Irinotecan or oxaliplatin combined with leucovorin and 5-fluorouracil as first-line treatment in advanced colorectal cancer: A multicenter, randomized, phase II study

Annals of Oncology

Volumn 16, Issue 6, 2005, Pages 869-877

  Kalofonos, H P ^a,k   Aravantinos, G ^b   Kosmidis, P ^c   Papakostas, P ^d   Economopoulos, T ^e   Dimopoulos, M ^f   Skarlos, D ^g   Bamias, A ^h   Pectasides, D ^e   Chalkidou, S ⁱ   Karina, M ^j   Koutras, A ^a   Samantas, E ^b   Bacoyiannis, C ^c   Samelis, G F ^d   Basdanis, G ^j   Kalfarentzos, F ^a   Fountzilas, G ^j  

^a UNIVERSITY HOSPITAL OF PATRAS   (Greece)

^b AGII ANARGIRI CANCER HOSPITAL   (Greece)

^c HYGEIA HOSPITAL   (Greece)

^d HIPPOKRATION HOSPITAL   (Greece)

^e NATIONAL AND KAPODISTRIAN UNIVERSITY OF ATHENS   (Greece)

^f UNIVERSITY OF ATHENS MEDICAL SCHOOL   (Greece)

^g Henry Dunan Hospital   (Greece)

^h Oncology Department   (Greece)

ⁱ Hellenic Cooperative Oncology Group   (Greece)

^j ARISTOTLE UNIVERSITY OF THESSALONIKI   (Greece)

^k UNIVERSITY OF PATRAS   (Greece)

more..

Author keywords

Chemotherapy; Colorectal cancer; Irinotecan; Oxaliplatin

Indexed keywords

FLUOROURACIL; FOLINIC ACID; IRINOTECAN; OXALIPLATIN;

ADULT; ADVANCED CANCER; AGED; ALOPECIA; ANAPHYLAXIS; ANEMIA; ARTICLE; BONE MARROW TOXICITY; CANCER COMBINATION CHEMOTHERAPY; CANCER GROWTH; CANCER SURVIVAL; CLINICAL TRIAL; COLORECTAL CANCER; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DOSE RESPONSE; DRUG EFFICACY; DRUG FATALITY; DRUG FEVER; DRUG PREFERENCE; DRUG RESPONSE; DRUG SAFETY; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FISHER EXACT TEST; HUMAN; HYPERTENSION; LEUKEMIA; LIVER TOXICITY; MAJOR CLINICAL STUDY; MALE; MUCOSA INFLAMMATION; MULTICENTER STUDY; NAUSEA AND VOMITING; NEPHROTOXICITY; NEUROTOXICITY; NEUTROPENIA; PAIN; PERIPHERAL NEUROPATHY; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SENSORY NEUROPATHY; SKIN INFECTION; SURVIVAL RATE; SURVIVAL TIME; THROMBOCYTOPENIA;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAMPTOTHECIN; COLORECTAL NEOPLASMS; FEMALE; FLUOROURACIL; HUMANS; LEUCOVORIN; MALE; MIDDLE AGED; ORGANOPLATINUM COMPOUNDS;

EID: 21344448162     PISSN: 09237534     EISSN: None     Source Type: Journal    
DOI: 10.1093/annonc/mdi193     Document Type: Article

References (26)

