title: Surgery plus chemotherapy compared with surgery alone for localized squamous cell carcinoma of the thoracic esophagus: a Japan Clinical Oncology Group Study--JCOG9204.
abstract: OBJECTIVE
  We performed a multicenter randomized controlled trial to determine whether postoperative adjuvant chemotherapy improves outcome in patients with esophageal squamous cell carcinoma undergoing radical surgery.
  
  
  METHODS
  Patients undergoing transthoracic esophagectomy with lymphadenectomy between July 1992 and January 1997 at 17 institutions were randomly assigned to receive surgery alone or surgery plus chemotherapy including two courses of cisplatin (80 mg/m2 of body-surface area x 1 day) and fluorouracil (800 mg/m2 x 5 days) within 2 months after surgery. Adaptive stratification factors were institution and lymph node status (pN0 versus pN1). The primary end point was disease-free survival.
  
  
  RESULTS
  Of the 242 patients, 122 were assigned to surgery alone, and 120 to surgery plus chemotherapy. In the surgery plus chemotherapy group, 91 patients (75%) received both full courses of chemotherapy; grade 3 or 4 hematologic or nonhematologic toxicities were limited. The 5-year disease-free survival rate was 45% with surgery alone, and 55% with surgery plus chemotherapy (one-sided log-rank, P =.037). The 5-year overall survival rate was 52% and 61%, respectively (P =.13). Risk reduction by postoperative chemotherapy was remarkable in the subgroup with lymph node metastasis.
  
  
  CONCLUSIONS
  Postoperative adjuvant chemotherapy with cisplatin and fluorouracil is better able to prevent relapse in patients with esophageal cancer than surgery alone.
authors.affiliation: Departmentof Surgery, Keio University School of Medicine, Japan. nando@tdc.ac.jp
authors.forename: Nobutoshi
authors.initials: N
authors.lastname: Ando
authors.forename: Toshifumi
authors.initials: T
authors.lastname: Iizuka
authors.forename: Hiroko
authors.initials: H
authors.lastname: Ide
authors.forename: Kaoru
authors.initials: K
authors.lastname: Ishida
authors.forename: Masayuki
authors.initials: M
authors.lastname: Shinoda
authors.forename: Tadashi
authors.initials: T
authors.lastname: Nishimaki
authors.forename: Wataru
authors.initials: W
authors.lastname: Takiyama
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Watanabe
authors.forename: Kaichi
authors.initials: K
authors.lastname: Isono
authors.forename: Norio
authors.initials: N
authors.lastname: Aoyama
authors.forename: Hiroyasu
authors.initials: H
authors.lastname: Makuuchi
authors.forename: Otsuo
authors.initials: O
authors.lastname: Tanaka
authors.forename: Hideaki
authors.initials: H
authors.lastname: Yamana
authors.forename: Shunji
authors.initials: S
authors.lastname: Ikeuchi
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Kabuto
authors.forename: Kagami
authors.initials: K
authors.lastname: Nagai
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Shimada
authors.forename: Yoshihide
authors.initials: Y
authors.lastname: Kinjo
authors.forename: Haruhiko
authors.initials: H
authors.lastname: Fukuda
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000601:surgery*; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000601:surgery*; D016629:Esophagectomy; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008197:Lymph Node Excision; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies
chemical_list: D002945:Cisplatin; D005472:Fluorouracil