Adjuvant chemoradiotherapy of advanced resectable rectal cancer: Results of a randomised trial comparing modulation of 5-fluorouracil with folinic acid or with interferon-α

British Journal of Cancer

Volumn 103, Issue 8, 2010, Pages 1163-1172

  Kornmann, M ^a   Staib, L ^b   Wiegel, T ^a   Kreuser, E D ^b   Kron, M ^a   Baumann, W ^b   Henne Bruns, D ^a   Link, K H ^b  

^a UNIVERSITY OF ULM   (Germany)

^b Study Group Oncology of Gastrointestinal Tumors (FOGT)   (Germany)

Author keywords

5 fluorouracil; adjuvant chemoradiotherapy; folinic acid; interferon; rectal cancer

Indexed keywords

ALPHA INTERFERON; FLUOROURACIL; FOLINATE CALCIUM; FOLINIC ACID; LEVAMISOLE; RECOMBINANT ALPHA2A INTERFERON; ANTINEOPLASTIC AGENT;

ADJUVANT CHEMOTHERAPY; ADJUVANT THERAPY; ADULT; ADVANCED CANCER; AGED; ARTICLE; CANCER CHEMOTHERAPY; CANCER RADIOTHERAPY; CANCER RECURRENCE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CYTOTOXICITY; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; OVERALL SURVIVAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RECTUM CANCER; ADENOCARCINOMA; ALGORITHM; DISEASE COURSE; MIDDLE AGED; MORTALITY; MULTIMODALITY CANCER THERAPY; RECTAL NEOPLASMS; VERY ELDERLY; YOUNG ADULT;

ADENOCARCINOMA; ADULT; AGED; AGED, 80 AND OVER; ALGORITHMS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CHEMOTHERAPY, ADJUVANT; COMBINED MODALITY THERAPY; DISEASE PROGRESSION; FEMALE; FLUOROURACIL; HUMANS; INTERFERON-ALPHA; LEUCOVORIN; MALE; MIDDLE AGED; RADIOTHERAPY, ADJUVANT; RECTAL NEOPLASMS; YOUNG ADULT;

EID: 77958020139     PISSN: 00070920     EISSN: 15321827     Source Type: Journal    
DOI: 10.1038/sj.bjc.6605871     Document Type: Article

References (46)

