Adjuvant 5-fluorouracil plus doxorubicin in D2-3 resected gastric carcinoma - 15-year experience at a single institute

BACKGROUND. The authors evaluated the efficacy of adjuvant chemotherapy wit h 5-fluorouracil (5-FU) plus doxorubicin in gastric carcinoma after D2-3 cu rative resection. They also evaluated the effect of dose-related factors (d elivered total dose/m(2), actual dose intensity [ADI], relative dose intens ity [RDI]) of this regimen on patient survival. METHODS. A total of 301 patients with Stage II to IV ten bloc resected T4b; 1984 American Joint Committee on Cancer staging) were accrued between 1984 and 1996. Chemotherapy was started within 4 weeks of surgery according to the following schedule: intravenous bolus injection of doxorubicin 40 mg/m( 2) every 3 weeks for 12 cycles and 5-FU 400 mg/m(2) weekly for 60 weeks. Th e toxicity and survival were evaluated. RESULTS. The median follow-up duration was 58 months. Sixty-four percent of the total patients and 71.7% of the patients who did not experience recurr ence during the chemotherapy finished the protocol completely with acceptab le toxicities. The 5- and 10-year disease free survival rates of total 301 patients were 58.4% and 46.5%, and the overall survival rates were 62.1% an d 50.5%, respectively. Treatment completion group showed survival benefit o ver the early termination group in 5-year survival (75.2% vs. 52.9%; P = 0. 0005). The median ADI of 5-FU and doxorubicin were 349 and 11 mg/m(2)/week, and the median RDIs of 5-FU and doxorubicin were 0.87 and 0.83, respective ly. Multivariate analysis demonstrated that completion of chemotherapy is a n independent prognostic factor of both disease free and overall survival. However, ADI and RDI did now show any effect on survival. CONCLUSIONS, Adjuvant chemotherapy with 5-FU plus doxorubicin for 60 weeks after D2-3 dissection induced promising survival duration with acceptable t oxicities. Full administration of the planned dosage of the combined drugs is recommendable as opposed to early termination of the chemotherapy in gas tric carcinoma. Cancer 2001;91:2016-25, (C) 2001 American Cancer Society.