FOLFOXIRI (folinic acid, 5-fluorouracil, oxaliplatin and irinotecan) vs FOLFIRI (folinic acid, 5-fluorouracil and irinotecan) as first-line treatment in metastatic colorectal cancer (MCC): a multicentre randomised phase III trial from the Hellenic Oncology Research Group (HORG).
FOLFOXIRI (folinic acid, 5-fluorouracil, oxaliplatin and irinotecan) vs FOLFIRI (folinic acid, 5-fluorouracil and irinotecan) as first-line treatment in metastatic colorectal cancer (MCC): a multicentre randomised phase III trial from the Hellenic Oncology Research Group (HORG).
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DOI：
10.1038/sj.bjc.6603011
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发表时间：
2006-03-27
影响因子：
8.8
通讯作者：
中科院分区：
文献类型：
--
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比较奥沙利铂（L-OHP）联合伊立替康（CPT-11）、5-氟尿嘧啶（5-FU）和亚叶酸（LV）（FOLFOXIRI）与伊立替康和5-FU/LV（FOLFIRI）一线治疗转移性结直肠癌（MCC）患者的疗效和毒性。共入组了283例未经化疗的MCC患者（FOLFIRI组：n=146; FOLFOXIRI组：n=137）。在FOLFOXIRI组中，CPT-11（150 mg m−2）在第1天给药，L-OHP（65 mg m− 2）在第2天给药，LV（200 mg m−2）在第2天和第3天给药，5-FU（400 mg m−2静脉推注，600 mg m − 2持续静脉输注22 h）在第2天和第3天给药。在FOLFIRI组中，CPT-11（180 mg m−2）在第1天给药，而LV和5-FU的给药方式与FOLFOXIRI方案相同。两种方案均每2周给药一次。总生存期（FOLFIRI组和FOLFOXIRI组的中位OS分别为19.5和21.5个月; P=0.337）、至疾病进展的中位时间（FOLFIRI组和FOLFOXIRI组分别为6.9和8.4个月; P=0.17）、缓解率（FOLFIRI组和FOLFOXIRI组分别为33.6%和43%; P=0.168）无差异。FOLFOXIRI治疗患者的脱发（P=0.0001）、腹泻（P=0.0001）和感觉神经毒性（P=0.001）发生率显著高于FOLFIRI治疗患者。尽管观察到的中位OS是文献中报告的最佳OS之一，但本研究未能证明FOLFOXIRI联合治疗与FOLFIRI方案相比具有任何优效性。
To compare the efficacy and toxicity of oxaliplatin (L-OHP) in combination with irinotecan (CPT-11), 5-fluorouracil (5-FU) and leucovorin (LV) (FOLFOXIRI) vs irinotecan and 5-FU/LV (FOLFIRI) as first-line treatment of patients with metastatic colorectal cancer (MCC). A total of 283 chemotherapy-naïve patients with MCC were enrolled (FOLFIRI arm: n=146; FOLFOXIRI arm: n=137). In the FOLFOXIRI arm, CPT-11 (150 mg m−2) was given on d1, L-OHP (65 mg m−2) on d2, LV (200 mg m−2) on days 2 and 3 and 5-FU (400 mg m−2 as i.v. bolus and 600 mg m−2 as 22 h i.v. continuous infusion) on days 2 and 3. In the FOLFIRI arm, CPT-11 (180 mg m−2) was given on d1 whereas LV and 5-FU were administered in the same way as in the FOLFOXIRI regimen. Both regimens were administered every 2 weeks. There was no difference in terms of overall survival (median OS: 19.5 and 21.5 months, for FOLFIRI and FOLFOXIRI, respectively; P=0.337), median time to disease progression (FOLFIRI: 6.9 and FOLFOXIRI: 8.4 months; P=0.17), response rates (33.6 and 43% for FOLFIRI and FOLFOXIRI, respectively; P=0.168). Patients treated with FOLFOXIRI had a significantly higher incidence of alopecia (P=0.0001), diarrhoea (P=0.0001) and neurosensory toxicity (P=0.001) compared with patients treated with FOLFIRI. The present study failed to demonstrate any superiority of the FOLFOXIRI combination compared with the FOLFIRI regimen, although the observed median OS is one of the best ever reported in the literature.
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影响因子：
45.3
作者：
POON, MA;OCONNELL, MJ;WIESENFELD, M
通讯作者：
WIESENFELD, M
影响因子：
45.3
作者：
Sastre, J;Marcuello, E;Díaz-Rubio, E
通讯作者：
Díaz-Rubio, E
影响因子：
1.9
作者：
OBRIEN, PC;FLEMING, TR
通讯作者：
FLEMING, TR
影响因子：
8.8
作者：
Bleiberg, H
通讯作者：
Bleiberg, H
影响因子：
254.7
作者：
Parkin, DM;Bray, F;Pisani, P
通讯作者：
Pisani, P