title: Randomized trial of adjuvant chemotherapy with mitomycin, Fluorouracil, and Cytosine arabinoside followed by oral Fluorouracil in serosa-negative gastric cancer: Japan Clinical Oncology Group 9206-1.
abstract: OBJECTIVE
  To evaluate the survival benefit of adjuvant chemotherapy after curative resection in serosa-negative gastric cancer patients (excluding patients who were T1N0), we conducted a multicenter phase III clinical trial in which 13 cancer centers in Japan participated.
  
  
  METHODS
  From January 1993 to December 1994, 252 patients were enrolled into the study and allocated randomly to adjuvant chemotherapy or surgery alone. The chemotherapy comprised intravenous mitomycin 1.33 mg/m2, fluorouracil (FU) 166.7 mg/m2, and cytarabine 13.3 mg/m2 twice weekly for the first 3 weeks after surgery, and oral FU 134 mg/m2 daily for the next 18 months for a total dose of 67 g/m2. The primary end point was relapse-free survival. Overall survival and the site of recurrence were secondary end points.
  
  
  RESULTS
  Ninety-eight percent of patients underwent gastrectomy with D2 or greater lymph node dissection. There were no treatment-related deaths and few serious adverse events. There was no significant difference in relapse-free and overall survival between the arms (5-year relapse-free survival 88.8% chemotherapy v 83.7% surgery alone; P =.14 and 5-year survival 91.2% chemotherapy v 86.1% surgery alone; P =.13, respectively). Nine patients (7.1%) in the chemotherapy arm and 17 patients (13.8%) in the surgery-alone arm had cancer recurrence.
  
  
  CONCLUSIONS
  There was no statistically significant relapse-free or overall survival benefit with this adjuvant chemotherapy for patients with macroscopically serosa-negative gastric cancer after curative resection, and there was no statistical difference between the two arms relating to the types of cancer recurrence. We do not recommend adjuvant chemotherapy with this regimen for this population in clinical practice.
authors.affiliation: Department of Surgery, Niigata Cancer Center Hospital, 2-15-3 Kawagishicho, Niigata 951-8566, Japan. nasimoto@niigata-cc.niigata.niigata.jp
authors.forename: Atsushi
authors.initials: A
authors.lastname: Nashimoto
authors.forename: Toshifusa
authors.initials: T
authors.lastname: Nakajima
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Furukawa
authors.forename: Masatsugu
authors.initials: M
authors.lastname: Kitamura
authors.forename: Taira
authors.initials: T
authors.lastname: Kinoshita
authors.forename: Yoshitaka
authors.initials: Y
authors.lastname: Yamamura
authors.forename: Mitsuru
authors.initials: M
authors.lastname: Sasako
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Kunii
authors.forename: Hisahiko
authors.initials: H
authors.lastname: Motohashi
authors.forename: Seiichiro
authors.initials: S
authors.lastname: Yamamoto
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols; D017024:Chemotherapy, Adjuvant; D003131:Combined Modality Therapy; D003561:Cytarabine / Q000008:administration & dosage; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005743:Gastrectomy; D006801:Humans; D007262:Infusions, Intravenous; D007564:Japan; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage; D009364:Neoplasm Recurrence, Local; D011446:Prospective Studies; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000601:surgery; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D003561:Cytarabine; D016685:Mitomycin; D005472:Fluorouracil