Marsoni S
Southern Europe New Drug Organisation, Milano, Italy.
Semin Oncol. 2001 Feb;28(1 Suppl 1):14-9. doi: 10.1053/sonc.2001.19723.
The International Multicenter Pooled Analysis of Colon Cancer Trials (IMPACT) investigators have now completed two large systematic reviews of adjuvant therapy trials in colon cancer. The IMPACT 1 study pooled data from three separate trials each comparing the efficacy of 5-fluorouracil (5-FU)/leucovorin with observation alone as adjuvant treatment for 1,526 patients with Dukes' B or C colon cancer. The results showed that treatment with 5-FU/leucovorin significantly reduced mortality by 22% (P = .029) and events such as relapse, second tumor, or death by 35% (P < .0001) after 3 years of follow-up. The side effects associated with 5-FU/leucovorin were clinically acceptable. The IMPACT 1 study also showed a clear benefit of adjuvant treatment for patients with Dukes' C colon cancer, but not for stage-B patients. After up to 10 years of follow-up, 5-FU/leucovorin significantly reduced mortality by 30% for patients with Dukes' C disease (P = .003), but only reduced mortality by 8% in patients with Dukes' B colon cancer (P = .658). The aim of the IMPACT 2 study was to determine whether 5-FU/leucovorin is an effective adjuvant treatment for patients with Dukes' B2 colon cancer. Results were pooled from five separate trials that randomized 1,016 patients. After a median of 5.75 years of follow-up, B2 patients receiving 5-FU/leucovorin did not have a significant increase in overall survival or event-free survival. At 5 years, the hazard ratio for overall survival was 0.86 (90% confidence interval, 0.68 to 1.07) and for event-free survival was 0.83 (90% confidence interval, 0.72 to 1.07). 5-Fluorouracil/leucovorin was not recommended as a standard adjuvant treatment for all patients with Dukes' B2 colon cancer.
国际结肠癌试验多中心汇总分析（IMPACT）研究人员现已完成了两项关于结肠癌辅助治疗试验的大型系统评价。IMPACT 1研究汇总了三项独立试验的数据，每项试验均比较了5-氟尿嘧啶（5-FU）/亚叶酸与单纯观察作为1526例杜克B期或C期结肠癌患者辅助治疗的疗效。结果显示，在3年的随访期后，5-FU/亚叶酸治疗使死亡率显著降低了22%（P = 0.029），使复发、二次肿瘤或死亡等事件减少了35%（P < 0.0001）。与5-FU/亚叶酸相关的副作用在临床上是可接受的。IMPACT 1研究还显示，辅助治疗对杜克C期结肠癌患者有明显益处，但对B期患者则不然。经过长达10年的随访，5-FU/亚叶酸使杜克C期疾病患者的死亡率显著降低了30%（P = 0.003），但在杜克B期结肠癌患者中仅使死亡率降低了8%（P = 0.658）。IMPACT 2研究的目的是确定5-FU/亚叶酸对杜克B2期结肠癌患者是否为有效的辅助治疗。结果汇总了五项独立试验，这些试验将1016例患者随机分组。在中位随访5.75年后，接受5-FU/亚叶酸治疗的B2期患者的总生存期或无事件生存期没有显著增加。在5年时，总生存期的风险比为0.86（90%置信区间，0.68至1.07），无事件生存期的风险比为0.83（90%置信区间，0.72至1.07）。不推荐将5-氟尿嘧啶/亚叶酸作为所有杜克B2期结肠癌患者的标准辅助治疗。
