Τίτλος:
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)
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
To compare the efficacy and toxicity of oxaliplatin (L-OHP) in combination with irinotecan (CPT-11), 5-fluorouracil (5-FU) and leucovorin (LV) (FOLFOXIRI) vs irinotecan and 5-FU/LV (FOLFIRI) as first-line treatment of patients with metastatic colorectal cancer (MCC). A total of 283 chemotherapy-naïve patients with MCC were enrolled (FOLFIRI arm: n = 146; FOLFOXIRI arm: n = 137). In the FOLFOXIRI arm, CPT-11 (150 mg m-2) was given on d1, L-OHP (65 mg m-2) on d2, LV (200 mg m-2) on days 2 and 3 and 5-FU (400 mg m-2 as i.v. bolus and 600 mg m -2 as 22 h i.v. continuous infusion) on days 2 and 3. In the FOLFIRI arm, CPT-11 (180 mg m-2) was given on d1 whereas LV and 5-FU were administered in the same way as in the FOLFOXIRI regimen. Both regimens were administered every 2 weeks. There was no difference in terms of overall survival (median OS: 19.5 and 21.5 months, for FOLFIRI and FOLFOXIRI, respectively; P = 0.337), median time to disease progression (FOLFIRI: 6.9 and FOLFOXIRI: 8.4 months; P = 0.17), response rates (33.6 and 43% for FOLFIRI and FOLFOXIRI, respectively; P = 0.168). Patients treated with FOLFOXIRI had a significantly higher incidence of alopecia (P = 0.0001), diarrhoea (P = 0.0001) and neurosensory toxicity (P = 0.001) compared with patients treated with FOLFIRI. The present study failed to demonstrate any superiority of the FOLFOXIRI combination compared with the FOLFIRI regimen, although the observed median OS is one of the best ever reported in the literature. © 2006 Cancer Research UK.
Συγγραφείς:
Souglakos, J.
Androulakis, N.
Syrigos, K.
Polyzos, A.
Ziras, N.
Athanasiadis, A.
Kakolyris, S.
Tsousis, S.
Kouroussis, Ch.
Vamvakas, L.
Kalykaki, A.
Samonis, G.
Mavroudis, D.
Georgoulias, V.
Περιοδικό:
British Journal of Cancer
Λέξεις-κλειδιά:
atropine; cetuximab; fluorouracil; folinic acid; irinotecan; loperamide; oxaliplatin, adult; aged; alopecia; anemia; article; cancer chemotherapy; chemotherapy induced emesis; clinical protocol; clinical trial; colorectal carcinoma; controlled clinical trial; controlled study; diarrhea; disease course; drug efficacy; drug infusion; drug safety; dysesthesia; fatigue; febrile neutropenia; female; functional disease; human; major clinical study; male; medical literature; metastasis; mucosa inflammation; multicenter study; nausea; neurologic disease; neurosensory toxicity; neurotoxicity; neutropenia; paresthesia; phase 3 clinical trial; priority journal; randomization; randomized controlled trial; skin disease; thrombocytopenia, Adenocarcinoma; Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Camptothecin; Colorectal Neoplasms; Female; Fluorouracil; Humans; Infusions, Intravenous; Injections, Intravenous; Leucovorin; Male; Middle Aged; Organoplatinum Compounds; Survival Analysis; Treatment Outcome
DOI:
10.1038/sj.bjc.6603011
