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


Autoria(s): HOFF, P. M.; KOPETZ, S.; THOMAS, M. B.; LANGLEBEN, A.; RINALDI, D.; ANTHONY, L.; WOLFF, R. A.; LASSERE, Y.; ABBRUZZESE, J. L.
Contribuinte(s)

UNIVERSIDADE DE SÃO PAULO

Data(s)

19/10/2012

19/10/2012

2008

Resumo

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.

Identificador

BRITISH JOURNAL OF CANCER, v.99, n.5, p.722-726, 2008

0007-0920

http://producao.usp.br/handle/BDPI/23488

10.1038/sj.bjc.6604541

http://dx.doi.org/10.1038/sj.bjc.6604541

Idioma(s)

eng

Publicador

NATURE PUBLISHING GROUP

Relação

British Journal of Cancer

Direitos

restrictedAccess

Copyright NATURE PUBLISHING GROUP

Palavras-Chave #UFT #dosing #twice daily #thrice daily #metastatic colorectal cancer #FLUOROURACIL PLUS LEUCOVORIN #ORAL LEUCOVORIN #TEGAFUR/URACIL #CAPECITABINE #Oncology
Tipo

article

original article

publishedVersion