title: Phase I/II trial with docetaxel and S-1 for patients with advanced or recurrent gastric cancer with consideration to age.
abstract: OBJECTIVE
  To determine the dose-limiting toxicity (DLT) and activity of combination with docetaxel and S-1 on unresectable gastric cancer.
  
  
  METHODS
  Docetaxel was administered intravenously on day 1 and S-1 was administered orally on days 1-14, every 3 weeks. Doses of each drug in phase I study were docetaxel 60-75 mg/m(2) and S-1 60-80 mg/m(2). A phase II study was conducted with the recommended dose (RD) based on phase I.
  
  
  RESULTS
  Sixty-five patients (median age 54 years) were enrolled. The DLTs were neutropenia with fever or stomatitis. The RD was docetaxel 75 mg/m(2) and S-1 60 mg/m(2). Two patients (aged 66 and 64 years) developed septic shock during the initial part of phase II study. A phase I study at lower dose (docetaxel 60 mg/m(2) and S-1 80 mg/m(2)) was conducted for patients older than 60 years, and this dose was determined as the RD for these patients. In the phase II study, frequent grade 3/4 toxicities were neutropenia (47%) and febrile neutropenia (26%). The overall response rate was 50% (95% CI, 35-66%) and median survival was 15.3 months (95% CI, 10.0-20.6 months).
  
  
  CONCLUSIONS
  Combination with docetaxel and S-1 was active against advanced gastric cancer and gave manageable toxicities.
authors.affiliation: Department of lnternal Medicine, Hallym University Medical Center and Hallym University College of Medicine, Anyang, South Korea. fhdzang@hallym.or.kr
authors.forename: Dae Young
authors.initials: DY
authors.lastname: Zang
authors.forename: Dae Hyun
authors.initials: DH
authors.lastname: Yang
authors.forename: Hae Wan
authors.initials: HW
authors.lastname: Lee
authors.forename: Se Won
authors.initials: SW
authors.lastname: Hwang
authors.forename: Hun Ho
authors.initials: HH
authors.lastname: Song
authors.forename: Joo Young
authors.initials: JY
authors.lastname: Jung
authors.forename: Jung Hye
authors.initials: JH
authors.lastname: Kwon
authors.forename: Hyo Jung
authors.initials: HJ
authors.lastname: Kim
authors.forename: Jung Han
authors.initials: JH
authors.lastname: Kim
authors.forename: Sa Rah
authors.initials: SR
authors.lastname: Park
authors.forename: Min-Jeong
authors.initials: MJ
authors.lastname: Kim
authors.forename: Kyung Mi
authors.initials: KM
authors.lastname: Jang
authors.forename: Choong Kee
authors.initials: CK
authors.lastname: Park
authors.forename: Jong Hyeok
authors.initials: JH
authors.lastname: Kim
authors.forename: Bong Hwa
authors.initials: BH
authors.lastname: Lee
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000077143:Docetaxel; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D010094:Oxonic Acid / Q000008:administration & dosage; D012008:Recurrence; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D043823:Taxoids / Q000008:administration & dosage; D005641:Tegafur / Q000008:administration & dosage
chemical_list: D004338:Drug Combinations; D043823:Taxoids; C079198:S 1 (combination); D005641:Tegafur; D000077143:Docetaxel; D010094:Oxonic Acid