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 - Tập 13 - Trang 679-687 - 2012
Claus Rödel1, Torsten Liersch2, Heinz Becker2, Rainer Fietkau3, Werner Hohenberger4, Torsten Hothorn5,6, Ullrich Graeven7, Dirk Arnold8, Marga Lang-Welzenbach3, Hans-Rudolf Raab9, Heiko Sülberg10, Christian Wittekind11, Sergej Potapov12, Ludger Staib13, Clemens Hess14, Karin Weigang-Köhler15, Gerhard G Grabenbauer16, Hans Hoffmanns7, Fritz Lindemann17, Anke Schlenska-Lange18
1Department of Radiotherapy and Oncology, University of Frankfurt, Frankfurt, Germany
2Department of General Surgery, University of Göttingen, Göttingen, Germany
3Department of Radiation Therapy, University of Erlangen-Nürnberg, Erlangen and Nürnberg, Germany
4Department of Surgery, University of Erlangen-Nürnberg, Erlangen and Nürnberg, Germany
5Department of Statistics, University of Munich, Munich, Germany
6Division of Biostatistics, University of Zurich, Zurich, Switzerland
7Kliniken Maria Hilf GmbH, Mönchengladbach, Germany
8Hubertus Wald University Cancer Center, Universitätsklinikum Eppendorf, Hamburg, Germany
9Department of General and Visceral Surgery, Klinikum Oldenburg, Oldenburg, Germany
10WiSP Research Institute, Langenfeld, Germany
11Institute of Pathology, University of Leipzig, Leipzig, Germany
12Department of Medical Informatics, Biometry, and Epidemiology, University of Erlangen-Nürnberg, Erlangen and Nürnberg, Germany
13Department of Surgery, Klinikum Esslingen, Esslingen, Germany
14Department of Radiation Oncology and Radiotherapy, University of Göttingen, Göttingen, Germany
15Department of Hematology and Oncology, Klinikum Nürnberg, Nürnberg, Germany
16Department of Radiation Oncology and Radiotherapy, DiaCura & Klinikum Coburg, Coburg, Germany
17Department of General and Visceral Surgery, Klinikum Friedberg, Friedberg, Germany
18Department of Internal Medicine, Oncology, Hematology, Krankenhaus Barmherzige Brüder, Regensburg, Germany

Tài liệu tham khảo

Sauer, 2004, Preoperative versus postoperative chemoradiotherapy for rectal cancer, N Engl J Med, 351, 1731, 10.1056/NEJMoa040694 Gerard, 2006, Preoperative radiotherapy with or without concurrent fluorouracil and leucovorin in T3-4 rectal cancers: results of FFCD 9203, J Clin Oncol, 24, 4620, 10.1200/JCO.2006.06.7629 Bosset, 2006, Chemotherapy with preoperative radiotherapy in rectal cancer, N Engl J Med, 355, 1114, 10.1056/NEJMoa060829 Roh, 2009, Preoperative multimodality therapy improves disease-free survival in patients with carcinoma of the rectum: NSABP R-03, J Clin Oncol, 27, 5124, 10.1200/JCO.2009.22.0467 Sebag-Montefiore, 2009, Preoperative radiotherapy versus selective postoperative chemoradiotherapy in patients with rectal cancer (MRC CR07 and NCIC-CTG C016): a multicentre, randomised trial, Lancet, 373, 811, 10.1016/S0140-6736(09)60484-0 van Gijn, 2011, Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer: 12-year follow-up of the multicentre, randomised controlled TME trial, Lancet Oncol, 12, 575, 10.1016/S1470-2045(11)70097-3 Rödel, 2003, Phase I/II trial of capecitabine, oxaliplatin, and radiation for rectal cancer, J Clin Oncol, 21, 3098, 10.1200/JCO.2003.02.505 Rödel, 2007, Multicenter phase II trial of chemoradiation with oxaliplatin for rectal cancer, J Clin Oncol, 25, 110, 10.1200/JCO.2006.08.3675 Schmiegel, 2008, Update S3-guideline colorectal cancer 2008, Z Gastroenterol, 46, 799, 10.1055/s-2008-1027726 2002 Quirke, 2009, Effect of the plane of surgery achieved on local recurrence in patients with operable rectal cancer: a prospective study using data from the MRC CR07 and NCIC-CTG CO16 randomised clinical trial, Lancet, 373, 821, 10.1016/S0140-6736(09)60485-2 Dworak, 1997, Pathological features of rectal cancer after preoperative radiochemotherapy, Int J Colorectal Dis, 12, 19, 10.1007/s003840050072 2012 Aschele, 2011, 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, J Clin Oncol, 29, 2773, 10.1200/JCO.2010.34.4911 Gerard, 2010, Comparison of two neoadjuvant chemoradiotherapy regimens for locally advanced rectal cancer: results of the phase III trial ACCORD 12/0405-Prodige 2, J Clin Oncol, 28, 1638, 10.1200/JCO.2009.25.8376 Roh, 2011, The impact of capecitabine and oxaliplatin in the preoperative multimodality treatment in patients with carcinoma of the rectum: NSABP R-04, Proc Am Soc Clin Oncol, 29 Rich, 2004, Four decades of continuing innovation with fluorouracil: current and future approaches to fluorouracil chemoradiation therapy, J Clin Oncol, 22, 2214, 10.1200/JCO.2004.08.009 Hofheinz, 2012, Chemoradiotherapy with capecitabine versus fluorouracil for locally advanced rectal cancer: a randomised, multicentre, non-inferiority, phase 3 trial, Lancet Oncol, 10.1016/S1470-2045(12)70116-X Valentini, 2008, Evidence and research in rectal cancer, Radiother Oncol, 87, 449, 10.1016/j.radonc.2008.05.022 Nagtegaal, 2002, Macroscopic evaluation of rectal cancer resection specimen: clinical significance of the pathologist in quality control, J Clin Oncol, 20, 1729, 10.1200/JCO.2002.07.010 Fernandez-Martos, 2010, J Clin Oncol, 28, 859, 10.1200/JCO.2009.25.8541 Chua, 2010, Neoadjuvant capecitabine and oxaliplatin before chemoradiotherapy and total mesorectal excision in MRI-defined poor-risk rectal cancer: a phase 2 trial, Lancet Oncol, 11, 241, 10.1016/S1470-2045(09)70381-X