Preliminary results of phase I trial of oral uracil/tegafur (UFT), leucovorin plus irinotecan and radiation therapy for patients with locally recurrent rectal cancer

World Journal of Surgical Oncology

Volumn 4, Issue , 2006, Pages

  Yasui, Masayoshi ^a   Ikeda, Masataka ^a   Sekimoto, Mitsugu ^a   Yamamoto, Hirofumi ^a   Takemasa, Ichiro ^a   Ueda, Takafumi ^a   Shimizu, Junzo ^b   Fukunaga, Mutsumi ^b   Suzuki, Osamu ^a   Inoue, Takehiro ^a   Monden, Morito ^a  

^a OSAKA UNIVERSITY   (Japan)

^b SAKAI MUNICIPAL HOSPITAL   (Japan)

Author keywords

[No Author keywords available]

Indexed keywords

FOLINIC ACID; IRINOTECAN; UFT;

ABDOMINAL PAIN; ADULT; AGED; ANEMIA; ANOREXIA; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER CONTROL; CANCER RADIOTHERAPY; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; DIARRHEA; DISEASE FREE SURVIVAL; DISEASE SEVERITY; DRUG DOSE ESCALATION; DRUG DOSE SEQUENCE; DRUG SAFETY; DRUG WITHDRAWAL; FEASIBILITY STUDY; HUMAN; INTESTINE FISTULA; LEUKOPENIA; MALE; MAXIMUM TOLERATED DOSE; MULTICENTER STUDY; NAUSEA AND VOMITING; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; PREOPERATIVE TREATMENT; RADIATION DOSE; RECOMMENDED DRUG DOSE; RECTUM CANCER; RECTUM SURGERY; RECURRENT CANCER; SURVIVAL TIME; THROMBOCYTOPENIA; TREATMENT RESPONSE;

EID: 33845430414     PISSN: 14777819     EISSN: 14777819     Source Type: Journal    
DOI: 10.1186/1477-7819-4-83     Document Type: Article

References (45)

