Gastroenterology Research and Practice
Volume 2015, Article ID 273489, 8 pages
http://dx.doi.org/10.1155/2015/273489
Does the Addition of Cetuximab to Radiochemotherapy Improve Outcome of Patients with Locally Advanced Rectal Cancer? Long-Term Results from Phase II Trials
1III. Medizinische Klinik, Universitätsmedizin Mannheim, Universität Heidelberg, Theodor-Kutzer-Ufer 1-3, 68167 Mannheim, Germany
2Chirurgische Klinik, Universitätsmedizin Mannheim, Universität Heidelberg, Theodor-Kutzer-Ufer 1-3, 68167 Mannheim, Germany
3Klinik für Strahlentherapie und Radioonkologie, Universitätsmedizin Mannheim, Universität Heidelberg, Theodor-Kutzer-Ufer 1-3, 68167 Mannheim, Germany
4Pathologisches Institut, Universitätsmedizin Mannheim, Universität Heidelberg, Theodor-Kutzer-Ufer 1-3, 68167 Mannheim, Germany
5Interdisziplinäres Tumorzentrum, Universitätsmedizin Mannheim, Universität Heidelberg, Theodor-Kutzer-Ufer 1-3, 68167 Mannheim, Germany
Received 15 December 2014; Accepted 3 March 2015
Academic Editor: Eiji Sakai
Copyright © 2015 M. Kripp et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Linked References
- D. Cunningham, W. Atkin, H.-J. Lenz et al., “Colorectal cancer,” The Lancet, vol. 375, no. 9719, pp. 1030–1047, 2010. View at Publisher · View at Google Scholar · View at Scopus
- J. Giralt, M. de Las Heras, L. Cerezo et al., “The expression of epidermal growth factor receptor results in a worse prognosis for patients with rectal cancer treated with preoperative radiotherapy: a multicenter, retrospective analysis,” Radiotherapy and Oncology, vol. 74, no. 2, pp. 101–108, 2005. View at Publisher · View at Google Scholar · View at Scopus
- J.-S. Kim, J.-M. Kim, S. Li et al., “Epidermal growth factor receptor as a predictor of tumor downstaging in locally advanced rectal cancer patients treated with preoperative chemoradiotherapy,” International Journal of Radiation Oncology Biology Physics, vol. 66, no. 1, pp. 195–200, 2006. View at Publisher · View at Google Scholar · View at Scopus
- R. Kopp, E. Rothbauer, E. Mueller, F. W. Schildberg, K.-W. Jauch, and A. Pfeiffer, “Reduced survival of rectal cancer patients with increased tumor epidermal growth factor receptor levels,” Diseases of the Colon and Rectum, vol. 46, no. 10, pp. 1391–1399, 2003. View at Publisher · View at Google Scholar · View at Scopus
- V. Velenik, J. Ocvirk, I. Oblak, and F. Anderluh, “A phase II study of cetuximab, capecitabine and radiotherapy in neoadjuvant treatment of patients with locally advanced resectable rectal cancer,” European Journal of Surgical Oncology, vol. 36, no. 3, pp. 244–250, 2010. View at Publisher · View at Google Scholar · View at Scopus
- F. Bertolini, S. Chiara, C. Bengala et al., “Neoadjuvant treatment with single-agent cetuximab followed by 5-FU, cetuximab, and pelvic radiotherapy: a phase II study in locally advanced rectal cancer,” International Journal of Radiation Oncology Biology Physics, vol. 73, no. 2, pp. 466–472, 2009. View at Publisher · View at Google Scholar · View at Scopus
- J.-P. Machiels, C. Sempoux, P. Scalliet et al., “Phase I/II study of preoperative cetuximab, capecitabine, and external beam radiotherapy in patients with rectal cancer,” Annals of Oncology, vol. 18, no. 4, pp. 738–744, 2007. View at Publisher · View at Google Scholar · View at Scopus
- C. Rödel, D. Arnold, M. Hipp et al., “Phase I-II trial of cetuximab, capecitabine, oxaliplatin, and radiotherapy as preoperative treatment in rectal cancer,” International Journal of Radiation Oncology, Biology, Physics, vol. 70, no. 4, pp. 1081–1086, 2008. View at Google Scholar
- K. Horisberger, A. Treschl, S. Mai et al., “Cetuximab in combination with capecitabine, irinotecan, and radiotherapy for patients with locally advanced rectal cancer: results of a Phase II MARGIT trial,” International Journal of Radiation Oncology Biology Physics, vol. 74, no. 5, pp. 1487–1493, 2009. View at Publisher · View at Google Scholar · View at Scopus
