Phase II trial of epirubicin, cisplatin, oral uracil and tegafur, and leucovorin in patients with advanced gastric carcinoma

Yoon Tae Jeen, So Y. Yoon, Sang Won Shin, Byung Soo Kim, Young Jae Mok, Chong S. Kim, Jin H. Hyun, Jun Suk Kim, Yeul Hong Kim

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29 Citations (Scopus)

Abstract

BACKGROUND. The results of chemotherapy for patients with gastric carcinoma generally have been modest, although regimens developed more recently have produced higher response rates. One such regimen is epirubicin, cisplatin, and protracted infusion of 5-fluorouracil (ECF). The advantage of a long-term oral administration of uracil and tegafur (UFT) is that this treatment may be used to mimic the protracted infusion of 5-fluorouracil (5-FU). In addition, UFT treatment combined with leucovorin had a favorable activity and tolerable toxicity in patients with advanced gastric carcinoma. Instead of the inconvenience of an infusion pump and intravenous catheter for the protracted infusion of 5-FU, the authors administered UFT plus leucovorin in an ECF regimen for the treatment of patients with advanced gastric carcinoma. METHODS. Fifty-two patients with advanced gastric carcinoma received epirubicin, cisplatin, and oral UFT plus leucovorin. Epirubicin 50 mg/m2 and cisplatin 60 mg/m2 were administered on Day 1 by intravenous injection. Tegafur and uracil 360 mg/m2/day orally was administered in conjunction with leucovorin administered at a fixed dose of 45 mg/day orally in divided daily doses for 21 days followed by a 7-day rest period. These courses were repeated every 4 weeks. The median age of the patients was 59 years with a median World Health Organization performance status of 1. Patients received a median of five courses of treatment (range, 1-10). RESULTS. Among the 47 patients evaluated, three patients achieved complete response, and 24 patients had partial responses, for an overall response rate of 57.5% (95% confidence interval, 71.5-43.3%). Stable disease was reported in 11 patients (23.4%), and another 9 patients (19.1%) showed disease progression. The median duration of survival was 15 months (range, 2-33+). The main toxicity was nausea/vomiting and neutropenia. Significant toxicity (modified National Cancer Institute common toxicity Grade 3 or 4) included neutropenia in 22 patients (42%), nausea in 14(27%), vomiting in 9 (18%), oral mucositis in 3 (6%), and diarrhea in 3 (6%) patients. CONCLUSIONS. The authors conclude that epirubicin, cisplatin, and oral UFT plus leucovorin, a convenient regimen, has a significant activity and tolerable toxicities in patients with gastric carcinoma.

Original languageEnglish
Pages (from-to)2288-2293
Number of pages6
JournalCancer
Volume91
Issue number12
DOIs
Publication statusPublished - 2001 Jun 15

Fingerprint

Tegafur
Epirubicin
Uracil
Leucovorin
Cisplatin
Stomach
Carcinoma
Fluorouracil
Neutropenia
Nausea
Vomiting
Infusion Pumps
Stomatitis
National Cancer Institute (U.S.)
Therapeutics
Intravenous Injections

Keywords

  • Cisplatin
  • Combination chemotherapy
  • Epirubicin
  • Gastric carcinoma
  • Leucovorin
  • Uracil and tegafur (UFT)

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Phase II trial of epirubicin, cisplatin, oral uracil and tegafur, and leucovorin in patients with advanced gastric carcinoma. / Jeen, Yoon Tae; Yoon, So Y.; Shin, Sang Won; Kim, Byung Soo; Mok, Young Jae; Kim, Chong S.; Hyun, Jin H.; Kim, Jun Suk; Kim, Yeul Hong.

In: Cancer, Vol. 91, No. 12, 15.06.2001, p. 2288-2293.

