An open, multi-centre, phase II clinical trial to evaluate the efficacy and safety of paclitaxel, UFT, and leucovorin in patients with advanced gastric cancer

Y. Chao, C. P. Li, T. Y. Chao, W. C. Su, R. K. Hsieh, M. F. Wu, K. H. Yeh, W. Y. Kao, L. T. Chen, A. L. Cheng

Research output: Contribution to journalArticle

14 Citations (Scopus)

Abstract

The aim of the study was to evaluate the response rate and safety of weekly paclitaxel (Taxol®) combination chemotherapy with UFT (tegafur, an oral 5-fluorouracil prodrug, and uracil at a 1 : 4 molar ratio) and leucovorin (LV) in patients with advanced gastric cancer. Patients with histologically confirmed, locally advanced or recurrent/metastatic gastric cancer were studied. Paclitaxel 1-h infusion at a dose of 100 mg m-2 on days 1 and 8 and oral UFT 300 mg m- day-1 plus LV 90 mg day-1 were given starting from day 1 for 14 days, followed by a 7-day period without treatment. Treatment was repeated every 21 days. From February 2003 to October 2004, 55 patients were enrolled. The median age was 62 years (range: 32-82). Among the 48 patients evaluated for tumour response, two achieved a complete response and 22 a partial response, with an overall response rate of 50% (95% confidence interval: 35-65%). All 55 patients were evaluated for survival and toxicities. Median time to progression and overall survival were 4.4 and 9.8 months, respectively. Major grade 3-4 toxicities were neutropenia in 25 patients (45%) and diarrhoea in eight patients (15%). Although treatment was discontinued owing to treatment-related toxicities in nine patients (16%), there was no treatment-related mortality. Weekly paclitaxel plus oral UFT/LV is effective, convenient, and well tolerated in treating patients with advanced gastric cancer.

Original languageEnglish
Pages (from-to)159-163
Number of pages5
JournalBritish Journal of Cancer
Volume95
Issue number2
DOIs
Publication statusPublished - Jul 17 2006
Externally publishedYes

Fingerprint

Phase II Clinical Trials
Leucovorin
Paclitaxel
Stomach Neoplasms
Safety
Tegafur
Therapeutics
Survival
Uracil
Prodrugs
Combination Drug Therapy
Neutropenia
Fluorouracil
Diarrhea
Confidence Intervals
Mortality

Keywords

  • Gastric cancer
  • Leucovorin
  • Paclitaxel
  • UFT

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

An open, multi-centre, phase II clinical trial to evaluate the efficacy and safety of paclitaxel, UFT, and leucovorin in patients with advanced gastric cancer. / Chao, Y.; Li, C. P.; Chao, T. Y.; Su, W. C.; Hsieh, R. K.; Wu, M. F.; Yeh, K. H.; Kao, W. Y.; Chen, L. T.; Cheng, A. L.

In: British Journal of Cancer, Vol. 95, No. 2, 17.07.2006, p. 159-163.

Research output: Contribution to journalArticle

Chao, Y. ; Li, C. P. ; Chao, T. Y. ; Su, W. C. ; Hsieh, R. K. ; Wu, M. F. ; Yeh, K. H. ; Kao, W. Y. ; Chen, L. T. ; Cheng, A. L. / An open, multi-centre, phase II clinical trial to evaluate the efficacy and safety of paclitaxel, UFT, and leucovorin in patients with advanced gastric cancer. In: British Journal of Cancer. 2006 ; Vol. 95, No. 2. pp. 159-163.
@article{0bbcd90d8a5444ab82ea47a122c4f063,
title = "An open, multi-centre, phase II clinical trial to evaluate the efficacy and safety of paclitaxel, UFT, and leucovorin in patients with advanced gastric cancer",
abstract = "The aim of the study was to evaluate the response rate and safety of weekly paclitaxel (Taxol{\circledR}) combination chemotherapy with UFT (tegafur, an oral 5-fluorouracil prodrug, and uracil at a 1 : 4 molar ratio) and leucovorin (LV) in patients with advanced gastric cancer. Patients with histologically confirmed, locally advanced or recurrent/metastatic gastric cancer were studied. Paclitaxel 1-h infusion at a dose of 100 mg m-2 on days 1 and 8 and oral UFT 300 mg m- day-1 plus LV 90 mg day-1 were given starting from day 1 for 14 days, followed by a 7-day period without treatment. Treatment was repeated every 21 days. From February 2003 to October 2004, 55 patients were enrolled. The median age was 62 years (range: 32-82). Among the 48 patients evaluated for tumour response, two achieved a complete response and 22 a partial response, with an overall response rate of 50{\%} (95{\%} confidence interval: 35-65{\%}). All 55 patients were evaluated for survival and toxicities. Median time to progression and overall survival were 4.4 and 9.8 months, respectively. Major grade 3-4 toxicities were neutropenia in 25 patients (45{\%}) and diarrhoea in eight patients (15{\%}). Although treatment was discontinued owing to treatment-related toxicities in nine patients (16{\%}), there was no treatment-related mortality. Weekly paclitaxel plus oral UFT/LV is effective, convenient, and well tolerated in treating patients with advanced gastric cancer.",
keywords = "Gastric cancer, Leucovorin, Paclitaxel, UFT",
author = "Y. Chao and Li, {C. P.} and Chao, {T. Y.} and Su, {W. C.} and Hsieh, {R. K.} and Wu, {M. F.} and Yeh, {K. H.} and Kao, {W. Y.} and Chen, {L. T.} and Cheng, {A. L.}",
year = "2006",
month = "7",
day = "17",
doi = "10.1038/sj.bjc.6603225",
language = "English",
volume = "95",
pages = "159--163",
journal = "British Journal of Cancer",
issn = "0007-0920",
publisher = "Nature Publishing Group",
number = "2",

