A phase II study of oral uracil/ftorafur (UFT®) plus leucovorin combined with oxaliplatin (TEGAFOX) as first-line treatment in patients with metastatic colorectal cancer

This phase II trial was performed to evaluate the efficacy and tolerability of a new combination of Uracil/Ftorafur (UFT ® )/leucovorin (LV) and oxaliplatin in patients (pts) with metastatic colorectal cancer (MCRC) who had not received prior chemotherapy for metastatic disease. Between February 200...

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Bibliographic Details
Published in:British journal of cancer Vol. 94; no. 1; pp. 69 - 73
Main Authors: Bennouna, J, Perrier, H, Paillot, B, Priou, F, Jacob, J H, Hebbar, M, Bordenave, S, Seitz, J F, Cvitkovic, F, Dorval, E, Malek, K, Tonelli, D, Douillard, J Y
Format: Journal Article
Language:English
Published: London Nature Publishing Group UK 16.01.2006
Nature Publishing Group
Subjects:
Administration, Oral
Adult
Aged
Aged, 80 and over
Antineoplastic Combined Chemotherapy Protocols - administration & dosage
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Biological and medical sciences
Biomedical and Life Sciences
Biomedicine
Cancer Research
Clinical Study
Colorectal Neoplasms - drug therapy
Colorectal Neoplasms - pathology
Diarrhea - chemically induced
Drug Resistance
Epidemiology
Female
Gastroenterology. Liver. Pancreas. Abdomen
Humans
Infusions, Intravenous
Leucovorin - administration & dosage
Male
Medical sciences
Middle Aged
Molecular Medicine
Neoplasm Metastasis
Oncology
Organoplatinum Compounds - administration & dosage
Peripheral Nervous System - drug effects
Stomach. Duodenum. Small intestine. Colon. Rectum. Anus
Survival Analysis
Tegafur - administration & dosage
Treatment Outcome
Tumors
Uracil - administration & dosage
oxaliplatin
UFT
colorectal cancer
combination treatment
Antineoplastic agent
Human
Rectal disease
Colorectal cancer
Calcium folinate
Malignant tumor
Metastasis
First line treatment
Colonic disease
Alkylating agent
Cancerology
Oxaliplatin
Phase II trial
Digestive diseases
Intestinal disease
Advanced stage
Uracil
colorectal cancer combination treatment
Platinum II Complexes
ISSN:0007-0920, 1532-1827
Online Access:Get full text
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Summary:This phase II trial was performed to evaluate the efficacy and tolerability of a new combination of Uracil/Ftorafur (UFT ® )/leucovorin (LV) and oxaliplatin in patients (pts) with metastatic colorectal cancer (MCRC) who had not received prior chemotherapy for metastatic disease. Between February 2002 and October 2002, 64 patients received UFT ® 300 mg m −2  day −1 and LV 90 mg day −1 from day 1 to day 14 combined with oxaliplatin 130 mg m −2 on day 1, every 3 weeks. All patients were evaluable for safety analysis and 58 of 64 patients were eligible for efficacy. Responses were reviewed by an independent review committee. Of the 58 per-protocol defined assessable patients, 1 complete response and 20 partial responses were observed yielding a response rate of 34% (95% CI: 22–47). The median response duration was 8.74 months (range 1.6–14). The median time to progression and the median survival were 5.88 months (95% CI: 4.34–8.21) and 18.2 months (95% CI: 10–20.7), respectively. Diarrhoea and peripheral neuropathy were the most frequent and predictable toxicities. These events were reversible, noncumulative and manageable. Grade 3 diarrhoea occurred in only 11% of the patients. No grade 4 gastrointestinal toxicity was reported in the study. The incidence of grade 3/4 (National Cancer Institute Common Toxicity Criteria 2: NCI-CTC 2) peripheral neuropathy was 15%. Haematological toxicity was of mild to moderate intensity with 10% of the patients with Grade 3/4 neutropenia without any episode of complication. The TEGAFOX regimen, a new combination using UFT ® /LV and oxaliplatin every 3 weeks is feasible on an outpatient basis. The combination is safe and active and may offer a promising alternative to the intravenous route. Nevertheless this efficacy results should be confirmed by randomized phase III trials.
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ISSN:0007-0920
1532-1827
DOI:10.1038/sj.bjc.6602913