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

 Y. S. Hong  ;  S. Y. Song  ;  J. Y. Cho  ;  K. S. Lee  ;  J. H. Kang  ;  J. Y. Han  ;  J. N. Park  ;  S. H. Noh  ;  S. H. Choi  ;  H. C. Chung  ;  S. I. Lee 
 ANNALS OF ONCOLOGY, Vol.15(9) : 1344-1347, 2004 
Journal Title
Issue Date
Administration, Oral ; Adult ; Aged ; Anorexia/chemically induced ; Antimetabolites, Antineoplastic/administration & dosage ; Antimetabolites, Antineoplastic/therapeutic use* ; Capecitabine ; Deoxycytidine/administration & dosage ; Deoxycytidine/analogs & derivatives* ; Deoxycytidine/therapeutic use* ; Diarrhea/chemically induced ; Female ; Fluorouracil/analogs & derivatives ; Humans ; Liver Neoplasms/secondary ; Lung Neoplasms/secondary ; Lymphatic Metastasis ; Male ; Middle Aged ; Nausea/chemically induced ; Neoplasm Staging ; Stomach Neoplasms/drug therapy* ; Stomach Neoplasms/mortality ; Stomach Neoplasms/pathology ; Survival Rate ; Time Factors ; Treatment Outcome
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 1250 mg/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.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Surgery (외과학교실) > 1. Journal Papers
Yonsei Authors
Noh, Sung Hoon(노성훈) ORCID logo https://orcid.org/0000-0003-4386-6886
Song, Si Young(송시영) ORCID logo https://orcid.org/0000-0002-1417-4314
Lee, Kwan Sik(이관식) ORCID logo https://orcid.org/0000-0002-3672-1198
Lee, Sang In(이상인)
Chung, Hyun Cheol(정현철) ORCID logo https://orcid.org/0000-0002-0920-9471
Cho, Jae Yong(조재용) ORCID logo https://orcid.org/0000-0002-0926-1819
Choi, Seung Ho(최승호) ORCID logo https://orcid.org/0000-0002-9872-3594
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