A novel biweekly multidrug regimen of gemcitabine, oxaliplatin, 5-fluorouracil (5-FU), and folinic acid (FA) in pretreated patients with advanced colorectal carcinoma

British Journal of Cancer

Volumn 90, Issue 9, 2004, Pages 1710-1714

  Correale, P ^a   Messinese, S ^a   Caraglia, M ^b   Marsili, S ^a   Piccolomini, A ^a   Petrioli, R ^a   Ceciarini, F ^a   Micheli, L ^a   Nencini, C ^a   Neri, A ^a   Vuolo, G ^a   Guarnieri, A ^a   Abbruzzese, A ^c   Prete, S D ^b   Giorgi, G ^a   Francini, G ^a  

^a UNIVERSITY OF SIENA   (Italy)

^b Frattamaggiore Hospital   (Italy)

^c SECOND UNIVERSITY OF NAPLES   (Italy)

Author keywords

5 fluorouracil; Colorectal cancer; Folinic acid; Gemcitabine; Oxaliplatin

Indexed keywords

FLUOROURACIL; FOLINIC ACID; GEMCITABINE; OXALIPLATIN;

ADULT; ADVANCED CANCER; AGED; ANEMIA; ANOREXIA; ARTICLE; ASTHENIA; BLOOD TOXICITY; CANCER CHEMOTHERAPY; CANCER GROWTH; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL TRIAL; COLORECTAL CANCER; DIARRHEA; DRUG FATALITY; DRUG RESPONSE; DRUG SCREENING; DRUG TOLERABILITY; FEMALE; FEVER; GASTROINTESTINAL TOXICITY; HEART ARRHYTHMIA; HEART ATRIUM FIBRILLATION; HUMAN; HYPERSENSITIVITY; HYPOTENSION; HYPOVOLEMIC SHOCK; MALE; METASTASIS; MUCOSA INFLAMMATION; NAUSEA; NEUROTOXICITY; NEUTROPENIA; PHARMACEUTICAL CARE; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; SIDE EFFECT; STOMACH HEMORRHAGE; THROMBOCYTOPENIA; VOMITING;

EID: 2642573446     PISSN: 00070920     EISSN: None     Source Type: Journal    
DOI: 10.1038/sj.bjc.6601783     Document Type: Article

References (42)

