在癌中,标准化疗与低剂量化疗 (PLATO-ACT4):第二阶段随机对照试验的短期结果
Alexandra Gilbert1, Richard Adams2, Joanne Webster3
1Leeds Institute of Medical Research at St James's, University of Leeds, St James's University Hospital, Leeds, UK; Leeds Cancer Research UK Clinical Trials Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
早期门癌的低剂量化疗和放射治疗显示出有前途的结果. 这种方法似乎被很好地容忍,保持高响应率,同时可能降低患者的治疗毒性.
科学领域:
- 在瘤学瘤学.
- 辐射瘤学 辐射瘤学
- 临床试验 临床试验
背景情况:
- 门局部状细胞癌通常用激进化学放射疗法治疗,这种疗法是有效的,但与显著的发病率相关.
- 需要在不影响局部控制率的情况下,评估早期门癌的较少毒性治疗选择.
- 该ACT4试验调查了减少剂量强度调节放射治疗 (rd-IMRT) 方案.
研究的目的:
- 评估低剂量化疗或放射治疗方案是否可以在早期门癌症中保持高局部控制率.
- 评估与标准剂量IMRT相比,减少治疗相关毒性的次要目标.
- 分析二次终点,包括完整的临床反应,合规性,患者报告的结果和治疗后6个月的安全性.
主要方法:
- 一个第二阶段,前性,多中心,随机对照试验 (ACT4),比较标准剂量IMRT (sd-IMRT) 与减少剂量IMRT (rd-IMRT) 以及并发化疗.
- 符合条件的患者有T1-2 (≤4厘米) N0-NxM0早期门癌,ECOG表现状态为0-1.
- 患者被随机分配1:2分为sd-IMRT (50.4Gy) 或rd-IMRT (41.4Gy),两种药物分别是mitomycin和capecitabine;二级终点在6个月后进行分析.
主要成果:
- 6个月的完整临床响应在两个手臂都很高:sd-IMRT的87%,rd-IMRT的92%.
- 与标准剂量相比,低剂量IMRT显示了较低的放射治疗中断率 (15%vs26%),化疗修改率 (37%vs49%) 和3级或更严重的急性毒性 (35%vs46%) 的趋势.
- 严重的不良事件是可比的,患者报告的结果通常在6周后得到解决,尽管在sd-IMRT后6个月观察到性功能较差.
结论:
- 标准剂量和减少剂量的化学放射治疗方案都在早期门癌症中实现了良好的6个月的完整临床响应率.
- 早期发现表明,减少剂量的IMRT疗法耐受性良好,并保持瘤结果.
- 关于三年地方区域失效率的长期数据尚未公布,但初步结果支持rd-IMRT作为降低毒性的可行选择.
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