A phase I study of oral UFT given concomitantly with standard preoperative radiotherapy for rectal cancer

Israel Medical Association Journal

Volumn 6, Issue 10, 2004, Pages 595-598

  Pfeffer, M Raphael ^a,b   Kundel, Yulia ^a,b   Zehavi, Meir ^a,b   Catane, Raphael ^a,b   Koller, Moshe ^a,b   Zmora, Oded ^a,b   Elkayam, Ruth ^a,b   Symon, Zvi ^a,b  

^a SHEBA MEDICAL CENTER   (Israel)

^b TEL AVIV UNIVERSITY   (Israel)

Author keywords

Chemoradiation; Phase 1 trial; Preoperative radiotherapy; Rectal cancer; UFT

Indexed keywords

FLUOROURACIL DERIVATIVE; FOLINIC ACID; UFT;

ADULT; AGED; ANUS SPHINCTER; ARTICLE; CANCER MORTALITY; CANCER RADIOTHERAPY; CANCER STAGING; CLINICAL ARTICLE; CLINICAL TRIAL; COLOSTOMY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG RESPONSE; FEMALE; FEVER; GASTROINTESTINAL TOXICITY; HOSPITALIZATION; HUMAN; HUMAN TISSUE; LEUKOPENIA; MALE; MAXIMUM TOLERATED DOSE; NEUTROPENIA; PATHOLOGY; PELVIS; PHASE 1 CLINICAL TRIAL; PREOPERATIVE CARE; RECTUM CANCER; SKIN TOXICITY; SURGEON; SURGICAL TECHNIQUE; TUMOR LOCALIZATION; URINARY TRACT DISEASE;

ADENOCARCINOMA; ADMINISTRATION, ORAL; ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; COLECTOMY; COMBINED MODALITY THERAPY; FEMALE; FOLIC ACID; HUMANS; LEUCOVORIN; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOADJUVANT THERAPY; NEOPLASM STAGING; RADIOTHERAPY; RECTAL NEOPLASMS; TEGAFUR; TREATMENT OUTCOME; URACIL;

EID: 5044220053     PISSN: 15651088     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (25)

1. Camma C, Giunta M, Fiorico F, Pagliaro L, Craxi A, Cotone M. Preoperative radiotherapy for resectable rectal cancer, a meta-analysis. JAMA 2000;284:1008-15.
2. Swedish Rectal Cancer Trial. Improved survival with preoperative radiotherapy in resectable rectal cancer. N Engl J Med 1997;336:980-7.
3. Stockholm Rectal Cancer Study Group. Preoperative short-term radiation therapy in operable rectal carcinoma, a prospective randomized trial. Cancer 1990;66:49-55.
4. Holm T, Singnomklao T, Rutqvist L-E, Cedermark B. Adjuvant preoperative radiotherapy in patients with rectal carcinoma. Adverse effects during long term follow up of two randomized trials. Cancer 1996;78:968-76.
5. Dahlberg M, Glimelius B, Graf W, Pahlman L. Preoperative irradiation affects functional results after surgery for rectal cancer: results from a randomized study. Dis Colon Rectum 1998;41:543-9.
6. Francois Y, Nemoz CJ, Baulieux J, et al. Influence of the interval between preoperative radiation therapy and surgery on downstaging and on the rate of sphincter-sparing surgery for rectal cancer: the Lyon R90-1 randomized trial. J Clin Oncol 1999;17:2396-402.
7. Krook JE, Moertel CG, Gunderson LL, et al. Effective surgical adjuvant therapy for high risk rectal carcinoma. N Engl J Med 1991;324:709-15.
8. NIH consensus conference. Adjuvant therapy for patients with colon and rectal cancer. JAMA 1990;260:1440-50.
9. Minsky BD, Kemeny N, Cohen AM, et al. Preoperative high dose leucovorin/5-fluorouracil and radiation therapy for unresectable rectal cancer. Cancer 1991;67:2859-66.
10. Horiot J-C, Bosset JF. Pre-operative radiotherapy for rectal cancer: What benefit? What technical parameters? Eur J Cancer 1994;30A:1597-9.
11. O'Connell MJ, Martenson JA, Wieand HS, et al. Improving adjuvant therapy for rectal cancer by combining protracted infusion fluorouracil with radiation therapy after curative surgery. N Engl J Med 1994;331:502-7.
12. Rich TA, Skibber JM, Ajani JA, et al. Preoperative infusional chemoradiation therapy for stage T3 rectal cancer. Int J Radiat Oncol Biol Phys 1995;32:1025-9.
13. Ngan SY, Burmeister BH, Fisher R, et al. Early toxicity from preoperative radiotherapy with continuous infusion 5-fluorouracil for resectable adenocarcinoma of the rectum: a phase II trial for the Trans-Tasman Radiation Oncology Group. Int J Radiat Oncol Biol Phys 2001;50:883-7.
14. Ho DH, Pazdur R, Covington W, et al. Comparison of 5-fluorouracil pharmacokinetics in patients receiving continuous- 5-fluorouracil infusion and oral uracil plus N1-(2′-tetrahydrofuryl)-5-fluorouracil. Clin Cancer Res 1998; 4:2085-8.
15. Douillard JY, Hoff PM, Skillings JR, et al. Multicenter phase III study of uracil/tegafur and oral leucovorin versus fluorouracil and leucovorin in patients with previously untreated metastatic colorectal cancer. J Clin Oncol 2002;20:3605-16.
16. Carmichael J, Popiela T, Radstone D, et al. Randomized comparative study of tegafur/uracil and oral leucovorin versus parenteral fluorouracil and leucovorin in patients with previously untreated metastatic colorectal cancer. J Clin Oncol 2002;20:3617-27.
17. Liu G, Franssen E, Fitch M, Warner E. Patient preference for oral versus intravenous palliative chemotherapy. J Clin Oncol 1997;15:110-15.
18. Partridge AH, Avorn J, Wang PS, Winer EP. Adherence to therapy with oral antineoplastic agents. J Natl Cancer Inst 2002;94:652-61.
19. Cunningham D, Coleman R. New options for outpatient chemotherapy-the role of oral fluoropyrimidines. Cancer Treat Rev 2001;27:211-20.
20. Diasio RB. Improving fluorouracil chemotherapy with novel orally administered fluoropyrimidines. Drugs 1999;58(Suppl 3):119-26.
21. de la Torre A, Ramos S, Valcarcel FJ, et al. 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.
22. Hoff PM, Janjan N, Saad ED, et al. Phase I study of preoperative oral uracil and tegafur plus leucovorin and radiation therapy in rectal cancer. J Clin Oncol 2000;18:3529-34.
23. Minsky B, Cohen A, Enker W, et al. Pre-operative 5FU, low dose leucovorin, and concurrent radiation therapy for rectal cancer. Cancer 1994;73:273-8.
24. Bosset JF, Pavy JJ, Hamers HP, et al. Determination of the optimal dose of 5-fluorouracil when combined with low dose D,L- leucovorin and irradiation in rectal cancer: results of 3 consecutive phase II studies. Eur J Cancer 1993;29a:1406-10.
25. Poon MA, O'Connell MJ, Moertel CM. Biochemical modulation of fluorouracil: evidence of significant improvement of survival and quality of life in patients with advanced colorectal carcinoma. J Clin Oncol 1989;7:1407-18.