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

John S. Macdonald, Thomas R. Fleming, Robert F. Peterson, Jeffrey L. Berenberg, Suzanne McClure, Robert A. Chapman, Harman J. Eyre, Dilip Solanki, Anatolio B. Cruz, Robert Gagliano, Norman C. Estes, Catherine M. Tangen, Saul Rivkin

Research output: Contribution to journalArticlepeer-review

127 Scopus citations

Abstract

Purpose: 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. Patients and 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). Conclusion: 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.

Original languageEnglish (US)
Pages (from-to)488-494
Number of pages7
JournalAnnals of Surgical Oncology
Volume2
Issue number6
DOIs
StatePublished - Nov 1995
Externally publishedYes

Keywords

  • Adjuvant chemotherapy
  • Gastric cancer

ASJC Scopus subject areas

  • Surgery
  • Oncology

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