1. Allen WL, Johnston PG (2005) Role of genomic markers in colorectal cancer treatment. J Clin Oncol 23: 4545-4552
2. André T, Boni C, Navarro M, Tabernero J, Hickish T, Topham C, Bonetti A, Clingan P, Bridgewater J, Rivera F, de Gramont A (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: 3109-3116
3. Bosset JF, Collette L, Calais G, Mineur L, Maingon P, Radosevic-Jelic L, Daban A, Bardet E, Beny A, Ollier JC, EORTC Radiotherapy Group Trial 22921 (2006) Chemotherapy with preoperative radiotherapy in rectal cancer. N Engl J Med 355: 1114-1123
4. Bujko K, Nowacki MP, Nasierowska-Guttmejer A, Michalski W, Bebenek M, Kryj M (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: 1215-1223
5. Collette L, Bosset JF, den Dulk M, Nguyen F, Mineur L, Maingon P, Radosevic-Jelic L, Piérart M, Calais G, European Organisation for Research and Treatment of Cancer Radiation Oncology Group (2007) Patients with curative resection of cT3-4 rectal cancer after preoperative radiotherapy or radiochemotherapy: does anybody benefit from adjuvant fluorouracil-based chemotherapy? A trial of the European Organisation for Research and Treatment of Cancer Radiation Oncology Group. J Clin Oncol 25: 4379-4386
6. Corfu-A Study Group (1995) Phase III randomized study of two fluorouracil combinations with either interferon alfa-2a or leucovorin for advanced colorectal cancer. J Clin Oncol 13: 921-928
7. Dahl O, Fluge Ø, Carlsen E, Wiig JN, Myrvold HE, Vonen B, Podhorny N, Bjerkeset O, Eide TJ, Halvorsen TB, Tveit KM, Norwegian Gastrointestinal Cancer Group (2009) Final results of a randomised phase III study on adjuvant chemotherapy with 5 FU and levamisol in colon and rectum cancer stage II and III by the Norwegian Gastrointestinal Cancer Group. Acta Oncol 48: 368-376
8. de Gramont A, Haller DG (2008) Accomplishments in 2007 in the adjuvant treatment of colorectal cancer. Gastrointest Cancer Res 2(3, Suppl): S2-S6
9. den Dulk M, Putter H, Collette L, Marijnen CA, Folkesson J, Bosset JF, Rödel C, Bujko K, Pahlman L, van de Velde CJ (2009) The abdominoperineal resection itself is associated with an adverse outcome: the European experience based on a pooled analysis of five European randomised clinical trials on rectal cancer. Eur J Cancer 45: 1175-1183
10. Fisher B, Wolmark N, Rockette H, Redmond C, Deutsch M, Wickerham DL, Fisher ER, Caplan R, Jones J, Lerner H (1988) Postoperative adjuvant chemotherapy or radiation therapy for rectal cancer: results from NSABP protocol R-01. J Natl Cancer Inst 80: 21-29 (Pubitemid 18076565)
11. Gastrointestinal Tumor Study Group (1985) Prolongation of the disease-free interval in surgically treated rectal carcinoma. N Engl J Med 312: 1465-1472
12. Gérard JP, Conroy T, Bonnetain F, Bouché O, Chapet O, Closon-Dejardin MT, Untereiner M, Leduc B, Francois E, Maurel J, Seitz JF, Buecher B, Mackiewicz R, Ducreux M, Bedenne L (2006) Preoperative radiotherapy with or without concurrent fluorouracil and leucovorin in T3-4 rectal cancers: results of FFCD 9203. J Clin Oncol 24: 4620-4625
13. Glimelius B, Dahl O, Cedermark B, Jakobsen A, Bentzen SM, Starkhammar H, Grönberg H, Hultborn R, Albertsson M, Pahlman L, Tveit KM, Nordic Gastrointestinal Tumour Adjuvant Therapy Group (2005) Adjuvant chemotherapy in colorectal cancer: a joint analysis of randomised trials by the Nordic Gastrointestinal Tumour Adjuvant Therapy Group. Acta Oncol 44: 904-912
14. Glynne-Jones R, Mawdsley S, Harrison M (2010) Cetuximab and chemoradiation for rectal cancer - is the water getting muddy? Acta Oncol 49: 278-286
15. Gunderson LL, Sargent DJ, Tepper JE, O'Connell MJ, Allmer C, Smalley SR, Martenson JA, Haller DG, Mayer RJ, Rich TA, Ajani JA, Macdonald JS, Goldberg RM (2002) Impact of T and N substage on survival and disease relapse in adjuvant rectal cancer: a pooled analysis. Int J Radiat Oncol Biol Phys 54: 386-396
