Triplet chemotherapy in patients with metastatic colorectal cancer: Toward the best way to safely administer a highly active regimen in clinical practice

Clinical Colorectal Cancer

Volumn 11, Issue 4, 2012, Pages 229-237

  Ficorella, Corrado ^a   Bruera, Gemma ^a   Cannita, Katia ^a   Porzio, Giampiero ^a   Baldi, Paola Lanfiuti ^a   Tinari, Nicola ^b   Natoli, Clara ^b   Ricevuto, Enrico ^a  

^a UNIVERSITY OF L'AQUILA   (Italy)

^b UNIVERSITY OF CHIETI   (Italy)

Author keywords

Intensive treatment

Indexed keywords

BEVACIZUMAB; CETUXIMAB; FLUOROURACIL; FOLINIC ACID; GRANULOCYTE COLONY STIMULATING FACTOR; IRINOTECAN; OXALIPLATIN;

ABDOMINAL CRAMP; AGE; ASTHENIA; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; COLORECTAL CANCER; CONTINUOUS INFUSION; DEEP VEIN THROMBOSIS; DEHYDRATION; DIARRHEA; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG INDUCED DISEASE; DRUG MEGADOSE; DRUG SAFETY; EVENING DOSAGE; FATIGUE; FEBRILE NEUTROPENIA; HEART MUSCLE ISCHEMIA; HUMAN; HYPERTENSION; LIVER METASTASIS; METASTASIS; MORNING DOSAGE; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; NEUROTOXICITY; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL (TOPIC); PROGRESSION FREE SURVIVAL; REVIEW; SIDE EFFECT; STOMATITIS; SURVIVAL TIME;

ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; COLORECTAL NEOPLASMS; DISEASE MANAGEMENT; HUMANS; NEOPLASM METASTASIS; PRACTICE GUIDELINES AS TOPIC;

EID: 84868356904     PISSN: 15330028     EISSN: 19380674     Source Type: Journal    
DOI: 10.1016/j.clcc.2012.05.001     Document Type: Review

References (57)

