A phase II trial of capecitabine in previously untreated patients with advanced and/or metastatic gastric cancer

Y. S. Hong, S. Y. Song, S. I. Lee, H. C. Chung, S. H. Choi, S. H. Noh, J. N. Park, J. Y. Han, J. H. Kang, K. S. Lee, Jae Yong Cho

Research output: Contribution to journalArticle

102 Citations (Scopus)

Abstract

Background: Capecitabine (Xeloda®) is a novel, oral, selectively tumor-activated fluoropyrimidine with proven activity in the treatment of advanced colorectal cancer. This trial was conducted to evaluate the efficacy, safety and feasibility of capecitabine in previously untreated patients with advanced and/or metastatic gastric cancer, with a view to replacing 5-fluorouracil (5-FU) in such patients. Patients and methods: Forty-four patients received capecitabine 1250mg/m2 twice daily (2500 mg/m2/day) for 14 days followed by 7 days of rest, for up to six cycles. Results: Capecitabine produced an objective response rate of 34% (all partial responses) and stable disease in 14 patients (30%). The median time to disease progression (TTP) was 3.2 months [95% confidence interval (CI) 2.7-6.4 months] and median overall survival was 9.5 months (95% CI 6.9-13.2 months). Hand-foot syndrome (HFS), nausea, anorexia, diarrhea and vomiting were the most common adverse events. While HFS was the most frequent grade 3/4 toxicity (National Cancer Institute Common Toxicity Criteria), only 9% of patients experienced grade 3 HFS. Severe myelosuppression was not reported during the study. Conclusions: Capecitabine monotherapy is active and well tolerated as first-line therapy in patients with advanced/metastatic gastric cancer. Larger comparative trials investigating capecitabine-based combination regimens in patients with advanced gastric cancer are warranted.

Original languageEnglish
Pages (from-to)1344-1347
Number of pages4
JournalAnnals of Oncology
Volume15
Issue number9
DOIs
Publication statusPublished - 2004 Sep 1

Fingerprint

Stomach Neoplasms
Hand-Foot Syndrome
Confidence Intervals
National Cancer Institute (U.S.)
Capecitabine
Anorexia
Fluorouracil
Nausea
Vomiting
Disease Progression
Colorectal Neoplasms
Diarrhea
Safety
Survival
Therapeutics
Neoplasms

All Science Journal Classification (ASJC) codes

  • Hematology
  • Oncology

Cite this

Hong, Y. S. ; Song, S. Y. ; Lee, S. I. ; Chung, H. C. ; Choi, S. H. ; Noh, S. H. ; Park, J. N. ; Han, J. Y. ; Kang, J. H. ; Lee, K. S. ; Cho, Jae Yong. / A phase II trial of capecitabine in previously untreated patients with advanced and/or metastatic gastric cancer. In: Annals of Oncology. 2004 ; Vol. 15, No. 9. pp. 1344-1347.
@article{b8cb1ccd46934e3ca19165185e936e71,
title = "A phase II trial of capecitabine in previously untreated patients with advanced and/or metastatic gastric cancer",
abstract = "Background: Capecitabine (Xeloda{\circledR}) is a novel, oral, selectively tumor-activated fluoropyrimidine with proven activity in the treatment of advanced colorectal cancer. This trial was conducted to evaluate the efficacy, safety and feasibility of capecitabine in previously untreated patients with advanced and/or metastatic gastric cancer, with a view to replacing 5-fluorouracil (5-FU) in such patients. Patients and methods: Forty-four patients received capecitabine 1250mg/m2 twice daily (2500 mg/m2/day) for 14 days followed by 7 days of rest, for up to six cycles. Results: Capecitabine produced an objective response rate of 34{\%} (all partial responses) and stable disease in 14 patients (30{\%}). The median time to disease progression (TTP) was 3.2 months [95{\%} confidence interval (CI) 2.7-6.4 months] and median overall survival was 9.5 months (95{\%} CI 6.9-13.2 months). Hand-foot syndrome (HFS), nausea, anorexia, diarrhea and vomiting were the most common adverse events. While HFS was the most frequent grade 3/4 toxicity (National Cancer Institute Common Toxicity Criteria), only 9{\%} of patients experienced grade 3 HFS. Severe myelosuppression was not reported during the study. Conclusions: Capecitabine monotherapy is active and well tolerated as first-line therapy in patients with advanced/metastatic gastric cancer. Larger comparative trials investigating capecitabine-based combination regimens in patients with advanced gastric cancer are warranted.",
author = "Hong, {Y. S.} and Song, {S. Y.} and Lee, {S. I.} and Chung, {H. C.} and Choi, {S. H.} and Noh, {S. H.} and Park, {J. N.} and Han, {J. Y.} and Kang, {J. H.} and Lee, {K. S.} and Cho, {Jae Yong}",
year = "2004",
month = "9",
day = "1",
doi = "10.1093/annonc/mdh343",
language = "English",
volume = "15",
pages = "1344--1347",
journal = "Annals of Oncology",
issn = "0923-7534",
publisher = "Oxford University Press",
number = "9",

