Irinotecan/fluorouracil/leucovorin or the same regimen followed by oxaliplatin/fluorouracil/leucovorin in metastatic colorectal cancer.

Abstract

BACKGROUND:

This study reports the long-term follow-up of patients with metastatic colorectal cancer (CRC) participating in a randomised phase II study that compared the efficacy and toxicity of the combination of irinotecan (IRI), fluorouracil (FU) with leucovorin (LV) (arm A) versus sequential chemotherapy with IRI plus FU/LV followed by oxaliplatin (OXA) plus FU/LV (arm B) as first line therapy.

MATERIALS AND METHODS:

Intent-to-treat analysis was performed on 417 patients (211 in arm A and 206 in arm B). Treatment schedules of weekly IRI 80 mg/m(2) or OXA 45 mg/m(2) plus LV 200 mg/m(2) immediately followed by intravenous bolus FU 450 mg/m(2) for 6 weeks were followed by a 2-week rest period. Treatment continued for 4 cycles. Patients in arm A were treated with IRI/FU/LV for 4 cycles, while patients in arm B were initially treated with IRI/FU/LV for 2 cycles followed by sequential administration of 2 cycles of OXA/FU/LV.

RESULTS:

No significant difference emerged in overall response rate or overall survival. There was a difference in progression-free survival (median, 7.3 versus 8.2 months, p=0.040) in favour of arm B. Toxicity profiles were similar in both arms.

CONCLUSION:

IRI/FU/LV and IRI/FU/LV followed by OXA/FU/LV showed comparable activity with a manageable toxicity profile.

• Authors: Haralabos P Kalofonos, Pavlos Papakostas, Thomas Makatsoris, Demetrios Papamichael, Georgia Vourli, Ioannis Xanthakis, Gerasimos Aravantinos, Christos Papadimitriou, George Pentheroudakis, Ioannis Varthalitis, George Samelis, Kostas N Syrigos, Nikolaos Xiros, Michalis Stavropoulos, Paris Kosmidis, Christos Christodoulou, Helen Linardou, Maria Skondra, Dimitrios Pectasides, Theofanis Economopoulos, George Fountzilas
• Journal: Anticancer research (Anticancer Res) Vol. 30 Issue 10 Pg. 4325-33 (Oct 2010) ISSN: 1791-7530 [Electronic] Greece
• PMID: 21036759 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Organoplatinum Compounds
• Oxaliplatin
• Irinotecan
• Leucovorin
• Fluorouracil
• Camptothecin

Topics

• Adenocarcinoma (drug therapy)
• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Camptothecin (administration & dosage, adverse effects, analogs & derivatives)
• Colorectal Neoplasms (drug therapy)
• Female
• Fluorouracil (administration & dosage, adverse effects)
• Follow-Up Studies
• Humans
• Irinotecan
• Leucovorin (administration & dosage, adverse effects)
• Male
• Middle Aged
• Organoplatinum Compounds (administration & dosage, adverse effects)
• Oxaliplatin