Division of Gynecologic Oncology, Department of Obstetrics, Gynecology, and Reproductive Sciences, Magee-Womens' Hospital of the University of Pittsburgh Medical Center, 300 Halket Street, Suite 1750, Pittsburgh, PA 15213, United States.
Department of Radiation Oncology, University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center, 5115 Centre Avenue, Pittsburgh, PA 15232, United States.
Gynecol Oncol. 2022 Jan;164(1):129-135. doi: 10.1016/j.ygyno.2021.10.071. Epub 2021 Nov 2.
Tumor molecular analyses in endometrial cancer (EC) includes 4 distinct subtypes: (1) POLE-mutated, (2) mismatch repair protein (MMR) deficient, (3) p53 mutant, and (4) no specific molecular profile. Recently, a sub-analysis of PORTEC-3 demonstrated notable differences in treatment response between molecular classification (MC) groups. Cost of testing is one barrier to widespread adoption of MC. Therefore, we sought to determine the cost-effectiveness of MC in patients with stage I and II high-risk EC.
A Markov decision model was developed to compare tumor molecular classification (TMC) vs. no testing (NT). A healthcare payor's perspective and 5-year time horizon were used. Base case data were abstracted from PORTEC-3 and the molecular sub-analysis. Cost and utility data were derived from public databases, peer-reviewed literature, and expert input. Strategies were compared using the incremental cost-effectiveness ratio (ICER) with effectiveness in quality-adjusted life years (QALYs) and evaluated with a willingness-to-pay threshold of $100,000 per QALY gained. Sensitivity analyses were performed to test model robustness.
When compared to NT, TMC was cost effective with an ICER of $25,578 per QALY gained; incremental cost was $1780 and incremental effectiveness was 0.070 QALYs. In one-way sensitivity analyses, results were most sensitive to the cost of POLE testing, but TMC remained cost-effective over all parameter ranges.
TMC in early-stage high-risk EC is cost-effective, and the model results were robust over a range of parameters. Given that MC can be used to guide adjuvant treatment decisions, these findings support adoption of TMC into routine practice.
子宫内膜癌（EC）的肿瘤分子分析包括 4 个不同的亚型：（1）POLE 突变型，（2）错配修复蛋白（MMR）缺陷型，（3）p53 突变型，和（4）无特定分子谱型。最近，PORTEC-3 的一项亚分析表明，分子分类（MC）组之间的治疗反应存在显著差异。测试成本是广泛采用 MC 的一个障碍。因此，我们旨在确定 MC 在 I 期和 II 期高危 EC 患者中的成本效益。
我们开发了一个马尔可夫决策模型，用于比较肿瘤分子分类（TMC）与不检测（NT）。采用医疗保健支付者的观点和 5 年时间范围。基础病例数据从 PORTEC-3 和分子亚分析中提取。成本和效用数据来自公共数据库、同行评议文献和专家意见。使用增量成本效益比（ICER）和以质量调整生命年（QALYs）衡量的有效性来比较策略，并以每获得一个 QALY 的 10 万美元的意愿支付阈值进行评估。进行敏感性分析以测试模型的稳健性。
与 NT 相比，TMC 具有成本效益，ICER 为每获得一个 QALY 增加 25578 美元；增量成本为 1780 美元，增量效果为 0.070 QALYs。在单因素敏感性分析中，结果对 POLE 检测成本最为敏感，但在所有参数范围内，TMC 仍然具有成本效益。
在早期高危 EC 中，TMC 具有成本效益，并且模型结果在一系列参数范围内具有稳健性。鉴于 MC 可用于指导辅助治疗决策，这些发现支持将 TMC 纳入常规实践。
