Phase III trial of irinotecan plus infusional 5-fluorouracil/folinic acid versus irinotecan plus oxaliplatin as first-line treatment of advanced colorectal cancer

European Journal of Cancer

Volumn 47, Issue 2, 2011, Pages 206-214

  Von Weikersthal, Ludwig Fischer ^b   Schalhorn, Andreas ^a   Stauch, Martina ^c   Quietzsch, Detlef ^d   Maubach, Peter A ^e   Lambertz, Helmut ^f   Oruzio, Daniel ^g   Schlag, Rudolf ^h   Weigang Köhler, Karin ⁱ   Vehling Kaiser, Ute ^j   Schulze, Manfred ^h   Truckenbrodt, Juergen ^k   Goebeler, Mariele ^l   Mittermüller, Johann ^m   Bosse, Daniel ^e   Szukics, Borika ^a   Grundeis, Marc ^h   Zwingers, Thomas ⁿ   Giessen, Clemens ^a   Heinemann, Volker ^a  

^a LUDWIG MAXIMILIANS UNIVERSITY   (Germany)

^b Klinikum Sankt Marien   (Germany)

^c Oncologic Practice   (Germany)

^d KLINIKUM CHEMNITZ   (Germany)

^e Oncological Practice   (Germany)

^f Klinikum Garmisch Partenkirchen   (Germany)

^g KLINIKUM AUGSBURG   (Germany)

^h Oncological Practice Wuerzburg ^*  (Germany)

ⁱ KLINIKUM NÜRNBERG   (Germany)

^j Oncological Practice   (Germany)

^k Georgius Agricola Klinikum   (Germany)

^l UNIVERSITY HOSPITAL WÜRZBURG   (Germany)

^m Oncological Practice   (Germany)

ⁿ Fa Estimate GmbH Augsburg   (Germany)

more..

Author keywords

5 Fluorouracil; Chemotherapy; First line treatment; Irinotecan; Metastatic colorectal cancer; Oxaliplatin; Phase III

Indexed keywords

FLUOROURACIL; FOLINIC ACID; IRINOTECAN; OXALIPLATIN;

ADULT; ADVANCED CANCER; AGED; ALOPECIA; ANEMIA; ARTICLE; CANCER SURVIVAL; COLORECTAL CANCER; CONSTIPATION; DIARRHEA; DRUG MEGADOSE; FEBRILE NEUTROPENIA; FEMALE; FEVER; HUMAN; LEUKOPENIA; MAJOR CLINICAL STUDY; MALE; MORTALITY; MUCOSA INFLAMMATION; MULTICENTER STUDY; NAUSEA; OPEN STUDY; OVERALL SURVIVAL; PAIN; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; SENSORY NEUROPATHY; SKIN TOXICITY; THROMBOCYTOPENIA; TREATMENT RESPONSE; VOMITING;

ADENOCARCINOMA; ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAMPTOTHECIN; COLONIC NEOPLASMS; DISEASE-FREE SURVIVAL; FEMALE; FLUOROURACIL; HUMANS; INFUSIONS, INTRAVENOUS; LEUCOVORIN; MALE; MIDDLE AGED; ORGANOPLATINUM COMPOUNDS; RECTAL NEOPLASMS; YOUNG ADULT;

EID: 78650683300     PISSN: 09598049     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejca.2010.09.022     Document Type: Article

References (26)