16. Haller DG, Catalano PJ, MacDonald JS (1998) Fluorouracil (FU), leucovorin (LV) and levamisole (LEV) adjuvant therapy for colon cancer: five year final report of INT-0089. Proc Am Soc Clin Oncol 17: 256
17. Haller DG, Catalano PJ, Macdonald JS, O'Rourke MA, Frontiera MS, Jackson DV, Mayer RJ (2005) Phase III study of fluorouracil, leucovorin, and levamisole in high-risk stage II and III colon cancer: final report of Intergroup 0089. J Clin Oncol 23: 8671-8678
18. Heald RJ, Moran BJ, Brown G, Daniels IR (2004) Optimal total mesorectal excision for rectal cancer is by dissection in front of Denonvilliers' fascia. Br J Surg 91: 121-123
19. Herfahrt C, Schlag P (1991) Richtlinien Zur Operativen Therapie Maligner Tumoren. Karl Demeter Verlag: Stuttgart
20. Hyams DM, Mamounas EP, Petrelli N, Rockette H, Jones J, Wieand HS, Deutsch M, Wickerham L, Fisher B, Wolmark N (1997) A clinical trial to evaluate the worth of preoperative multimodality therapy in patients with operable carcinoma of the rectum: a progress report of National Surgical Breast and Bowel Project Protocol R-03. Dis Colon Rectum 40: 131-139
21. International Multicentre Pooled Analysis of Colon Cancer Trials (IMPACT) investigators (1995) Efficacy of adjuvant fluorouracil and folinic acid in colon cancer. Lancet 345: 939-944
22. Kornmann M, Henne-Bruns D, Porzsolt F (2008) Neoadjuvant treatment of rectal carcinoma: assessment of health care services by physicians and lay persons. J Clin Oncol 26: 4866-4868
23. Kornmann M, Schwabe W, Sander S, Kron M, Sträter J, Polat S, Kettner E, Weiser HF, Baumann W, Schramm H, Häusler P, Ott K, Behnke D, Staib L, Beger HG, Link KH (2003) Thymidylate synthase and dihydropyrimidine dehydrogenase mRNA expression levels: predictors for survival in colorectal cancer patients receiving adjuvant 5-fluorouracil. Clin Cancer Res 9: 4116-4124
24. Krook JE, Moertel CG, Gunderson LL, Wieand HS, Collins RT, Beart RW, Kubista TP, Poon MA, Meyers WC, Mailliard JA (1991) Effective surgical adjuvant therapy for high-risk rectal carcinoma. N Engl J Med 324: 709-715
25. Kuebler JP, Wieand HS, O'Connell MJ, Smith RE, Colangelo LH, Yothers G, Petrelli NJ, Findlay MP, Seay TE, Atkins JN, Zapas JL, Goodwin JW, Fehrenbacher L, Ramanathan RK, Conley BA, Flynn PJ, Soori G, Colman LK, Levine EA, Lanier KS, Wolmark N (2007) Oxaliplatin combined with weekly bolus fluorouracil and leucovorin as surgical adjuvant chemotherapy for stage II and III colon cancer: results from NSABP C-7. J Clin Oncol 25: 2198-2204 (Pubitemid 46954643)
26. Link KH, Kornmann M, Staib L, Redenbacher M, Kron M, Beger HG, Study Group Oncology of Gastrointestinal Tumors (2005) Increase of survival benefit in advanced resectable colon cancer by extent of adjuvant treatment: results of a randomized trial comparing modulation of 5-FU+levamisole with folinic acid or with interferon-alpha. Ann Surg 242: 178-187
27. Makower D, Wadler S (1999) Interferons as biomodulators of fluoropyr-imidines in the treatment of colorectal cancer. Semin Oncol 26: 663-671
28. Martling AL, Holm T, Rutqvist LE, Moran BJ, Heald RJ, Cedermark B (2000) Effect of a surgical training programme on outcome of rectal cancer in the County of Stockholm. Stockholm Colorectal Cancer Study Group, Basingstoke Bowel Cancer Research Project. Lancet 356: 93-96
29. Nagtegaal ID, Quirke P (2008) What is the role for the circumferential margin in the modern treatment of rectal cancer? J Clin Oncol 26: 303-312
30. NIH Consensus Conference (1990) Adjuvant therapy for patients with colon and rectal cancer. JAMA 264: 1444-1450
31. O'Connell MJ, Laurie JA, Kahn M, Fitzgibbons Jr RJ, Erlichman C, Shepherd L, Moertel CG, Kocha WI, Pazdur R, Wieand HS, Rubin J, Vukov AM, Donohue JH, Krook JE, Figueredo A (1998) Prospectively randomized trial of postoperative adjuvant chemotherapy in patients with high-risk colon cancer. J Clin Oncol 16: 295-300