1. McDermott FT, Hughes ES, Pihl E, Johnson WR, Price AB: Local recurrence after potentially curative resection for rectal cancer in a series of 1008 patients. Br J Surg 1985, 72:34-37.
2. Sagar PM, Pemberton JH: Surgical management of locally recurrent rectal cancer. Br J Surg 1996, 83:293-304.
3. Bozzetti F, Bertario L, Rossetti C, Gennari L, Andreola S, Baratti D, Gronchi A: Surgical treatment of locally recurrent rectal carcinoma. Dis Colon Rectum 1997, 40:1421-1424.
4. Wanebo HJ, Antoniuk P, Koness RJ, Levy A, Vezeridis M, Cohen SI, Wrobleski DE: Pelvic resection of recurrent rectal cancer: technical considerations and outcomes. Dis Colon Rectum 1999, 42:1438-1448.
5. Maetani S, Nishikawa T, Iijima Y, Tobe T, Kotoura Y, Shikata J, Yamamura T: Extensive en bloc resection of regionally recurrent carcinoma of the rectum. Cancer 1992, 69:2876-2883.
6. Moriya Y, Akasu T, Fujita S, Yamamoto S: Total pelvic exenteration with distal sacrectomy for fixed recurrent rectal cancer in the pelvis. Dis Colon Rectum 2004, 47:2047-2053. discussion 2053-2054
7. Takagi H, Morimoto T, Hara S, Suzuki R, Horio S: Seven cases of pelvic exenteration combined with sacral resection for locally recurrent rectal cancer. J Surg Oncol 1986, 32:184-188.
8. Temple WJ, Ketcham AS: Sacral resection for control of pelvic tumors. Am J Surg 1992, 163:370-374.
9. Wanebo HJ, Koness RJ, Vezeridis MP, Cohen SI, Wrobleski DE: Pelvic resection of recurrent rectal cancer. Ann Surg 1994, 220:586-595. discussion 595-597
10. Temple WJ, Saettler EB: Locally recurrent rectal cancer: role of composite resection of extensive pelvic tumors with strategies for minimizing risk of recurrence. J Surg Oncol 2000, 73:47-58.
11. Bakx R, van Lanschot JJ, Zoetmulder FA: Sacral resection in cancer surgery: surgical technique and experience in 26 procedures. J Am Coll Surg 2004, 198:846-851.
12. Heald RJ, Moran BJ, Ryall RD, Sexton R, MacFarlane JK: Rectal cancer: the Basingstoke experience of total mesorectal excision, 1978-1997. Arch Surg 1998, 133:894-899.
13. Nagtegaal ID, van de Velde CJH, Marijnen CA, van Krieken JH, Quirke P: Low rectal cancer: A call for a change of approach in abdominoperineal resection. J Clin Oncol 2005, 23:9257-9264.
14. Sauer R, Becker H, Hohenberger W, Rodel 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 versus postoperative chemoradiotherapy for rectal cancer. N Engl J Med 2004, 351:1731-1740.
15. Gerard JP, Bonnetain F, Conroy T, Bouche 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 (preop) radiotherapy (RT) ± 5FU/folinic acid (FA) in T3-4 rectal cancers: results of the FFCD 9203 randomized trial. Proc Am Soc Clin Oncol 2005, 23:247s. [Abstr 3504]
16. Bosset JF, Calais G, Mineur L, Maingon P, Radosevic-Jelic L, Daban A, Bardet E, Beny A, Ollier JC, Collette L: Preoperative radiation (Preop RT) in rectal cancer. Effect and timing of additional chemotherapy (CT). 5-year results of the EORTC 22921 trial. Proc Am Soc Clin Oncol 2005, 23:247s [http://www.asco.org/por tal/site/ASCO/ menuitem.34d60f56624ba07fd506fe310ee37a01d/?vgn extoid=76f8201eb61a7010VgnVCM100000ed730adIRCRD&vmview= abst_detail_view&confId=34&abstractID=31296]. [Abstr 3505]
17. Douglass HO Jr, Moertel CG, Mayer RJ, Thomas PR, Lindblad AS, Mittleman A, Stablein DM, Bruckner HW: Survival after postoperative combination treatment of rectal cancer. N Engl J Med 1986, 315:1294-1295.
18. Krook JE, Moertel CG, Gunderson LL, Wieand HS, Collins RT, Beart RW, Kubista TP, Poon MA, Meyers WC, Mailliard JA, et al.: Effective surgical adjuvant therapy for high-risk rectal carcinoma. N Engl J Med 1991, 324:709-715.
19. Rodel C, Grabenbauer GG, Papadopoulos T, Hohenberger W, Schmoll HJ, Sauer R: Phase I/II trial of capecitabine, oxaliplatin, and radiation for rectal cancer. J Clin Oncol 2003, 21:3098-3104.
20. Machiels JP, Duck L, Honhon B, Coster B, Coche JC, Scalliet P, Humblet Y, Aydin S, Kerger J, Remouchamps V, Canon JL, Van Maele P, Gilbeau L, Laurent S, Kirkove C, Octave-Prignot M, Baurain JF, Kartheuser A, Sempoux C: Phase II study of preoperative oxaliplatin, capecitabine and external beam radiotherapy in patients with rectal cancer: the RadiOxCape study. Ann Oncol 2005, 16:1898-1905.
21. 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, 93:993-998.
22. Willeke F, Tiefenbacher U, Hochhaus A. Wenz F, von Gerstenbergk B, Gnad-Vogt U, Horisberger K, Post S, Hofheinz R: Phase II trial of capecitabine and irinotecan in combination with concurrent radiotherapy for neoadjuvant treatment of locally advanced rectal cancer. Proc Am Soc Clin Oncol 2005, 23:268s [http://meeting. jco.org/cgi/content/abstract/ 23/16 suppl/3589. [Abstr 3589]
23. Lin EH, Skibber J, Delcos M, Eng C, Christopher C, Brown T, Vadhan S, Hoff P, Rodriguez-Bigas M, Janjan NA: A phase II study of capecitabine and concomitant boost radiotherapy (XRT) in patients (pts) with locally advanced rectal cancer (LARC). Proc Am Soc Clin Oncol 2005, 23:269s [http://www.asco.org/portal/sitASCO/ menuitem.34d60f5624ba07fd506fe310ee37a01d/?vgnex toid=76f8201eb61a7010VgnVCM100000ed730adIRCRD&vmview= abst_detail_view&confID=34&abstractID=32452]. [Abstr 3593].
24. Mohiuddin M, Winter K, Mitchell E, Hanna N, Yuen A, Nichols C, Shane R, Hayostek C, Willett C: Randomized phase II study of neoadjuvant combined modality chemoradiation for distal rectal cancer: radiation therapy oncology group trial 0012. J Clin Oncol 2006, 24:650-655.
