Phase II study of UFT with leucovorin and irinotecan (TEGAFIRI): First-line therapy for metastatic colorectal cancer

British Journal of Cancer

Volumn 97, Issue 3, 2007, Pages 297-301

  Delord, J P ^a   Bennouna, J ^b   Artru, P ^c   Perrier, H ^d   Husseini, F ^e   Desseigne, F ^f   Francois E ^g   Faroux, R ^h   Smith, D ⁱ   Piedbois, P ^j   Naman, H ^k   Douillard, J Y ^b   Bugat, R ^a  

^a INSTITUT CLAUDIUS REGAUD   (France)

^b CENTRE RENÉ GAUDUCHEAU   (France)

^c Clinique Saint Jean   (France)

^d HÔPITAL SAINT JOSEPH   (France)

^e HÔPITAL CIVIL   (France)

^f CENTRE LÉON BÉRARD   (France)

^g CENTRE ANTOINE LACASSAGNE   (France)

^h Centre Hospitalier Departemental   (France)

ⁱ BORDEAUX UNIVERSITY HOSPITAL   (France)

^j HENRI MONDOR HOSPITAL   (France)

^k Centre Azuréen Cancérologie   (France)

more..

Author keywords

Colorectal cancer; First line treatment; Irinotecan; Leucovorin; UFT

Indexed keywords

FOLINIC ACID; IRINOTECAN; LOPERAMIDE; UFT;

ABDOMINAL PAIN; ADULT; AGED; ALOPECIA; ANEMIA; ANOREXIA; ARTICLE; ASTHENIA; BLEEDING DISORDER; BODY WEIGHT; BONE MARROW SUPPRESSION; CANCER COMBINATION CHEMOTHERAPY; CHOLINERGIC SYNDROME; CLINICAL TRIAL; COLORECTAL CANCER; CONFIDENCE INTERVAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG EFFECT; DRUG EFFICACY; DRUG FATALITY; DRUG FEVER; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DYSPNEA; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; GASTROINTESTINAL DISEASE; HAND FOOT SYNDROME; HUMAN; INOPERABLE CANCER; LEUKOPENIA; MAJOR CLINICAL STUDY; MALE; MEDIASTINITIS; MEDICAL ASSESSMENT; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUROLOGIC DISEASE; NEUTROPENIA; OVERALL SURVIVAL; PARESTHESIA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; SIDE EFFECT; SURVIVAL RATE; SURVIVAL TIME; THERAPY EFFECT; THROMBOCYTOPENIA; TREATMENT OUTCOME; TREATMENT RESPONSE; VERTIGO; VOMITING;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAMPTOTHECIN; COLORECTAL NEOPLASMS; FEMALE; HUMANS; LEUCOVORIN; MALE; MIDDLE AGED; NEOPLASM METASTASIS; TEGAFUR; TREATMENT OUTCOME; URACIL;

EID: 34547589584     PISSN: 00070920     EISSN: 15321827     Source Type: Journal    
DOI: 10.1038/sj.bjc.6603889     Document Type: Article

References (23)

