title: Phase II study of adjuvant vinorelbine and cisplatin in Japanese patients with completely resected stage II and III non-small cell lung cancer.
abstract: OBJECTIVE
  Adjuvant vinorelbine and cisplatin chemotherapy is recognized as a standard regimen for patients with completely resected stage II and III non-small cell lung cancer (NSCLC). However, efficacy of adjuvant chemotherapy in Japanese phase III trials with cisplatin-containing regimen has been controversial, and data are limited on the long-term outcome of adjuvant vinorelbine and cisplatin chemotherapy for NSCLC patients.
  
  
  METHODS
  This was a single-arm phase II study in patients with completely resected pathological stage II or III NSCLC, who had not received prior chemotherapy or radiotherapy. Patients received 4 cycles of vinorelbine [25 mg/m(2) of body surface area (BSA)] and cisplatin (40 mg/m(2) of BSA) on days 1 and 8, every 4 weeks. Primary end point was the 3-year relapse-free survival; secondary end points were overall survival and safety.
  
  
  RESULTS
  Between December 2006 and January 2011, 60 patients (40 men and 20 women, median age 64 years) were enrolled; all patients were evaluable for survival and safety. Three-year relapse-free survival rate was 55.0 % (95 % confidence interval 42.4-67.6 %). Three- and five-year overall survival rates were 83.3 and 77.8 %, respectively. There were no chemotherapy-related deaths, and adverse effects were acceptable.
  
  
  CONCLUSIONS
  Adjuvant vinorelbine and cisplatin chemotherapy was safe and showed a valid relapse-free survival rate. This regimen could be used as a standard regimen and deserves to be a control arm of trials on adjuvant chemotherapy in the Japanese NSCLC patient population.
authors.affiliation: Department of Thoracic Surgery, Kyoto University Hospital, Shogoin-Kawara-cho 54, Sakyo-ku, Kyoto, 606-8507, Japan, mysonobe@kuhp.kyoto-u.ac.jp.
authors.forename: Makoto
authors.initials: M
authors.lastname: Sonobe
authors.forename: Ken-ichi
authors.initials: K
authors.lastname: Okubo
authors.forename: Satoshi
authors.initials: S
authors.lastname: Teramukai
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Yanagihara
authors.forename: Masaaki
authors.initials: M
authors.lastname: Sato
authors.forename: Toshihiko
authors.initials: T
authors.lastname: Sato
authors.forename: Fengshi
authors.initials: F
authors.lastname: Chen
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Sato
authors.forename: Takuji
authors.initials: T
authors.lastname: Fujinaga
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Shoji
authors.forename: Mitsugu
authors.initials: M
authors.lastname: Omasa
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Sakai
authors.forename: Ryo
authors.initials: R
authors.lastname: Miyahara
authors.forename: Toru
authors.initials: T
authors.lastname: Bando
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Date
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D044466:Asian People; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D017024:Chemotherapy, Adjuvant / Q000379:methods; D002945:Cisplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D015996:Survival Rate; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine