Jeung H-C, Moon Y W, Rha S Y, Yoo N C, Roh J K, Noh S H, Min J S, Kim B S, Chung H C
Yonsei Cancer Center, Seoul, Korea.
Ann Oncol. 2008 Mar;19(3):520-6. doi: 10.1093/annonc/mdm536. Epub 2007 Nov 20.
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.
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.
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.
These results indicate a survival advantage of chemoimmunotherapy with a regimen of FA and poly A:U in curatively resected gastric adenocarcinoma.
本III期试验旨在比较5-氟尿嘧啶（5-FU）、阿霉素和聚腺苷酸-聚尿苷酸（聚A:U）联合方案与5-氟尿嘧啶加阿霉素（FA）方案用于可手术胃癌的疗效。
1984年至1989年期间，接受D(2-3)根治性切除术的患者被随机分配接受化疗或化疗免疫治疗。化疗方案为每周12mg/kg的5-氟尿嘧啶，持续18个月，每3周40mg/m²阿霉素，共12个周期。化疗免疫治疗方案为FA联合每周100mg聚A:U，共6个周期，6个月后每周追加50mg，共6次。
共纳入292例患者。排除12例不符合条件的患者后，每组各有142例和138例患者接受相应治疗。患者在预后变量方面均衡：年龄、性别、肿瘤位置、分化程度、肿瘤浸润深度（T2-T4a）和淋巴结状态（N0-N2）。在15年的随访中，与单纯化疗相比，化疗免疫治疗显著延长了总生存期（P = 0.013）和无复发生存期（P = 0.005）。在T3/T4a、N2或III期患者亚组中，生存获益尤为显著。两组治疗的耐受性总体良好。
这些结果表明，在根治性切除的胃腺癌中，FA和聚A:U联合化疗免疫治疗具有生存优势。
