在晚期结肠直肠癌中FOLFIRI跟随FOLFOX6或反向序列:一个随机的GERCOR研究
Christophe Tournigand1, Thierry André1, Emmanuel Achille1
1From the GERCOR; Hôpital Saint-Antoine; Hôpital Tenon; Hôpital Georges Pompidou; Aventis; International Drug Development Institute, Paris; Clinique de l'Orangerie, Strasbourg; Clinique Saint-Jean, Lyon; Clinique Drevon, Dijon; Centre Jean Bernard, Le Mans; Clinique Courlancy, Reims, France; International Drug Development Institute, Brussels, Belgium.
概括
这项研究比较了转移性结直肠癌的两种化疗序列,发现FOLFIRI跟随FOLFOX6和FOLFOX6跟随FOLFIRI的整体存活率和疗效相似. 这两种疗法表现出相似的结果,但具有不同的毒性概况.
科学领域:
- 在瘤学瘤学.
- 临床药理学 临床药理学
- 癌症治疗方法 癌症治疗方法
背景情况:
- 甲酸 (FU) 加上leucovorin (LV) 结合义利诺坦或氧沙在转移性结直肠癌中表现出优势.
- 优化化疗序列对于改善转移性结直肠癌患者的治疗结果至关重要.
研究的目的:
- 为了比较两个连续化疗方案在以前未经治疗的转移性结直肠癌患者的疗效和安全性.
- 研究folinic acid,FU和irinotecan (FOLFIRI) 之后 folinic acid,FU和oxaliplatin (FOLFOX6) 的序列与反向序列 (FOLFOX6然后FOLFIRI) 相比.
主要方法:
- 第三阶段随机试验,涉及以前未经治疗的转移性结直肠癌患者.
- 患者在疾病进展后接受了FOLFIRI,其次是FOLFOX6 (A臂) 或FOLFOX6,其次是FOLFIRI (B臂).
- 化疗包括特定剂量和输液的leucovorin,甲,伊诺诺坦,和oxaliplatin.
主要成果:
- 两只手臂的中位生存时间相似 (21.5个月与20.6个月,P = .99).
- 第二次无进展生存 (PFS) 没有显著差异 (14.2个月与10.9个月,P = .64).
- 第一线FOLFIRI和FOLFOX6的反应率 (56%对54%) 和PFS中位数 (8.5个月对8.0个月) 是可比的.
结论:
- 两种连续的FOLFIRI和FOLFOX6疗法都在转移性结直肠癌中实现了延长的生存期和类似的疗效.
- 这两种治疗序列表现出不同的毒性概况,FOLFIRI与更多的粘膜炎和恶心/吐有关,而FOLFOX6与更多的中性衰竭和神经传感毒性有关.
- 治疗顺序不会显著影响整体存活率,但毒性管理应考虑具体的治疗方案.
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