title: Adjuvant chemotherapy with 5-FU, adriamycin, and mitomycin-C (FAM) versus surgery alone for patients with locally advanced gastric adenocarcinoma: A Southwest Oncology Group study.
abstract: OBJECTIVE
  To evaluate FAM [5-FU (5-fluorouracil), doxorubicin, mitomycin C] chemotherapy as adjuvant therapy for patients with resected TNM stage I, II, or III gastric carcinoma.
  
  
  METHODS
  One hundred ninety-three eligible patients were accrued from 1978 to 1991 in a phase III trial comparing six cycles (1 year) of postoperative FAM chemotherapy with observation only.
  
  
  RESULTS
  The median follow-up on this study was 9.5 years. For all patients, no differences (log-rank analysis) in disease-free survival (p = 0.45) and overall survival (p = 0.57) between FAM therapy (93 cases) and surgery (100 cases) were observed. Quality of surgical resection affected survival irrespective of FAM use. Cases with curative resection, defined in a retrospective review of pathology and surgical reports as cases having no evidence of residual disease in the abdomen and tumor-free margins > 1 cm, had superior survival compared to cases not meeting these requirements (p < 0.001). FAM was well tolerated with 6% (five of 90) of cases demonstrating grade IV hematologic toxicity. There were two drug-related fatalities (one cardiomyopathy, one hematolytic uremic syndrome).
  
  
  CONCLUSIONS
  FAM is not effective adjuvant therapy for TNM stage I, II, and III patients with resected gastric cancer. Future adjuvant studies must emphasize prospective surgical quality control to assure enrollment of appropriately staged and resected cases and wide participation to assure adequate case accrual over a reasonable period.
authors.affiliation: Temple University, Philadelphia, Pennsylvania 19140-5102, USA.
authors.forename: J S
authors.initials: JS
authors.lastname: Macdonald
authors.forename: T R
authors.initials: TR
authors.lastname: Fleming
authors.forename: R F
authors.initials: RF
authors.lastname: Peterson
authors.forename: J L
authors.initials: JL
authors.lastname: Berenberg
authors.forename: S
authors.initials: S
authors.lastname: McClure
authors.forename: R A
authors.initials: RA
authors.lastname: Chapman
authors.forename: H J
authors.initials: HJ
authors.lastname: Eyre
authors.forename: D
authors.initials: D
authors.lastname: Solanki
authors.forename: A B
authors.initials: AB
authors.lastname: Cruz
authors.forename: R
authors.initials: R
authors.lastname: Gagliano
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage; D009364:Neoplasm Recurrence, Local; D011379:Prognosis; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery*
chemical_list: D016685:Mitomycin; D004317:Doxorubicin; D005472:Fluorouracil