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作为全球耐受性衡量标准的FACT-GP5:对缺失评估的响应性和稳定性
Cara Arizmendi1,2, Yanyan Zhu3, Maryam Khan3
1AstraZeneca, Oncology Digital Health R&D, Gaithersburg, MD, USA. cara.arizmendi@astrazeneca.com.
概括
实际上,FACT-GP5有效地测量了患者报告的晚期乳腺癌治疗耐受性. 它对副作用的反应能力通常很强,即使缺少数据,但随着时间的推移变化需要仔细考虑.
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:
- 癌症治疗项目的功能评估 (FACT-GP5) 评估了患者感知到的治疗耐受性.
- 纵向评估和缺失数据 (缺失非随机) 对FACT-GP5的影响以前没有被探索过.
- 本研究评估了FACT-GP5对缺失数据假设的稳定性及其对关键副作用的响应能力.
研究的目的:
- 评估FACT-GP5在晚期乳腺癌患者的纵向轨迹.
- 评估FACT-GP5对关键临床指标的响应能力,如CTCAE等级和ECOG性能状态.
- 确定缺少数据对FACT-GP5的有效性和可靠性的影响.
主要方法:
- 一项随机,双盲研究 (NCT00065325) 涉及618名患有HR+晚期乳腺癌的绝经后妇女.
- 患者接受了富勒韦斯坦或埃克塞梅斯坦,并每月完成FACT测量,持续7个月.
- 累积链接混合模型 (CLMM) 用于分析FACT-GP5轨迹和响应能力,并对失踪随机 (MAR) 假设进行灵敏度分析.
主要成果:
- 患者报告的副作用烦随着时间的推移而增加.
- FACT-GP5显示了与其他FACT项目,ECOG绩效状态和CTCAE等级的积极人体内相关性.
- 缺少FACT-GP5评估影响了轨迹,但没有影响与其他项目之间的关系,除了恶心.
结论:
- FACT-GP5是一种响应性测量,用于评估患者报告的治疗耐受性.
- 实际上,FACT-GP5对缺失数据的响应能力通常很强大.
- 在解释FACT-GP5分数的纵向变化时,应考虑缺失的数据.
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