A phase II study of FOLFIRI-3 (double infusion of irinotecan combined with LV5FU) after FOLFOX in advanced colorectal cancer patients

British Journal of Cancer

Volumn 94, Issue 9, 2006, Pages 1287-1292

  Mabro, M ^a   Artru, P ^b   Andre T ^c   Flesch, M ^d   Maindrault Goebel, F ^e   Landi, B ^f   Lledo, G ^b   Plantade, A ^a   Louvet, C ^e   De Gramont, A ^e  

^a FOCH HOSPITAL   (France)

^b Clinique Saint Jean   (France)

^c HÔPITAL TENON   (France)

^d Hôpital de Dijon   (France)

^e HÔPITAL SAINT ANTOINE   (France)

^f HÔPITAL EUROPÉEN GEORGES POMPIDOU   (France)

Author keywords

5 fluorouracil; Colorectal cancer; Combination chemotherapy; Irinotecan; Leucovorin; Phase II study

Indexed keywords

FLUOROURACIL; FOLINIC ACID; IRINOTECAN; OXALIPLATIN;

ADULT; ADVANCED CANCER; AGED; ALOPECIA; ANEMIA; ARTICLE; ASTHENIA; CANCER COMBINATION CHEMOTHERAPY; CANCER GRADING; CANCER PATIENT; CANCER SURVIVAL; CLINICAL TRIAL; COLORECTAL CANCER; CONTINUOUS INFUSION; DIARRHEA; DOSE RESPONSE; DRUG EFFICACY; DRUG SAFETY; FEBRILE NEUTROPENIA; FEMALE; HAND FOOT AND MOUTH DISEASE; HUMAN; MAJOR CLINICAL STUDY; MALE; MUCOSA INFLAMMATION; NAUSEA; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; SIDE EFFECT; THROMBOCYTOPENIA; VOMITING;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAMPTOTHECIN; COLORECTAL NEOPLASMS; DISEASE PROGRESSION; FEMALE; FLUOROURACIL; HUMANS; INFUSIONS, INTRAVENOUS; LEUCOVORIN; MALE; MIDDLE AGED; ORGANOPLATINUM COMPOUNDS; SURVIVAL ANALYSIS; TREATMENT OUTCOME;

EID: 33646526110     PISSN: 00070920     EISSN: 15321827     Source Type: Journal    
DOI: 10.1038/sj.bjc.6603095     Document Type: Article

References (28)

