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滑落:危险比率的滑落超过数据削减及其对免疫瘤学的影响 组合经济评估
Dawn Lee1, Zain Ahmad1, Caroline Farmer1
1PenTAG, University of Exeter, Exeter, England, UK.
概括
预测晚期细胞癌组合疗法的生存益处是具有挑战性的,因为危险比率的滑落. 早期数据预测可以显著影响治疗价值评估,需要改进的预测模型.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 卫生经济学 卫生经济学
背景情况:
- 晚期细胞癌 (RCC) 治疗通常涉及组合疗法,包括PD-L) -1 抑制剂和氨酸激酶抑制剂 (TKI).
- 准确预测整体存活 (OS) 益处对于治疗疗效评估和经济评估至关重要.
- 早期临床试验随访的不成熟数据可能导致对治疗结果的预测不可靠.
研究的目的:
- 评估危险比率 (HR) 滑落对高级RCC组合治疗的OS预测的影响.
- 评估不同后续持续时间的卡普兰-梅尔数据的参数曲线拟合的准确性.
- 为了确定生存预测的不准确性对新型疗法的经济合理价格 (eJP) 的影响.
主要方法:
- 数字化了来自多个数据切割的四个RCC试验的Kaplan-Meier曲线.
- 安装了标准参数曲线 (例如,Lognormal,Gompertz) 来估计OS并计算受限平均存活时间 (RMST).
- 根据假设的效用和支付意愿的门计算了eJP的变化,反映了治疗成本和生存率的差异.
主要成果:
- 随着时间的推移,观察到HRs的显著滑落,特别是在随访时间较长的试验中.
- 逻辑正常和逻辑逻辑曲线倾向于预测过多的操作系统,而戈珀茨和马曲线预测得不到观察到的结果.
- 数据削减之间预测的增量寿命年数的差异大大改变了JEP,突出显示了数据不成熟的影响.
结论:
- 使用早期,不成熟的数据预测新疗法的治疗益处存在重大挑战.
- 生存益处预测的准确性受到诸如后续治疗和耐药性发展等因素的影响.
- 纳入关于后续治疗策略的信息对于提高未来治疗益处预测的可靠性至关重要.
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