title: Docetaxel, nedaplatin, and S-1 (DGS) chemotherapy for advanced esophageal carcinoma: a phase I dose-escalation study.
abstract: OBJECTIVE
  More effective regimens are urgently needed for treatment of esophageal carcinoma; therefore, we conducted a phase I trial of a combination of docetaxel, nedaplatin, and S-1 (DGS) to determine the optimal dose in patients with advanced esophageal carcinoma.
  
  
  METHODS
  We studied 14 patients with previously untreated advanced cervical esophageal carcinoma with T3-4 tumors and/or M1 staging and esophageal carcinoma with cervical lymph node metastasis. The patients received an infusion of docetaxel at different dose levels (levels 1, 2, 3, 4: 25, 30, 35, 40 mg/m(2), respectively) and an infusion of nedaplatin (40 mg/m(2)) on day 8 plus oral administration of S1 (80 mg/m(2)/day) for two consecutive weeks at two-week intervals.
  
  
  RESULTS
  Dose-limiting toxicities (DLTs) included febrile neutropenia and leukopenia. DLTs occurred in 2 out of 5 patients at level 4. The response rate was 78.6 (11/14)%, including a complete response rate of 35.7(5/14)%.
  
  
  CONCLUSIONS
  The DGS regimen reported here was well tolerated and toxicities were manageable. The maximum tolerated dose was level 4, and the recommended dose was determined to be docetaxel at 35 mg/m(2) with nedaplatin at 40 mg/m(2) plus S1 at 80 mg/m(2). We found that our regimen, administered on an outpatient basis, showed high activity and tolerance. A phase II study has been started.
authors.affiliation: Department of Surgical Oncology, Gifu Graduate School of Medicine, 1-1 Yanagido, Gifu City, Gifu 501-1194, Japan.
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Tanaka
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Yoshida
authors.forename: Shinji
authors.initials: S
authors.lastname: Osada
authors.forename: Kazuya
authors.initials: K
authors.lastname: Yamaguchi
authors.forename: Takao
authors.initials: T
authors.lastname: Takahashi
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000627:therapeutic use*; D010094:Oxonic Acid / Q000627:therapeutic use*; D043823:Taxoids / Q000627:therapeutic use*; D005641:Tegafur / Q000627:therapeutic use*; D014057:Tomography, X-Ray Computed / Q000379:methods
chemical_list: D000970:Antineoplastic Agents; D004338:Drug Combinations; D009944:Organoplatinum Compounds; D043823:Taxoids; C079198:S 1 (combination); D005641:Tegafur; D000077143:Docetaxel; D010094:Oxonic Acid; C053989:nedaplatin