1. André T, Louvet C, Maindrault-Goebel F, Couteau C, Mabro M, Lotz JP, Gilles-Amar V, Krulik M, Carola E, Izrael V, de Gramont A (1999) CPT-11 (irinotecan) addition to bimonthly, high-dose leucovorin and continuous-infusion 5-fluorouracil (FOLFIRI) for pretreated metastatic colorectal cancer. Eur J Cancer 35: 1343-1347
2. 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 vs supportive care alone after fluorouracil failure for patients with metastatic colorectal cancer. Lancet 352: 1413-1418
3. de Gramont A, Figer A, Seymour M, Homerin M, Hmissi A, Cassidy J, Boni C, Cortes-Funes H, Cervantes A, Freyer G, Papamichael D, Le Bail N, Louvet C, Hendler D, de Braud F, Wilson C, Morvan F, Bonetti A (2000) Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer. J Clin Oncol 18: 2938-2947
4. Douillard JY, Cunningham D, Roth AD, Navarro M, James RD, Karasek P, Jandik P, Iveson T, Carmichael J, Alakl 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
5. Ducreux M, Ychou M, Seitz JF, Bonnay M, Bexon A, Armand JP, Mahjoubi M, Mery-Mignard D, Rougier P (1999) Irinotecan combined with bolus fluorouracil, continuous infusion fluorouracil, and high-dose leucovorin every two weeks (LV5FU2 regimen): a clinical dose finding and pharmacokinetic study in patients with pretreated metastatic colorectal cancer. J Clin Oncol 17: 2901-2908
6. Falcone A, di Paolo A, Masi G, Allegrini G, Danesi R, Lencioni M, Pfanner E, Comis S, Del Tacca M, Conte P (2001) Sequence effect of irinotecan on pharmacokinetics and toxicity in chemotherapy-naive metastatic colorectal cancer patients. J Clin Oncol 19: 3456-3462
7. Fuchs CS, Moore MR, Harker G, Villa L, Rinaldi D, Hecht J (2003) Phase III comparison of two irinotecan dosing regimens in second-line therapy of metastatic colorectal cancer. J Clin Oncol 21: 807-814
8. Gil-Delgado MA, Guinet F, Castaing D, Adam R, Coeffic D, Durrani AK, Bismuth H, Khayat D (2001) Prospective phase II trial of irinotecan, 5-fluorouacil, and leucovorin in combination as salvage therapy for advanced colorectal cancer. Am J Clin Oncol 24: 101-105
9. Goldberg RM, Sargent DJ, Morton RF, Fuchs CS, Ramanathan RK, Williamson SK, Findlay BP, Pitot HC, Alberts SR (2004) A randomised controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer. J Clin Oncol 22: 4-6
10. Grothey A, Deschler B, Kroening H, Ridwelski K, Reichardt P, Kretzschmar A, Clemens M, Hirschmann W, Lorenz M, Asperger W, Buechele T, Schmoll HJ (2002) Phase III study of bolus 5-fluorouracil (5FU)/folinic acid (FA) (Mayo) vs weekly high-dose 24 h 5-FU infusion/FA+oxaliplatin (OXA) in advanced colorectal cancer (ACRC). Proc Am Soc Clin Oncol (Orlando, FL, USA) 21: 129a (abstract)
11. Guichard S, Cussac D, Hennebelle I, Bugat R, Canal P (1997) Sequence-dependent activity of the irinotecan-5FU combination in human colon-cancer model HT-29 in vitro and in vivo. Int J Cancer 73: 729-734
12. Kaplan EL, Meier P (1958) Nonparametric estimation from incomplete observations. J Am Stat Assoc 53: 457-481
13. Mabro M, Louvet C, André T, Carola E, Gilles-Amar V, Artru P, Krulik M, de Gramont A, on behalf GERCOR (2003) Bimonthly leucovorin, infusion, 5-fluorouracil, hydroxyurea, and irinotecan (FOLFIRI-2) for pretreated metastatic colorectal cancer. Am J Clin Oncol 25: 254-258
14. MacDonald J, Haller D, Mayer R (1995) Grading of toxicity. In: Manual of Oncologic Therapeutics, MacDonald J, Haller D, Mayer R (eds) pp 519-523. Lippincott: Philadelphia
15. Maindrault F, Louvet C, Tournigand C, Gervais H, Mabro M, Artru P, Garcia ML, André T, Carola C, de Gramont A (2002) Leucovorin, 5-fluorouracil infusion and irinotecan (FOLFIRI-3) in pretreated patients with metastatic colorectal cancer. Proc Am Soc Clin Oncol (Orlando, FL, USA) 21: 658a (abstract)
16. Mans DRA, Grivicich I, Peters GJ, Schwartsmann G (1999) Sequence-dependent growth inhibition and DNA damage by the irinotecan-5- fluorouracil combination in human colon carcinoma cell lines. Eur J Cancer 35: 1851-1861
17. Mullany S, Svingen PA, Kaufmann SH, Erlichman C (1998) Effect of adding the topoisomerase I poison 7-ethyl 10-hydroxycamptothecin (SN 38) to 5-fluorouracil and folinic acid in HCT8 cells: elevated dTTP pools and enhanced cytotoxicity. Cancer Chemother Pharm 42: 391-399
18. Pitot HC, Wender DB, O'Connell MJ, Schroeder G, Goldberg RM, Rubin J, Mailliard JA, Knost JA, Ghosh C, Kirschling RJ, Levitt R, Windschitl HE (1997) Phase II trial of irinotecan in patients with metastatic colorectal carcinoma. J Clin Oncol 15: 2910-2919
19. Rothenberg ML, Cox JV, DeVore RF, Hainsworth JD, Pazdur R, Rivkin SE, Macdonald JS, Geyer Jr CE, Sandbach J, Wolf DL, Mohrland JS, Elfring GL, Miller LL, Von Hoff DD (1999) A multicenter, phase II trial of weekly irinotecan (CPT-11) in patients with previously treated colorectal carcinoma. Cancer 85: 786-795
20. Rougier P, Bugat R, Douillard JY, Culine S, Suc E, Brunet P, Becouarn Y, Ychou M, Marty M, Extra JM, Bonneterre J, Adenis A, Seitz JF, Ganem G, Namer M, Conroy T, Negrier S, Merrouche Y, Burki F, Mousseau M, Herait P, Mahjoubi M (1997) Phase II study of irinotecan in the treatment of advanced colorectal cancer in chemotherapy naive patients and patients pretreated with fluorouracil based chemotherapy. J Clin Oncol 15: 251-260
21. Rougier P, Lepille D, Bennouna J, Marre A, Ducreux M, Mignot L, Hua A, Mery-Mignard D (2002) Antitumour activity of three second-line treatment combinations in patients with metastatic colorectal cancer after optimal 5-FU regimen failure: a randomised, multicentre phase II study. Ann Oncol 13: 1558-1567
22. 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 vs fluorouracil by continuous infusion after fluorouracil failure in patients with metastatic colorectal cancer. Lancet 352: 1407-1412
23. Rowland KM, Pitot HC, Sargent DJ, Philip PA, Mitchell EP, Mailliard JA, Goldberg RM, Alberts SR (2005) Results of third line therapy on N9841: a randomized phase III trial of oxaliplatin/5-fluorouracil/leucovorin (FOLFOX4) vs irinotecan (CPT-11) in patients with advanced colorectal cancer previously treated with prior 5FU chemotherapy. Proc Am Soc Clin Oncol (Orlando, FL, USA) 24: 3519a (abstract)
24. 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. Irinotecan study group. N Engl J Med 343: 905-914
25. Seymour MT, for the UK NCRI Colorectal Clinical Studies Group and FOCUS Trial Investigators (2005) Fluorouracil, oxaliplatin and CPT-11 (irinotecan), use and sequencing (MRC FOCUS): a 2135-patient randomized trial in advanced colorectal cancer (ACRC). Proc Am Soc Clin Oncol (Orlando, FL, USA) 24: 3518a (abstract)
26. 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 establish response to treatment in solid tumors. J Nat Cancer Inst 92: 205-216
27. Tournigand C, André T, Achille E, Lledo G, Flesh M, Mery-Mignard D, Quinaux E, Couteau C, Buyse M, Ganem G, Landi B, Colin P, Louvet C, de Gramont A (2004) FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study. J Clin Oncol 22: 229-237
28. Van Cutsem E, Cunningham D, Ten Bokkel Huinink WW, Punt CJ, Alexopoulos CG, Dirix L, Symann M, Blijham GH, Cholet P, Fillet G, Van Groeningen C, Vannetzel JM, Levi F, Panagos G, Unger C, Wils J, Cote C, Blanc C, Herait P, Bleiberg H (1999) Clinical activity and benefit of irinotecan (CPT-11) in patients with colorectal cancer truly resistant to 5-fluorouracil (5-FU). Eur J Cancer 35: 54-59