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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

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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.

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Authors and Affiliations

  1. Comprehensive Cancer Center, Temple University, 3322 N. Broad Street, 19140-5102, Philadelphia, PA, USA

    John S. Macdonald MD

  2. Southwest Oncology Group Statistical Center, Seattle, Washington, USA

    Thomas R. Fleming PhD & Catherine M. Tangen MS

  3. Scott & White Clinic/Texas A&M, Temple, Texas, USA

    Robert F. Peterson MD

  4. Cancer Center of Hawaii, Honolulu, Hawaii, USA

    Jeffrey L. Berenberg MD

  5. University of Texas Medical Branch-Galveston, Galveston, Texas, USA

    Suzanne McClure MD, PhD

  6. Henry Ford Hospital, Detroit, Michigan, USA

    Robert A. Chapman MD

  7. University of Utah Medical Center, Salt Lake City, Utah, USA

    Harman J. Eyre MD

  8. University of Oklahoma Health Science Center, Oklahoma City, Oklahoma, USA

    Dilip Solanki MD

  9. University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA

    Anatolio B. Cruz Jr MD

  10. Humana Hospital Sunrise, Las Vegas, Nevada, USA

    Robert Gagliano MD

  11. University of Kansas Medical Center, Kansas City, Kansas, USA

    Norman C. Estes MD

  12. Puget Sound Oncology Consortium, Seattle, Washington, USA

    Saul Rivkin MD

Authors
  1. John S. Macdonald MD
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  2. Thomas R. Fleming PhD
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  3. Robert F. Peterson MD
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  4. Jeffrey L. Berenberg MD
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  5. Suzanne McClure MD, PhD
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  6. Robert A. Chapman MD
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  7. Harman J. Eyre MD
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  8. Dilip Solanki MD
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  9. Anatolio B. Cruz Jr MD
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  10. Robert Gagliano MD
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  11. Norman C. Estes MD
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  12. Catherine M. Tangen MS
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  13. Saul Rivkin MD
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Additional information

Address reprint requests to Southwest Oncology Group (SWOG-7804), Operations Office, 14980 Omicron Drive, San Antonio TX 78245-3217, USA.

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Macdonald, J.S., Fleming, T.R., Peterson, R.F. et al. 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. Annals of Surgical Oncology 2, 488–494 (1995). https://doi.org/10.1007/BF02307081

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  • DOI: https://doi.org/10.1007/BF02307081

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