1. J.Y. Douillard, D. Cunningham, and 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
2. L.B. Saltz, J.V. Cox, and C. Blanke Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan Study Group N Engl J Med 343 2000 905 914
3. A. De Gramont, A. Figer, and M. Seymour Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer J Clin Oncol 18 2000 2938 2947
4. N. Zeghari-Squalli, E. Raymond, and E. Cvitkovic Cellular pharmacology of the combination of the DNA topoisomerase I inhibitor SN-38 and the diaminocyclohexane platinum derivative oxaliplatin Clin Cancer Res 5 1999 1189 1196
5. E. Wasserman, C. Cuvier, and F. Lokiec Combination of oxaliplatin plus irinotecan in patients with gastrointestinal tumors: results of two independent phase I studies with pharmacokinetics J Clin Oncol 17 1999 1751 1759
6. W. Scheithauer, G.V. Kornek, and M. Raderer Combined irinotecan and oxaliplatin plus granulocyte colony-stimulating factor in patients with advanced fluoropyrimidine/leucovorin-pretreated colorectal cancer J Clin Oncol 17 1999 902 906
7. F. Goldwasser, M. Gross-Goupil, and J.M. Tigaud Dose escalation of CPT-11 in combination with oxaliplatin using an every two weeks schedule: a phase I study in advanced gastrointestinal cancer patients Ann Oncol 11 2000 1463 1470
8. N. Kemeny, W. Tong, and M. Gonen Phase I study of weekly oxaliplatin plus irinotecan in previously treated patients with metastatic colorectal cancer Ann Oncol 13 2002 1490 1496
9. P. Rougier, D. Lepille, and J. Bennouna 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 2002 1558 1567
10. E. Bajetta, E. Beretta, and M. Di Bartolomeo Efficacy of treatment with irinotecan and oxaliplatin combination in FU-resistant metastatic colorectal cancer patients Oncology 66 2004 132 137
11. E. Timotheadou, P. Papakostas, and D. Tsavdaridis Irinotecan and oxaliplatin combination, as second-line treatment, in fluoropyrimidine- pretreated advanced colorectal cancer. A phase II study by the Hellenic Cooperative Oncology Group (HeCOG) Tumori 91 2005 309 313
12. D. Cunningham, S. Pyrhonen, and R.D. James Randomised trial of irinotecan plus supportive care versus supportive care alone after fluorouracil failure for patients with metastatic colorectal cancer Lancet 352 1998 1413 1418
13. P. Rougier, E. Van Cutsem, and E. Bajetta Randomised trial of irinotecan versus fluorouracil by continuous infusion after fluorouracil failure in patients with metastatic colorectal cancer Lancet 352 1998 1407 1412
14. M.L. Rothenberg, A.M. Oza, and R.H. Bigelow Superiority of oxaliplatin and fluorouracil-leucovorin compared with either therapy alone in patients with progressive colorectal cancer after irinotecan and fluorouracil-leucovorin: interim results of a phase III trial J Clin Oncol 21 2003 2059 2069
15. G. Colucci, V. Gebbia, and G. Paoletti 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 2005 4866 4875
16. R.M. Goldberg, D.J. Sargent, and 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
17. C.H. Koehne, E. van Cutsem, and J. Wils 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 2005 4856 4865
18. G. Folprecht, A. Grothey, and S. Alberts Neoadjuvant treatment of unresectable colorectal liver metastases: correlation between tumour response and resection rates Ann Oncol 16 2005 1311 1319
19. A.C. Ashley, D.J. Sargent, and S.R. Alberts Updated efficacy and toxicity analysis of irinotecan and oxaliplatin (IROX) : intergroup trial N9741 in first-line treatment of metastatic colorectal cancer Cancer 110 2007 670 677
20. Y. Becouarn, P. Senesse, and S. Thezenas A randomized phase II trial evaluating safety and efficacy of an experimental chemotherapy regimen (irinotecan + oxaliplatin, IRINOX) and two standard arms (LV5 FU2 + irinotecan or LV5 FU2 + oxaliplatin) in first-line metastatic colorectal cancer: a study of the Digestive Group of the Federation Nationale des Centres de Lutte Contre le Cancer Ann Oncol 18 2007 2000 2005
21. D.G. Haller, M.L. Rothenberg, and A.O. Wong Oxaliplatin plus irinotecan compared with irinotecan alone as second-line treatment after single-agent fluoropyrimidine therapy for metastatic colorectal carcinoma J Clin Oncol 26 2008 4544 4550
22. C. Tournigand, T. Andre, and 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
23. A. Grothey, D. Sargent, and 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
24. H. Hurwitz, L. Fehrenbacher, and W. Novotny Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer N Engl J Med 350 2004 2335 2342
25. L.B. Saltz, S. Clarke, and E. Diaz-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
26. E. Van Cutsem, C.H. Kohne, and E. Hitre Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer N Engl J Med 360 2009 1408 1417