1. Berlin JD, Alberti DB, Arzoomanian RZ, Feierabend CA, Simon KJ, Binger KA, Marnocha RM, Wilding G (1998-99) A phase I study of gemcitabine, 5-fluorouracil and leucovorin in patients with advanced, recurrent, and/ or metastatic solid tumors. Invest New Drugs 16(4): 325-330
2. Cancer TMA (1998) Toxicity of fluorouracil in patients with advanced colorectal cancer: effect of administration schedule and prognostic factors. Meta-Analysis Group in Cancer. J Clin Oncol 16: 3537-3541
3. Chu E, Mota AC, Fogarasi MC (2001) Antimetabolites. In Cancer Principles and Practice of Oncology, De Vita V, Hellman S, Rosenberg SA (eds). 6th edn, pp 388-415. Philadelphia: Lippincott Williams and Wilkins
4. Correale P, Cerretani D, Clerici M, Cozzi C, Bruni G, Pozzessere D, Petrioli R, Marsili S, Messinese S, Sabatino M, Giorgi G, Francini G (2000a) Gemcitabine (dFdC), 5-flurouracil (5FU) and folinic acid (FA) in the treatment of patients with gastroenteric carcinomas: a clinical and pharmacological study. Ann Oncol 11(Suppl 2): H20 (abstract)
5. Correale P, Cerretani D, Marsili S, Pozzessere D, Petrioli R, Messinese S, Sabatino M, Roviello F, Pinto E, Francini G, Giorgi G (2003) Gemcitabine increases 5-fluorouracil systemic exposure in advanced cancer patients: pharmacokinetic considerations. Eur J Cancer 39(11): 1547-1551
6. Correale P, Cerretani D, Petrioli R, Marsili S, Giorgi G, Francini G (2000b) Gemcitabine (dFdC) and 5 fluorouracil (5FU) in the treatment of patients with pancreas and colo-rectal carcinoma: a clinical and pharmacological study, Proceedings of the 10th International Congress on anti-Cancer treatment, Paris (I-293, abstract)
7. Correale P, Cerretani D, Petrioli R, Marsili S, Pozzessere D, Giorgi G, Francini G (1999) Gemcitabine (dFdC) affects 5-fluorouracil (5FU) pharmacokinetic in cancer patients. Proc Annu Meeting Am Assoc Cancer Res 40: 2546
8. Correale P, Pozzessere D, Di Palma T, Petrioli R, Marsili S, Messinese S, Sabatino M, Francini G (2002) Gemcitabine in combination with oxaliplatin, 5-fluorouracil (5-FU), and leucovorin (GOLF) for the treatment of advanced colo-rectal carcinoma, Proceedings of the 12th International Congress on Anti-cancer Treatment, Paris (214, abstract)
9. Culy CR, Clement D, Wiseman LR (2000) Oxaliplatin. A review of its pharmacological properties and clinical efficacy in metastatic colorectal cancer and its potential in other malignancies. Drugs 60(4): 895-924
10. de Gramont A, Figer A, Seymour M, Homerin M, Le Bail N, Cassidy J, Boni C, Cortes-Funes H, Freyer G, Hendler D, Louvet C (1998) A randomized trial of leucovorin (LV) and 5-fluorouracil (5-FU) with or without oxaliplatin in advanced colorectal cancer (CRC). Proc Am Soc Clin Oncol 17: 257a (abstract 985)
11. de Gramont A, Vignoud J, Tournigand C, Louvet C, Andre T, Varette C, Raymond E, Moreau S, Le Bail N, Krulik M (1997) Oxaliplatin with high-dose leucovorin and 5-fluorouracil 48-h continuous infusion in pretreated metastatic colorectal cancer. Eur J Cancer 33(2): 214-219
12. Faivre S, Raymond E, Woynarowski JM, Cvitkovic E (1999) Supraadditive effect of 2′,2′-difluorodeoxycytidine (gemcitabine) in combination with oxaliplatin in human cancer cell lines. Cancer Chemother Pharmacol 44(2): 117-123
13. Fischel JL, Etienne MC, Formento P, Milano G (1998) Search for the optimal schedule for the oxaliplatin/5-fluorouracil association modulated or not by folinic acid: preclinical data. Clin Cancer Res 4(10): 2529-2535
14. Fischel JL, Formento P, Ciccolini J, Rostagno P, Etienne MC, Catalin J, Milano G (2002) Impact of the oxaliplatin-5 fluorouracil-folinic acid combination on respective intracellular determinants of drug activity. Br J Cancer 86(7): 1162-1168
15. Francini G, Petrioli R, Lorenzini L, Mancini S, Armenio S, Tanzini G, Marsili S, Aquino A, Marzocca G, Civitelli S, Mariani L, De Sandro D, Lorenzi M (1994) Folinic acid and 5-fluorouracil as adjuvant chemotherapy in colon cancer. Gastroenterology 106(4): 899-906
16. Giacchetti S, Perpoint B, Zidani R, Le Bail N, Faggiuolo R, Focan C, Chollet P, Llory JF, Letourneau Y, Coudert B, Bertheaut-Cvitkovic F, Larregain-Fournier D, Le Rol A, Walter S, Adam R, Misset JL, Levi F (2000) Phase III multicenter randomized trial of oxaliplatin added to chronomodulated fluorouraci-leucovorin as first-line treatment of metastatic colorectal cancer. J Clin Oncol 18(1): 136-147
17. Gill S, Thomas RR, Goldberg RM (2003) Review article: colorectal cancer chemotherapy. Aliment Pharmacol Ther 18(7): 683-692
