Long-term outcome in patients with a pathological complete response after chemoradiation for rectal cancer: a pooled analysis of individual patient data

The Lancet Oncology - Tập 11 - Trang 835-844 - 2010
Monique Maas1,2, Patty J Nelemans3, Vincenzo Valentini4, Prajnan Das5, Claus Rödel6, Li-Jen Kuo7, Felipe A Calvo8, Julio García-Aguilar9, Rob Glynne-Jones10, Karin Haustermans11, Mohammed Mohiuddin12, Salvatore Pucciarelli13, William Small14, Javier Suárez15, George Theodoropoulos16, Sebastiano Biondo17,18, Regina GH Beets-Tan2, Geerard L Beets1
1Department of Surgery, Maastricht University Medical Centre, Maastricht, Netherlands
2Department of Radiology, Maastricht University Medical Centre, Maastricht, Netherlands
3Department of Epidemiology, Maastricht University Medical Centre, Maastricht, Netherlands
4Department of Radiation Oncology, Università Cattolica S. Cuore, Rome, Italy
5Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA
6Department of Radiation Oncology, Universitätsklinikum Frankfurt, Frankfurt, Germany
7Department of Colorectal Surgery, Taipei Medical University Hospital, Taipei, Taiwan
8Department of Oncology, General University Hospital Gregorio Marañón, Madrid, Spain
9Department of Surgery, City of Hope, Duarte, CA, USA
10Department of Clinical Oncology, Mount Vernon Hospital, London, UK
11Department of Radiation Oncology, University Hospital Leuven, Belgium
12Oncology Centre, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia
13Department of Oncological and Surgical Sciences, Surgical Clinic 2nd, University of Padova, Padova, Italy
14Department of Radiation Oncology, Robert H Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL, USA
15Department of Surgery, Hospital de Navarra, Pamplona (Navarra), Spain
16First Department of Propaedeutic Surgery, Athens Medical School, Hippocration General Hospital, Athens, Greece
17Department of Surgery, Bellvitge University Hospital, Barcelona, Spain
18IDIBELL, University of Barcelona, Barcelona, Spain

Tài liệu tham khảo

Sauer, 2004, Preoperative versus postoperative chemoradiotherapy for rectal cancer, N Engl J Med, 351, 1731, 10.1056/NEJMoa040694 Janjan, 1999, Tumor downstaging and sphincter preservation with preoperative chemoradiation in locally advanced rectal cancer: the M. D. Anderson Cancer Center experience, Int J Radiat Oncol Biol Phys, 44, 1027, 10.1016/S0360-3016(99)00099-1 Pucciarelli, 2004, Complete pathologic response following preoperative chemoradiation therapy for middle to lower rectal cancer is not a prognostic factor for a better outcome, Dis Colon Rectum, 47, 1798, 10.1007/s10350-004-0681-1 Diaz-Gonzalez, 2006, Prognostic factors for disease-free survival in patients with T3-4 or N+ rectal cancer treated with preoperative chemoradiation therapy, surgery, and intraoperative irradiation, Int J Radiat Oncol Biol Phys, 64, 1122, 10.1016/j.ijrobp.2005.09.020 Rödel, 2005, Prognostic significance of tumor regression after preoperative chemoradiotherapy for rectal cancer, J Clin Oncol, 23, 8688, 10.1200/JCO.2005.02.1329 Valentini, 2002, Does downstaging predict improved outcome after preoperative chemoradiation for extraperitoneal locally advanced rectal cancer? A long-term analysis of 165 patients, Int J Radiat Oncol Biol Phys, 53, 664, 10.1016/S0360-3016(02)02764-5 Vecchio, 2005, The relationship of pathologic tumor regression grade (TRG) and outcomes after preoperative therapy in rectal cancer, Int J Radiat Oncol Biol Phys, 62, 752, 10.1016/j.ijrobp.2004.11.017 Chari, 1995, Preoperative radiation and chemotherapy in the treatment of adenocarcinoma of the rectum, Ann Surg, 221, 778, 10.1097/00000658-199506000-00016 Borschitz, 2008, Neoadjuvant chemoradiation and local excision for T2-3 rectal cancer, Ann Surg Oncol, 15, 712, 10.1245/s10434-007-9732-x Habr-Gama, 2004, Operative versus nonoperative treatment for stage 0 distal rectal cancer following chemoradiation therapy: long-term results, Ann Surg, 240, 711, 