A phase II study of S-1 monotherapy administered for 2 weeks of a 3-week cycle in advanced gastric cancer patients with poor performance status

H. C. Jeung, S. Y. Rha, S. J. Shin, J. B. Ahn, S. H. Noh, J. K. Roh, H. C. Chung

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Abstract

Systemic chemotherapy for gastric cancer is often associated with treatment-related toxicity, which is particularly severe in patients with a poor performance status. In this paper, we describe the first study to evaluate S-1 monotherapy as an option for advanced gastric cancer patients who are not candidates for combination chemotherapy due to poor clinical condition. Fifty-two patients with Eastern Cooperative Oncology Group (ECOG) performance scale 2-3, whose general condition had made use of combination chemotherapy impossible, were enrolled. S-1 was administered to 30 patients as second- or third-line therapy. The initial dose of S-1 was 35 mg m-2, administered b.i.d for 14 days every 3 weeks. With a median follow-up period of 33 weeks, the median progression-free survival, and overall survival were 11 weeks (95% CI, 8-14) and 33 weeks (95% CI, 19-47), respectively. The overall 1-year survival rate was 29% by intent-to-treat analysis. The overall response rate was 12% (95% CI, 3-21), and the percentage of stable disease was 35%, resulting in the disease control rate of 47% (95% CI, 32-60). Significant drug-related toxicity included grade 3 diarrhoea (14%), anorexia (14%), fatigue (10%), neutropenia (10%), and leucopenia (6%). In conclusion, this study indicated the modest activity of S-1 in gastric cancer patients with poor performance status.

Original languageEnglish
Pages (from-to)458-463
Number of pages6
JournalBritish journal of cancer
Volume97
Issue number4
DOIs
Publication statusPublished - 2007 Aug 14

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Stomach Neoplasms
Combination Drug Therapy
Leukopenia
Anorexia
Neutropenia
Drug-Related Side Effects and Adverse Reactions
Disease-Free Survival
Fatigue
Diarrhea
Survival Rate
Drug Therapy
Survival
Therapeutics

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

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title = "A phase II study of S-1 monotherapy administered for 2 weeks of a 3-week cycle in advanced gastric cancer patients with poor performance status",
abstract = "Systemic chemotherapy for gastric cancer is often associated with treatment-related toxicity, which is particularly severe in patients with a poor performance status. In this paper, we describe the first study to evaluate S-1 monotherapy as an option for advanced gastric cancer patients who are not candidates for combination chemotherapy due to poor clinical condition. Fifty-two patients with Eastern Cooperative Oncology Group (ECOG) performance scale 2-3, whose general condition had made use of combination chemotherapy impossible, were enrolled. S-1 was administered to 30 patients as second- or third-line therapy. The initial dose of S-1 was 35 mg m-2, administered b.i.d for 14 days every 3 weeks. With a median follow-up period of 33 weeks, the median progression-free survival, and overall survival were 11 weeks (95{\%} CI, 8-14) and 33 weeks (95{\%} CI, 19-47), respectively. The overall 1-year survival rate was 29{\%} by intent-to-treat analysis. The overall response rate was 12{\%} (95{\%} CI, 3-21), and the percentage of stable disease was 35{\%}, resulting in the disease control rate of 47{\%} (95{\%} CI, 32-60). Significant drug-related toxicity included grade 3 diarrhoea (14{\%}), anorexia (14{\%}), fatigue (10{\%}), neutropenia (10{\%}), and leucopenia (6{\%}). In conclusion, this study indicated the modest activity of S-1 in gastric cancer patients with poor performance status.",
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A phase II study of S-1 monotherapy administered for 2 weeks of a 3-week cycle in advanced gastric cancer patients with poor performance status. / Jeung, H. C.; Rha, S. Y.; Shin, S. J.; Ahn, J. B.; Noh, S. H.; Roh, J. K.; Chung, H. C.

In: British journal of cancer, Vol. 97, No. 4, 14.08.2007, p. 458-463.

Research output: Contribution to journalArticle

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AU - Shin, S. J.

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AU - Chung, H. C.

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AB - Systemic chemotherapy for gastric cancer is often associated with treatment-related toxicity, which is particularly severe in patients with a poor performance status. In this paper, we describe the first study to evaluate S-1 monotherapy as an option for advanced gastric cancer patients who are not candidates for combination chemotherapy due to poor clinical condition. Fifty-two patients with Eastern Cooperative Oncology Group (ECOG) performance scale 2-3, whose general condition had made use of combination chemotherapy impossible, were enrolled. S-1 was administered to 30 patients as second- or third-line therapy. The initial dose of S-1 was 35 mg m-2, administered b.i.d for 14 days every 3 weeks. With a median follow-up period of 33 weeks, the median progression-free survival, and overall survival were 11 weeks (95% CI, 8-14) and 33 weeks (95% CI, 19-47), respectively. The overall 1-year survival rate was 29% by intent-to-treat analysis. The overall response rate was 12% (95% CI, 3-21), and the percentage of stable disease was 35%, resulting in the disease control rate of 47% (95% CI, 32-60). Significant drug-related toxicity included grade 3 diarrhoea (14%), anorexia (14%), fatigue (10%), neutropenia (10%), and leucopenia (6%). In conclusion, this study indicated the modest activity of S-1 in gastric cancer patients with poor performance status.

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