一项随机III期多中心试验，比较伊立替康联合北欧推注5-氟尿嘧啶和亚叶酸方案或推注/输注德格拉蒙方案（LV5FU2）用于转移性结直肠癌患者的疗效。

A randomized phase III multicenter trial comparing irinotecan in combination with the Nordic bolus 5-FU and folinic acid schedule or the bolus/infused de Gramont schedule (Lv5FU2) in patients with metastatic colorectal cancer.

作者信息

Glimelius B, Sørbye H, Balteskard L, Byström P, Pfeiffer P, Tveit K, Heikkilä R, Keldsen N, Albertsson M, Starkhammar H, Garmo H, Berglund A

机构信息

Department of Oncology, Radiology and Clinical Immunology, Uppsala University Hospital, Uppsala, Sweden.

出版信息

Ann Oncol. 2008 May;19(5):909-14. doi: 10.1093/annonc/mdm588. Epub 2008 Jan 21.

DOI:10.1093/annonc/mdm588

PMID:18209013

Abstract

BACKGROUND

To compare irinotecan with the Nordic 5-fluorouracil (5-FU) and folinic acid (FA) bolus schedule [irinotecan 180 mg/m(2) on day 1, 5-FU 500 mg/m(2) and FA 60 mg/m(2) on day 1 and 2 (FLIRI)] or the Lv5FU2 schedule [irinotecan 180 mg/m(2) on day 1, FA 200 mg/m(2), 5-FU bolus 400 mg/m(2) and infused 5-FU 600 mg/m(2) on day 1 and 2 (Lv5FU2-IRI)] due to uncertainties about how to administrate 5-FU with irinotecan.

PATIENTS AND METHODS

Patients (n = 567) with metastatic colorectal cancer were randomly assigned to receive FLIRI or Lv5FU2-IRI. Primary end point was progression-free survival (PFS).

RESULTS

Patient characteristics were well balanced. PFS did not differ between groups (median 9 months, P = 0.22). Overall survival (OS) was also similar (median 19 months, P = 0.9). Fewer objective responses were seen in the FLIRI group (35% versus 49%, P = 0.001) but the metastatic resection rate did not differ (4% versus 6%, P = 0.3). Grade 3/4 neutropenia (11% versus 5%, P = 0.01) and grade 2 alopecia (18% versus 9%, P = 0.002) were more common in the FLIRI group. The 60-day mortality was 2.4% versus 2.1%.

CONCLUSIONS

Irinotecan with the bolus Nordic schedule (FLIRI) is a convenient treatment with PFS and OS comparable to irinotecan with the Lv5FU2 schedule. Neutropenia and alopecia are more prevalent, but both regimens are equally well tolerated.

摘要

背景

由于在如何将5-氟尿嘧啶（5-FU）与伊立替康联合使用方面存在不确定性，故将伊立替康与北欧的5-氟尿嘧啶和亚叶酸（FA）推注方案[第1天给予伊立替康180mg/m²，第1天和第2天给予5-氟尿嘧啶500mg/m²和亚叶酸60mg/m²（FLIRI）]或与Lv5FU2方案[第1天给予伊立替康180mg/m²，第1天和第2天给予亚叶酸200mg/m²、5-氟尿嘧啶推注400mg/m²和5-氟尿嘧啶输注600mg/m²（Lv5FU2-IRI）]进行比较。

患者与方法

567例转移性结直肠癌患者被随机分配接受FLIRI或Lv5FU2-IRI治疗。主要终点为无进展生存期（PFS）。

结果

患者特征均衡良好。两组间PFS无差异（中位值9个月，P = 0.22）。总生存期（OS）也相似（中位值19个月，P = 0.9）。FLIRI组观察到的客观缓解较少（35%对49%，P = 0.001），但转移灶切除率无差异（4%对6%，P = 0.3）。3/4级中性粒细胞减少症（11%对5%，P = 0.01）和2级脱发（18%对9%，P = 0.002）在FLIRI组更常见。60天死亡率分别为2.4%和2.1%。