A phase II trial of continuous 5-fluorouracil in recurrent or metastatic transitional cell carcinoma of the urinary tract
A phase II trial of continuous 5-fluorouracil in recurrent or metastatic transitional cell carcinoma of the urinary tract
AIMS: To assess the activity of a continuous infusion of 5-fluorouracil in patients with recurrent locally advanced or metastatic transitional cell carcinoma of the urinary tract.
MATERIALS AND METHODS: Eight centres within the UK entered 50 patients into the study. Twenty-four weeks of continuously infused 5-fluorouracil, 300mg/m(2)/day through a mini-pump, were planned. The primary outcome was tumour response at 8 weeks after the start of treatment.
RESULTS: The median age of the patients was 68 years and 37 (80.4%) had a World Health Organization performance status of 0 or 1. The overall response rate at 8 weeks, according to the response evaluation criteria in solid tumors (RECIST) criteria in 46 evaluable patients, was 15% (95% confidence interval 5-26%) and 20% (95% confidence interval 8-31%) when assessments at all time points were included. The median progression-free survival was 1.9 months (95% confidence interval 1.8-2.7 months) and the median overall survival was 6.5 months (95% confidence interval 4.1-8.5 months). The most frequent grade 3/4 toxicities were mucositis and diarrhoea (each in 6.5% of patients) and nausea/vomiting and hand-foot syndrome (each in 4.3% of patients).
CONCLUSIONS: Continuous infusional 5-fluorouracil has activity in transitional cell carcinoma of the urinary tract. Prolonged fluoropyrimidine administration may be a useful component of future combination regimens for this disease, particularly in patients with poor renal function.
Aged, Antineoplastic Agents, Carcinoma, Transitional Cell, Female, Fluorouracil, Humans, Infusion Pumps, Male, Middle Aged, Neoplasm Metastasis, Neoplasm Recurrence, Local, Survival Analysis, Urologic Neoplasms, Clinical Trial, Phase II, Journal Article, Multicenter Study
394-400
Highley, M.S.
56a7d6cc-97e1-49e6-8a97-70b07f3170e8
Griffiths, G.O.
7fd300c0-d279-4ff6-842d-aa1f2b9b864d
Uscinska, B.M.
6bcb4367-19f0-47c9-95f5-fec657623fe1
Huddart, R.A.
4491c174-99e7-4cfe-a5c2-845be33405dc
Barber, J.B.P.
d5e48d38-6f9d-49f0-85e6-776119bf4586
Parmar, M.K.B.
44634dd0-3f2b-4263-9f16-308a9e9260b8
Harper, P.G.
43921ac2-78de-4b35-89f7-37a84b91aea3
NCRI Bladder Cancer Clinical Studies Group
June 2009
Highley, M.S.
56a7d6cc-97e1-49e6-8a97-70b07f3170e8
Griffiths, G.O.
7fd300c0-d279-4ff6-842d-aa1f2b9b864d
Uscinska, B.M.
6bcb4367-19f0-47c9-95f5-fec657623fe1
Huddart, R.A.
4491c174-99e7-4cfe-a5c2-845be33405dc
Barber, J.B.P.
d5e48d38-6f9d-49f0-85e6-776119bf4586
Parmar, M.K.B.
44634dd0-3f2b-4263-9f16-308a9e9260b8
Harper, P.G.
43921ac2-78de-4b35-89f7-37a84b91aea3
Highley, M.S., Griffiths, G.O., Uscinska, B.M., Huddart, R.A., Barber, J.B.P., Parmar, M.K.B. and Harper, P.G.
,
NCRI Bladder Cancer Clinical Studies Group
(2009)
A phase II trial of continuous 5-fluorouracil in recurrent or metastatic transitional cell carcinoma of the urinary tract.
Clinical Oncology, 21 (5), .
(doi:10.1016/j.clon.2009.01.011).
Abstract
AIMS: To assess the activity of a continuous infusion of 5-fluorouracil in patients with recurrent locally advanced or metastatic transitional cell carcinoma of the urinary tract.
MATERIALS AND METHODS: Eight centres within the UK entered 50 patients into the study. Twenty-four weeks of continuously infused 5-fluorouracil, 300mg/m(2)/day through a mini-pump, were planned. The primary outcome was tumour response at 8 weeks after the start of treatment.
RESULTS: The median age of the patients was 68 years and 37 (80.4%) had a World Health Organization performance status of 0 or 1. The overall response rate at 8 weeks, according to the response evaluation criteria in solid tumors (RECIST) criteria in 46 evaluable patients, was 15% (95% confidence interval 5-26%) and 20% (95% confidence interval 8-31%) when assessments at all time points were included. The median progression-free survival was 1.9 months (95% confidence interval 1.8-2.7 months) and the median overall survival was 6.5 months (95% confidence interval 4.1-8.5 months). The most frequent grade 3/4 toxicities were mucositis and diarrhoea (each in 6.5% of patients) and nausea/vomiting and hand-foot syndrome (each in 4.3% of patients).
CONCLUSIONS: Continuous infusional 5-fluorouracil has activity in transitional cell carcinoma of the urinary tract. Prolonged fluoropyrimidine administration may be a useful component of future combination regimens for this disease, particularly in patients with poor renal function.
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More information
Accepted/In Press date: 28 January 2009
e-pub ahead of print date: 9 March 2009
Published date: June 2009
Keywords:
Aged, Antineoplastic Agents, Carcinoma, Transitional Cell, Female, Fluorouracil, Humans, Infusion Pumps, Male, Middle Aged, Neoplasm Metastasis, Neoplasm Recurrence, Local, Survival Analysis, Urologic Neoplasms, Clinical Trial, Phase II, Journal Article, Multicenter Study
Organisations:
Clinical Trials Unit
Identifiers
Local EPrints ID: 406332
URI: http://eprints.soton.ac.uk/id/eprint/406332
ISSN: 0936-6555
PURE UUID: 871b5370-e1b3-4c4e-a497-093bd3a62cd5
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Date deposited: 10 Mar 2017 10:45
Last modified: 16 Mar 2024 04:19
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Contributors
Author:
M.S. Highley
Author:
B.M. Uscinska
Author:
R.A. Huddart
Author:
J.B.P. Barber
Author:
M.K.B. Parmar
Author:
P.G. Harper
Corporate Author: NCRI Bladder Cancer Clinical Studies Group
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