1. A.F. Sobrero, C. Aschele, J.R. Bertino Fluorouracil in colorectal cancer-a tale of two drugs: implications for biochemical modulation J Clin Oncol 15 1997 368 381
2. R.J. Mayer Moving beyond fluorouracil for colorectal cancer N Engl J Med 343 2000 963 964
3. D. Machover A comprehensive review of 5-fluorouracil and leucovorin in patients with metastatic colorectal carcinoma Cancer 80 1997 1179 1187
4. L.B. Saltz, J.V. Cox, C. Blanke Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer Irinotecan Study Group N Engl J Med 343 2000 905 914
5. J.Y. Douillard, D. Cunningham, A.D. Roth Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial Lancet 355 2000 1041 1047
6. S. Giacchetti, B. Perpoint, R. Zidani Phase III multicenter randomized trial of oxaliplatin added to chronomodulated fluorouracil-leucovorin as first-line treatment of metastatic colorectal cancer J Clin Oncol 18 2000 136 147
7. A. De Gramont, A. Figer, M. Seymour Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer J Clin Oncol 18 2000 2938 2967
8. E. Bajetta, M. Di Bartolomeo, L. Mariani Randomized multicenter Phase II trial of two different schedules of irinotecan combined with capecitabine as first-line treatment in metastatic colorectal carcinoma Cancer 100 2004 279 287
9. P. Comella, D. Natale, A. Farris Capecitabine plus oxaliplatin for the first-line treatment of elderly patients with metastatic colorectal carcinoma: final results of the Southern Italy Cooperative Oncology Group Trial 0108 Cancer 104 2005 282 289
10. A. Grothey, M.P. Goetz Oxaliplatin plus oral fluoropyrimidines in colorectal cancer Clin Colorectal Cancer 4 Suppl 1 2004 S37 S42
11. A. Falcone, S. Ricci, I. Brunetti 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 J Clin Oncol 25 2007 1670 1676
12. J. Souglakos, N. Androulakis, K. Syrigos 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 2006 798 805
13. F. Kabbinavar, H.I. Hurwitz, L. Fehrenbacher Phase II, randomized trial comparing bevacizumab plus fluorouracil (FU)/leucovorin (LV) with FU/LV alone in patients with metastatic colorectal cancer J Clin Oncol 21 2003 60 65
14. F.F. Kabbinavar, J. Hambleton, R.D. Mass Combined analysis of efficacy: the addition of bevacizumab to fluorouracil/leucovorin improves survival for patients with metastatic colorectal cancer J Clin Oncol 23 2005 3706 3712
15. H.I. Hurwitz, L. Fehrenbacher, J.D. Hainsworth Bevacizumab in combination with fluorouracil and leucovorin: an active regimen for first-line metastatic colorectal cancer J Clin Oncol 23 2005 3502 3508
16. H.I. Hurwitz, L. Fehrenbacher, W.F. Novotny Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer N Engl J Med 350 2004 2335 2342
17. H.S. Hochster, L.L. Hart, R.K. Ramanathan Safety and efficacy of oxaliplatin and fluoropyrimidine regimens with or without bevacizumab as first-line treatment of metastatic colorectal cancer: results of the TREE Study J Clin Oncol 26 2008 3523 3529
18. L.B. Saltz, S. Clarke, E. Díaz-Rubio Bevacizumab in combination with oxaliplatin-based chemotherapy as first-line therapy in metastatic colorectal cancer: a randomized phase III study J Clin Oncol 26 2008 2013 2019
19. E. Van Cutsem, C.H. Köhne, E. Hitre Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer N Engl J Med 360 2009 1408 1417
20. C. Bokemeyer, I. Bondarenko, A. Makhson Fluorouracil, leucovorin, and oxaliplatin with and without cetuximab in the first-line treatment of metastatic colorectal cancer J Clin Oncol 27 2009 663 671
21. J.Y. Douillard, S. Siena, J. Cassidy Randomized, phase III trial of panitumumab with infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX4) versus FOLFOX4 alone as first-line treatment in patients with previously untreated metastatic colorectal cancer: the PRIME study J Clin Oncol 28 2010 4697 4705
22. Meta-Analysis Group in Cancer Efficacy of intravenous continous infusion of fluorouracil compared with bolus administration in advanced colorectal cancer J Clin Oncol 16 1998 301 308
23. C.H. Köhne, P. Schöffski, H. Wilke Effective biomodulation by leucovorin of high-dose infusion fluorouracil given as a weekly 24-hour infusion: results of a randomized trial in patients with advanced colorectal cancer J Clin Oncol 16 1998 418 426
24. A. de Gramont, J.F. Bosset, C. Milan Randomized trial comparing monthly low-dose leucovorin and fluorouracil bolus with bimonthly high-dose leucovorin and fluorouracil bolus plus continuous infusion for advanced colorectal cancer: a French intergroup study J Clin Oncol 15 1997 808 815
25. 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 1998 3537 3541
26. P.J. O'Dwyer, J. Manola, F.H. Valone Fluorouracil modulation in colorectal cancer: lack of improvement with N -phosphonoacetyl-l-aspartic acid or oral leucovorin or interferon, but enhanced therapeutic index with weekly 24-hour infusion schedule-an Eastern Cooperative Oncology Group/Cancer and Leukemia Group B Study J Clin Oncol 19 2001 2413 2421
27. C.H. Köhne, J. Wils, M. Lorenz Randomized phase III study of high-dose fluorouracil given as a weekly 24-hour infusion with or without leucovorin versus bolus fluorouracil plus leucovorin in advanced colorectal cancer: European Organization of Research and Treatment of Cancer Gastrointestinal Group Study 40952 J Clin Oncol 21 2003 3721 3728
28. M.L. Rothenberg, N.J. Meropol, E.A. Poplin Mortality associated with irinotecan plus bolus fluorouracil/leucovorin: summary findings of an independent panel J Clin Oncol 19 2001 3801 3807
29. R.M. Goldberg, D.J. Sargent, R.F. Morton A randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer J Clin Oncol 22 2004 23 30
