Lancet. 1995 Feb 11;345(8946):349-53.
The efficacy of adjuvant chemotherapy after surgery for colorectal cancer remains unproven. We have investigated the efficacy of a perioperative intraportal cytotoxic regimen in a randomised trial of 533 patients with operable colorectal carcinoma. Patients were randomly assigned either a single course of portal infusion with mitomycin (10 mg/m2, one dose) plus fluorouracil (500 mg/m2 per 24 h for 7 days) starting immediately after surgery, or no adjuvant treatment. 505 (94%) were evaluable. At median follow-up of 8 years, adjuvant therapy reduced the risk of recurrence by 21% (hazard ratio 0.79 [95% CI 0.62-1.00], p = 0.051) and the risk of death by 26% (0.74 [0.57-0.97], p = 0.026). The lower risk of relapse was observed in all subgroups based on node status or localisation of the tumour; the risk reduction was greatest in patients with tumour-involved lymph nodes (Dukes' C; 0.67 [0.45-0.99], p = 0.045) and for those with colon cancer (0.78 [0.56-1.09], p = 0.151). Most of the difference in overall and disease-free survival could be attributed to a consistent reduction of all kinds of tumour recurrences (local relapses, liver metastases, and other distant metastases) in the treated group, rather than to a reduction of liver relapses only. We conclude that part of the benefit obtained with a single course of adjuvant chemotherapy via the portal vein for patients with operable colorectal carcinoma might be due to the systemic effects of the portal chemotherapy.
结直肠癌术后辅助化疗的疗效尚未得到证实。我们在一项针对533例可手术切除的结直肠癌患者的随机试验中，研究了围手术期门静脉内细胞毒性方案的疗效。患者被随机分配接受术后立即开始的单疗程门静脉输注丝裂霉素（10mg/m²，一剂）加氟尿嘧啶（每24小时500mg/m²，共7天），或不接受辅助治疗。505例（94%）患者可进行评估。在中位随访8年时，辅助治疗使复发风险降低了21%（风险比0.79[95%可信区间0.62 - 1.00]，p = 0.051），死亡风险降低了26%（0.74[0.57 - 0.97]，p = 0.026）。基于淋巴结状态或肿瘤部位的所有亚组中均观察到复发风险降低；在肿瘤累及淋巴结的患者（Dukes' C期；0.67[0.45 - 0.99]，p = 0.045）和结肠癌患者（0.78[0.56 - 1.09]，p = 0.151）中风险降低最为显著。总生存和无病生存的大部分差异可归因于治疗组各种肿瘤复发（局部复发、肝转移和其他远处转移）的持续减少，而非仅肝转移的减少。我们得出结论，对于可手术切除的结直肠癌患者，单疗程门静脉辅助化疗所获得的部分益处可能归因于门静脉化疗的全身效应。
