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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| Authors: | 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 |
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| Institution: | (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 |
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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.
Address reprint requests to Southwest Oncology Group (SWOG-7804), Operations Office, 14980 Omicron Drive, San Antonio TX 78245-3217,
USA. |
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| Keywords: | Gastric cancer Adjuvant chemotherapy |
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