title: Phase I/II trial of a biweekly combination of S-1 plus docetaxel in patients with previously treated non-small cell lung cancer (KRSG-0601).
abstract: BACKGROUND
  Combination of S-1, an oral fluorouracil derivative, plus docetaxel against non-small cell lung cancer (NSCLC) showed promising efficacy but clinically problematic emesis. A phase I/II study utilising a new schedule for this combination was conducted.
  
  
  METHODS
  A biweekly regimen of docetaxel on day 1 with oral S-1 on days 1-7 was administered to previously treated NSCLC patients. Doses of docetaxel/S-1 were escalated to 30/80, 35/80, and 40/80 mg m(-2), respectively, and its efficacy was investigated at the recommended dose below maximum tolerated dose (MTD).
  
  
  RESULTS
  In phase I study employing 13 patients, dose-limiting toxicities were febrile neutropenia and treatment delay, with the respective MTDs for docetaxel 40 mg m(-2)/S-1 80 mg m(-2). In the phase II study, 34 patients were treated with docetaxel 35 mg m(-2)/S-1 80 mg m(-2) for a median cycle of 6. The response and disease control rates were 34.3% (95% confidence interval (CI), 18.6-50.0%) and 62.9% (95% CI, 46.8-72.9%), respectively. Median progression-free survival was 150.5 days. Haematologic grade 4 toxicities were observed in neutropenia (11.8%) and thrombocytopenia (2.9%). Regarding non-haematologic toxicities, including emesis, there were no grade 3/4 side effects.
  
  
  CONCLUSIONS
  Combination of 1-week administration of S-1 with biweekly docetaxel is safe and active for NSCLC.
authors.affiliation: Department of Respiratory Medicine, Saitama Medical University, International Medical Center, 1397-1 Yamane, Hidaka City, Saitama 350-1298, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Komiyama
authors.forename: K
authors.initials: K
authors.lastname: Kobayashi
authors.forename: S
authors.initials: S
authors.lastname: Minezaki
authors.forename: F
authors.initials: F
authors.lastname: Kotajima
authors.forename: A
authors.initials: A
authors.lastname: Sutani
authors.forename: T
authors.initials: T
authors.lastname: Kasai
authors.forename: K
authors.initials: K
authors.lastname: Mori
authors.forename: E
authors.initials: E
authors.lastname: Hoshi
authors.forename: N
authors.initials: N
authors.lastname: Takayanagi
authors.forename: S
authors.initials: S
authors.lastname: Koyama
authors.forename: K
authors.initials: K
authors.lastname: Eguchi
authors.forename: M
authors.initials: M
authors.lastname: Nakayama
authors.forename: K
authors.initials: K
authors.lastname: Kikuchi
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D018572:Disease-Free Survival; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004338:Drug Combinations; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D010094:Oxonic Acid / Q000008:administration & dosage / Q000009:adverse effects; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D004338:Drug Combinations; D043823:Taxoids; C079198:S 1 (combination); D005641:Tegafur; D000077143:Docetaxel; D010094:Oxonic Acid