}

Hong, YS, Song, SY, Lee, SI, Chung, HC, Choi, SH, Noh, SH, Park, JN, Han, JY, Kang, JH, Lee, KS & Cho, JY 2004, 'A phase II trial of capecitabine in previously untreated patients with advanced and/or metastatic gastric cancer', Annals of Oncology, vol. 15, no. 9, pp. 1344-1347. https://doi.org/10.1093/annonc/mdh343

A phase II trial of capecitabine in previously untreated patients with advanced and/or metastatic gastric cancer. / Hong, Y. S.; Song, S. Y.; Lee, S. I.; Chung, H. C.; Choi, S. H.; Noh, S. H.; Park, J. N.; Han, J. Y.; Kang, J. H.; Lee, K. S.; Cho, Jae Yong.

In: Annals of Oncology, Vol. 15, No. 9, 01.09.2004, p. 1344-1347.

Research output: Contribution to journalArticle

TY - JOUR

T1 - A phase II trial of capecitabine in previously untreated patients with advanced and/or metastatic gastric cancer

AU - Hong, Y. S.

AU - Song, S. Y.

AU - Lee, S. I.

AU - Chung, H. C.

AU - Choi, S. H.

AU - Noh, S. H.

AU - Park, J. N.

AU - Han, J. Y.

AU - Kang, J. H.

AU - Lee, K. S.

AU - Cho, Jae Yong

PY - 2004/9/1

Y1 - 2004/9/1

N2 - Background: Capecitabine (Xeloda®) is a novel, oral, selectively tumor-activated fluoropyrimidine with proven activity in the treatment of advanced colorectal cancer. This trial was conducted to evaluate the efficacy, safety and feasibility of capecitabine in previously untreated patients with advanced and/or metastatic gastric cancer, with a view to replacing 5-fluorouracil (5-FU) in such patients. Patients and methods: Forty-four patients received capecitabine 1250mg/m2 twice daily (2500 mg/m2/day) for 14 days followed by 7 days of rest, for up to six cycles. Results: Capecitabine produced an objective response rate of 34% (all partial responses) and stable disease in 14 patients (30%). The median time to disease progression (TTP) was 3.2 months [95% confidence interval (CI) 2.7-6.4 months] and median overall survival was 9.5 months (95% CI 6.9-13.2 months). Hand-foot syndrome (HFS), nausea, anorexia, diarrhea and vomiting were the most common adverse events. While HFS was the most frequent grade 3/4 toxicity (National Cancer Institute Common Toxicity Criteria), only 9% of patients experienced grade 3 HFS. Severe myelosuppression was not reported during the study. Conclusions: Capecitabine monotherapy is active and well tolerated as first-line therapy in patients with advanced/metastatic gastric cancer. Larger comparative trials investigating capecitabine-based combination regimens in patients with advanced gastric cancer are warranted.

AB - Background: Capecitabine (Xeloda®) is a novel, oral, selectively tumor-activated fluoropyrimidine with proven activity in the treatment of advanced colorectal cancer. This trial was conducted to evaluate the efficacy, safety and feasibility of capecitabine in previously untreated patients with advanced and/or metastatic gastric cancer, with a view to replacing 5-fluorouracil (5-FU) in such patients. Patients and methods: Forty-four patients received capecitabine 1250mg/m2 twice daily (2500 mg/m2/day) for 14 days followed by 7 days of rest, for up to six cycles. Results: Capecitabine produced an objective response rate of 34% (all partial responses) and stable disease in 14 patients (30%). The median time to disease progression (TTP) was 3.2 months [95% confidence interval (CI) 2.7-6.4 months] and median overall survival was 9.5 months (95% CI 6.9-13.2 months). Hand-foot syndrome (HFS), nausea, anorexia, diarrhea and vomiting were the most common adverse events. While HFS was the most frequent grade 3/4 toxicity (National Cancer Institute Common Toxicity Criteria), only 9% of patients experienced grade 3 HFS. Severe myelosuppression was not reported during the study. Conclusions: Capecitabine monotherapy is active and well tolerated as first-line therapy in patients with advanced/metastatic gastric cancer. Larger comparative trials investigating capecitabine-based combination regimens in patients with advanced gastric cancer are warranted.

UR - http://www.scopus.com/inward/record.url?scp=4644271767&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=4644271767&partnerID=8YFLogxK

U2 - 10.1093/annonc/mdh343

DO - 10.1093/annonc/mdh343

M3 - Article

C2 - 15319239

AN - SCOPUS:4644271767

VL - 15

SP - 1344

EP - 1347

JO - Annals of Oncology

JF - Annals of Oncology

SN - 0923-7534

IS - 9

ER -