18. Goldberg RM, Morton RF, Sargent DJ, Fuchs C, Ramanathan RK, Williamson S, Findlay B, NCCTG, CALGB, ECOG, SWOG, NCIC (2002) Oxaliplatin or CPT-11+5-Fluorouracil/leucovorin or Oxa+CPT-11 in Advanced Colorectal Cancer (ACRC), efficacy and safety results from a North American Gastrointestinal Intergroup Study (N9741), Perspectives in Colorectal Cancer, A Consensus Meeting, 4th International Conference, Barcelona, June (abs # 6)
19. Goldberg RM, Sargent DJ, Morton RF, Fuchs CS, Ramanathan RK, Williamson SK, Findlay BP, Pitot HC, Alberts SR (2004) A randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer. J Clin Oncol 22(1): 23-30
20. Grem JL (1996) 5-Fluoropyrimidines. In Cancer Chemotherapy and Biotherapy: Principles and Practice, Chabner BA, Longo DL (eds). 2nd edn, pp 149-163. Philadelphia: Lippincot William & Wilkins
21. Grem JL, Takimoto CH, Multani P, Chu E, Ryan D, Chabner BA, Allegra CJ, Johnston PG (1999) Antimetabolites. Cancer Chemother Biol Response Modif 18: 1-38
22. Grothey A, Schmoll HJ (2001) New chemotherapy approaches in colorectal cancer. Curr Opin Oncol 13(4): 275-286
23. Heinemann V (2001) Gemcitabine: progress in the treatment of pancreatic cancer. Oncology 60(1): 8-18
24. Hidalgo M, Castellano D, Paz-Ares L, Gravalos C, Diaz Puente M, Hitt R, Alonso S, Cortes-Funes H (1999) Phase I-II study of gemcitabine and fluorouracil as a continuous infusion in patients with pancreatic cancer. J Clin Oncol 17(2): 585-592
25. Kohne CH (2003) Palliative therapy of colorectal cancer. Onkologie 26(Suppl 7): 41-47
26. Madajewicz S, Hentschel P, Burns P, Caruso R, Fiore J, Fried M, Malhotra H, Ostrow S, Sugarman S, Viola M (2000) Phase I chemotherapy study of biochemical modulation of folinic acid and fluorouracil by gemcitabine in patients with solid tumor malignancies. J Clin Oncol 18(20): 3553-3557
27. Mani S, Manalo J, Bregman D (2000) Novel combinations with oxaliplatin. Oncology 14(Suppl 11): 52-58
28. Mathe G, Kidani Y, Segiguchi M, Eriguchi M, Fredj G, Peytavin G, Misset JL, Brienza S, de Vassals F, Chenu E, Bourut C (1989) Oxalato-platinum or 1-OHP, a third-generation platinum complex: an experimental and clinical appraisal and preliminary comparison with cis-platinum and carboplatinum. Biomed Pharmacother 43(4): 237-250
29. O'Connell MJ, Laurie JA, Kahn M, Fitzgibbons Jr RJ, Erlichman C, Shepherd L, Moertel CG, Kocha WI, Pazdur R, Wieand HS, Rubin J, Vukov AM, Donohue JH, Krook JE, Figueredo A (1998) Prospectively randomized trial of postoperative adjuvant chemotherapy in patients with high-risk colon cancer. J Clin Oncol 16: 295-300
30. Peters GJ, van der Wilt CL, van Moorsel CJ, Kroep JR, Bergman AM, Ackland SP (2000) Basis for effective combination cancer chemotherapy with antimetabolites. Pharmacol Ther 87(2-3): 227-253
31. Plunkett W, Huang P, Searcy CE, Gandhi V (1996) Gemcitabine: preclinical pharmacology and mechanisms of action. Semin Oncol 23(5 Suppl 10): 3-15
32. Poon MA, O'Connell MJ, Moertel CG, Wieand HS, Cullinan SA, Everson LK, Krook JE, Mailliard JA, Laurie JA, Tschetter LK (1989) Biochemical modulation of fluorouracil: evidence of significant improvement of survival and quality of life in patients with advanced colorectal carcinoma. J Clin Oncol 7(10): 1407-1418
33. Poon MA, O'Connell MJ, Wieand HS, Krook JE, Gerstner JB, Tschetter LK, Levitt R, Kardinal CG, Mailliard JA (1991) Biochemical modulation of fluorouracil with leucovorin: confirmatory evidence of improved therapeutic efficacy in advanced colorectal cancer. J Clin Oncol 9(11): 1967-1972
34. Poplin E, Roberts J, Tombs M, Grant S, Rubin E (1999) Leucovorin, 5-fluorouracil, and gemcitabine: a phase I study. Invest New Drugs 17(1): 57-62
35. Raymond E, Faivre S, Coudray AM, Louvet C, Gespach C (2001) Preclinical studies of oxaliplatin in combination chemotherapy. Bull Cancer 88: S26-S34
36. Schulz L, Schalhorn A, Wilmanns W, Heinemann V (1998) Synergistic interaction of dFdC and 5-FU in colon cancer cells. Proc Am Soc Clin Oncol 17: 251a (abstract)
37. Skibber JM, Minsky BD, Hoff PM (2001) Cancer of the colon. In Cancer Principles and Practice of Oncology, De Vita V, Hellman S, Rosenberg SA (eds). 6th edn, pp 1216-1271. Philadelphia: Lippincott Williams & Wilkins
38. Soulie P, Raymond E, Brienza S, Cvitkovic E (1997) Oxaliplatin: the first DACH platinum in clinical practice. Bull Cancer 84(6): 665-673
39. Tournigand C, Andre 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(2): 229-237
40. Von Hoff DD (1998) Promising new agents for treatment of patients with colorectal cancer. Semin Oncol 25: 47-52
41. Wiseman LR, Adkins JC, Plosker GL, Goa KL (1999) Oxaliplatin: a review of its use in the management of metastatic colorectal cancer. Drug Aging 14(6): 459-475
42. World Health Organization (1979) WHO Handbook for Reporting Results of Cancer Treatment. Geneve: World Health Organization