title: [Phase I study of sequential S-1 and cyclophosphamide therapy in patients with metastatic breast cancer].
abstract: S-1 is a novel oral anticancer agent consisting of tegafur, a prodrug of 5-fluorouracil, and 2 modulators. A phase I study of sequential S-1 and cyclophosphamide(CPA)therapy was conducted to determine the dose-limiting toxicities(DLTs)and recommended doses(RDs)in patients with metastatic or recurrent breast cancer(MBC). Patients with MBC received sequential S-1 and CPA. Chemotherapy consisted of administration of S-1 twice daily on days 1-14 at escalating doses of 40, 50, 65, and 80mg/m2/day and CPA at 100 mg/body/day on days 15-28. The schedule was repeated twice at a 4-week interval. The purposes of this study were to determine the RDs, safety, and efficacy of the regimen. A total of 12 patients were registered. No patients experienced DLTs, and the RDs of S-1 and CPA were 80mg/m2/day and 100 mg/body/day, respectively. The response rate was 50. 0%. In conclusion, sequential therapy with S-1 and CPA could be safely and effectively used for the treatment of MBC, and the RDs for this regimen were determined to be 80mg/m2/day for S-1 and 100 mg/m2/day for CPA.
authors.affiliation: Dept. of Thoracic and Visceral Organ Surgery, Gunma University Graduate School of Medicine, Japan.
authors.forename: Jun
authors.initials: J
authors.lastname: Horiguchi
authors.forename: Daisuke
authors.initials: D
authors.lastname: Takata
authors.forename: Nana
authors.initials: N
authors.lastname: Rokutanda
authors.forename: Rin
authors.initials: R
authors.lastname: Nagaoka
authors.forename: Hideaki
authors.initials: H
authors.lastname: Tokiniwa
authors.forename: Hiroki
authors.initials: H
authors.lastname: Odawara
authors.forename: Mami
authors.initials: M
authors.lastname: Kikuchi
authors.forename: Ayako
authors.initials: A
authors.lastname: Sato
authors.forename: Izumi
authors.initials: I
authors.lastname: Takeyoshi
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D010094:Oxonic Acid / Q000008:administration & dosage / Q000009:adverse effects; D012008:Recurrence; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D003520:Cyclophosphamide