- S. Y. Kim, Y. S. Hong, D. Y. Kim et al., “Preoperative chemoradiation with cetuximab, irinotecan, and capecitabine in patients with locally advanced resectable rectal cancer: a multicenter phase II study,” International Journal of Radiation Oncology Biology Physics, vol. 81, no. 3, pp. 677–683, 2011. View at Publisher · View at Google Scholar · View at Scopus
- A. Dewdney, D. Cunningham, J. Tabernero et al., “Multicenter randomized phase II clinical trial comparing neoadjuvant oxaliplatin, capecitabine, and preoperative radiotherapy with or without cetuximab followed by total mesorectal excision in patients with high-risk rectal cancer (EXPERT-C),” Journal of Clinical Oncology, vol. 30, no. 14, pp. 1620–1627, 2012. View at Publisher · View at Google Scholar · View at Scopus
- E. van Cutsem, C.-H. Köhne, I. Láng et al., “Cetuximab plus irinotecan, fluorouracil, and leucovorin as first-line treatment for metastatic colorectal cancer: updated analysis of overall survival according to tumor KRAS and BRAF mutation status,” Journal of Clinical Oncology, vol. 29, no. 15, pp. 2011–2019, 2011. View at Publisher · View at Google Scholar · View at Scopus
- S. Stintzing, A. Jung, L. Rossius et al., “Mutations within the EGFR signaling pathway: influence on efficacy in FIRE-3—a randomized phase III study of FOLFIRI plus cetuximab or bevacizumab as first-line treatment for wild-type (WT) KRAS (exon 2) metastatic colorectal cancer (mCRC) patients,” Journal of Clinical Oncology, vol. 32, supplement 3, 2014, Gastrointestinal Cancers Symposium, Abstract 445. View at Google Scholar
- C. Weiss, D. Arnold, K. Dellas et al., “Preoperative radiotherapy of advanced rectal cancer with capecitabine and oxaliplatin with or without cetuximab: a pooled analysis of three prospective phase I-II trials,” International Journal of Radiation Oncology Biology Physics, vol. 78, no. 2, pp. 472–478, 2010. View at Publisher · View at Google Scholar · View at Scopus
- P.-L. Sun, B. Li, and Q.-F. Ye, “Effect of neoadjuvant cetuximab, capecitabine, and radiotherapy for locally advanced rectal cancer: results of a phase II study,” International Journal of Colorectal Disease, vol. 27, no. 10, pp. 1325–1332, 2012. View at Publisher · View at Google Scholar · View at Scopus
- V. Velenik, J. Ocvirk, I. Oblak, and F. Anderluh, “Cetuximab in preoperative treatment of rectal cancer-term outcome of the XERT trial,” Radiology and Oncology, vol. 46, no. 3, pp. 252–257, 2012. View at Publisher · View at Google Scholar · View at Scopus
- A. Debucquoy, K. Haustermans, A. Daemen et al., “Molecular response to cetuximab and efficacy of preoperative cetuximab-based chemoradiation in rectal cancer,” Journal of Clinical Oncology, vol. 27, no. 17, pp. 2751–2757, 2009. View at Publisher · View at Google Scholar · View at Scopus
- E. Fokas, L. Conradi, C. Weiss et al., “Preoperative chemoradiation therapy with capecitabine/oxaliplatin and cetuximab in rectal cancer: long-term results of a prospective phase 1/2 study,” International Journal of Radiation Oncology Biology Physics, vol. 87, no. 5, pp. 992–999, 2013. View at Publisher · View at Google Scholar · View at Scopus
- F. Sclafani, D. Gonzalez, D. Cunningham et al., “RAS mutations and cetuximab in locally advanced rectal cancer: results of the EXPERT-C trial,” European Journal of Cancer, vol. 50, no. 8, pp. 1430–1436, 2014. View at Publisher · View at Google Scholar · View at Scopus
- O. Dworak, L. Keilholz, and A. Hoffmann, “Pathological features of rectal cancer after preoperative radiochemotherapy,” International Journal of Colorectal Disease, vol. 12, no. 1, pp. 19–23, 1997. View at Publisher · View at Google Scholar · View at Scopus
- D. Helbling, G. Bodoky, O. Gautschi et al., “Neoadjuvant chemoradiotherapy with or without panitumumab in patients with wild-type KRAS, locally advanced rectal cancer (LARC): a randomized, multicenter, phase II trial SAKK 41/07,” Annals of Oncology, vol. 24, no. 3, pp. 718–725, 2013. View at Publisher · View at Google Scholar · View at Scopus
- F. Willeke, K. Horisberger, U. Kraus-Tiefenbacher et al., “A phase II study of capecitabine and irinotecan in combination with concurrent pelvic radiotherapy (CapIri-RT) as neoadjuvant treatment of locally advanced rectal cancer,” British Journal of Cancer, vol. 96, no. 6, pp. 912–917, 2007. View at Publisher · View at Google Scholar · View at Scopus
