Phase II study of preoperative radiation plus concurrent daily tegafur-uracil (UFT) with leucovorin for locally advanced rectal cancer

BMC Cancer

Volumn 11, Issue , 2011, Pages

  Cellier, Patrice ^a   Leduc, Bernard ^b   Martin, Laurent ^c   Vié, Brigitte ^d   Chevelle, Christian ^e   Vendrely, Véronique ^f   Salemkour, Augustin ^g   Carrie, Christian ^h   Calais, Gilles ⁱ   Burtin, Pascal ^j   Campion, Loïc ^a   Boisdron Celle, Michèle ^{a,b,c,d,e,f,g,h,i,j,k,l}   Morel, Alain ^{a,b,c,d,e,f,g,h,i,j,k,l}   Berger, Virginie ^a   Gamelin, Erick ^{a,b,c,d,e,f,g,h,i,j,k,l}  

^a CENTRE PAUL PAPIN   (France)

^b CENTRE HOSPITALIER   (France)

^c Guillaume le Conquérant Center   (France)

^d CENTRE FRANÇOIS BACLESSE   (France)

^e CLINIQUE PASTEUR   (France)

^f HÔPITAL SAINT ANDRÉ   (France)

^g Centre d'Onco Radiothérapie d'Eure et Loire   (France)

^h CENTRE LÉON BÉRARD   (France)

ⁱ CHU BRETONNEAU   (France)

^j ANGERS UNIVERSITY HOSPITAL   (France)

^k CENTRE RENÉ GAUDUCHEAU   (France)

^l Team 12   (France)

more..

Author keywords

[No Author keywords available]

Indexed keywords

DIHYDROPYRIMIDINE DEHYDROGENASE; FLUOROURACIL; FOLINIC ACID; OXALIPLATIN; UFT; ANTINEOPLASTIC AGENT; TEGAFUR; URACIL;

ADULT; ADVANCED CANCER; AGED; ANEMIA; ANUS SPHINCTER; ARTICLE; CANCER ADJUVANT THERAPY; CANCER RADIOTHERAPY; CANCER STAGING; CEREBROVASCULAR ACCIDENT; CYSTITIS; DIARRHEA; DISEASE FREE SURVIVAL; DRUG EFFICACY; DRUG TOLERABILITY; ENZYME ACTIVITY; EPISTAXIS; FEMALE; HAND FOOT SYNDROME; HETEROZYGOTE; HUMAN; LEUKOPENIA; LUNG DISEASE; MAJOR CLINICAL STUDY; MALE; MUCOSA INFLAMMATION; MULTICENTER STUDY; NAUSEA; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; PREOPERATIVE RADIOTHERAPY; PROCTITIS; RADIATION DERMATITIS; RECTUM CANCER; SENSITIVITY AND SPECIFICITY; SUBOCCLUSIVE SYNDROME; SYNDROME; THROMBOPHLEBITIS; TREATMENT RESPONSE; ULTRASOUND; VALIDATION STUDY; VOMITING; ADENOCARCINOMA; ADJUVANT CHEMOTHERAPY; ADJUVANT THERAPY; ADOLESCENT; CLINICAL TRIAL; MIDDLE AGED; MULTIMODALITY CANCER THERAPY; PREOPERATIVE PERIOD; RECTUM TUMOR;

ADENOCARCINOMA; ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CHEMOTHERAPY, ADJUVANT; COMBINED MODALITY THERAPY; FEMALE; HUMANS; LEUCOVORIN; MALE; MIDDLE AGED; PREOPERATIVE PERIOD; RADIOTHERAPY, ADJUVANT; RECTAL NEOPLASMS; TEGAFUR; URACIL; YOUNG ADULT;

EID: 79952703627     PISSN: None     EISSN: 14712407     Source Type: Journal    
DOI: 10.1186/1471-2407-11-98     Document Type: Article

References (45)