Research output: Contribution to journalArticle

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abstract = "BACKGROUND. The results of chemotherapy for patients with gastric carcinoma generally have been modest, although regimens developed more recently have produced higher response rates. One such regimen is epirubicin, cisplatin, and protracted infusion of 5-fluorouracil (ECF). The advantage of a long-term oral administration of uracil and tegafur (UFT) is that this treatment may be used to mimic the protracted infusion of 5-fluorouracil (5-FU). In addition, UFT treatment combined with leucovorin had a favorable activity and tolerable toxicity in patients with advanced gastric carcinoma. Instead of the inconvenience of an infusion pump and intravenous catheter for the protracted infusion of 5-FU, the authors administered UFT plus leucovorin in an ECF regimen for the treatment of patients with advanced gastric carcinoma. METHODS. Fifty-two patients with advanced gastric carcinoma received epirubicin, cisplatin, and oral UFT plus leucovorin. Epirubicin 50 mg/m2 and cisplatin 60 mg/m2 were administered on Day 1 by intravenous injection. Tegafur and uracil 360 mg/m2/day orally was administered in conjunction with leucovorin administered at a fixed dose of 45 mg/day orally in divided daily doses for 21 days followed by a 7-day rest period. These courses were repeated every 4 weeks. The median age of the patients was 59 years with a median World Health Organization performance status of 1. Patients received a median of five courses of treatment (range, 1-10). RESULTS. Among the 47 patients evaluated, three patients achieved complete response, and 24 patients had partial responses, for an overall response rate of 57.5{\%} (95{\%} confidence interval, 71.5-43.3{\%}). Stable disease was reported in 11 patients (23.4{\%}), and another 9 patients (19.1{\%}) showed disease progression. The median duration of survival was 15 months (range, 2-33+). The main toxicity was nausea/vomiting and neutropenia. Significant toxicity (modified National Cancer Institute common toxicity Grade 3 or 4) included neutropenia in 22 patients (42{\%}), nausea in 14(27{\%}), vomiting in 9 (18{\%}), oral mucositis in 3 (6{\%}), and diarrhea in 3 (6{\%}) patients. CONCLUSIONS. The authors conclude that epirubicin, cisplatin, and oral UFT plus leucovorin, a convenient regimen, has a significant activity and tolerable toxicities in patients with gastric carcinoma.",
keywords = "Cisplatin, Combination chemotherapy, Epirubicin, Gastric carcinoma, Leucovorin, Uracil and tegafur (UFT)",
author = "Jeen, {Yoon Tae} and Yoon, {So Y.} and Shin, {Sang Won} and Kim, {Byung Soo} and Mok, {Young Jae} and Kim, {Chong S.} and Hyun, {Jin H.} and Kim, {Jun Suk} and Kim, {Yeul Hong}",
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T1 - Phase II trial of epirubicin, cisplatin, oral uracil and tegafur, and leucovorin in patients with advanced gastric carcinoma

AU - Jeen, Yoon Tae

AU - Yoon, So Y.

AU - Shin, Sang Won

AU - Kim, Byung Soo

AU - Mok, Young Jae

AU - Kim, Chong S.

AU - Hyun, Jin H.

