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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. Jeung  ;  Y. W. Moon  ;  S. Y. Rha  ;  N. C. Yoo  ;  J. K. Roh  ;  S. H. Noh  ;  J. S. Min  ;  B. S. Kim  ;  H. C. Chung 
 ANNALS OF ONCOLOGY, Vol.19(3) : 520-526, 2008 
Journal Title
Issue Date
Adenocarcinoma/drug therapy* ; Adenocarcinoma/mortality ; Adenocarcinoma/secondary ; Adenocarcinoma/surgery* ; Adjuvants, Immunologic/administration & dosage ; Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use* ; Chemotherapy, Adjuvant ; Colorectal Neoplasms/secondary ; Disease-Free Survival ; Doxorubicin/administration & dosage ; Female ; Fluorouracil/administration & dosage ; Follow-Up Studies ; Humans ; Immunotherapy ; Male ; Middle Aged ; Multivariate Analysis ; Neoplasm Recurrence, Local/epidemiology ; Neoplasms, Second Primary/epidemiology ; Poly A-U/administration & dosage ; Prognosis ; Stomach Neoplasms/drug therapy* ; Stomach Neoplasms/mortality ; Stomach Neoplasms/surgery* ; Survival Rate
adjuvant chemotherapy ; chemoimmunotherapy ; gastric cancer ; poly A:U
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 D(2-3) 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.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Surgery (외과학교실) > 1. Journal Papers
Yonsei Authors
Noh, Sung Hoon(노성훈) ORCID logo https://orcid.org/0000-0003-4386-6886
Roh, Jae Kyung(노재경)
Rha, Sun Young(라선영) ORCID logo https://orcid.org/0000-0002-2512-4531
Moon, Yong Wha(문용화)
Min, Jin Sik(민진식)
Yoo, Nae Choon(유내춘)
Chung, Hyun Cheol(정현철) ORCID logo https://orcid.org/0000-0002-0920-9471
Jeung, Hei Cheul(정희철) ORCID logo https://orcid.org/0000-0003-0952-3679
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