1. Rich TA, Skibber JM, Ajani JA, Buchholz DJ, Cleary KR, Dubrow RA, Levin B, Lynch PM, Meterissian SH, Roubein LD, Ota DM. Preoperative infusional chemoradiation therapy for stage T3 rectal cancer. Int J Radiat Oncol Biol Phys 1995, 32:1025-9. 10.1016/0360-3016(95)00152-O, 7607922.
2. Bosset JF, Magnin V, Maingon P, Mantion G, Pelissier EP, Mercier M, Chaillard G, Horiot JC. Preoperative radiochemotherapy in rectal cancer: long-term results of a phase II trial. Int J Radiat Oncol Biol Phys 2000, 46:323-7. 10.1016/S0360-3016(99)00411-3, 10661338.
3. Lawrence TS, Tepper JE, Blackstock AW. Fluoropyrimidine-radiation interactions in cells and tumors. Semin Radiat Oncol 1997, 7:260-6. 10.1016/S1053-4296(97)80024-0, 10717223.
4. Smalley SR, Benedetti JK, Williamson SK, Robertson JM, Estes NC, Maher T, Fisher B, Rich TA, Martenson JA, Kugler JW, Benson AB, Haller DG, Mayer RJ, Atkins JN, Cripps C, Pedersen J, Periman PO, Tanaka MS, Leichman CG, Macdonald JS. Phase III trial of fluorouracil-based chemotherapy regimens plus radiotherapy in postoperative adjuvant rectal cancer: GI INT 0144. J Clin Oncol 2006, 24:3542-7. 10.1200/JCO.2005.04.9544, 16877719.
5. Borner MM, Schöffski P, de Wit R, Caponigro F, Comella G, Sulkes A, Greim G, Peters GJ, van der Born K, Wanders J, de Boer RF, Martin C, Fumoleau P. Patient preference and pharmacokinetics of oral modulated UFT versus intravenous fluorouracil and leucovorin: a randomised crossover trial in advanced colorectal cancer. Eur J Cancer 2002, 38:349-58. 10.1016/S0959-8049(01)00371-9, 11818199.
6. Hoff PM, Janjan N, Saad ED, Skibber J, Crane C, Lassere Y, Cleary KR, Benner S, Randolph J, Abbruzzese JL, Pazdur R. Phase I study of preoperative oral uracil and tegafur plus leucovorin and radiation therapy in rectal cancer. J Clin Oncol 2000, 18:3529-34.
7. de la Torre A, Ramos S, Valcárcel FJ, Candal A, Regueiro CA, Romero J, Magallón R, Salinas J, de las Heras M, Veiras C, Tisaire JL, Aragón G. Phase II study of radiochemotherapy with UFT and low-dose oral leucovorin in patients with unresectable rectal cancer. Int J Radiat Oncol Biol Phys 1999, 45:629-34. 10.1016/S0360-3016(99)00225-4, 10524415.
8. de la Torre A, García-Berrocal MI, Arias F, Mariño A, Valcárcel F, Magallón R, Regueiro CA, Romero J, Zapata I, de la Fuente C, Fernández-Lizarbe E, Vergara G, Belinchón B, Veiras M, Molerón R, Millán I. Preoperative chemoradiotherapy for rectal cancer: randomized trial comparing oral uracil and tegafur and oral leucovorin vs. intravenous 5-fluorouracil and leucovorin. Int J Radiat Oncol Biol Phys 2008, 70:102-10. 10.1016/j.ijrobp.2007.05.068, 17869446.
9. Feliu J, Calvillo J, Escribano A, de Castro J, Sánchez ME, Mata A, Espinosa E, García Grande A, Mateo A, González Barón M. Neoadjuvant therapy of rectal carcinoma with UFT-leucovorin plus radiotherapy. Ann Oncol 2002, 13:730-6. 10.1093/annonc/mdf116, 12075741.
10. Wang LW, Yang SH, Lin JK, Lin TC, Chan WK, Chen WS, Wang HS, Jiang JK, Lee RC, Li AF, Chao Y, Chi KH, Yen SH. Preoperative chemoradiotherapy with oral tegafur-uracil and leucovorin for rectal cancer. J Surg Oncol 2005, 89:256-64. 10.1002/jso.20168, 15726610.
