title: A randomized trial comparing postoperative adjuvant chemotherapy with cisplatin and 5-fluorouracil versus preoperative chemotherapy for localized advanced squamous cell carcinoma of the thoracic esophagus (JCOG9907).
abstract: BACKGROUND
  Patients with esophageal carcinoma receiving postoperative chemotherapy showed superior disease-free survival than those receiving surgery alone in a Japan Clinical Oncology Group trial (JCOG9204). The purpose of this study was to evaluate optimal perioperative timing-that is, before or after surgery-for providing chemotherapy in patients with locally advanced esophageal squamous cell carcinoma.
  
  
  METHODS
  Eligible patients with clinical stage II or III, excluding T4, squamous cell carcinoma were randomized to undergo surgery followed (group 1) or preceded (group 2) by chemotherapy consisting of two courses of cisplatin plus 5-fluorouracil. The primary end point was progression-free survival.
  
  
  RESULTS
  We randomized 330 patients, with 166 assigned to group 1 and 164 to group 2, between May 2000 and May 2006. The planned interim analysis was conducted after completion of patient accrual. Progression-free survival did not reach the stopping boundary, but overall survival in group 2 was superior to that of group 1 (P = 0.01). Therefore, the Data and Safety Monitoring Committee recommended early publication. Updated analyses showed the 5-year overall survival to be 43% in group 1 and 55% in group 2 (hazard ratio 0.73, 95% confidence interval 0.54-0.99, P = 0.04), where the median follow-up of censored patients was 61.6 months. Concerning operative morbidity, renal dysfunction after surgery in group 2 was slightly higher than in group 1.
  
  
  CONCLUSIONS
  Preoperative chemotherapy with cisplatin plus 5-fluorouracil can be regarded as standard treatment for patients with stage II/III squamous cell carcinoma.
authors: Department of Surgery, Tokyo Dental College Ichikawa General Hospital, Ichikawa, Japan. nando@tdc.ac.jp
authors: Nobutoshi
authors: N
authors: Ando
authors: Hoichi
authors: H
authors: Kato
authors: Hiroyasu
authors: H
authors: Igaki
authors: Masayuki
authors: M
authors: Shinoda
authors: Soji
authors: S
authors: Ozawa
authors: Hideaki
authors: H
authors: Shimizu
authors: Tsutomu
authors: T
authors: Nakamura
authors: Hiroshi
authors: H
authors: Yabusaki
authors: Norio
authors: N
authors: Aoyama
authors: Akira
authors: A
authors: Kurita
authors: Kenichiro
authors: K
authors: Ikeda
authors: Tatsuo
authors: T
authors: Kanda
authors: Toshimasa
authors: T
authors: Tsujinaka
authors: Kenichi
authors: K
authors: Nakamura
authors: Haruhiko
authors: H
authors: Fukuda
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery*; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery*; D016629:Esophagectomy; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D009367:Neoplasm Staging; D011184:Postoperative Period; D057234:Preoperative Period; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D002945:Cisplatin; D005472:Fluorouracil