Abstract | BACKGROUND: PATIENTS AND METHODS: Patients with previously untreated mCRC were randomised to arm A [two-weekly oxaliplatin 85 mg/m(2) + either continuous intravenous infusion (CIV) of 5-FU without LV or two-weekly bolus and CIV 5-FU + LV (LV5FU2)] or arm B (5-FU CIV or LV5FU2 alone). Irinotecan monotherapy was planned on progression. RESULTS: A total of 725 patients were enrolled. After a fixed follow-up of 2 years for each patient, 2-year survival rates were 27.3% and 24.8% in arms A and B, respectively (hazard ratio 0.93; 95% confidence interval 0.78-1.10). The addition of oxaliplatin significantly improved response rates (54.1 versus 29.8%; P < 0.0001) and median progression-free survival (7.9 versus 5.9 months; P < 0.0001). The most common grade 3-4 toxic effects were neutropenia (arm A, 33%; arm B, 5%), diarrhoea (arm A, 14%; arm B, 8%), and fatigue (arm A, 9%; arm B, 8%). CONCLUSIONS: Despite improved rates of tumour control, these results failed to demonstrate a survival benefit from the addition of oxaliplatin to infused 5-FU and lend further support to the use of sequential monotherapy in some patients with mCRC.
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Authors | D Cunningham, B Sirohi, A Pluzanska, B Utracka-Hutka, J Zaluski, R Glynne-Jones, P Koralewski, J Bridgewater, P Mainwaring, H Wasan, J-Y Wang, C Szczylik, P Clingan, R T T Chan, I Tabah-Fisch, J Cassidy |
Journal | Annals of oncology : official journal of the European Society for Medical Oncology
(Ann Oncol)
Vol. 20
Issue 2
Pg. 244-50
(Feb 2009)
ISSN: 1569-8041 [Electronic] England |
PMID | 18854549
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Organoplatinum Compounds
- Oxaliplatin
- Irinotecan
- Leucovorin
- Fluorouracil
- Camptothecin
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Topics |
- Antineoplastic Combined Chemotherapy Protocols
(administration & dosage, adverse effects)
- Camptothecin
(administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
- Colorectal Neoplasms
(drug therapy, mortality, pathology)
- Diarrhea
(chemically induced)
- Disease Progression
- Disease-Free Survival
- Dose-Response Relationship, Drug
- Drug Administration Schedule
- Fatigue
(chemically induced)
- Fluorouracil
(administration & dosage, adverse effects, therapeutic use)
- Follow-Up Studies
- Humans
- Infusions, Intravenous
- Irinotecan
- Leucovorin
(administration & dosage, adverse effects, therapeutic use)
- Neoplasm Metastasis
- Neutropenia
(chemically induced)
- Organoplatinum Compounds
(administration & dosage, adverse effects, therapeutic use)
- Oxaliplatin
- Survival Analysis
- Time Factors
- Treatment Outcome
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