11. Fernández-Martos C, Aparicio J, Bosch C, Torregrosa M, Campos JM, Garcera S, Vicent JM, Maestu I, Climent MA, Mengual JL, Tormo A, Hernandez A, Estevan R, Richart JM, Viciano V, Uribe N, Campos J, Puchades R, Arlandis F, Almenar D. Preoperative uracil, tegafur, and concomitant radiotherapy in operable rectal cancer: a phase II multicenter study with 3 years' follow-up. J Clin Oncol 2004, 22:3016-22.
12. Vestermark LW, Jacobsen A, Qvortrup C, Vestermark LW, Jacobsen A, Qvortrup C, Hansen F, Bisgaard C, Baatrup G, Rasmussen P, Pfeiffer P. Long-term results of a phase II trial of high-dose radiotherapy (60 Gy) and UFT/l-leucovorin in patients with non-resectable locally advanced rectal cancer (LARC). Acta Oncol 2008, 47:428-33. 10.1080/02841860701798866, 18348002.
13. Kundel Y, Brenner B, Symon Z, Oberman B, Sadezki S, Koller M, Catane R, Pfeffer R. A phase II study of oral UFT and leucovorin concurrently with pelvic irradiation as neoadjuvant chemoradiation for rectal cancer. Anticancer Res 2007, 27:2877-80.
14. Giralt J, Tabernero J, Navalpotro B, Capdevila J, Espin E, Casado E, Mañes A, Landolfi S, Sanchez-Garcia JL, de Torres I, Armengol M. Pre-operative chemoradiotherapy with UFT and Leucovorin in patients with advanced rectal cancer: a phase II study. Radiother Oncol 2008, 89:263-9. 10.1016/j.radonc.2008.07.010, 18768230.
15. Seck K, Riemer S, Kates R, Ullrich T, Lutz V, Harbeck N, Schmitt M, Kiechle M, Diasio R, Gross E. Analysis of the DPYD gene implicated in 5-fluorouracil catabolism in a cohort of Caucasian individuals. Clin Cancer Res 2005, 11:5886-92. 10.1158/1078-0432.CCR-04-1784, 16115930.
16. Diasio RB, Johnson MR. Dihydropyrimidine dehydrogenase: its role in 5-fluorouracil clinical toxicity and tumor resistance. Clin Cancer Res 1999, 5:2672-3.
17. Saif MW, Diasio R. Is capecitabine safe in patients with gastrointestinal cancer and dihydropyrimidine dehydrogenase deficiency. Clin Colorectal Cancer 2006, 5:359-62. 10.3816/CCC.2006.n.007, 16512996.
18. Van Kuilenburg ABP, Abreu R, Van Gennip A. Pharmacogenetic and clinical aspects of dihydropyrimidine dehydrogenase deficiency. Ann Clin Biochem 2003, 40:41-5. 10.1258/000456303321016150, 12542909.
19. Miller AB, Hoogstraten B, Staquet M, Winkler A. Reporting results of cancer treatment. Cancer 1981, 47:207-14. 10.1002/1097-0142(19810101)47:1<207::AID-CNCR2820470134>3.0.CO;2-6, 7459811.
20. Mornex F, Pavy JJ, Denekamp J, Bolla M. Scoring system of late effects of radiations on normal tissues: the SOMA-LENT scale. Cancer Radiother 1997, 1:622-68. article in French.
21. Sobin LH, Wittekind CH. TNM Classification of Malignant Tumours (5th ed). 1997, Wiley-Liss; New York.
22. Meterissian S, Skibber J, Rich T, Roubein L, Ajani J, Cleary K, Ota DM. Patterns of residual disease after pre-operative chemoradiation in ultrasound T3 rectal carcinoma. Ann Surg Oncol 1994, 1:111-6. 10.1007/BF02303553, 7834435.
23. Minsky BD, Cohen AM, Enker WE, Paty P. Sphincter preservation with preoperative radiation therapy and coloanal anastomosis. Int J Radiat Oncol Biol Phys 1995, 31:553-9. 10.1016/0360-3016(94)00375-U, 7852119.
