Glimelius B, Sørbye H, Balteskard L, Byström P, Pfeiffer P, Tveit K, Heikkilä R, Keldsen N, Albertsson M, Starkhammar H, Garmo H, Berglund A
Department of Oncology, Radiology and Clinical Immunology, Uppsala University Hospital, Uppsala, Sweden.
Ann Oncol. 2008 May;19(5):909-14. doi: 10.1093/annonc/mdm588. Epub 2008 Jan 21.
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 (n = 567) with metastatic colorectal cancer were randomly assigned to receive FLIRI or Lv5FU2-IRI. Primary end point was progression-free survival (PFS).
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%.
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.
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。
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）。
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%。
伊立替康与北欧推注方案（FLIRI）是一种方便的治疗方法，其PFS和OS与伊立替康与Lv5FU2方案相当。中性粒细胞减少症和脱发更普遍，但两种方案的耐受性相当。
