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
- Dr. John S. Macdonald MD,
- Thomas R. Fleming PhD,
- Robert F. Peterson MD,
- Jeffrey L. Berenberg MD,
- Suzanne McClure MD, PhD,
- Robert A. Chapman MD,
- Harman J. Eyre MD,
- Dilip Solanki MD,
- Anatolio B. Cruz Jr MD,
- Robert Gagliano MD,
- Norman C. Estes MD,
- Catherine M. Tangen MS,
- Saul Rivkin MD
- … show all 13 hide
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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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- 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
Volume 2, Issue 6 , pp 488-494
- Cover Date
- Print ISSN
- Online ISSN
- Additional Links
- Gastric cancer
- Adjuvant chemotherapy
- Industry Sectors
- Dr. John S. Macdonald MD (1)
- Thomas R. Fleming PhD (2)
- Robert F. Peterson MD (3)
- Jeffrey L. Berenberg MD (4)
- Suzanne McClure MD, PhD (5)
- Robert A. Chapman MD (6)
- Harman J. Eyre MD (7)
- Dilip Solanki MD (8)
- Anatolio B. Cruz Jr MD (9)
- Robert Gagliano MD (10)
- Norman C. Estes MD (11)
- Catherine M. Tangen MS (2)
- Saul Rivkin MD (12)
- Author Affiliations
- 1. Comprehensive Cancer Center, Temple University, 3322 N. Broad Street, 19140-5102, Philadelphia, PA, USA
- 2. Southwest Oncology Group Statistical Center, Seattle, Washington, USA
- 3. Scott & White Clinic/Texas A&M, Temple, Texas, USA
- 4. Cancer Center of Hawaii, Honolulu, Hawaii, USA
- 5. University of Texas Medical Branch-Galveston, Galveston, Texas, USA
- 6. Henry Ford Hospital, Detroit, Michigan, USA
- 7. University of Utah Medical Center, Salt Lake City, Utah, USA
- 8. University of Oklahoma Health Science Center, Oklahoma City, Oklahoma, USA
- 9. University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA
- 10. Humana Hospital Sunrise, Las Vegas, Nevada, USA
- 11. University of Kansas Medical Center, Kansas City, Kansas, USA
- 12. Puget Sound Oncology Consortium, Seattle, Washington, USA