5-氟尿嘧啶联合亚叶酸钙是根治性切除的III期结肠癌有效的辅助化疗方案：adjCCA-01试验的长期随访结果

5-Fluorouracil plus leucovorin is an effective adjuvant chemotherapy in curatively resected stage III colon cancer: long-term follow-up results of the adjCCA-01 trial.

作者信息

Arkenau H T, Bermann A, Rettig K, Strohmeyer G, Porschen R

机构信息

Clinic of Internal Medicine, Central Hospital Bremen East, Bremen, Germany.

出版信息

Ann Oncol. 2003 Mar;14(3):395-9. doi: 10.1093/annonc/mdg100.

DOI:10.1093/annonc/mdg100

PMID:12598344

Abstract

BACKGROUND

Adjuvant postoperative treatment with 5-fluorouracil (5-FU) and leucovorin in curatively resected stage III colon cancer significantly reduces the risk of cancer recurrences and improves survival. The impact of 5-FU plus leucovorin on survival and tumor recurrence was analyzed in a long-term follow-up study in comparison with the effects of 5-FU plus levamisole in the prospective multicenter trial adjCCA-01.

PATIENTS AND METHODS

Patients with a curatively resected stage III (International Union Against Cancer) colon cancer were stratified according to tumor, node and grading category and randomly assigned to receive one of the two adjuvant treatment schemes: 5-FU 400 mg/m2 body surface area intravenously in the first chemotherapy course, then 450 mg/m2 x 5 days, plus leucovorin 100 mg/m2, 12 cycles (arm A), or 5-FU plus levamisole (Moertel scheme; arm B).

RESULTS

Six hundred and eighty (96.9%) of 702 patients enrolled into this study were eligible. To date, 261 patients have died, 117 on arm A and 144 on arm B (P = 0.007). After a median follow-up time of 82 months, the 5-FU plus leucovorin combination significantly improved disease-free survival [79.8 months in arm A versus 69.3 months in arm B (P = 0.012)] and significantly increased median overall survival (88.9 months in arm A versus 78.6 months in arm B; P = 0.003). Adjuvant treatment with 5-FU plus levamisole as well as 5-FU plus leucovorin was generally well tolerated; only a minority of patients experienced grade 3 and 4 toxicities.

CONCLUSIONS

After curative resection of a stage III colon cancer, adjuvant treatment with 5-FU plus leucovorin is generally well tolerated. This long-term follow-up study demonstrates that adjuvant treatment with 5-FU plus leucovorin given for 12 cycles is significantly more effective than 5-FU plus levamisole (Moertel scheme) in reducing tumor relapse and improving survival.

摘要

背景

在根治性切除的III期结肠癌患者中，术后使用5-氟尿嘧啶（5-FU）和亚叶酸进行辅助治疗可显著降低癌症复发风险并提高生存率。在一项长期随访研究中，分析了5-FU加亚叶酸对生存和肿瘤复发的影响，并与前瞻性多中心试验adjCCA-01中5-FU加左旋咪唑的效果进行了比较。

患者与方法

将根治性切除的III期（国际抗癌联盟）结肠癌患者根据肿瘤、淋巴结和分级类别进行分层，并随机分配接受两种辅助治疗方案之一：在第一个化疗疗程中静脉注射5-FU 400mg/m²体表面积，然后450mg/m²×5天，加亚叶酸100mg/m²，共12个周期（A组），或5-FU加左旋咪唑（莫氏方案；B组）。

结果

本研究纳入的702例患者中有680例（96.9%）符合条件。迄今为止，261例患者死亡，A组117例，B组144例（P = 0.007）。中位随访时间82个月后，5-FU加亚叶酸联合方案显著改善了无病生存期[A组为79.8个月，B组为69.3个月（P = 0.012）]，并显著提高了中位总生存期（A组为88.9个月，B组为78.6个月；P = 0.003）。5-FU加左旋咪唑以及5-FU加亚叶酸的辅助治疗总体耐受性良好；只有少数患者出现3级和4级毒性反应。