A phase II study of UFT with leucovorin administered as a twice daily schedule in the treatment of patients with metastatic colorectal cancer

Prolonged infusions have been shown to be safer and potentially more effective than bolus regimens of 5-fluorouracil (5-FU) as treatment for metastatic colorectal cancer (mCRC). However, infusional 5-FU requires central venous access and costly infusion pumps. Oral fluoropyrimidines enable longer ex...

Full description

Saved in:
Bibliographic Details
Published in:British journal of cancer 2008-09, Vol.99 (5), p.722-726
Main Authors: Hoff, P M, Kopetz, S, Thomas, M B, Langleben, A, Rinaldi, D, Anthony, L, Wolff, R A, Lassere, Y, Abbruzzese, J L
Format: Article
Language:English
Subjects:
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
Drug Administration Schedule
Drug Combinations
Drug Resistance
Epidemiology
Female
Gastroenterology. Liver. Pancreas. Abdomen
Humans
Leucovorin - administration & dosage
Male
Medical sciences
Middle Aged
Molecular Medicine
Neoplasm Metastasis
Oncology
Stomach. Duodenum. Small intestine. Colon. Rectum. Anus
Survival Analysis
Tegafur - administration & dosage
Treatment Outcome
Tumors
Uracil - administration & dosage
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Prolonged infusions have been shown to be safer and potentially more effective than bolus regimens of 5-fluorouracil (5-FU) as treatment for metastatic colorectal cancer (mCRC). However, infusional 5-FU requires central venous access and costly infusion pumps. Oral fluoropyrimidines enable longer exposures to 5-FU with increased convenience. Tegafur–uracil (UFT) with leucovorin (LV) given thrice daily has improved safety plus comparable survival and response rates to bolus 5-FU/LV. We conducted a phase II clinical study in 98 patients with mCRC to evaluate if UFT with LV given twice daily provided comparable time to progression (TTP), efficacy and tolerability to that reported for thrice daily in two phase III clinical studies. Secondary objectives included overall response rate (ORR) and overall survival (OS). Median TTP was 3.8 months, when compared with 3.5 months for thrice daily. The ORR (11%) and median OS (12.8 months) with twice daily administration were similar to that of thrice daily administration (12% and 12.4 months). The incidence of grade 3/4 treatment-related diarrhoea was 30% on the twice daily and 21% on the thrice daily schedule. These results suggest that twice daily administration has similar efficacy and tolerability to thrice daily administration and is an acceptable alternative for patients who would benefit from UFT with LV therapy.
ISSN:0007-0920
1532-1827
DOI:10.1038/sj.bjc.6604541