10.1097/01.sla.0000141194.27992.32 Shivnani, 2007, Preoperative chemoradiation for rectal cancer: results of multimodality management and analysis of prognostic factors, Am J Surg, 193, 389, 10.1016/j.amjsurg.2006.09.030 Hughes, 2006, Can pathological complete response in the primary tumour following pre-operative pelvic chemoradiotherapy for T3-T4 rectal cancer predict for sterilisation of pelvic lymph nodes, a low risk of local recurrence and the appropriateness of local excision?, Int J Colorectal Dis, 21, 11, 10.1007/s00384-005-0749-y Ahmad, 1997, Long-term results of preoperative radiation therapy alone for stage T3 and T4 rectal cancer, Br J Surg, 84, 1445, 10.1002/bjs.1800841029 Berger, 1997, Preoperative radiotherapy (RT) for rectal cancer: predictive factors of tumor downstaging and residual tumor cell density (RTCD): prognostic implications, Int J Radiat Oncol Biol Phys, 37, 619, 10.1016/S0360-3016(96)00577-9 Bujko, 2004, Sphincter preservation following preoperative radiotherapy for rectal cancer: report of a randomised trial comparing short-term radiotherapy vs. conventionally fractionated radiochemotherapy, Radiother Oncol, 72, 15, 10.1016/j.radonc.2003.12.006 Kaminsky, 1998, Prognostic implications of downstaging following preoperative radiation therapy for operable T3-T4 rectal cancer, Int J Radiat Oncol Biol Phys, 42, 935, 10.1016/S0360-3016(98)00345-9 Rouanet, 1995, Conservative surgery for low rectal carcinoma after high-dose radiation. Functional and oncologic results, Ann Surg, 221, 67, 10.1097/00000658-199501000-00008 Ruo, 2002, Long-term prognostic significance of extent of rectal cancer response to preoperative radiation and chemotherapy, Ann Surg, 236, 75, 10.1097/00000658-200207000-00012 Tsujinaka, 2008, Long-term efficacy of preoperative radiotherapy for locally advanced low rectal cancer, Int J Colorectal Dis, 23, 67, 10.1007/s00384-007-0369-9 Vermaas, 2005, Preoperative radiotherapy improves outcome in recurrent rectal cancer, Dis Colon Rectum, 48, 918, 10.1007/s10350-004-0891-6 Maingon, 1998, Conservative management of rectal adenocarcinoma by radiotherapy, Int J Radiat Oncol Biol Phys, 40, 1077, 10.1016/S0360-3016(97)00948-6 Rengan, 2005, Distal cT2N0 rectal cancer: is there an alternative to abdominoperineal resection?, J Clin Oncol, 23, 4905, 10.1200/JCO.2005.10.041 Wiig, 2005, Clinical outcome in patients with complete pathologic response (pT0) to preoperative irradiation/chemo-irradiation operated for locally advanced or locally recurrent rectal cancer, J Surg Oncol, 92, 70, 10.1002/jso.20340 Ceelen, 2006, Pre-operative combined modality therapy in the management of locally advanced rectal cancer, Eur J Surg Oncol, 32, 259, 10.1016/j.ejso.2005.12.002 Benzoni, 2006, Prognostic value of tumour regression grading and depth of neoplastic infiltration within the perirectal fat after combined neoadjuvant chemo-radiotherapy and surgery for rectal cancer, J Clin Pathol, 59, 505, 10.1136/jcp.2005.031609 Bosset, 2000, Preoperative radiochemotherapy in rectal cancer: long-term results of a phase II trial, Int J Radiat Oncol Biol Phys, 46, 323, 10.1016/S0360-3016(99)00411-3 Grann, 2001, Preoperative combined modality therapy for clinically resectable uT3 rectal adenocarcinoma, Int J Radiat Oncol Biol Phys, 49, 987, 10.1016/S0360-3016(00)01529-7 Grann, 1997, Preliminary results of preoperative 5-fluorouracil, low-dose leucovorin, and concurrent radiation therapy for clinically resectable T3 rectal cancer, Dis Colon Rectum, 40, 515, 10.1007/BF02055370 Mohiuddin, 2000, Preoperative chemoradiation in fixed distal rectal cancer: dose time factors for pathological complete response, Int J Radiat Oncol Biol Phys, 46, 883, 10.1016/S0360-3016(99)00486-1 Onaitis, 2001, Neoadjuvant chemoradiation for rectal cancer: analysis of clinical outcomes from a 13-year institutional experience, Ann Surg, 233, 778, 10.1097/00000658-200106000-00007 Pucciarelli, 2000, Preoperative combined radiotherapy and chemotherapy for