A randomised phase II study of modified FOLFIRI.3 vs modified FOLFOX as second-line therapy in patients with gemcitabine-refractory advanced pancreatic cancer
A randomised phase II study of modified FOLFIRI.3 vs modified FOLFOX as second-line therapy in patients with gemcitabine-refractory advanced pancreatic cancer
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DOI：
10.1038/sj.bjc.6605374
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发表时间：
2009-11-10
影响因子：
8.8
通讯作者：
Lee, J-L
中科院分区：
文献类型：
--
作者：
Yoo, C.;Hwang, J. Y.;Lee, J-L
背景技术背景：只有少数临床试验在一线吉西他滨化疗失败后的晚期胰腺癌患者中进行。因此，目前对这些患者的治疗尚无共识。我们对改良FOLFIRI.3（mFOLFIRI.3;一种联合5-氟尿嘧啶（5-FU）、亚叶酸和伊立替康的方案）和改良FOLFOX（mFOLFOX;一种联合亚叶酸、5-FU和奥沙利铂的方案）方案作为吉西他滨难治性胰腺癌患者的二线治疗进行了一项随机II期研究。mFOlFIRI.3方案包括伊立替康（70 mg m（-2）;第1和3天）、亚叶酸（400 mg m（-2）;第1天）和5-FU（2000 mg m（-2）;第1和2天）每2周一次。mFOLFOX方案包括奥沙利铂（85 mg m（-2）;第1天）、甲酰四氢叶酸（400 mg m（-2）;第1天）和5-FU（2000 mg m（-2）;第1天和第2天），每2周一次。结果：61例患者被随机分配至mFOLFIRI. 3（n = 31）或mFOLFOX（n = 30）方案。6个月生存率分别为27%（95%置信区间（CI）= 13-46%）和30%（95% CI = 15-49%）。中位总生存期分别为16.6周和14.9周。分别有23%（95% CI = 10-42%）和17%（95% CI = 6-35%）的患者实现了疾病控制。至少发生1次3/4级毒性的患者数量相同两组（11例患者，38%）：中性粒细胞减少症（mFOLFIRI.3方案7例患者vs mFOLFOX方案6例患者）、乏力（1 vs 4）、呕吐腹泻（2 vs 0）和粘膜炎（1 vs 2）。结论：mFOLFIRI.3和mFOLFOX方案均可耐受，毒性可管理，作为晚期胰腺癌患者的二线治疗提供了适度的活性，British Journal of Cancer（2009）101，1658-1663. doi：10.1038/sj.bjc.6605374 www.bjcancer. com在线发布2009年10月13日（C）2009英国癌症研究
BACKGROUND: Only a few clinical trials have been conducted in patients with advanced pancreatic cancer after failure of first-line gemcitabine-based chemotherapy. Therefore, there is no current consensus on the treatment of these patients. We conducted a randomised phase II study of the modified FOLFIRI.3 (mFOLFIRI.3; a regimen combining 5-fluorouracil (5-FU), folinic acid, and irinotecan) and modified FOLFOX (mFOLFOX; a regimen combining folinic acid, 5-FU, and oxaliplatin) regimens as second-line treatments in patients with gemcitabine-refractory pancreatic cancer.METHODS: The primary end point was the 6-month overall survival rate. The mFOlFIRI.3 regimen consisted of irinotecan (70 mg m(-2); days 1 and 3), leucovorin (400 mg m(-2); day 1), and 5-FU (2000 mg m(-2); days 1 and 2) every 2 weeks. The mFOLFOX regimen was composed of oxaliplatin (85 mg m(-2); day 1), leucovorin (400 mg m(-2); day 1), and 5-FU (2000 mg m(-2); days 1 and 2) every 2 weeks. RESULTS: Sixty-one patients were randomised to mFOLFIRI.3 (n = 31) or mFOLFOX (n = 30) regimen. The six-month survival rates were 27% (95% confidence interval (CI) = 13-46%) and 30% (95% CI = 15-49%), respectively. The median overall survival periods were 16.6 and 14.9 weeks, respectively. Disease control was achieved in 23% (95% CI = 10-42%) and 17% patients (95% CI = 6-35%), respectively. The number of patients with at least one grade 3/4 toxicity was identical (11 patients, 38%) in both groups: neutropenia (7 patients under mFOLFIRI.3 regimen vs 6 patients under mFOLFOX regimen), asthaenia (1 vs 4), vomiting (3 in both), diarrhoea (2 vs 0), and mucositis (1 vs 2).CONCLUSION: Both mFOLFIRI.3 and mFOLFOX regimens were tolerated with manageable toxicity, offering modest activities as second-line treatments for patients with advanced pancreatic cancer, previously treated with gemcitabine.British Journal of Cancer (2009) 101, 1658-1663. doi: 10.1038/sj.bjc.6605374 www.bjcancer.comPublished online 13 October 2009 (C) 2009 Cancer Research UK