32. Peeters KC, Marijnen CA, Nagtegaal ID, Kranenbarg EK, Putter H, Wiggers T, Rutten H, Pahlman L, Glimelius B, Leer JW, van de Velde CJ, Dutch Colorectal Cancer Group (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: 693-701
33. Porschen R, Bermann A, Löffler T, Haack G, Rettig K, Anger Y, Strohmeyer G, Arbeitsgemeinschaft Gastrointestinale Onkologie (2001) Fluorouracil plus leucovorin as effective adjuvant chemotherapy in curatively resected stage III colon cancer results of the trial adjCCA-01. J Clin Oncol 19: 1787-1794
34. QUASAR Collaborative Group (2000) Comparison of fluorouracil with additional levamisole, higher-dose folinic acid, or both, as adjuvant chemotherapy for colorectal cancer: a randomised trial. Lancet 355: 1588-1596
35. Rödel C, Sauer R (2007) Integration of novel agents into combined-modality treatment for rectal cancer patients. Strahlenther Onkol 183: 227-235
36. Sauer R, Becker H, Hohenberger W, Rödel C, Wittekind C, Fietkau R, Martus P, Tschmelitsch J, Hager E, Hess CF, Karstens JH, Liersch T, Schmidberger H, Raab R, German Rectal Cancer Study Group (2004) Preoperative versus postoperative chemoradiotherapy for rectal cancer. N Engl J Med 351: 1731-1740
37. Sebag-Montefiore D, Stephens RJ, Steele R, Monson J, Grieve R, Khanna S, Quirke P, Couture J, de Metz C, Myint AS, Bessell E, Griffiths G, Thompson LC, Parmar M (2009) Preoperative radiotherapy versus selective postoperative chemoradiotherapy in patients with rectal cancer (MRC CR07 and NCIC-CTG C016): a multicentre, randomised trial. Lancet 373: 811-820
38. Slaton JW, Perrotte P, Inoue K, Dinney CP, Fidler IJ (1999) Interferonalpha-mediated down-regulation of angiogenesis-related genes and therapy of bladder cancer are dependent on optimization of biological dose and schedule. Clin Cancer Res 5: 2726-2734
39. Swedish Rectal Cancer Trial (1997) Improved survival with preoperative radiotherapy in resectable rectal cancer. N Engl J Med 336: 980-987
40. Tepper JE, O'Connell M, Niedzwiecki D, Hollis DR, Benson III AB, Cummings B, Gunderson LL, Macdonald JS, Martenson JA, Mayer RJ (2002) Adjuvant therapy in rectal cancer: analysis of stage, sex, and local control - final report of Intergroup 0114. J Clin Oncol 20: 1744-1750
41. Van Triest B, Pinedo HM, Giaccone G, Peters GJ (2000) Downstream molecular determinants of response to 5-fluorouracil and antifolate thymidylate synthase inhibitors. Ann Oncol 11: 385-391
42. Weiss C, Arnold D, Dellas K, Liersch T, Hipp M, Fietkau R, Sauer R, Hinke A, Rödel C (2010) Preoperative radiotherapy of advanced rectal cancer with capecitabine and oxaliplatin with or without cetuximab: a pooled analysis of three prospective phase I-II trials. Int J Radiat Oncol Biol Phys 8: 194-199
43. Weiss J, Moghanaki D, Plastaras JP, Haller DG (2009) Improved patient and regimen selection in locally advanced rectal cancer: who, how, and what next? Clin Colorectal Cancer 8: 194-199
44. Wibe A, Møller B, Norstein J, Carlsen E, Wiig JN, Heald RJ, Langmark F, Myrvold HE, Søreide O, Norwegian Rectal Cancer Group (2002) A national strategic change in treatment policy for rectal cancer - implementation of total mesorectal excision as routine treatment in Norway. A national audit. Dis Colon Rectum 45: 857-866
45. Wilson PM, Ladner RD, Lenz HJ (2007) Predictive and prognostic markers in colorectal cancer. Gastrointest Cancer Res 1: 237-246
46. Wolmark N, Wieand HS, Hyams DM, Colangelo L, Dimitrov NV, Romond EH, Wexler M, Prager D, Cruz Jr AB, Gordon PH, Petrelli NJ, Deutsch M, Mamounas E, Wickerham DL, Fisher ER, Rockette H, Fisher B (2000) Randomized trial of postoperative adjuvant chemotherapy with or without radiotherapy for carcinoma of the rectum: National Surgical Adjuvant Breast and Bowel Project Protocol R-02. J Natl Cancer Inst 92: 388-396