Higgins G A, Amadeo J H, Smith D E, Humphrey E W, Keehn R J
Cancer. 1983 Sep 15;52(6):1105-12. doi: 10.1002/1097-0142(19830915)52:6<1105::aid-cncr2820520629>3.0.co;2-z.
This prospective evaluation of 5-fluorouracil (5-FU) and methyl-CCNU administered in combination to patients with surgery for histologically proved gastric adenocarcinoma is based upon 312 patients randomized between August 1974 and May 1980. Patients were stratified into three categories of resectability, (1) complete, (2) proven incomplete, and (3) nonresectable, prior to random treatment assignment to surgery alone or surgery followed by adjuvant chemotherapy. Drug therapy consisted of discrete 5-day courses administered at 7-week intervals. Toxic reactions were reported in association with 42% of the courses. Treatment was suspended or discontinued in 6% of the courses because of hematologic toxicity. Treated patients with curative resections experienced a more favorable survival than did controls, but the early advantage was lost by the end of the second follow-up year. However, no statistically significant improvements in survival or reductions in risks of recurrence were observed. Similar proportions of treated and control deaths were attributable to residual or recurrent disease.
这项针对经组织学证实为胃腺癌且接受手术治疗的患者联合使用5-氟尿嘧啶（5-FU）和甲基环己亚硝脲（methyl-CCNU）的前瞻性评估，基于1974年8月至1980年5月期间随机分组的312例患者。在随机分配接受单纯手术或手术加辅助化疗之前，患者被分为三类可切除性：（1）完全切除，（2）证实不完全切除，（3）不可切除。药物治疗由间隔7周进行的为期5天的离散疗程组成。42%的疗程报告了毒性反应。由于血液学毒性，6%的疗程中止或停止治疗。接受根治性切除的治疗患者比对照组有更有利的生存率，但在第二次随访年末早期优势丧失。然而，未观察到生存率有统计学上的显著改善或复发风险降低。治疗组和对照组相似比例的死亡归因于残留或复发性疾病。
