Adjuvant chemotherapy with uracil-tegafur for pathological stage III rectal cancer after mesorectal excision with selective lateral pelvic lymphadenectomy: A multicenter randomized controlled trial
Adjuvant chemotherapy with uracil-tegafur for pathological stage III rectal cancer after mesorectal excision with selective lateral pelvic lymphadenectomy: A multicenter randomized controlled trial
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DOI：
10.1093/jjco/hyl014
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发表时间：
2006-04-01
影响因子：
2.4
通讯作者：
Kodaira, Susumu
中科院分区：
文献类型：
--
作者：
Akasu, Takayuki;Moriya, Yoshihiro;Kodaira, Susumu
背景资料：虽然辅助放疗被证明是有效的局部控制直肠癌，即使在标准化直肠系膜切除术后，辅助化疗的作用，这种标准化手术后仍有待澄清。我们的目的是评估尿嘧啶和替加氟联合治疗通过标准化直肠系膜切除术和选择性侧盆腔淋巴结切除术治疗的病理III期直肠癌的疗效。方法：我们随机分配了完全切除的III期直肠癌患者，这些患者接受了标准化直肠系膜切除术和选择性盆腔外侧淋巴结切除术，接受口服尿嘧啶-替加氟（400 mg/m2/天）治疗一年或不治疗。通过使用日本结肠直肠癌协会的指南，确保手术和病理技术的标准化和质量控制。主要终点是无复发生存期。次要终点是总生存率。结果：我们招募并随机分配了276例患者。排除两名不合格的患者，274名患者被纳入分析。计划的中期分析后2年的累积终止显示显着延长无复发生存期（P = 0.001）和总生存期（P = 0.005）的尿嘧啶-替加氟组。化疗组3年无复发生存率和总生存率分别为78%和91%，单纯手术组分别为60%和81%。两组的局部复发率均较低。3级事件发生在17%的化疗患者，但没有4级或以上的事件发生。结论：辅助化疗与尿嘧啶，替加氟提高了III期直肠癌患者的生存率后，标准化的直肠系膜切除术与选择性盆腔外侧淋巴结清扫术。
Background: Although adjuvant radiotherapy was proved to be effective for local control of rectal cancer even after standardized mesorectal excision, the role of adjuvant chemotherapy after such standardized surgery remains to be clarified. We aimed to assess the efficacy of a combination of uracil and tegafur for pathological stage III rectal cancer treated by standardized mesorectal excision with selective lateral pelvic lymphadenectomy.Methods: We randomly assigned patients with completely resected stage III rectal cancer, who underwent standardized mesorectal excision with selective lateral pelvic lymphadenectomy, to receive either oral uracil-tegafur (400 mg/m(2) tegafur per day) for one year or no treatment. Standardization and quality control of the surgery and pathological techniques were ensured by use of the guidelines of the Japanese Society for Cancer of the Colon and Rectum. The primary endpoint was relapse-free survival. The secondary endpoint was overall survival.Results: We enrolled and randomized 276 patients. Excluding two ineligible patients, 274 were included in the analysis. Planned interim analysis 2 years after accrual termination revealed significant prolongation of relapse-free survival (P = 0.001) and overall survival (P = 0.005) in the uracil-tegafur group. The 3-year relapse-free survival and overall survival rates were 78 and 91% in the chemotherapy group and 60 and 81% in the surgery-alone group, respectively. Local recurrence rates were low in both groups. Grade 3 events occurred in 17% of the chemotherapy patients, but no grade 4 or more events occurred.Conclusion: Adjuvant chemotherapy with uracil-tegafur improves survival of patients with stage III rectal cancer after standardized mesorectal excision with selective lateral pelvic lymphadenectomy.