24. Morel A, Boisdron-Celle M, Fey L, Soulié P, Craipeau MC, Traore S, Gamelin E. Clinical relevance of different dihydropyrimidine dehydrogenase gene single nucleotide polymorphisms (SNP) on 5-fluorouracil tolerance. Mol Cancer Ther 2006, 5:2895-904. 10.1158/1535-7163.MCT-06-0327, 17121937.
25. Remaud G, Boisdron-Celle M, Hameline C, Morel A, Gamelin E. An accurate dihydrouracil/uracil determination using improved high performance liquid chromatography method for preventing fluoropyrimidines-related toxicity in clinical practice. J Chromatogr B Analyt Technol Biomed Life Sci 2005, 823:98-107. 10.1016/j.jchromb.2005.05.044, 16027050.
26. Boisdron-Celle M, Remaud G, Traore S, Poirier AL, Gamelin L, Morel A, Gamelin E. 5-Fluorouacil-related severe toxicity: A comparison of different methods for the pretherapeutic detection of dihydropyrimidine dehydrogenase deficiency. Cancer Lett 2007, 249:271-82. 10.1016/j.canlet.2006.09.006, 17064846.
27. Gamelin E, Boisdron-Celle M, Guérin-Meyer V, Delva R, Lortholary A, Genevieve F, Larra F, Ifrah N, Robert J. Correlation between uracil and dihydrouracil plasma ratio, fluorouracil (5-FU) pharmacokinetic parameters, and tolerance in patients with advanced colorectal cancer: A potential interest for predicting 5-FU toxicity and determining optimal 5-FU dosage. J Clin Oncol 1999, 17:1105-10.
28. Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials 1989, 10:1-10. 10.1016/0197-2456(89)90015-9, 2702835.
29. Kim DY, Jung KH, Kim TH, Kim DW, Chang HJ, Jeong JY, Kim YH, Son SH, Yun T, Hong CW, Sohn DK, Lim SB, Choi HS, Jeong SY, Park JG. Comparison of 5-fluorouracil/leucovorin and capecitabine in preoperative chemoradiotherapy for locally advanced rectal cancer. Int J Radiat Oncol Biol Phys 2007, 67:378-84. 10.1016/j.ijrobp.2006.08.063, 17097835.
30. Dunst J, Debus J, Rudat V, Wulf J, Budach W, Hoelscher T, Reese T, Mose S, Roedel C, Zuehlke H, Hinke A. Neadjuvant capecitabine combined with standard radiotherapy in patients with locally advanced rectal cancer mature results of a phase II trial. Strahlentther Onkol 2008, 184:450-6.
31. 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 Preoperative chemoradiotherapy for rectal cancer. N Eng J Med 2004, 351:17316-40. German Rectal Cancer Study Group.
32. Calvo FA, Serrano FJ, Diaz-González JA, Gomez-Espi M, Lozano E, Garcia R, de la Mata D, Arranz JA, García-Alfonso P, Pérez-Manga G, Álvarez E. Improved incidence of pT0 downstaged surgical specimens in locally advanced rectal cancer (LARC) treated with induction oxaliplatin plus 5-fluorouracil and preoperative chemoradiation. Ann Oncol 2006, 17:1103-10. 10.1093/annonc/mdl085, 16670204.
33. Ryan DP, Niedzwiecki D, Hollis D, Mediema BE, Wadler S, Tepper JE, Goldberg RM, Mayer RJ. Phase I/II study of preoperative oxaliplatin, fluorouracil, and external-beam radiation therapy in patients with locally advanced rectal cancer: Cancer and Leukemia Group B 89901. J Clin Oncol 2006, 24:2557-62. 10.1200/JCO.2006.05.6754, 16636336.