- R.-D. Hofheinz, B. von Gerstenberg-Helldorf, F. Wenz et al., “Phase I trial of capecitabine and weekly irinotecan in combination with radiotherapy for neoadjuvant therapy of rectal cancer,” Journal of Clinical Oncology, vol. 23, no. 7, pp. 1350–1357, 2005. View at Publisher · View at Google Scholar · View at Scopus
- P. Erben, P. Ströbel, K. Horisberger et al., “KRAS and BRAF mutations and PTEN expression do not predict efficacy of cetuximab-based chemoradiotherapy in locally advanced rectal cancer,” International Journal of Radiation Oncology Biology Physics, vol. 81, no. 4, pp. 1032–1038, 2011. View at Publisher · View at Google Scholar · View at Scopus
- W. van Gijn, C. A. Marijnen, I. D. Nagtegaal et al., “Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer: 12-year follow-up of the multicentre, randomised controlled TME trial,” The Lancet Oncology, vol. 12, no. 6, pp. 575–582, 2011. View at Publisher · View at Google Scholar · View at Scopus
- R. Sauer, T. Liersch, S. Merkel et al., “Preoperative versus postoperative chemoradiotherapy for locally advanced rectal cancer: results of the German CAO/ARO/AIO-94 randomized phase III trial after a median follow-up of 11 years,” Journal of Clinical Oncology, vol. 30, no. 16, pp. 1926–1933, 2012. View at Publisher · View at Google Scholar · View at Scopus
- C. Aschele, L. Cionini, S. Lonardi et al., “Primary tumor response to preoperative chemoradiation with or without oxaliplatin in locally advanced rectal cancer: pathologic results of the STAR-01 randomized phase III trial,” Journal of Clinical Oncology, vol. 29, no. 20, pp. 2773–2780, 2011. View at Publisher · View at Google Scholar · View at Scopus
- J.-P. Gérard, D. Azria, S. Gourgou-Bourgade et al., “Clinical outcome of the ACCORD 12/0405 PRODIGE 2 randomized trial in rectal cancer,” Journal of Clinical Oncology, vol. 30, no. 36, pp. 4558–4565, 2012. View at Publisher · View at Google Scholar · View at Scopus
- C. Rödel, T. Liersch, H. Becker et al., “Preoperative chemoradiotherapy and postoperative chemotherapy with fluorouracil and oxaliplatin versus fluorouracil alone in locally advanced rectal cancer: initial results of the German CAO/ARO/AIO-04 randomised phase 3 trial,” The Lancet Oncology, vol. 13, no. 7, pp. 679–687, 2012. View at Publisher · View at Google Scholar · View at Scopus
- S. T. Martin, H. M. Heneghan, and D. C. Winter, “Systematic review and meta-analysis of outcomes following pathological complete response to neoadjuvant chemoradiotherapy for rectal cancer,” British Journal of Surgery, vol. 99, no. 7, pp. 918–928, 2012. View at Publisher · View at Google Scholar · View at Scopus
- F. Bonnetain, J. F. Bosset, J. P. Gerard et al., “What is the clinical benefit of preoperative chemoradiotherapy with 5FU/leucovorin for T3-4 rectal cancer in a pooled analysis of EORTC 22921 and FFCD 9203 trials: surrogacy in question?” European Journal of Cancer, vol. 48, no. 12, pp. 1781–1790, 2012. View at Publisher · View at Google Scholar · View at Scopus
- S. Y. Kim, E. K. Shim, H. Y. Yeo et al., “KRAS mutation status and clinical outcome of preoperative chemoradiation with cetuximab in locally advanced rectal cancer: a pooled analysis of 2 phase II trials,” International Journal of Radiation Oncology Biology Physics, vol. 85, no. 1, pp. 201–207, 2013. View at Publisher · View at Google Scholar · View at Scopus
- G. Y. Ku, B. A. Haaland, and G. de Lima Lopes Jr., “Cetuximab in the first-line treatment of K-ras wild-type metastatic colorectal cancer: the choice and schedule of fluoropyrimidine matters,” Cancer Chemotherapy and Pharmacology, vol. 70, no. 2, pp. 231–238, 2012. View at Publisher · View at Google Scholar · View at Scopus
- F. Sclafani, D. Gonzalez, D. Cunningham et al., “TP53 mutational status and cetuximab benefit in rectal cancer: 5-year results of the EXPERT-C trial,” Journal of the National Cancer Institute, vol. 106, no. 7, 2014. View at Publisher · View at Google Scholar