo Oncologico dell’Italia Meridionale (prot. GOIM 2402). Proc. Am. Soc. Clin. Oncol.24, (2006) (Abstract 3559).
   Google Scholar
• Dittrich C, Hoehler T, Lordick F et al. A Phase I/II study of cetuximab in combination with weekly 5-fluorouracil (5-FU)/folinic acid (FA) plus oxaliplatin (L-OHP) (FUFOX) in the first-line treatment of patients with EGFR-expressing metastatic colorectal cancer (mCRC). Preliminary results. Ann. Oncol.17(Suppl. 9) (2006) (Abstract O-019).
   Google Scholar
• Laurie JA, Moertel CG, Fleming TR et al. Surgical adjuvant therapy of large-bowel carcinoma: an evaluation of levamisole and the combination of levamisole and fluorouracil: the North Central Cancer Treatment Group and the Mayo Clinic. J. Clin. Oncol.7, 1447–1456 (1989).
   PubMed Web of Science ®Google Scholar
• Moertel CG, Fleming TR, Macdonald JS et al. Levamisole and fluorouracil for adjuvant therapy of resected colon carcinoma. N. Engl. J. Med.32, 352–358 (1990).
   Google Scholar
• NIH consensus conference. Adjuvant therapy for patients with colon and rectal cancer. JAMA264, 1444–1450 (1990).
   PubMed Web of Science ®Google Scholar
• Wolmark N, Rockette H, Fisher B et al. The benefit of leucovorin-modulated fluorouracil as postoperative adjuvant therapy for primary colon cancer: results from National Surgical Adjuvant Breast and Bowel Project protocol C-03. J. Clin. Oncol.11, 1879–1887 (1993).
   PubMed Web of Science ®Google Scholar
• International Multicenter Pooled Analysis of Colon Cancer Trials (IMPACT) Investigators. Efficacy of adjuvant fluorouracil and folinic acid in colon cancer. Lancet345, 939–944 (1995).
   PubMed Web of Science ®Google Scholar
• O’Connell MJ, Laurie JA, Kahn M et al. Prospectively randomized trial of postoperative adjuvant chemotherapy in patients with high-risk colon cancer. J. Clin. Oncol.16, 295–300 (1998).
   PubMed Web of Science ®Google Scholar
• André T, Colin P, Louvet C et al. Semimonthly versus monthly regimen of fluorouracil and leucovorin administered for 24 or 36 weeks as adjuvant therapy in stage II and III colon cancer: results of a randomized trial. J. Clin. Oncol.21, 2896–2903 (2003).
   PubMed Web of Science ®Google Scholar
• Tournigand C, Andre T, Achille E et al. FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study. J. Clin. Oncol.22, 229–237 (2004).
   PubMed Web of Science ®Google Scholar
• de Gramont A, Boni C, Navarro M et al. Oxaliplatin/5-FU/LV in stage II and III colon cancer: updated results (as of January 04) for efficacy and neurotoxicity of the MOSAIC trial. Ann. Oncol.15(Suppl. 3), iii73 (2004).
   Google Scholar
• Saltz LB, Niedzwiecki D, Hollis D et al. Irinotecan plus fluorouracil/leucovorin (IFL) versus fluorouracil/leucovorin alone (FL) in stage III colon cancer (intergroup trial CALGB C89803). Proc. Am. Soc. Clin. Oncol.25(23), 3456–3461 (2004).
   Google Scholar
• Van Cutsem E. Randomized Phase III trial comparing infused irinotecan/ 5-fluorouracil (5-FU)/folinic acid (IF) versus 5-FU/FA (F) in stage III colon cancer patients. (PETACC 3). J. Clin. Oncol.23(Suppl. 16) (2005) (Abstract 8).
   Google Scholar
• Saltz LB, Meropol NJ, Loehrer PJ et al. Phase II trial of cetuximab in patients with refractory colorectal cancer that expresses the epidermal growth factor receptor. J. Clin. Oncol.22, 1201–1208 (2004).
