长度患者报告的基因型导向义诺他干剂量结果:可行性和临床相关性
Jonathan D Sorah1,2, Allison M Deal1, Sophia I Stein1
1Lineberger Comprehensive Cancer Center, Chapel Hill, NC 27599, United States.
The oncologist
|June 3, 2024
概括
在临床试验中,将患者报告的结果 (PRO) 与临床医生评估 (CTCAE) 整合起来是可行的. 患者比临床医生更早,更频繁地报告严重症状,这表明PRO可以改善毒性检测和患者安全.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 患者报告的结果
背景情况:
- 临床试验中的标准不良事件 (AE) 评估依赖于基于研究人员的标准 (CTCAE).
- 纳入患者报告的结果 (PROs) 提高了对患者毒性的理解,并使早期AE检测成为可能.
- 这项研究评估了PRO-CTCAE在临床工作流程中的纵向整合.
研究的目的:
- 评估在II期临床试验中使用PRO-CTCAE与标准临床医生评估 (CTCAE) 一起整合患者报告结果 (PROs) 的可行性.
- 评估患者和临床医生完成PRO-CTCAE表格的完成率.
- 确定患者和临床医生报告症状和症状发病时间之间的一致性.
主要方法:
- 在接受FOLFIRI和bevacizumab的转移性结直肠癌患者的II期试验中的一个子研究.
- 患者填写了13个不良事件的PRO-CTCAE表格.
- 主要目标:至少80%的时间由患者和临床医生填写估计表格. 二级目标:估计一致性和时间到第一个症状得分.
主要成果:
- 实现可行性:96%的患者和临床医生与患者对完成至少80%的表格;79%的患者完成了100%的表格.
- 患者和临床医生之间严重症状的症状一致性为73%.
- 患者报告的严重症状比临床医生更频繁,更早;患者报告的毒性与剂量下降密切相关.
结论:
- 在临床试验中,PRO-CTCAE与CTCAE的纵向整合是可行的.
- 患者比临床医生更频繁,更早地报告严重症状.
- 常规纳入PRO可以提高早期毒性检测,改善患者的安全和生活质量.
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