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

The Lancet - Tập 377 - Trang 2103-2114 - 2011
Timothy S Maughan1, Richard A Adams1, Christopher G Smith1, Angela M Meade2, Matthew T Seymour3, Richard H Wilson4, Shelley Idziaszczyk1, Rebecca Harris1, David Fisher2, Sarah L Kenny2, Edward Kay2, Jenna K Mitchell2, Ayman Madi1, Bharat Jasani1, Michelle D James1, John Bridgewater5, M John Kennedy6, Bart Claes7, Diether Lambrechts7, Richard Kaplan2
1School of Medicine, Cardiff University, Cardiff, UK
2Medical Research Council Clinical Trials Unit, London, UK
3St James's University Hospital and University of Leeds, Leeds, UK
4Queens University Belfast, Belfast, UK
5University College London Cancer Institute, London, UK
6ICORG, All Ireland Co-operative Oncology Research Group, Dublin, Ireland
7VIB Vesalius Research Center, University of Leuven, Leuven, Belgium

Tài liệu tham khảo

Lynch, 2004, Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib, N Engl J Med, 350, 2129, 10.1056/NEJMoa040938 Paez, 2004, EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy, Science, 304, 1497, 10.1126/science.1099314 Khambata-Ford, 2007, Expression of epiregulin and amphiregulin and K-ras mutation status predict disease control in metastatic colorectal cancer patients treated with cetuximab, J Clin Oncol, 25, 3230, 10.1200/JCO.2006.10.5437 Lièvre, 2006, KRAS mutation status is predictive of response to cetuximab therapy in colorectal cancer, Cancer Res, 66, 3992, 10.1158/0008-5472.CAN-06-0191 Karapetis, 2008, K-ras mutations and benefit from cetuximab in advanced colorectal cancer, N Engl J Med, 359, 1757, 10.1056/NEJMoa0804385 Amado, 2008, Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer, J Clin Oncol, 26, 1626, 10.1200/JCO.2007.14.7116 De Roock, 2010, Effects of KRAS, BRAF, NRAS, and PIK3CA mutations on the efficacy of cetuximab plus chemotherapy in chemotherapy-refractory metastatic colorectal cancer: a retrospective consortium analysis, Lancet Oncol, 11, 753, 10.1016/S1470-2045(10)70130-3 Adams, 2011, Intermittent versus continuous oxaliplatin and fluoropyrimidine combination chemotherapy for first-line treatment of advanced colorectal cancer: results of the randomised phase 3 MRC COIN trial, Lancet Oncol, 10.1016/S1470-2045(11)70102-4 Adams, 2009, Toxicity associated with combination oxaliplatin plus fluoropyrimidine with or without cetuximab in the MRC COIN trial experience, Br J Cancer, 100, 251, 10.1038/sj.bjc.6604877 Therasse, 2000, New guidelines to evaluate the response to treatment in solid tumors (RECIST Guidelines), J Natl Cancer Inst, 92, 205, 10.1093/jnci/92.3.205 Chung, 2005, Cetuximab shows activity in colorectal cancer patients with tumors that do not express the epidermal growth factor receptor by immunohistochemistry, J Clin Oncol, 23, 1803, 10.1200/JCO.2005.08.037 Köhne, 2002, Clinical determinants of survival in patients with 5-fluorouracil based treatment for metastatic colorectal cancer: results of a multivariate analysis of 3825 patients, Ann Oncol, 13, 308, 10.1093/annonc/mdf034 De Roock, 2010, Association of KRAS p.G13D mutation with outcome in patients with chemotherapy refractory metastatic colorectal cancer treated with cetuximab, JAMA, 304, 1812, 10.1001/jama.2010.1535 Tol, 2009, Chemotherapy, bevacizumab, and cetuximab in metastatic colorectal cancer, N Engl J Med, 360, 563, 10.1056/NEJMoa0808268 Hecht, 2009, A randomized phase IIIB trial of chemotherapy, bevacizumab, and panitumumab compared with chemotherapy and bevacizumab alone for metastatic colorectal cancer, J Clin Oncol, 27, 672, 10.1200/JCO.2008.19.8135 Van Cutsem, 2009, Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer, N Engl J Med, 360, 1408, 10.1056/NEJMoa0805019 Peeters, 2010, 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, 28, 4706, 10.1200/JCO.2009.27.6055 Bokemeyer, 2008, KRAS status and efficacy of first-line treatment of patients with metastatic colorectal cancer (mCRC) with FOLFOX with or without cetuximab: the OPUS experience, Proc Am Soc Clin Oncol, 26 Douillard, 2010, 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, 28, 4697, 10.1200/JCO.2009.27.4860 Tveit, 2011, Proc Am Soc Clin Oncol, 29 Borner, 2008, 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, 19, 1288, 10.1093/annonc/mdn058 Coleman, 2011, Cancer survival in Australia, Canada, Denmark, Norway, Sweden, and the UK, 1995–2007 (the International Cancer Benchmarking Partnership): an analysis of population-based cancer registry data, Lancet, 377, 127, 10.1016/S0140-6736(10)62231-3 2009