title: A multicenter phase II study of adjuvant chemotherapy with oral fluoropyrimidine S-1 for non-small-cell lung cancer: high completion and survival rates.
abstract: BACKGROUND
  Oral adjuvant chemotherapy without hospitalization might reduce the physiological and psychological burden on patients if effectiveness could be guaranteed. We conducted a multicenter feasibility study using S-1, an oral derivative of 5-fluorouracil, as postoperative adjuvant chemotherapy in patients with curatively resected pathologically stage IB-IIIA non-small-cell lung cancer.
  
  
  METHODS
  Adjuvant chemotherapy comprised 8 courses (4-week administration, 2-week withdrawal) of S-1 at 80-120 mg per day. Fifty-one patients from 7 institutions were enrolled in this pilot study, from June 2005 to March 2007. The primary end point was the completion rate of scheduled adjuvant chemotherapy. Secondary end points were the incidence and grade of adverse reactions.
  
  
  RESULTS
  Fifty patients were eligible. The completion rate for the planned 8 courses of S-1 administration was 72.0% (36 patients). Total percentage administration amount was 71.1%. Grade 3 adverse reactions such as neutropenia (4.0%), anorexia (4.0%), thrombopenia (2.0%), anemia (2.0%), elevated total bilirubin (2.0%), hypokalemia (2.0%), nausea (2.0%), and diarrhea (2.0%) were observed, but no grade 4 adverse effects were encountered. Overall and relapse-free survival rates at 3 years were 87.7% and 69.4%, respectively.
  
  
  CONCLUSIONS
  Postoperative 1-year administration of S-1 seems feasible as oral adjuvant chemotherapy for lung cancer. The oral formulation and low incidence of adverse reactions permit treatment on an outpatient basis. The present study would be reasonable to follow up with a properly powered phase III trial.
authors.affiliation: Division of Surgical Oncology, Department of Translational Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki City, Japan.
authors.forename: Tomoshi
authors.initials: T
authors.lastname: Tsuchiya
authors.forename: Takeshi
authors.initials: T
authors.lastname: Nagayasu
authors.forename: Naoya
authors.initials: N
authors.lastname: Yamasaki
authors.forename: Keitaro
authors.initials: K
authors.lastname: Matsumoto
authors.forename: Takuro
authors.initials: T
authors.lastname: Miyazaki
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Tagawa
authors.forename: Akihiro
authors.initials: A
authors.lastname: Nakamura
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Minami
authors.forename: Hideki
authors.initials: H
authors.lastname: Taniguchi
authors.forename: Shinji
authors.initials: S
authors.lastname: Akamine
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Hisano
authors.forename: Yoshitaka
authors.initials: Y
authors.lastname: Taniguchi
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000553:Ambulatory Care / Q000379:methods; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D017024:Chemotherapy, Adjuvant / Q000379:methods; D003131:Combined Modality Therapy; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D010094:Oxonic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000964:Antimetabolites, Antineoplastic; D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid