Neoadjuvant capecitabine and oxaliplatin before chemoradiotherapy and total mesorectal excision in MRI-defined poor-risk rectal cancer: a phase 2 trial

The Lancet Oncology - Tập 11 - Trang 241-248 - 2010
Yu Jo Chua1,2, Yolanda Barbachano3, David Cunningham1, Jacqui R Oates1, Gina Brown4, Andrew Wotherspoon5, Diana Tait6, Alison Massey1, Niall C Tebbutt1,7, Ian Chau1
1Department of Medicine, Royal Marsden Hospital, Sutton, Surrey, UK
2Medical Oncology Unit, The Canberra Hospital, Canberra, ACT, Australia
3Department of Statistics, Royal Marsden Hospital, Sutton, Surrey, UK
4Diagnostic Imaging, Royal Marsden Hospital, Sutton, Surrey, UK
5Department of Histopathology, Royal Marsden Hospital, Sutton, Surrey, UK
6Department of Radiotherapy, Royal Marsden Hospital, Sutton, Surrey, UK
7Ludwig Institute for Cancer Research, Austin Health, Melbourne, VIC, Australia

Tài liệu tham khảo

Havenga, 1999, Improved survival and local control after total mesorectal excision or D3 lymphadenectomy in the treatment of primary rectal cancer: an international analysis of 1411 patients, Eur J Surg Oncol, 25, 368, 10.1053/ejso.1999.0659 Nesbakken, 2002, Local recurrence after mesorectal excision for rectal cancer, Eur J Surg Oncol, 28, 126, 10.1053/ejso.2001.1231 Heald, 1998, Rectal cancer: the Basingstoke experience of total mesorectal excision, 1978–1997, Arch Surg, 133, 894, 10.1001/archsurg.133.8.894 Kapiteijn, 2002, Impact of the introduction and training of total mesorectal excision on recurrence and survival in rectal cancer in The Netherlands, Br J Surg, 89, 1142, 10.1046/j.1365-2168.2002.02196.x Sauer, 2004, Preoperative versus postoperative chemoradiotherapy for rectal cancer, N Engl J Med, 351, 1731, 10.1056/NEJMoa040694 Kapiteijn, 2001, Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer, N Engl J Med, 345, 638, 10.1056/NEJMoa010580 Bosset, 2006, Chemotherapy with preoperative radiotherapy in rectal cancer, N Engl J Med, 355, 1114, 10.1056/NEJMoa060829 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 Bujko, 2006, Long-term results of a randomized trial comparing preoperative short-course radiotherapy with preoperative conventionally fractionated chemoradiation for rectal cancer, Br J Surg, 93, 1215, 10.1002/bjs.5506 Peeters, 2007, The TME trial after a median follow-up of 6 years: increased local control but no survival benefit in irradiated patients with resectable rectal carcinoma, Ann Surg, 246, 693, 10.1097/01.sla.0000257358.56863.ce de Gramont, 2000, Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer, J Clin Oncol, 18, 2938, 10.1200/JCO.2000.18.16.2938 Kuebler, 2007, 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, 10.1200/JCO.2006.08.2974 Andre, 2009, Improved overall survival with oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment in stage II or III colon cancer in the MOSAIC trial, J Clin Oncol, 27, 3109, 10.1200/JCO.2008.20.6771 Chau, 2003, Neoadjuvant systemic fluorouracil and mitomycin C prior to synchronous chemoradiation is an effective strategy in locally advanced rectal cancer, Br J Cancer, 88, 1017, 10.1038/sj.bjc.6600822 Wibe, 2002, Prognostic significance of the circumferential resection margin following total mesorectal excision for rectal cancer, Br J Surg, 89, 327, 10.1046/j.0007-1323.2001.02024.x Nagtegaal, 2002, Circumferential margin involvement is still an important predictor of local recurrence in rectal carcinoma: not one millimeter but two millimeters is the limit, Am J Surg Pathol, 26, 350, 10.1097/00000478-200203000-00009 Quirke, 1986, Local recurrence of rectal adenocarcinoma due to inadequate surgical resection: histopathological study of lateral tumour spread and surgical excision, Lancet, 2, 996, 10.1016/S0140-6736(86)92612-7 2006, Diagnostic accuracy of preoperative magnetic resonance imaging in predicting curative resection of rectal cancer: prospective observational study, BMJ, 333, 779, 10.1136/bmj.38937.646400.55 Chau, 2006, Neoadjuvant capecitabine and oxaliplatin followed by synchronous chemoradiation and total mesorectal excision in magnetic resonance imaging-defined poor-risk rectal cancer, J Clin Oncol, 24, 668, 10.1200/JCO.2005.04.4875 Brown, 2005, Thin section MRI in multidisciplinary pre-operative decision making for patients with rectal cancer, Br J Radiol, 78, S117, 10.1259/bjr/15128198 Brown, 2005, Techniques and trouble-shooting in high spatial resolution thin slice MRI for rectal cancer, Br J Radiol, 78, 245, 10.1259/bjr/33540239 Therasse, 2000, New guidelines to evaluate the response to treatment in solid tumors, J Natl Cancer Inst, 92, 205, 10.1093/jnci/92.3.205 A'Hern, 2001, Sample size tables for exact single-stage phase II designs, Stat Med, 20, 859, 10.1002/sim.721 Kaplan, 1958, Nonparametric estimation from incomplete observations, J Am Stat Assoc, 53, 457, 10.1080/01621459.1958.10501452 Cassidy, 2008, Randomized phase III study of capecitabine plus oxaliplatin compared with fluorouracil/folinic acid plus oxaliplatin as first-line therapy for metastatic colorectal cancer, J Clin Oncol, 26, 2006, 10.1200/JCO.2007.14.9898 Porschen, 2007, Phase III study of capecitabine plus oxaliplatin compared with fluorouracil and leucovorin plus oxaliplatin in metastatic colorectal cancer: a final report of the AIO Colorectal Study Group, J Clin Oncol, 25, 4217, 10.1200/JCO.2006.09.2684 Diaz-Rubio, 2007, J Clin Oncol, 25, 4224, 10.1200/JCO.2006.09.8467 Gerard J, Azria D, Gourgou-Bourgade S, et al. Randomized multicenter phase III trial comparing two neoadjuvant chemoradiotherapy (CT-RT) regimens (RT45-Cap versus RT50-Capox) in patients (pts) with locally advanced rectal cancer (LARC): results of the ACCORD 12/0405 PRODIGE 2. 2009 ASCO Annual Meeting; Orlando, FL, USA; May 29–June 2, 2009. Abstract LBA4007. Aschele C, Pinto C, Cordio S, et al. Preoperative fluorouracil (FU)-based chemoradiation with and without weekly oxaliplatin in locally advanced rectal cancer: pathologic response analysis of the Studio Terapia Adiuvante Retto (STAR)-01 randomized phase III trial. 2009 ASCO Annual Meeting; Orlando, FL, USA; May 29–June 2, 2009. Abstract CRA2008. Fernandez-Martos C, Aparicio J, Salud A, et al. Multicenter randomized phase II study of chemoradiation (CRT) followed by surgery (S) and chemotherapy (CT) versus induction CT followed by CRT and S in high-risk rectal cancer: GCR-3 final efficacy and safety results. 2009 ASCO Annual Meeting; Orlando, FL, USA; May 29–June 2, 2009. Abstract 4103. Chau, 2004, The value of routine serum carcino-embryonic antigen measurement and computed tomography in the surveillance of patients after adjuvant chemotherapy for colorectal cancer, J Clin Oncol, 22, 1420, 10.1200/JCO.2004.05.041