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Cited by 440

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Phase II Study of S-1, a Novel Oral Derivative of 5-Fluorouracil, in Advanced Gastric Cancer

Koizumi, Wasaburo, Kurihara, Minoru, Nakano, Shuji, Hasegawa, Koichi·2000·Oncology

Abstract

Purpose: To assess the efficacy and safety of S-1, a novel oral fluoropyrimidine derivative, we conducted a multicenter late phase II study in patients with advanced gastric cancer. Patients and Methods: Fifty-one patients who had received no previous chemotherapy were enrolled. Fifty patients were eligible for efficacy and safety analyses. The overall response was evaluated for the 43 patients who had metastatic lesions. S-1 was administered orally after breakfast and dinner for 28 days, followed by a 14-day break. The dosages were assigned according to the patients’ body surface area (BSA): BSA <1.25 m 2, 40 mg; 1.25–1.5 m 2, 50 mg, and BSA ≥1.5 m 2, 60 mg, twice daily. Results: The overall response to treatment was evaluated as partial response in 19 of the 43 patients (44%; 95% confidence interval 30–59%). The median survival time in all patients was 207 days with 1- and 2-year survival rates of 36.0 and 14.0%, respectively. Grade 3 adverse reactions included decreased hemoglobin values in 2 patients, leukopenia, neutropenia and diarrhea in 1 patient each. No other grade 4 or unexpected adverse reactions were seen. Conclusions: S-1 is effective against advanced gastric cancer. This oral treatment is suitable for outpatients because of its mild toxicity. Further therapeutic benefits are likely to be obtained by combining S-1 with other chemotherapeutic agents.

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Metadata

Authors
Koizumi, W., Kurihara, M., Nakano, S., & Hasegawa, K.
Venue
Oncology
Publisher
S. Karger AG
Published
2000
Volume
58
Issue
3
Pages
191-197
ISSN
  • 0030-2414 (ISSN-L)
  • 1423-0232
OpenAlex
W2008575122
Cited by
440
References
17
FWCI
11.73
Type
journal article
Language
en
Open access
closed

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CoChat. (2026). Citation check: Phase II Study of S-1, a Novel Oral Derivative of 5-Fluorouracil, in Advanced Gastric Cancer. https://app.cochat.ai/papers/10.1159/000012099
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Koizumi, W., Kurihara, M., Nakano, S., & Hasegawa, K. (2000). Phase II Study of S-1, a Novel Oral Derivative of 5-Fluorouracil, in Advanced Gastric Cancer. Oncology. https://doi.org/10.1159/000012099

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