middle and lower rectal cancer: preliminary results, Ann Surg Oncol, 7, 38, 10.1007/s10434-000-0038-5 Valentini, 1998, Preoperative chemoradiation for extraperitoneal T3 rectal cancer: acute toxicity, tumor response, and sphincter preservation, Int J Radiat Oncol Biol Phys, 40, 1067, 10.1016/S0360-3016(97)00918-8 Videtic, 1998, Preoperative radiation with concurrent 5-fluorouracil continuous infusion for locally advanced unresectable rectal cancer, Int J Radiat Oncol Biol Phys, 42, 319, 10.1016/S0360-3016(98)00214-4 Wiltshire, 2006, Preoperative radiation with concurrent chemotherapy for resectable rectal cancer: effect of dose escalation on pathologic complete response, local recurrence-free survival, disease-free survival, and overall survival, Int J Radiat Oncol Biol Phys, 64, 709, 10.1016/j.ijrobp.2005.08.012 Bonnen, 2004, Long-term results using local excision after preoperative chemoradiation among selected T3 rectal cancer patients, Int J Radiat Oncol Biol Phys, 60, 1098, 10.1016/j.ijrobp.2004.04.062 Lim, 2007, Long-term outcomes of patients with localized rectal cancer treated with chemoradiation or radiotherapy alone because of medical inoperability or patient refusal, Dis Colon Rectum, 50, 2032, 10.1007/s10350-007-9062-x Janjan, 2001, Improved overall survival among responders to preoperative chemoradiation for locally advanced rectal cancer, Am J Clin Oncol, 24, 107, 10.1097/00000421-200104000-00001 Das, 2006, Preoperative chemoradiotherapy with capecitabine versus protracted infusion 5-fluorouracil for rectal cancer: a matched-pair analysis, Int J Radiat Oncol Biol Phys, 66, 1378, 10.1016/j.ijrobp.2006.07.1374 Biondo, 2005, Response to neoadjuvant therapy for rectal cancer: influence on long-term results, Colorectal Dis, 7, 472, 10.1111/j.1463-1318.2005.00864.x Brown, 2003, Response to preoperative chemoradiation in stage II and III rectal cancer, Dis Colon Rectum, 46, 1189, 10.1007/s10350-004-6714-y Chan, 2005, Correlation of different 5-FU regimens and time to surgery with pathological complete response in locally advanced rectal cancer patients treated by pre-operative chemo-radiation, J La State Med Soc, 157, 196 Ferrigno, 2006, Neoadjuvant radiochemotherapy in the treatment of fixed and semi-fixed rectal tumors. Analysis of results and prognostic factors, Radiat Oncol, 1, 5, 10.1186/1748-717X-1-5 García-Aguilar, 2003, A pathologic complete response to preoperative chemoradiation is associated with lower local recurrence and improved survival in rectal cancer patients treated by mesorectal excision, Dis Colon Rectum, 46, 298, 10.1007/s10350-004-6545-x Gavioli, 2005, Incidence and clinical impact of sterilized disease and minimal residual disease after preoperative radiochemotherapy for rectal cancer, Dis Colon Rectum, 48, 1851, 10.1007/s10350-005-0133-6 Goethals, 2005, Chemo-radiotherapy versus radiotherapy alone in the pre-operative treatment of resectable rectal cancer, Eur J Surg Oncol, 31, 969, 10.1016/j.ejso.2005.03.011 Guillem, 2005, Long-term oncologic outcome following preoperative combined modality therapy and total mesorectal excision of locally advanced rectal cancer, Ann Surg, 241, 829, 10.1097/01.sla.0000161980.46459.96 Kuo, 2007, Is final TNM staging a predictor for survival in locally advanced rectal cancer after preoperative chemoradiation therapy?, Ann Surg Oncol, 14, 2766, 10.1245/s10434-007-9471-z Losi, 2006, Prognostic value of Dworak grade of regression (GR) in patients with rectal carcinoma treated with preoperative radiochemotherapy, Int J Colorectal Dis, 21, 645, 10.1007/s00384-005-0061-x Minsky, 1997, Preoperative 5-FU, low-dose leucovorin, and radiation therapy for locally advanced and unresectable rectal cancer, Int J Radiat Oncol Biol Phys, 37, 289, 10.1016/S0360-3016(96)00487-7 Mohiuddin, 2000, Prognostic significance of postchemoradiation stage following preoperative chemotherapy and radiation for advanced/recurrent rectal cancers, Int J Radiat Oncol Biol Phys, 