1. Jemal A, Murray T, Samuels A et al. Cancer Statistics, 2003. CA Cancer J Clin 2003; 53: 5-26.
2. Simmonds PC. Palliative chemotherapy for advanced colorectal cancer: systemic review and meta-analysis. Colorectal Cancer Collaborative Group. BMJ 2000; 321: 531-535.
3. Ragnhammar P, Hafström L, Nygren P et al. A systematic overview of chemotherapy effects in colorectal cancer. Acta Oncol 2001; 40: 282-308.
4. Simmonds PC. Palliative chemotherapy for advanced colorectal cancer: systematic review and meta-analysis. Colorectal Cancer Collaborative Group. BMJ 2000; 321: 531-535.
5. Borner MM, Castiglione M, Bacchi M et al. The impact of adding low-dose leucovorin to monthly 5-fluorouracil in advanced colorectal carcinoma: results of a phase III trial. Swiss Group for Cancer Research (SAKK). Ann Oncol 1998; 9: 535-541.
6. Modulation of fluorouracil by leucovorin in patients with advanced colorectal cancer: evidence in terms of response rate. Advanced Colorectal Cancer Meta-Analysis Project. Advanced Colorectal Cancer Meta-Analysis Project. J Clin Oncol 1992; 10: 896-903.
7. Punt CJA. New options and old dilemmas in the treatment of patients with advanced colorectal cancer. Ann Oncol 2004; 15: 1453-1459.
8. Cunningham D, Pyrhönen S, James RD et al. Randomised trial of IRI plus supportive care versus supportive care alone after fluorouracil failure for patients with metastatic colorectal cancer. Lancet 1998; 352: 1413-1418.
9. Becouarn Y, Rougier P. Clinical efficacy of oxaliplatin monotherapy: phase II trials in advanced colorectal cancer. Sem Oncol 1998; 25: 23-31.
10. de Gramont A, Vignoud J, Tournigand C et al. Oxaliplatin with high-dose leucovorin and 5-fluorouracil 48-hour continuous infusion in pretreated metastatic colorectal cancer. Eur J Cancer 1997; 33: 214-219.
11. Janinis J, Papakostas P, Samelis G et al. Second-line chemotherapy with weekly oxaliplatin and high-dose 5-fluorouracil with folinic acid in metastatic colorectal carcinoma: a Hellenic Cooperative Oncology Group (HeCOG) phase II feasibility study. Ann Oncol 2000; 11: 163-167.
12. Andre T, Louvet C, Mandrault-Goebel F et al. IRI (IRI) addition to bimonthly, high-dose leucovorin and bolus and continuous-infusion 5-fluorouracil (FOLFIRI) for pretreated metastatic colorectal cancer. GERCOR. Eur J Cancer 1999; 35: 1343-1347.
13. Saltz LB, Cox JV, Blanke C et al. IRI plus fluorouracil and leucovorin for metastatic colorectal cancer, IRI Study Group. N Engl J Med 2000; 343: 1041-1047.
14. Kalofonos HP, Skarlos D, Bafaloukos D et al. A phase II study of IRI plus leucovorin and bolus IV 5-fluorouracil in patients with advanced colorectal carcinoma. Cancer Invest 2003; 21: 855-862.
15. Agresti A. Categorical Data Analysis. New York, NY: John Wiley & Sons 1990.
16. Cox D. Regression models and life tables (with discussion). J Royal Stat Soc B 1972; 34: 187-220.
17. Lentner C. Geigy Scientific Tables ('Exact Confidence Limits for p'). Ciba-Geigy: Switzerland 1982; 89-102.
18. Tournigand C, Andre T, Achille E et al. FOLFIRI followed by FOL-FOX6 or the reverse sequence in advanced colorectal cancer: randomised GERCOR study. J Clin Oncol 2004; 22: 229-237.
19. Grothey A, Jordan K, Kellner O et al. Capecitabine plus irinotecan vs capecitabine plus oxaliplatin as first-line therapy of advanced colorectal cancer: updated results of a randomised phase II trial. Eur J Cancer 2003; (Suppl 5) 590 (Abstr 295).
20. Goldberg RM, Sargent DJ, Morton RF et al. A randomised controlled trial of fluorouracil plus leucovorin, IRI, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer. J Clin Oncol 2004; 22: 23-30.
21. Rothenberg ML, Meropol NJ, Poplin EA et al. Mortality associated with IRI plus bolus fluorouracil/leucovorin: summary findings of an independent panel. J Clin Oncol 2001; 19: 3801-3807.
22. Hoff PM, Ansari R, Batist G et al. Comparison of oral capecitabine versus intravenous fluorouracil plus leucovorin as first-line treatment in 605 patients with metastatic colorectal cancer: results of a randomized phase III study. J Clin Oncol 2001; 19: 2282-2292.
23. Van Cutsem E, Twelves C, Cassidy J et al. Oral capecitabine compared with intravenous fluorouracil plus leucovorin in patients with metastatic colorectal cancer: results of a large phase III study. J Clin Oncol 2001; 19: 4097-4106.
24. Tewes M, Schleucher N, Achterrath W et al. Capecitabine and IRI as first-line chemotherapy in patients with metastatic colorectal cancer: results of an extended phase I study. Ann Oncol 2003; 14: 1442-1448.
25. Zeuli M, Nardoni C, Pino MS et al. Phase II study of capecitabine and oxaliplatin as first-line treatment in advanced colorectal cancer. Ann Oncol 2003; 14: 1378-1382.
26. Grothey A. Oxaliplatin-safety profile: neurotoxicity. Semin Oncol 2003; 30: 5-13.