25. Mitchell EP: Irinotecan in preoperative combined-modality therapy for locally advanced rectal cancer. Oncology (Huntingt) 2000, 14:56-59.
26. Shumate CR, Rich TA, Skibber JM, Alani JA, Ota DM: Preoperative chemotherapy and radiation therapy for locally advanced primary and recurrent rectal carcinoma. A report of surgical morbidity. Cancer 1993, 71:3690-3696.
27. Valentini V, Morganti AG, De Franco A, Coco C, Ratto C, Battista Doglietto G, Trodella L, Ziccarelli L, Picciocchi A, Cellini N: Chemoradiation with or without intraoperative radiation therapy in patients with locally recurrent rectal carcinoma: prognostic factors and long term outcome. Cancer 1999, 86:2612-2624.
28. Rodel C, Grabenbauer GG, Matzel KE, Schick C, Fietkau R, Papadopoulos T, Martus P, Hohenberger W, Sauer R: Extensive surgery after high-dose preoperative chemoradiotherapy for locally advanced recurrent rectal cancer. Dis Colon Rectum 2000, 43:312-319.
29. Vermaas M, Ferenschild FT, Nuyttens JJ, Marinelli AW, Wiggers T, van der Sijp JR, Verhoef C, Graveland WJ, Eggermont AM, de Wilt JH: Preoperative radiotherapy improves outcome in recurrent rectal cancer. Dis Colon Rectum 2005, 48:918-928.
30. Wiig JN, Larsen SG, Dueland S, Giercksky KE: 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 2005, 92:70-75.
31. Fukunaga H, Sekimoto M, Ikeda M, Higuchi I, Yasui M, Seshimo I, Takayama O, Yamamoto H, Ohue M, Tatsumi M, Hatazawa J, Ikenaga M, Nishimura T, Monden M: Fusion image of positron emission tomography and computed tomography for the diagnosis of local recurrence of rectal cancer. Ann Surg Oncol 2005, 12:561-569.
32. Mohiuddin M, Hayne M, Regine WF, Hanna N, Hagihara PF, McGrath P, Marks GM: Prognostic significance of postchemoradiation stage following preoperative chemotherapy and radiation for advanced/recurrent rectal cancers. Int J Radiation Oncology Biol Phys 2000, 48:1075-1080.
33. Rich TA, Kirichenko AV: Camptothecin schedule and timing of administration with irradiation. Oncology (Huntingt) 2001, 15:37-41.
34. Shimada Y, Yoshino M, Wakui A, Nakao I, Futatsuki K, Sakata Y, Kambe M, Taguchi T, Opwa N, CPT-II gastrointesitinal cancer study group: Phase II study of CPT-II, new camptothecine derivative, in metastatic colorectal cancer. J Clin Oncol 1993, 11:909-913.
35. Sasaki Y, Ohtsu A, Shimada Y, Ono K, Saijo N: Simultaneous administration of CPT-II and fluorouracil: alteration of the pharmacokinetics of CPT-II and SN-38 in patients with advanced colorectal cancer. J Natl Cancer Inst 1994, 86:1096-1098.
36. Ikeda M, Seshimo I, Takayama O, Yasui M, Fukunaga H, Ikenaga M, Yamamoto H, Ohue M, Sekimoto M, Monden M: A phase II study of the safety, pharmacokinetics and efficacy of CPT-II combined with uracil/ tegafur(UFT) in patients with unresectable colorectal cancer(CRC). Proc Am Soc Clin Oncol 2003, 22: [http:w.asco.org/portal/site/ASCO/menu item.34d60f5624ba07fd506fe310ee37a01d/?vgnex toid=76f8201eb61a7010VgnVCM100000ed730adIRCRD&vmview= abst_detail_view&confID=23&abstractID=101815]. abstr1312
37. Lowy AM, Rich TA, Skibber JM, Dubrow RA, Curley SA: Preoperative infusional chemoradiation, selective intraoperative radiation, and resection for locally advanced pelvic recurrence of colorectal adenocarcinoma. Ann Surg 1996, 223:177-185.
38. Gunderson LL. Nelson H, Martenson JA, Cha S, Haddock M, Devine R, Fieck JM, Wolff B, Dozois R, O'Connell MJ: Intraoperative electron and external beam irradiation with or without 5-fluorouracil and maximum surgical resection for previously unirradiated, locally recurrent colorectal cancer. Dis Colon Rectum 1996, 39:1379-1395.
39. 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, 18:3529-3534.
40. Schiebe ME, Reese T, Wenz F, Schmidberger H, Engenhart-Cabillic R, Dunst J, Hess CF, Hoffmann W: Phase I study of oral uracil and Tegafur plus leucovorin and pelvic radiation in patients with recurrent rectal cancer. Anticancer Drugs 2002, 13:1005-1009.
41. Fellu J, Calvilio J, Escribano A, de Castro J, Sanchez ME, Mata A, Espinosa E, Garcia Grande A, Mateo A, Gonzalez Baron M: Neoadjuvant therapy of rectal carcinoma with UFT-leucovorin plus radiotherapy. Ann Oncol 2002, 13:730-736.
42. Hofheinz RD, von Gerstenberg-Helldorf B, Wenz F, Gnad U, Kraus-Tiefenbacher U, Muldner A, Hehlmann R, Post S, Hochhaus A, Willeke F: Phase I trial of capecitabine and weekly irinotecan in combination with radiotherapy for neoadjuvant therapy of rectal cancer. J Clin Oncol 2005, 23:1350-1357.
43. Mehta VK, Cho C, Ford JM, Jambalos C, Poen J, Koong A, Lin A, Bastidas JA, Young H, Dunphy EP, Fisher G: Phase II trial of preoperative 3D conformal radiotherapy, protracted venous infusion 5-fluorouracil, and weekly CPT-II, followed by surgery for ultrasound-staged T3 rectal cancer. Int J Radiat Oncol Biol Phys 2003, 55:132-137.
44. Loi S, Ngan SY, Hicks RJ, Mukesh B, Mitchell P, Michael M, Zalcberg J, Leong T, Lim-Joon D, Mackay J, Rischin D: Oxaliplatin combined with infusional 5-fluorouracil and concomitant radiotherapy in inoperable and metastatic rectal cancer: a phase I study. Br J Cancer 2005, 92:655-661.
45. Fukuoka M, Negoro S, Niitani H, Furue H, Hasegawa K, Hara Y, Hara N, Taguchi T: A phase I study of weekly administration of CPT-II in lung cancer. Jpn J Cancer Chemother 1990, 17:993-997.