Maroun J A, Cripps C, Goel R, Dahrouge S, Boisvert D
Ottawa Regional Cancer Centre, Ontario, Canada.
Am J Clin Oncol. 1997 Aug;20(4):387-92. doi: 10.1097/00000421-199708000-00014.
Two regimens of 5FU and folinic acid in the treatment of metastatic colorectal cancer were retrospectively analyzed. 33 patients received the high dose (HD) schedule (5FU 370 mg/m2 and Folinic Acid 200 mg/m2 i.v. on D1-5, every 4 weeks), 61 patients received the low dose (LD) schedule (5FU 400 mg/m2 and Folinic Acid 20 mg/m2 i.v. on D1-5, every 4 weeks). One patient in each group achieved a complete response, the overall response rate was 28% and 11% for the HD and LD groups, respectively. The median response duration was 183 days for the HD and 112 days for the LD group. The median survival duration was 387 days for the HD and 405 days for the LD group. The response rate and duration of response were higher in the HD group though this did not reach statistical significance. There was no difference in overall survival between the two patient groups. Neutropenia and gastro-intestinal symptoms were the most common toxicities, they were equal in both groups. One patient (3%) in the HD and 5 patients (9%) in LD group discontinued treatment due to toxicity. There were no treatment related deaths. It is concluded that low dose folinic acid in combination with 5FU is effective and produces similar toxicities as high dose folinic acid. It is concluded that low dose folinic acid in combination with 5FU is an effective alternative to high dose regimen in the palliative management of patients with metastatic colorectal cancer. However though it did not reach statistical significance the high dose regimen was associated with a higher response rate. This could have a significant effect when the combination is used in the adjuvant treatment of high risk patients.
对两种5-氟尿嘧啶（5FU）与亚叶酸联合治疗转移性结直肠癌的方案进行了回顾性分析。33例患者接受高剂量（HD）方案（5FU 370 mg/m²，亚叶酸200 mg/m²，静脉注射，第1 - 5天，每4周一次），61例患者接受低剂量（LD）方案（5FU 400 mg/m²，亚叶酸20 mg/m²，静脉注射，第1 - 5天，每4周一次）。每组各有1例患者达到完全缓解，HD组和LD组的总缓解率分别为28%和11%。HD组的中位缓解持续时间为183天，LD组为112天。HD组的中位生存时间为387天，LD组为405天。HD组的缓解率和缓解持续时间更高，尽管未达到统计学显著性。两组患者的总生存期无差异。中性粒细胞减少和胃肠道症状是最常见的毒性反应，两组发生率相同。HD组有1例患者（3%）、LD组有5例患者（9%）因毒性反应而停止治疗。无治疗相关死亡。结论是低剂量亚叶酸联合5FU有效，且产生的毒性与高剂量亚叶酸相似。结论是低剂量亚叶酸联合5FU是转移性结直肠癌患者姑息治疗中高剂量方案的有效替代方案。然而，尽管未达到统计学显著性，但高剂量方案的缓解率更高。当该联合方案用于高危患者的辅助治疗时，这可能会产生显著影响。