30. U. Vanhoefer, A. Harstrick, C.H. Köhne Phase I study of a weekly schedule of irinotecan, high-dose leucovorin, and infusional fluorouracil as first-line chemotherapy in patients with advanced colorectal cancer J Clin Oncol 17 1999 907 913
31. A. Sobrero, D. Kerr, B. Glimelius New directions in the treatment of colorectal cancer: a look to the future Eur J Cancer 36 2000 559 566
32. M. Ducreux, M. Ychou, J.F. Seitz 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 1999 2901 2908
33. A. Ravaioli, M. Marangolo, E. Pasquini Bolus fluorouracil and leucovorin with oxaliplatin as first-line treatment in metastatic colorectal cancer J Clin Oncol 20 2002 2545 2550
34. A. Grothey, D. Sargent, R.M. Goldberg 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 2004 1209 1214
35. C. Tournigand, T. André, E. Achille FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study J Clin Oncol 22 2004 229 237
36. G. Masi, E. Vasile, F. Loupakis Randomized trial of two induction chemotherapy regimens in metastatic colorectal cancer: an updated analysis J Natl Cancer Inst 103 2011 21 30
37. J. Souglakos, D. Mavroudis, S. Kakolyris 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 2002 2651 2657
38. C. Garufi, E. Bria, B. Vanni A phase II study of irinotecan plus chronomodulated oxaliplatin, 5-fluorouracil and folinic acid in advanced colorectal cancer patients Br J Cancer 89 2003 1870 1875
39. G. Masi, G. Allegrini, S. Cupini First-line treatment of metastatic colorectal cancer with irinotecan, oxaliplatin and 5-fluorouracil/leucovorin (FOLFOXIRI): results of a phase II study with a simplified biweekly schedule Ann Oncol 15 2004 1766 1772
40. M. Ychou, F. Viret, A. Kramar Tritherapy with fluorouracil/leucovorin, irinotecan and oxaliplatin (FOLFIRINOX): a phase II study in colorectal cancer patients with non-resectable liver metastases Cancer Chemother Pharmacol 62 2008 195 201
41. M.F. Morelli, A. Santomaggio, E. Ricevuto Triplet schedule of weekly 5-fluorouracil and alternating irinotecan or oxaliplatin in advanced colorectal cancer: a dose-finding and phase II study Oncol Rep 23 2010 1635 1640
42. C. Ficorella, E. Ricevuto, M.F. Morelli Increased tolerability of bimonthly 12-hour timed flat infusion 5-fluorouracil/irinotecan regimen in advanced colorectal cancer: a dose-finding study Oncol Rep 15 2006 1345 1350
43. F. Levi Chronopharmacology of anticancer agents P.H. Redfern, B. Lemmer, Handbook of Experimental Pharmacology: Physiology and Pharmacology of Biological Rhythms-Cancer Chemotherapy 1997 Springer-Verlag Berlin 299301
44. B.E. Harris, R. Song, S.J. Soong Relationship between dihydropyrimidine dehydrogenase activity and plasma 5-fluorouracil levels with evidence for circadian variation of enzyme activity and plasma drug levels in cancer patients receiving 5-fluorouracil by protracted continuous infusion Cancer Res 50 1990 197 201
45. R. Smaaland, J.F. Abrahamsen, A.M. Svardal DNA cell cycle distribution and glutathione (GSH) content according to circadian stage in bone marrow of cancer patients Br J Cancer 66 1992 39 45
46. J.P. Caussanel, F. Levi, S. Brienza Phase I trial of 5-day continuous venous infusion at circadian rhythm modulated rate compared with constant rate J Natl Cancer Inst 82 1990 705 714
47. R. Smaaland, O.D. Laerum, K. Lote DNA synthesis in human bone marrow is circadian stage dependent Blood 77 1991 2603 2611
48. C. Garufi, F. Lévi, A.M. Aschelter A phase I trial of 5-day chronomodulated infusion of 5-fluorouracil and 1-folinic acid in patients with metastatic colorectal cancer Eur J Cancer 33 1997 1566 1571
49. H. Cure, V. Chevalier, D. Pezet Phase II trial of chronomodulated infusion of 5-fluorouracil and folinic acid in metastatic colorectal cancer Anticancer Res 20 2000 4649 4654
50. L. Vamvakas, A. Athanasiadis, A. Karampeazis Clinical outcome of elderly patients with metastatic colorectal cancer treated with FOLFOXIRI versus FOLFIRI: subgroup analysis of a randomized phase III trial from the Hellenic Oncology Research Group (HORG) Crit Rev Oncol Hematol 76 2010 61 70
51. F. Montagnani, A. Chiriatti, G. Turrisi A systematic review of FOLFOXIRI chemotherapy for the first-line treatment of metastatic colorectal cancer: improved efficacy at the cost of increased toxicity Colorectal Dis 13 2011 864-52
52. G. Masi, F. Loupakis, L. Salvatore Bevacizumab with FOLFOXIRI (irinotecan, oxaliplatin, fluorouracil, and folinate) as first-line treatment for metastatic colorectal cancer: a phase 2 trial Lancet Oncol 11 2010 845 852
53. G. Bruera, A. Santomaggio, K. Cannita "Poker" association of weekly alternating 5-fluorouracil, irinotecan, bevacizumab and oxaliplatin (FIr-B/FOx) in first line treatment of metastatic colorectal cancer: a phase II study BMC Cancer 10 2010 567
54. C. Garufi, A. Torsello, S. Tumolo Cetuximab plus chronomodulated irinotecan, 5-fluorouracil, leucovorin and oxaliplatin as neoadjuvant chemotherapy in colorectal liver metastases: POCHER trial Br J Cancer 103 2010 1542 1547
55. E. Assenat, F. Desseigne, S. Thezenas Cetuximab plus FOLFIRINOX (ERBIRINOX) as first-line treatment for unresectable metastatic colorectal cancer: a phase II trial Oncologist 16 2011 1557 1564
56. G. Folprecht, A. Grothey, S. Alberts Neoadjuvant treatment of unresectable colorectal liver metastases: correlation between tumour response and resection rates Ann Oncol 16 2005 1311 1319
57. G. Bruera, E. Ricevuto Intensive chemotherapy of metastatic colorectal cancer: weighing between safety and clinical efficacy Evaluation of Masi G, Loupakis F, Salvatore L, et al. Bevacizumab with FOLFOXIRI (irinotecan, oxaliplatin, fluorouracil, and folinate) as first-line treatment for metastatic colorectal cancer: a phase 2 trial Lancet Oncol 11 2010 845 852 Expert Opin Biol Ther 11 2011 821 824