两周一次CAPOX与三周一次CAPOX在术后CRC的辅助治疗中:一个随机对照试验
Hangyu Zhang1, Danyang Wang2, Zhou Tong1
1Department of Medical Oncology, First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, P. R. China.
PloS one
|July 11, 2025
概括
与标准的三周一次疗程相比,每两周一次的化疗 (capecitabine和oxaliplatin) 显示出较少的副作用,如血小板缺血和中性质缺血. 这两种疗法在结直肠癌患者中都显示出类似的3年无病生存率.
科学领域:
- 在瘤学瘤学.
- 临床药理学 临床药理学
- 癌症研究 癌症研究
背景情况:
- 结肠直肠癌 (CRC) 是一个重大的全球健康挑战.
- 辅助化疗在改善II期和III期高风险CRC患者的治疗结果方面发挥着至关重要的作用.
- 优化化疗方案的安全性和有效性是正在进行的研究领域.
研究的目的:
- 为了比较修改两周一次的capecitabine和oxaliplatin (CAPOX) 治疗方案的安全性和疗效,与传统的三周一次的CAPOX治疗方案相比.
- 评估血小板缺血的发病率作为主要安全终点.
- 评估3年无病生存率 (DFS) 作为二级疗效终点.
主要方法:
- 一项随机对照试验,涉及高风险II期和III期手术后CRC患者.
- 患者被分配到每三周一次的CAPOX组 (oxaliplatin 130 mg/m2,capecitabine 1000 mg/m2两次1-14天) 或每两周一次的CAPOX组 (oxaliplatin 85 mg/m2,capecitabine 1000 mg/m2两次1-10天).
- 主要终点:血小板缺血的发生率. 二级终点:三年期的DFS率. 后续工作至2024年10月.
主要成果:
- 与每两周一次的CAPOX组相比,每两周一次的CAPOX组显示出所有级别的血小板缺血率 (33%对49%,P=0.02) 和中性质缺血率 (36%对51%,P=0.04) 显著较低.
- 三年DFS率是可比的:每两周一次的CAPOX为85.1%,每三周一次的CAPOX为80.4% (P=0.51).
- 在两周一次的组中,不完整治疗率较低 (7.5%对15%,P=0.13).
结论:
- 与三周一次的CAPOX相比,两周一次的CAPOX是一种更安全的治疗方案,与三周一次的CAPOX相比,血小板缺血和中性缺血的发病率降低了.
- 这两种疗法在高风险II/III期手术后CRC患者中产生相似的3年无病生存率.
- 两周一次的治疗方案可能会提供更耐受的治疗选择,而不会影响长期的疗效.
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