随机II/III期试验比较肝切除术,其次是mFOLFOX6与肝切除术单独用于结肠直肠癌肝转移:JCOG0603的长期结果
Yukihide Kanemitsu1, Yasuhiro Shimizu2, Junki Mizusawa1
1National Cancer Center Hospital, Tokyo, Japan.
概括
结直肠肝转移 (CRLM) 手术后的辅助mFOLFOX6化疗并没有改善长期存活率,尽管早些时候发现了改善无病存活率. 这种治疗可能会延迟复发,但不会提高整体生存结果.
科学领域:
- 在瘤学瘤学.
- 手术瘤学手术瘤学
- 胃肠道瘤学 胃肠道瘤学
背景情况:
- 结肠直肠肝仅转移 (CRLM) 在癌症治疗中是一个重大挑战.
- 肝切除术后的辅助化疗是一种改善CRLM患者治疗结果的策略.
- 以前的研究,包括JCOG0603,表明mFOLFOX6对无病生存 (DFS) 有好处,但整体生存 (OS) 数据仍然不成熟.
研究的目的:
- 报告来自JCOG0603试验的长期整体生存 (OS) 数据.
- 评估mFOLFOX6辅助化疗与单独肝切除术相比在可切除CRLM.患者中的疗效.
- 为了确定辅助剂mFOLFOX6是否能改善长期生存结果,超出无病生存期.
主要方法:
- 一项随机对照试验,涉及患有结直肠腺癌和仅肝转移的患者.
- 患者被随机分配,接受辅助mFOLFOX6化疗或单独肝切除术.
- 无病生存 (DFS) 是主要终点,总生存 (OS) 是次要终点,长期随访.
主要成果:
- 长期随访显示,辅助mFOLFOX6和单独肝切除组 (HR,1.07) 之间的整体存活 (OS) 没有显著差异.
- 五年后的OS率为73.4% (mFOLFOX6) 和80.1% (仅肝切除术).
- 虽然辅助剂mFOLFOX6显示了改善DFS的趋势 (5年DFS:49.7%与40.5%相比),但它并没有转化为改善长期的OS.
结论:
- 在切除CRLM的肝切除术后,辅助的mFOLFOX6化疗并没有改善长期整体存活率.
- 治疗可能有助于延迟复发 (改善DFS),但这并不能提高长期存活率.
- 肝切除术本身仍然是这种患者群体中长期存活的可比治疗选择.
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