48, 1075, 10.1016/S0360-3016(00)00732-X Onaitis, 2001, Complete response to neoadjuvant chemoradiation for rectal cancer does not influence survival, Ann Surg Oncol, 8, 801, 10.1007/s10434-001-0801-2 Quah, 2008, Pathologic stage is most prognostic of disease-free survival in locally advanced rectal cancer patients after preoperative chemoradiation, Cancer, 113, 57, 10.1002/cncr.23516 Rich, 1995, Preoperative infusional chemoradiation therapy for stage T3 rectal cancer, Int J Radiat Oncol Biol Phys, 32, 1025, 10.1016/0360-3016(95)00020-Y Stipa, 2006, A pathologic complete response of rectal cancer to preoperative combined-modality therapy results in improved oncological outcome compared with those who achieve no downstaging on the basis of preoperative endorectal ultrasonography, Ann Surg Oncol, 13, 1047, 10.1245/ASO.2006.03.053 Suárez, 2008, Pathologic response assessed by Mandard grade is a better prognostic factor than down staging for disease-free survival after preoperative radiochemotherapy for advanced rectal cancer, Colorectal Dis, 10, 563, 10.1111/j.1463-1318.2007.01424.x Theodoropoulos, 2002, T-level downstaging and complete pathologic response after preoperative chemoradiation for advanced rectal cancer result in decreased recurrence and improved disease-free survival, Dis Colon Rectum, 45, 895, 10.1007/s10350-004-6325-7 Vauthey, 1999, Recent advances in the treatment and outcome of locally advanced rectal cancer, Ann Surg, 229, 745, 10.1097/00000658-199905000-00018 Capirci, 2008, Prognostic value of pathologic complete response after neoadjuvant therapy in locally advanced rectal cancer: long-term analysis of 566 ypCR patients, Int J Radiat Oncol Biol Phys, 72, 99, 10.1016/j.ijrobp.2007.12.019 Rödel, 2002, Apoptosis as a cellular predictor for histopathologic response to neoadjuvant radiochemotherapy in patients with rectal cancer, Int J Radiat Oncol Biol Phys, 52, 294, 10.1016/S0360-3016(01)02643-8 Kuremsky, 2009, Biomarkers for response to neoadjuvant chemoradiation for rectal cancer, Int J Radiat Oncol Biol Phys, 74, 673, 10.1016/j.ijrobp.2009.03.003 Kim, 2007, A comparative study of volumetric analysis, histopathologic downstaging, and tumor regression grade in evaluating tumor response in locally advanced rectal cancer following preoperative chemoradiation, Int J Radiat Oncol Biol Phys, 67, 204, 10.1016/j.ijrobp.2006.08.020 Bateman, 2009, Rectal cancer staging post neoadjuvant therapy—how should the changes be assessed?, Histopathology, 54, 713, 10.1111/j.1365-2559.2009.03292.x Ryan, 2005, Pathological response following long-course neoadjuvant chemoradiotherapy for locally advanced rectal cancer, Histopathology, 47, 141, 10.1111/j.1365-2559.2005.02176.x Mohiuddin, 2006, Randomized phase II study of neoadjuvant combined-modality chemoradiation for distal rectal cancer: Radiation Therapy Oncology Group Trial 0012, J Clin Oncol, 24, 650, 10.1200/JCO.2005.03.6095 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 Debucquoy, 2009, Molecular response to cetuximab and efficacy of preoperative cetuximab-based chemoradiation in rectal cancer, J Clin Oncol, 27, 2751, 10.1200/JCO.2008.18.5033 Valentini, 2008, Infusional 5-fluorouracil and ZD1839 (Gefitinib-Iressa) in combination with preoperative radiotherapy in patients with locally advanced rectal cancer: a phase I and II trial (1839IL/0092), Int J Radiat Oncol Biol Phys, 72, 644, 10.1016/j.ijrobp.2008.01.046 Kerr, 2008, Delaying surgery after neoadjuvant chemoradiotherapy for rectal cancer may reduce postoperative morbidity without compromising prognosis, Br J Surg, 95, 1534, 10.1002/bjs.6377 Tulchinsky, 2008, An interval >7 weeks between neoadjuvant therapy and surgery improves pathologic complete response and disease-free survival in patients with locally advanced rectal cancer, Ann Surg Oncol, 15, 2661, 10.1245/s10434-008-9892-3 Collette, 2007, J Clin Oncol, 25, 4379, 10.1200/JCO.2007.11.9685 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