A phase II study of S-1 in patients with metastatic breast cancer-A japanese trial by the S-1 cooperative study group, breast cancer working group

被引：106

作者：

Saeki T. ^{[1
]}

Takashima S. ^{[1
]}

Sane M. ^{[2
]}

Horikoshi N. ^{[3
]}

Miura S. ^{[4
]}

Shimizu S. ^{[5
]}

Morimoto K. ^{[6
]}

Kimura M. ^{[7
]}

Aoyama H. ^{[8
]}

Ota J. ^{[9
,10
]}

Noguchi S. ^{[11
,12
]}

Taguchi T. ^{[13
]}

机构：

[1] Department of Clinical Research and Surgery, National Shikoku Cancer Center Hospital, Matsuyama 790-0007

[2] Department of Surgery, Niigata Cancer Center

[3] Department of Medical Oncology, Cancer Institute Hospital Japanese Foundation for Cancer Research

[4] Department of Breast Surgery, Aichi Cancer Center Hospital

[5] Department of Surgery, Yokohama Minamikyousai Hospital

[6] Second Department of Surgery, Osaka City University, Medical School

[7] Department of Surgery, Gunma Cancer Center Hospital

[8] Department of Surgery, National Nagoya Hospital

[9] Department of Surgery, Hanwa Sumiyoshi General Hospital

[10] Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Disease

[11] Department of Surgical Oncology, Osaka University, Medical School

来源：

Breast Cancer | 2004年 / 11卷 / 2期

关键词：

Antimetabolite; Clinical trial; Dihydropyrimidine dehydrogenase; Gastrointestinal toxicity; Metastatic breast cancer;

D O I：

10.1007/BF02968301

中图分类号：

学科分类号：

摘要：

Background: S-1 is a newly developed novel oral dihydrouracil dehydrogenase inhibiting fluoropyrimidine drug consisting of i M tegafur (FT), 0.4 M 5-chloro-2, 4-dihydroxypyrimidine (gimeracil), and 1 M potassium oxonate (oteracil), with efficient antitumor activity and low gastrointestinal toxicity which is widely used in Japan against advanced gastric, head and neck cancers. We investigated its clinical efficacy against metastatic breast cancer. Methods: A non-blind phase il study was carried out to evaluate the efficacy and toxicity in metastatic breast cancer patients. Patients with measurable metastasis foci (n = 111) were enrolled, and 108 patients were regarded as eligible. S-1 was administered orally at a standard dose of 80 mg/m2/day b.i.d. One course consisted of 28 consecutive days of administration followed by a 14-day rest, and courses were repeated up to six times. Results: Among the eligible patients, 10 had a complete response and 35 had a partial response, with an overall response rate (CR plus PR) of 41.7% (95% confidence interval: CI, 32.3-51.5%). The incidences of toxicity (≥ grade 3) were neutropenia 9.1%, anemia 0.9%, anorexia 3.6%, stomatitis 1.8~ nausea/vomiting 1.8%, diarrhea 0.9%, and fatigue 2.7%, however no treatment-related deaths were observed. The median survival time was 872 days (95% CI, 572-1,110 days). There was no difference in response rate or toxicity between the under 65-year-old group and the older group. Conclusion: S-1 was demonstrated to have high efficacy with low gastrointestinal toxicity even in older patients and will be a promising new chemotherapy drug for metastatic breast cancer. © Springer, Part of Springer Science+Business Media.

引用

页码：194 / 202

页数：8

共 38 条

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