Final results of randomized trials by the National Surgical Adjuvant Study of Colorectal Cancer (NSAS-CC)
Final results of randomized trials by the National Surgical Adjuvant Study of Colorectal Cancer (NSAS-CC)
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DOI：
10.1007/s00280-010-1358-1
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发表时间：
2011-03-01
影响因子：
3
通讯作者：
Ohashi, Yasuo
中科院分区：
文献类型：
--
作者：
Hamaguchi, Tetsuya;Shirao, Kuniaki;Ohashi, Yasuo
在20世纪90年代后期，完全切除的III期结直肠癌的辅助化疗在日本仍然存在争议。我们在III期结肠癌和直肠癌患者中进行了两项独立的随机对照试验，患者被随机分配接受单独手术或手术后接受UFT（400 mg/m2/d）治疗，每周连续5天，持续1年。主要终点为无复发生存期（RFS），次要终点为总生存期（OS），共纳入334例结肠癌患者和276例直肠癌患者。UFT组和单纯手术组的患者特征相似。结肠癌的RFS或OS无显著差异。然而，在直肠癌中，UFT组的RFS和OS显著优于单纯手术组。UFT组中唯一的4级毒性是腹泻，发生在1例结肠癌患者和1例直肠癌患者中。III期直肠癌患者术后UFT辅助化疗成功耐受，并改善了RFS和OS。在结肠癌中，没有获得预期的益处（风险比= 0.89）。
In the latter 1990s, adjuvant chemotherapy for completely resected Stage III colorectal cancer remained controversial in Japan. We conducted two independent randomized controlled trials in patients with Stage III colon and rectal cancer.Patients were randomly assigned to receive surgery alone or surgery followed by treatment with UFT (400 mg/m(2)/day), given for five consecutive days per week for 1 year. The primary endpoint was relapse-free survival (RFS), and the secondary endpoint was overall survival (OS).A total of 334 patients with colon cancer and 276 with rectal cancer were enrolled. The patients' characteristics were similar between the UFT group and the Surgery-alone group. There was no significant difference in RFS or OS in colon cancer. In rectal cancer, however, RFS and OS were significantly better in the UFT group than in the Surgery-alone group. The only grade 4 toxicity in the UFT group was diarrhea, occurring in one patient with colon cancer and one patient with rectal cancer.Postoperative adjuvant chemotherapy with UFT is successfully tolerated and improves RFS and OS in patients with Stage III rectal cancer. In colon cancer, the expected benefits were not obtained (hazard ratio = 0.89).