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Japanese Journal of Clinical Oncology Advance Access published online on February 22, 2008
Japanese Journal of Clinical Oncology, doi:10.1093/jjco/hyn001
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© The Author (2008). Published by Oxford University Press. All rights reserved

Clinical Efficacy of S-1 in Pretreated Metastatic Breast Cancer Patients

Tadahiko Shien1, Chikako Shimizu2,, Sadako Akashi-Tanaka1, Kan Yonemori2, Tsutomu Kohno2, Takashi Hojo1, Masashi Ando2, Noriyuki Katsumata2, Takayuki Kinoshita1 and Yasuhiro Fujiwara2

1 Division of Surgical Oncology
2 Division of Medical Oncology, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan

For reprints and all correspondence: Chikako Shimizu, Division of Surgical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan. E-mail: cshimizu{at}ncc.go.jp

Received August 10, 2007; accepted December 26, 2007

Background: S-1, an oral fluoropyrimidine carbamate, is an active and well-tolerated agent against solid cancer. However, the clinical efficacy of S-1 in patients with metastatic breast cancer has not been determined.

Methods: We retrospectively evaluated the efficacy of S-1 and identified its adverse effects in patients with metastatic breast cancer who had failed to respond to prior chemotherapy regimens. All the patients were treated at the National Cancer Center Hospital and received S-1 twice daily at a dose of 80 mg/m2 for 4 weeks, followed by a 2-week rest interval.

Results: Between 2003 and 2007, 37 women with metastatic breast cancer received S-1 as a third line or greater chemotherapy regimen. All the patients had been previously treated with both anthracyclines and taxanes prior to S-1 chemotherapy. The median order of S-1 administration was as a fifth-line treatment, and 23 patients (62%) received S-1 as their final anticancer drug. One (3%) partial response and two (5%) stable diseases were observed. The median time to progression (TTP) was 84 days. Grade 2 adverse events, such as diarrhea, stomatitis and neutropenia occurred in 5 (16%), 1 (3%) and 1 (3%) patients, respectively.

Conclusions: S-1 was safety administered to heavily treated metastatic breast cancer patients with limited efficacy. Further evaluation of S-1 is necessary to elucidate its clinical role in breast cancer treatment.

Key Words: S-1 • metastatic breast • cancer • chemotherapy


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