   PubMed Web of Science ®Google Scholar
• 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.24, 4914–4921 (2006).
   PubMed Web of Science ®Google Scholar
• Jonker DJ, Karapetis CS, Moore M et al. Randomized Phase III trial of cetuximab monotherapy plus best supportive care versus BSC alone in patients with pretreated metastatic epidermal growth factor receptor (EGFR)-positive colorectal carcinoma: a trial of the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) and the Australasian Gastro-Intestinal Trials Group (ACITC). Proc. Am. Assoc. Clin. Res. (2007) (Abstract LB-1).
   Google Scholar
• Saltz L, Rubin M, Hochster H et al. Cetuximab (IMC-C225) plus irinotecan (CPT-11) is active in CPT-11-refractory colorectal cancer (CRC) that expresses epidermal growth factor receptor (EGFR). Proc. Am. Soc. Clin. Oncol.20, (2001) (Abstract 7).
   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.351, 337–345 (2004).
   PubMed Web of Science ®Google Scholar
• Peeters M, Raoul JL, Van Laethem JL et al. Cetuximab in combination with irinotecan/5-fluorouracil (5-FU)/folinic acid (FA) (FOLFIRI) in the first-line treatment of metastatic CRC (mCRC). Eur. J. Cancer (Suppl. 3), 188 (2005) (Abstract 664).
   Google Scholar
• 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.17, 450–456 (2006).
   PubMed Web of Science ®Google Scholar
• Van Cutsem E, Bodoky G, Roh JK et al. CRYSTAL: a randomized Phase III trial of cetuximab plus FOLFIRI vs FOLFIRI in first-line metastatic colorectal cancer (mCRC). Eur. J. Cancer5(Suppl. 4), 235 (2007) (Abstract O-3001).
   Google Scholar
• Heinemann V, Fischer von Weikersthal L, Moosmann N et al. Cetuximab + capecitabine + irinotecan (CCI) versus cetuximab + capecitabine + oxaliplatin (CCO) as first line therapy for patients with metastatic colorectal cancer (CRC): preliminary results of a randomized Phase II trial of the AIO CRC Study Group. Proc. Am. Soc. Clin. Oncol.24, (2006) (Abstract 3550).
   PubMedGoogle Scholar
• Cartwright TH, Kiefler P, Cohn A et al. Results of a Phase II trial of cetuximab + XELIRI as first-line therapy of patients with advanced and/or metastatic colorectal cancer. Presented at: 2007 Gastrointestinal Cancers Symposium (Abstract 292).
   Google Scholar
• Schrag D, Chung KY, Flombaum C, Saltz L. Cetuximab therapy and symptomatic hypomagnesemia. J. Natl Cancer Inst.97, 1221–1224 (2005).
   PubMed Web of Science ®Google Scholar
• Badarinath S, Mitchell EP, Jennis A et al. Cetuximab plus FOLFOX for colorectal cancer (EXPLORE): preliminary safety analysis of a randomized Phase III trial. Proc. Am. Soc. Clin. Oncol.22, (2004) (Abstract 3531).
   Google Scholar
• Bokemeyer C, Bondarenko I, Makhson A et al. Cetuximab plus 5-FU/FA/oxaliplatin (FOLFOX-4) versus FOLFOX-4 in the first-line treatment of metastatic colorectal cancer (mCRC): OPUS, a randomized Phase II study. J. Clin. Oncol.25(Suppl. 18) (2007) (Abstract 4035).
   Google Scholar
• Wilke H, Siena S, Thaler J et al. Impact of pre-medication on the frequency of infusion-related reactions (IRRs) and efficacy in patients (pts) treated with cetuximab plus irinotecan for metastatic colorectal cancer (mCRC): the MABEL study. Eur. J. Cancer14, (2007) (Abstract 3025).
   Google Scholar