Phase III trial of infusional fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI) compared with infusional fluorouracil, leucovorin, and irinotecan (FOLFIRI) as first-line treatment for metastatic colorectal cancer: The gruppo oncologico nord ovest

Journal of Clinical Oncology

Volumn 25, Issue 13, 2007, Pages 1670-1676

  Falcone, Alfredo ^a   Ricci, Sergio ^b   Brunetti, Isa ^b   Pfanner, Elisabetta ^b   Allegrine, Giacomo ^b   Barbara, Cecilia ^b   Crinò, Lucio ^b   Benedetti, Giovanni ^b   Evangelista, Walter ^b   Fanchini, Laura ^b   Cortesi, Enrico ^b   Picene, Vincenzo ^b   Vitello, Stefano ^b   Chiara, Silvana ^b   Granetto, Cristina ^b   Porcile, Gianfranco ^b   Fioretto, Luisa ^b   Orlandini, Cinzia ^b   Andreuccetti, Michele ^b   Masi, Gianluca ^b  

^a UNIVERSITY OF PISA   (Italy)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

FLUOROURACIL; FOLINIC ACID; IRINOTECAN; OXALIPLATIN;

ADULT; ADVANCED CANCER; AGED; ALOPECIA; ANEMIA; ARTICLE; ASTHENIA; CANCER SURGERY; CANCER SURVIVAL; CLINICAL TRIAL; COLORECTAL CANCER; COMBINATION CHEMOTHERAPY; CONTINUOUS INFUSION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG FATALITY; DRUG HYPERSENSITIVITY; FEBRILE NEUTROPENIA; FEMALE; HUMAN; INFECTION; MAJOR CLINICAL STUDY; MALE; METASTASIS; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA AND VOMITING; NEUROTOXICITY; NEUTROPENIA; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; QUALITY OF LIFE; STOMATITIS; THROMBOCYTOPENIA; TREATMENT RESPONSE;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAMPTOTHECIN; COLORECTAL NEOPLASMS; FEMALE; FLUOROURACIL; HUMANS; LEUCOVORIN; MALE; MIDDLE AGED; NEOPLASM METASTASIS; ORGANOPLATINUM COMPOUNDS; QUALITY OF LIFE; RECURRENCE; SURVIVAL ANALYSIS;

EID: 34249000361     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2006.09.0928     Document Type: Article

References (29)