1. Bennouna J, Perrier H, Paillot B, Priou F, Jacob JH, Hebbar H, Bordenave S, Seitz JF, Cvitkovic F, Dorval E, Malek K, Tonelli D, Douillard JY (2006) A phase II study of oral uracil/ftorafur (UFT®) plus leucovorin combined with oxaliplatin (TEGAFOX) as first-line treatment in patients with metastatic colorectal cancer. Br J Cancer 4: 69-73
2. Bobbio-Pallavicini E, Porta C, Moroni M, Spaghi A, Casagranda I, Nastasi G (1993) Folinic acid does improve 5-fluorouracil activity in vivo: results of a phase III study comparing 5-fluorouracil to 5-fluorouracil and folinic acid in advanced colon cancer patients. J Chemother 5: 52-55
3. Borner MM, Castiglione M, Bacchi M, Weber W, Herrmann R, Fey MF, Pagani O, Leyvraz S, Morant R, Pestalozzi B, Hanselmann S, Goldhirsch A (1998) The impact of adding low-dose leucovorin to monthly 5-fluorouracil in advanced colorectal carcinoma: results of phase III trial. Ann Oncol 9: 535-541
4. Borner MM, Schoffski 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 (2002) Patient preference and pharmacokinetics of oral modulated UFT versus intravenous fluorouracil and leucovorin: a randomised crossover trial in advanced colorectal cancer. Eur J Cancer 38: 348-358
5. Carmichael J, Popiela T, Radstone D, Falk S, Borner M, Oza A, Skovsgaard T, Munier S, Martin C (2002) 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 20: 3617-3627
6. Cunningham D, Pyrhönen S, James RD, Punt CJ, Hickish TF, Heikkila R, Johannesen TB, Starkhammar H, Topham CA, Awad L, Jacques C, Herait P (1998) Randomised trial of irinotecan plus supportive care versus supportive care alone after fluorouracil failure for patients with metastatic colorectal cancer. Lancet 352: 1413-1418
7. Douillard JY, Cunningham D, Roth AD, Navarro M, James RD, Karasek P, Jandik P, Iveson T, Carmichael J, Akakl M, Gruia G, Awad L, Rougier P (2000) Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial. Lancet 355: 1041-1047
8. Douillard JY, Hoff PM, Skillings JR, Eisenberg P, Davidson N, Harper P, Vincent MD, Lembersky BC, Thompson S, Maniero A, Benner SA (2002) Multicenter phase III study of uracil/tegafur and oral leucovorin versus 5-fluorouracil and leucovorin in patients with previously untreated metastatic colorectal cancer. J Clin Oncol 20: 3605-3616
9. El Sayed YM, Sadee W (1982) Metabolic activation of ftorafur [R,S-1(tetrahydro-2-furanyl)-5-fluorouracil]: the microsomal oxidative pathway. Biochem Pharmacol 31: 3006-3008
10. Hoff PM, Pazdur R (1998) UFT plus oral leucovorin: a new oral treatment for colorectal cancer. Oncologist 3: 155-164
11. Mackay HJ, Hill M, Twelves C, Glasspool R, Price T, Campbell S, Massey A, Macham MA, Uzzel M, Bailey SM, Martin C, Cunningham D (2003) A phase I/II study of oral uracil/tegafur (UFT), leucovorin and irinotecan in patients with advanced colorectal cancer. Ann Oncol 14: 1264-1269
12. Mendez M, Alfonso PG, Pujol E, Ganzales E, Castanon C, Cerezuela P, Lopez-Mateos Y, Cruz JJ (2005) Weekly irinotecan plus UFT and leucovorin as first-line chemotherapy of patients with advanced colorectal cancer. Invest New Drugs 23: 243-251
13. Meta-Analysis Group in Cancer (1998) Efficacy of intravenous continuous infusion of fluorouracil compared with bolus administration in advanced colorectal cancer. J Clin Oncol 16: 301-308
14. Meyerhardt JA, Mayer RJ (2005) Systemic therapy for colorectal cancer. New Engl J Med 352: 476-487
15. Murad AM, de Andrade CA, Delfino C (1997) Pharmaco-economic evaluation of tegafur-uracil (UFT) vs fluorouracil for the management of colorectal cancer in Brazil and Argentina. Clin Drug Invest 13: 90-98
16. Petrioli R, Lorenzi M, Aquino A, Marsili S, Frediani B, Palazzuoli V, Marzocca G, Botta G, Tani F, De Martino A (1995) Treatment of advanced colorectal cancer with high-dose intensity folinic acid and 5-fluorouracil plus supportive care. Eur J Cancer 31A: 2105-2108
17. Petrioli R, Sabatino M, Fiaschi AI, Marsili S, Pozzessere D, Messinese S, Correale P, Civitelli S, Tanzini G, Tani F, De Martino A, Marzocca G, Lorenzi M, Giorgi G, Francini G (2004) UFT/leucovorin and oxaliplatin alternated with UFT/leucovorin and irinotecan in metastatic colorectal cancer. Br J Cancer 90: 306-309
18. Price T, Hill M (2000) UFT/leucovorin plus irinotecan in advanced or metastatic colorectal cancer. Oncology 14(Suppl 9): 28-31
19. Rougier P, Van Cutsem E, Bajetta E, Niederle N, Possinger K, Labianca R, Navarro M, Morant R, Bleiberg H, Wils J, Awad L, Herait P, Jacques C (1998) Randomised trial of irinotecan versus fluorouracil by continuous infusion after failure in patients with metastatic colorectal cancer. Lancet 352: 1407-1412
20. Saltz LB, Cox JV, Blanke C, Rosen LS, Fehrenbacher L, Moore MJ, Maroun JA, Ackland SP, Locker PK, Pirotta N, Elfring GL, Miller LL (2000) Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. N Engl J Med 343: 905-914
21. Saltz LB, Douillard JY, Pirotta N, Alakl M, Gruia G, Awad L, Elfring GL, Locker PK, Miller LL (2001) Irinotecan plus fluorouracil/leucovorin for metastatic colorectal cancer: a new survival standard. Oncologist 6: 81-91
22. Sheikh HY, Valle JW, Palmer K, Sjursen A, Craven O, Wilson G, Swindell R, Saunders MP (2007) Concurrent irinotecan, oxaliplatin and UFT in first-line treatment of metastatic colorectal cancer: a phase I study. Br J Cancer 96: 38-43
23. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG (2000) New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 92: 205-216