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

The Lancet Oncology

Volumn 11, Issue 3, 2010, Pages 241-248

  Chua, Yu Jo ^a,b   Barbachano, Yolanda ^a   Cunningham, David ^a   Oates, Jacqui R ^a   Brown, Gina ^a   Wotherspoon, Andrew ^a   Tait, Diana ^a   Massey, Alison ^a   Tebbutt, Niall C ^a,c   Chau, Ian ^a  

^a ROYAL MARSDEN HOSPITAL   (United Kingdom)

^b CANBERRA HOSPITAL   (Australia)

^c LUDWIG INSTITUTE FOR CANCER RESEARCH   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

CAPECITABINE; OXALIPLATIN;

ADJUVANT THERAPY; ADULT; AGED; ANEMIA; ANGINA PECTORIS; ARTICLE; CANCER ADJUVANT THERAPY; CANCER COMBINATION CHEMOTHERAPY; CANCER RADIOTHERAPY; CANCER RELAPSE; CANCER SURGERY; CARDIOTOXICITY; CEREBROVASCULAR ACCIDENT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; FEBRILE NEUTROPENIA; FEMALE; GASTROINTESTINAL TOXICITY; HAND FOOT SYNDROME; HEART ARRHYTHMIA; HEART FAILURE; HEART INFARCTION; HUMAN; HUMAN TISSUE; INFECTION; LETHARGY; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALE; METASTASIS; MULTIPLE CYCLE TREATMENT; NAUSEA AND VOMITING; NEUROPATHY; NEUTROPENIA; NUCLEAR MAGNETIC RESONANCE IMAGING; OVERALL SURVIVAL; POSTOPERATIVE CARE; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RECTUM CANCER; RECTUM SURGERY; SKIN TOXICITY; STOMATITIS; SURGICAL TECHNIQUE; SURVIVAL RATE; THROMBOCYTOPENIA; THROMBOEMBOLISM; TREATMENT DURATION; TREATMENT RESPONSE; UROGENITAL TRACT DISEASE;

AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; DEOXYCYTIDINE; DRUG ADMINISTRATION SCHEDULE; FEMALE; FLUOROURACIL; HUMANS; MAGNETIC RESONANCE IMAGING; MALE; MIDDLE AGED; NEOADJUVANT THERAPY; NEOPLASM RECURRENCE, LOCAL; NEOPLASM STAGING; ORGANOPLATINUM COMPOUNDS; RECTAL NEOPLASMS; SURVIVAL ANALYSIS;

EID: 77349110719     PISSN: 14702045     EISSN: None     Source Type: Journal    
DOI: 10.1016/S1470-2045(09)70381-X     Document Type: Article

References (31)

1. Havenga K., Enker W.E., Norstein J., et al. 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 (1999) 368-374
2. Nesbakken A., Nygaard K., Westerheim O., Mala T., and Lunde O.C. Local recurrence after mesorectal excision for rectal cancer. Eur J Surg Oncol 28 (2002) 126-134
3. Heald R.J., Moran B.J., Ryall R.D., Sexton R., and MacFarlane J.K. Rectal cancer: the Basingstoke experience of total mesorectal excision, 1978-1997. Arch Surg 133 (1998) 894-899
4. Kapiteijn E., Putter H., van de Velde C.J., and cooperative investigators of the Dutch ColoRectal Cancer Group. Impact of the introduction and training of total mesorectal excision on recurrence and survival in rectal cancer in The Netherlands. Br J Surg 89 (2002) 1142-1149
5. Sauer R., Becker H., Hohenberger W., et al. Preoperative versus postoperative chemoradiotherapy for rectal cancer. N Engl J Med 351 (2004) 1731-1740
6. Kapiteijn E., Marijnen C.A., Nagtegaal I.D., et al. Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer. N Engl J Med 345 (2001) 638-646
7. Bosset J.F., Collette L., Calais G., et al. Chemotherapy with preoperative radiotherapy in rectal cancer. N Engl J Med 355 (2006) 1114-1123
8. Gerard J.P., Conroy T., Bonnetain F., et al. Preoperative radiotherapy with or without concurrent fluorouracil and leucovorin in T3-4 rectal cancers: results of FFCD 9203. J Clin Oncol 24 (2006) 4620-4625
9. Bujko K., Nowacki M.P., Nasierowska-Guttmejer A., Michalski W., Bebenek M., and Kryj M. Long-term results of a randomized trial comparing preoperative short-course radiotherapy with preoperative conventionally fractionated chemoradiation for rectal cancer. Br J Surg 93 (2006) 1215-1223
10. Peeters K.C., Marijnen C.A., Nagtegaal I.D., et al. 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 (2007) 693-701
11. de Gramont A., Figer A., Seymour M., et al. Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer. J Clin Oncol 18 (2000) 2938-2947
12. Kuebler J.P., Wieand H.S., O'Connell M.J., et al. 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 (2007) 2198-2204
13. Andre T., Boni C., Navarro M., et al. 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 (2009) 3109-3116
14. Chau I., Allen M., Cunningham D., et al. Neoadjuvant systemic fluorouracil and mitomycin C prior to synchronous chemoradiation is an effective strategy in locally advanced rectal cancer. Br J Cancer 88 (2003) 1017-1024
15. Wibe A., Rendedal P.R., Svensson E., et al. Prognostic significance of the circumferential resection margin following total mesorectal excision for rectal cancer. Br J Surg 89 (2002) 327-334
16. Nagtegaal I.D., Marijnen C.A., Kranenbarg E.K., van de Velde C.J., and van Krieken J.H. 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 (2002) 350-357
17. Quirke P., Durdey P., Dixon M.F., and Williams N.S. Local recurrence of rectal adenocarcinoma due to inadequate surgical resection: histopathological study of lateral tumour spread and surgical excision. Lancet 2 (1986) 996-999
18. MERCURY Study Group. Diagnostic accuracy of preoperative magnetic resonance imaging in predicting curative resection of rectal cancer: prospective observational study. BMJ 333 (2006) 779
19. Chau I., Brown G., Cunningham D., et al. 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 (2006) 668-674
20. Brown G. Thin section MRI in multidisciplinary pre-operative decision making for patients with rectal cancer. Br J Radiol 78 Spec No 2 (2005) S117-S127
21. Brown G., Daniels I.R., Richardson C., Revell P., Peppercorn D., and Bourne M. Techniques and trouble-shooting in high spatial resolution thin slice MRI for rectal cancer. Br J Radiol 78 (2005) 245-251
22. Therasse P., Arbuck S.G., Eisenhauer E.A., et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 92 (2000) 205-216
23. A'Hern R.P. Sample size tables for exact single-stage phase II designs. Stat Med 20 (2001) 859-866
24. Kaplan E.L., and Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 53 (1958) 457-481
25. Cassidy J., Clarke S., Diaz-Rubio E., et al. 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 (2008) 2006-2012
26. Porschen R., Arkenau H.T., Kubicka S., et al. 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 (2007) 4217-4223
27. Diaz-Rubio E., Tabernero J., Gomez-Espana A., et al. Phase III study of capecitabine plus oxaliplatin compared with continuous-infusion fluorouracil plus oxaliplatin as first-line therapy in metastatic colorectal cancer: final report of the Spanish Cooperative Group for the Treatment of Digestive Tumors Trial. J Clin Oncol 25 (2007) 4224-4230
28. 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.
29. 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.
30. 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.
31. Chau I., Allen M.J., Cunningham D., et al. 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 (2004) 1420-1429