1. Colorectal cancer, in Steward BW, Kleihues P (eds): World Cancer Report. Lyon, France, IACR Press, 2003, pp 198-202
2. Douillard JY, Cunningham D, Roth AD, et al: Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: A multicentre randomised trial. Lancet 355:1041-1047, 2000
3. Saltz LB, Cox JV, Blanke C, et al: Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. N Engl J Med 343:905-914, 2000
4. Kohne CH, van Cutsem E, Wils J, et al: Phase III study of weekly high-dose infusional fluorouracil plus folinic acid with or without irinotecan in patients with metastatic colorectal cancer: European Organisation for Research and Treatment of Cancer Gastrointestinal Group study 40986. J Clin Oncol 23: 4856-4865, 2005
5. Giacchetti S, Perpoint B, Zidani R, et al: Phase III multicenter randomized trial of oxaliplatin added to chronomodulated fluorouracil-leucovorin as first-line treatment of metastatic colorectal cancer. J Clin Oncol 18:136-147, 2000
6. De Gramont A, Figer A, Seymour M, et al: Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer. J Clin Oncol 18:2938-2947, 2000
7. Buyse M, Thirion P, Carlson RW, et al: Relation between tumor response to first-line chemotherapy and survival in advanced colorectal cancer: A meta-analysis. Lancet 356:373-378, 2000
8. Tournigand C, Andre T, Achille E, et al: FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: A randomized GERCOR study. J Clin Oncol 22:229-237, 2004
9. Grothey A, Sargent D, Goldberg RM, et al: Survival of patients with advanced colorectal cancer improves with the availability of fluorouracil-leucovorin, irinotecan, and oxaliplatin in the course of treatment. J Clin Oncol 22:1209-1214, 2004
10. Giacchetti S, Itzhaki M, Gruia G, et al: Long-term survival of patients with unresectable colorectal cancer liver metastases following infusional chemotherapy with 5-fluorouracil, leucovorin, oxaliplatin and surgery. Ann Oncol 10:663-669, 1999
11. Adam R, Avisar E, Ariche A, et al: Five-year survival following hepatic resection after neoadjuvant therapy for nonresectable colorectal. Ann Surg Oncol 8:347-353, 2001
12. Pozzo C, Basso M, Cassano A, et al: Neoadjuvant treatment of unresectable liver disease with irinotecan and 5-fluorouracil plus folinic acid in colorectal cancer patients. Ann Oncol 15:933-939, 2004
13. Folprecht G, Grothey A, Alberts S, et al: Neoadjuvant treatment of unresectable colorectal liver metastases: Correlation between tumour response and resection rates. Ann Oncol 16:1311-1319, 2005
14. Falcone A, Masi G, Allegrini G, et al: Biweekly chemotherapy with oxaliplatin, irinotecan, infusional Fluorouracil, and leucovorin: A pilot study in patients with metastatic colorectal cancer. J Clin Oncol 20: 4006-4014, 2002
15. Masi G, Allegrini G, Cupini S, et al: First line treatment of metastatic colorectal cancer with irinotecan, oxaliplatin and 5-fluorouracil/leucovorin (FOLFOXIRI): Results of phase II study with a simplified biweekly schedule. Ann Oncol 15:1766-1772, 2004
16. Masi G, Cupini S, Marcucci L, et al: Treatment with 5-fluorouracil/ folinic acid, oxaliplatin and irinotecan (FOLFOXIRI) enables surgical resection of metastases in patients with initially unresectable metastatic colorectal cancer. Ann Surg Oncol 13:58-65, 2006
17. Gill S, Goldberg RM: First-line treatment strategies to improve survival in patients with advanced colorectal cancer. Drugs 64:27-44, 2004
18. Hurwitz H, Fehrenbacher L, Novotny W, et al: Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med 350:2335-2342, 2004
19. Cunningham D, Humblet Y, Siena S, et al: Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. N Engl J Med 351:337-345, 2004
20. Souglakos J, Mavroudis D, Kakolyris S, et al: Triplet combination with irinotecan plus oxaliplatin plus continuous-infusion fluorouracil and leucovorin as first-line treatment in metastatic colorectal cancer: A multicenter phase II trial. J Clin Oncol 20: 2651-2657, 2002
21. Ychou M, Conroy T, Seitz JF, et al: An open phase I study assessing the feasibility of the triple combination: Oxaliplatin plus irinotecan plus leucovorin/5-fluorouracil every 2 weeks in patients with advanced solid tumors. Ann Oncol 14:481-489, 2003
22. Calvo E, Cortes J, Rodriguez J, et al: Irinotecan, oxaliplatin, and 5-fluorouracil/leucovorin combination chemotherapy in advanced colorectal carcinoma: A phase II study. Clin Colorectal Cancer 2:104-110, 2002
23. Garufi C, Bria E, Vanni B, et al: A phase II study of irinotecan plus chronomodulated oxaliplatin, 5-fluorouracil and folinic acid in advanced colorectal cancer patients. Br J Cancer 89:1870-1875, 2003
24. Comella P, Casaretti R, De Rosa V, et al: Oxaliplatin plus irinotecan and leucovorin-modulated 5-fluorouracil triplet regimen every other week: A dose-finding study in patients with advanced gastrointestinal malignancies. Ann Oncol 13:1874-1881, 2002
25. Goetz MP, Erlichman C, Windebank AJ, et al: Phase I and pharmacokinetic study of two different schedules of oxaliplatin, irinotecan, Fluorouracil, and leucovorin in patients with solid tumors. J Clin Oncol 21:3761-3769, 2003
26. Colucci G, Gebbia V, Paoletti G, et al: Phase III randomized trial of FOLFIRI versus FOLFOX4 in the treatment of advanced colorectal cancer: A multicenter study of the Gruppo Oncologico Dell'Italia Meridionale. J Clin Oncol 23:4866-4875, 2005
27. Seymour MT: Fluorouracil, Oxaliplatin and CPT-11 (irinotecan), Use and Sequencing (MRC FOCUS): A 2135-patient randomized trial in advanced colorectal cancer (ACRC). J Clin Oncol 23:16S (suppl; abstr 3518)
28. Labianca R, Floriani I, Cortesi E, et al: Alternating versus continuous "FOLFIRI" in advanced colorectal cancer (ACC): A randomized "GISCAD" trial. J Clin Oncol 24:18S (suppl; abstr 3505)
29. Souglakos J, Androulakis N, Syrigos K, et al: FOLFOXIRI (folinic acid, 5-fluorouracil, oxaliplatin and irinotecan) vs FOLFIRI (folinic acid, 5-fluorouracil and irinotecan) as first-line treatment in metastatic colorectal cancer (MCC): a multicentre randomised phase III trial from the Hellenic Oncology Research Group (HORG). Br J Cancer 94:798-805, 2006