}

TY - JOUR

T1 - An open, multi-centre, phase II clinical trial to evaluate the efficacy and safety of paclitaxel, UFT, and leucovorin in patients with advanced gastric cancer

AU - Chao, Y.

AU - Li, C. P.

AU - Chao, T. Y.

AU - Su, W. C.

AU - Hsieh, R. K.

AU - Wu, M. F.

AU - Yeh, K. H.

AU - Kao, W. Y.

AU - Chen, L. T.

AU - Cheng, A. L.

PY - 2006/7/17

Y1 - 2006/7/17

N2 - The aim of the study was to evaluate the response rate and safety of weekly paclitaxel (Taxol®) combination chemotherapy with UFT (tegafur, an oral 5-fluorouracil prodrug, and uracil at a 1 : 4 molar ratio) and leucovorin (LV) in patients with advanced gastric cancer. Patients with histologically confirmed, locally advanced or recurrent/metastatic gastric cancer were studied. Paclitaxel 1-h infusion at a dose of 100 mg m-2 on days 1 and 8 and oral UFT 300 mg m- day-1 plus LV 90 mg day-1 were given starting from day 1 for 14 days, followed by a 7-day period without treatment. Treatment was repeated every 21 days. From February 2003 to October 2004, 55 patients were enrolled. The median age was 62 years (range: 32-82). Among the 48 patients evaluated for tumour response, two achieved a complete response and 22 a partial response, with an overall response rate of 50% (95% confidence interval: 35-65%). All 55 patients were evaluated for survival and toxicities. Median time to progression and overall survival were 4.4 and 9.8 months, respectively. Major grade 3-4 toxicities were neutropenia in 25 patients (45%) and diarrhoea in eight patients (15%). Although treatment was discontinued owing to treatment-related toxicities in nine patients (16%), there was no treatment-related mortality. Weekly paclitaxel plus oral UFT/LV is effective, convenient, and well tolerated in treating patients with advanced gastric cancer.

AB - The aim of the study was to evaluate the response rate and safety of weekly paclitaxel (Taxol®) combination chemotherapy with UFT (tegafur, an oral 5-fluorouracil prodrug, and uracil at a 1 : 4 molar ratio) and leucovorin (LV) in patients with advanced gastric cancer. Patients with histologically confirmed, locally advanced or recurrent/metastatic gastric cancer were studied. Paclitaxel 1-h infusion at a dose of 100 mg m-2 on days 1 and 8 and oral UFT 300 mg m- day-1 plus LV 90 mg day-1 were given starting from day 1 for 14 days, followed by a 7-day period without treatment. Treatment was repeated every 21 days. From February 2003 to October 2004, 55 patients were enrolled. The median age was 62 years (range: 32-82). Among the 48 patients evaluated for tumour response, two achieved a complete response and 22 a partial response, with an overall response rate of 50% (95% confidence interval: 35-65%). All 55 patients were evaluated for survival and toxicities. Median time to progression and overall survival were 4.4 and 9.8 months, respectively. Major grade 3-4 toxicities were neutropenia in 25 patients (45%) and diarrhoea in eight patients (15%). Although treatment was discontinued owing to treatment-related toxicities in nine patients (16%), there was no treatment-related mortality. Weekly paclitaxel plus oral UFT/LV is effective, convenient, and well tolerated in treating patients with advanced gastric cancer.

KW - Gastric cancer

KW - Leucovorin

KW - Paclitaxel

KW - UFT

UR - http://www.scopus.com/inward/record.url?scp=33745960387&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=33745960387&partnerID=8YFLogxK

U2 - 10.1038/sj.bjc.6603225

DO - 10.1038/sj.bjc.6603225

M3 - Article

C2 - 16804524

AN - SCOPUS:33745960387

VL - 95

SP - 159

EP - 163

JO - British Journal of Cancer

JF - British Journal of Cancer

SN - 0007-0920

IS - 2

ER -