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Irinotecan/fluorouracil/leucovorin or the same regimen followed by oxaliplatin/fluorouracil/leucovorin in metastatic colorectal cancer. 2010
Haralabos P Kalofonos, and
Pavlos Papakostas, and
Thomas Makatsoris, and
Demetrios Papamichael, and
Georgia Vourli, and
Ioannis Xanthakis, and
Gerasimos Aravantinos, and
Christos Papadimitriou, and
George Pentheroudakis, and
Ioannis Varthalitis, and
George Samelis, and
Kostas N Syrigos, and
Nikolaos Xiros, and
Michalis Stavropoulos, and
Paris Kosmidis, and
Christos Christodoulou, and
Helen Linardou, and
Maria Skondra, and
Dimitrios Pectasides, and
Theofanis Economopoulos, and
George Fountzilas
Division of Oncology, Department of Medicine, University Hospital of Patras, Rion, Patras, Greece. kalofon@med.upatras.gr
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. 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. CONCLUSIONS IRI/FU/LV and IRI/FU/LV followed by OXA/FU/LV showed comparable activity with a manageable toxicity profile.
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