AU - Kim, Jun Suk

AU - Kim, Yeul Hong

PY - 2001/6/15

Y1 - 2001/6/15

N2 - BACKGROUND. The results of chemotherapy for patients with gastric carcinoma generally have been modest, although regimens developed more recently have produced higher response rates. One such regimen is epirubicin, cisplatin, and protracted infusion of 5-fluorouracil (ECF). The advantage of a long-term oral administration of uracil and tegafur (UFT) is that this treatment may be used to mimic the protracted infusion of 5-fluorouracil (5-FU). In addition, UFT treatment combined with leucovorin had a favorable activity and tolerable toxicity in patients with advanced gastric carcinoma. Instead of the inconvenience of an infusion pump and intravenous catheter for the protracted infusion of 5-FU, the authors administered UFT plus leucovorin in an ECF regimen for the treatment of patients with advanced gastric carcinoma. METHODS. Fifty-two patients with advanced gastric carcinoma received epirubicin, cisplatin, and oral UFT plus leucovorin. Epirubicin 50 mg/m2 and cisplatin 60 mg/m2 were administered on Day 1 by intravenous injection. Tegafur and uracil 360 mg/m2/day orally was administered in conjunction with leucovorin administered at a fixed dose of 45 mg/day orally in divided daily doses for 21 days followed by a 7-day rest period. These courses were repeated every 4 weeks. The median age of the patients was 59 years with a median World Health Organization performance status of 1. Patients received a median of five courses of treatment (range, 1-10). RESULTS. Among the 47 patients evaluated, three patients achieved complete response, and 24 patients had partial responses, for an overall response rate of 57.5% (95% confidence interval, 71.5-43.3%). Stable disease was reported in 11 patients (23.4%), and another 9 patients (19.1%) showed disease progression. The median duration of survival was 15 months (range, 2-33+). The main toxicity was nausea/vomiting and neutropenia. Significant toxicity (modified National Cancer Institute common toxicity Grade 3 or 4) included neutropenia in 22 patients (42%), nausea in 14(27%), vomiting in 9 (18%), oral mucositis in 3 (6%), and diarrhea in 3 (6%) patients. CONCLUSIONS. The authors conclude that epirubicin, cisplatin, and oral UFT plus leucovorin, a convenient regimen, has a significant activity and tolerable toxicities in patients with gastric carcinoma.

AB - BACKGROUND. The results of chemotherapy for patients with gastric carcinoma generally have been modest, although regimens developed more recently have produced higher response rates. One such regimen is epirubicin, cisplatin, and protracted infusion of 5-fluorouracil (ECF). The advantage of a long-term oral administration of uracil and tegafur (UFT) is that this treatment may be used to mimic the protracted infusion of 5-fluorouracil (5-FU). In addition, UFT treatment combined with leucovorin had a favorable activity and tolerable toxicity in patients with advanced gastric carcinoma. Instead of the inconvenience of an infusion pump and intravenous catheter for the protracted infusion of 5-FU, the authors administered UFT plus leucovorin in an ECF regimen for the treatment of patients with advanced gastric carcinoma. METHODS. Fifty-two patients with advanced gastric carcinoma received epirubicin, cisplatin, and oral UFT plus leucovorin. Epirubicin 50 mg/m2 and cisplatin 60 mg/m2 were administered on Day 1 by intravenous injection. Tegafur and uracil 360 mg/m2/day orally was administered in conjunction with leucovorin administered at a fixed dose of 45 mg/day orally in divided daily doses for 21 days followed by a 7-day rest period. These courses were repeated every 4 weeks. The median age of the patients was 59 years with a median World Health Organization performance status of 1. Patients received a median of five courses of treatment (range, 1-10). RESULTS. Among the 47 patients evaluated, three patients achieved complete response, and 24 patients had partial responses, for an overall response rate of 57.5% (95% confidence interval, 71.5-43.3%). Stable disease was reported in 11 patients (23.4%), and another 9 patients (19.1%) showed disease progression. The median duration of survival was 15 months (range, 2-33+). The main toxicity was nausea/vomiting and neutropenia. Significant toxicity (modified National Cancer Institute common toxicity Grade 3 or 4) included neutropenia in 22 patients (42%), nausea in 14(27%), vomiting in 9 (18%), oral mucositis in 3 (6%), and diarrhea in 3 (6%) patients. CONCLUSIONS. The authors conclude that epirubicin, cisplatin, and oral UFT plus leucovorin, a convenient regimen, has a significant activity and tolerable toxicities in patients with gastric carcinoma.

KW - Cisplatin

KW - Combination chemotherapy

KW - Epirubicin

KW - Gastric carcinoma

KW - Leucovorin

KW - Uracil and tegafur (UFT)

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