34. Sebag-Montefiore D, Glynne-Jones R, Falk S, Meadows HM, Maughan T. A phase I/II study of oxaliplatin when added to 5-fluorouracil and leucovorin and pelvic radiation in locally advanced rectal cancer: a Colorectal Clinical Oncology Group (CCOG) study. Br J Cancer 2005, 93:993-8. 10.1038/sj.bjc.6602818, 2361684, 16249791.
35. Janjan NA, Khoo VS, Abbruzzese J, Pazdur R, Dubrow R, Cleary KR, Allen PK, Lynch PM, Glober G, Wolff R, Rich TA, Skibber J. 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 1999, 44:1027-38. 10.1016/S0360-3016(99)00099-1, 10421535.
36. Chan AK, Wong A, Jenken D, Heine J, Buie D, Johnson D. Post-treatment TNM staging is a prognostic indicator of survival and recurrence in tethered or fixed rectal carcinoma after preoperative chemotherapy and radiotherapy. Int J Radiat Oncol Biol Phys 2005, 61:665-77. 10.1016/j.ijrobp.2004.06.206, 15708244.
37. Mawdsley S, Glynne-Jones R, Grainger J, Richman P, Makris A, Harrison M, Ashford R, Harrison RA, Osborne M, Livingstone JI, MacDonald P, Mitchell IC, Meyrick-Thomas J, Northover JM, Windsor A, Novell R, Wallace M. Can histopathologic assessment of circumferential margin after preoperative pelvic chemoradiotherapy for T3-T4 rectal cancer predict for 3-year disease-free survival?. Int J Radiat Oncol Biol Phys 2005, 63:745-52. 10.1016/j.ijrobp.2005.03.003, 16199310.
38. Muthusamy VR, Chang KJ. Optimal methods for staging rectal cancer. Clin Cancer Res 2007, 13:6877-84.
39. Rasheed S, Guenther T, Talbot I, McDonald P, Northover J, Stirling J, Culver L, Glynne-Jones R, Padhani AR. USPIO -- enhanced rectal cancer specimen MRI: how well does it correlate with node identification at histopathology?. Colorectal Dis 2006, 8:721.
40. 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. Preoperative radiotherapy with or without concurrent fluorouracil and leucovorin in T3-4 rectal cancers: results of FFCD 9203. J Clin Oncol 2006, 24:4620-5.
41. 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 Chemotherapy with preoperative radiotherapy in rectal cancer. N Engl J Med 2006, 355:1114-23. 10.1056/NEJMoa060829, 16971718, EORTC Radiotherapy Group Trial 22921.
42. Rodríguez-Ramírez SE, Uribe A, Ruiz-García EB, Labastida S, Luna-Pérez P. Risk factors for anastomotic leakage after preoperative chemoradiation therapy and low RA with total mesorectal excision for locally advanced rectal cancer. Rev Invest Clin 2006, 58:204-10.
43. Urso E, Serpentini S, Pucciarelli S, De Salvo GL, Friso ML, Fabris G, Lonardi S, Ferraro B, Bruttocao A, Aschele C, Nitti D. Complications, functional outcome and quality of life after intensive preoperative chemoradiotherapy for rectal cancer. Eur J Surg Oncol 2006, 32:1201-8. 10.1016/j.ejso.2006.07.003, 16872799.
44. Chen DJ, Nirodi CS. The epidermal growth factor receptor: a role in repair of radiation-induced DNA damage. Clin Cancer Res 2007, 13:6555-60. 10.1158/1078-0432.CCR-07-1610, 18006754.
45. Bosset JF, Nguyen F, Bosset M, Servagi-Vernat S, Schipman B. Recent advances in the treatment of localized rectal cancer. Curr Oncol Rep 2008, 10:220-4. 10.1007/s11912-008-0034-7, 18765152.