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Annals of Oncology Advance Access published online on November 20, 2007
Annals of Oncology, doi:10.1093/annonc/mdm536
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© 2007 European Society for Medical Oncology

Phase III trial of adjuvant 5-fluorouracil and adriamycin versus 5-fluorouracil, adriamycin, and polyadenylic–polyuridylic acid (poly A:U) for locally advanced gastric cancer after curative surgery: final results of 15-year follow-up

H.-C. Jeung1,2, Y. W. Moon1,2,3, S. Y. Rha1,2,3,5, N. C. Yoo1,2,3,5, J. K. Roh1,2,3,5, S. H. Noh1,2,4,5, J. S. Min1,2,4, B. S. Kim1,2 and H. C. Chung1,2,3,5,*

1 Yonsei Cancer Center
2 Cancer Metastasis Research Center
3 Department of Internal Medicine
4 Department of Surgery
5 Brain Korea 21 Project for Medical Science, Yonsei University College of Medicine, Seoul, Korea

* Correspondence to: Prof. H. C. Chung, Yonsei Cancer Center, Cancer Metastasis Research Center, Yonsei University College of Medicine, 250 Seongsanno, 134 Shinchon-Dong, Seodaemun-Gu, Seoul 120-752, Korea. Tel: +82-2-2228-8132; Fax: +82-2-362-5592; E-mail: unchung8{at}yuhs.ac

Background: This phase III trial was to compare 5-fluorouracil (5-FU), adriamycin, and polyadenylic–polyuridylic acid (poly A:U) against 5-fluorouracil plus adriamycin (FA) for operable gastric cancer.

Patients and methods: From 1984 to 1989, patients who had D2–3 curative resection were randomly assigned to receive chemotherapy or chemoimmunotherapy. Chemotherapy consisted of 12 mg/kg 5-FU every week for 18 months and 40 mg/m2 adriamycin every 3 weeks for 12 cycles. Chemoimmunotherapy consisted of FA plus 100 mg of poly A:U weekly for six cycles and was followed 6 months later by six weekly 50-mg booster injections.

Results: A total of 292 patients were enrolled. After excluding 12 ineligible patients, 142 and 138 patients were allocated to each treatment. Patients were balanced with prognostic variables: age, sex, tumor location, differentiation, degree of tumor invasion (T2–T4a), and lymph node status (N0–N2). During the 15-year follow-up, chemoimmunotherapy significantly prolonged overall (P = 0.013) and recurrence-free (P = 0.005) survivals compared with chemotherapy alone. The survival benefits were prominent in the subset of patients with T3/T4a, N2, or stage III. Treatments were generally well tolerated in both arms.

Conclusions: These results indicate a survival advantage of chemoimmunotherapy with a regimen of FA and poly A:U in curatively resected gastric adenocarcinoma.

adjuvant chemotherapy, chemoimmunotherapy, gastric cancer, poly A:U

Received for publication August 22, 2007. Accepted for publication October 22, 2007.


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