Department of Pharmacy, Nanxishan Hospital of Guangxi Zhuang Autonomous Region, Guilin, China.
Department of Oncology, Nanxishan Hospital of Guangxi Zhuang Autonomous Region, Guilin, China.
Expert Rev Pharmacoecon Outcomes Res. 2024 Oct;24(8):1027-1042. doi: 10.1080/14737167.2024.2378983. Epub 2024 Jul 15.
This study compares first-line pembrolizumab plus chemotherapy with chemotherapy alone for patients with HER2-negative advanced gastric cancer (GC) and gastroesophageal junction cancer (GEJC) in China.
A Markov state-transition model was developed based on the phase 3 randomized KEYNOTE-859 clinical trial data. The health state utility values and direct medical costs were derived from the KEYNOTE-859 clinical trial, the relevant literature, and local charges. The measured outcomes included quality-adjusted life-years (QALYs) and the incremental cost-effectiveness ratio (ICER). Probabilistic and one-way sensitivity analyses (OWSA) were performed to assess the uncertainty of the model.
In the base analysis, the incremental effectiveness and cost of pembrolizumab plus chemotherapy versus chemotherapy alone were 0.22 QALYs and $16,627.31, respectively, resulting in an ICER of $76,936.60/QALY, which is higher than the willingness-to-pay threshold in China ($35,864.61/QALY). Subgroup analyses revealed that the ICERs of pembrolizumab plus chemotherapy versus chemotherapy alone were $72,762.68 and $34,813.70 in the populations with PD-L1 CPS of 1 or higher (CPS ≥ 1) and PD-L1 CPS ≥ 10 (CPS ≥ 10), respectively.
As first-line therapy for patients with locally advanced or metastatic HER2-negative GC/GEJC in China, pembrolizumab plus chemotherapy is less cost-effective than chemotherapy alone, however, in the CPS ≥ 10 subgroup is more.
本研究比较了在中国,HER2 阴性晚期胃癌(GC)和胃食管结合部癌(GEJC)患者中,一线帕博利珠单抗联合化疗与单纯化疗的疗效。
基于 3 期 KEYNOTE-859 临床试验数据,建立了一个马尔可夫状态转移模型。健康状态效用值和直接医疗费用来源于 KEYNOTE-859 临床试验、相关文献和当地收费标准。主要结局指标包括质量调整生命年(QALYs)和增量成本效果比(ICER)。进行概率和单因素敏感性分析(OWSA)以评估模型的不确定性。
在基础分析中,与单纯化疗相比,帕博利珠单抗联合化疗的增量效果和成本分别为 0.22 QALYs 和 16627.31 美元,导致 ICER 为 76936.60 美元/QALY,高于中国的意愿支付阈值(35864.61 美元/QALY)。亚组分析显示,在 PD-L1 CPS≥1 和 PD-L1 CPS≥10 的人群中,帕博利珠单抗联合化疗对比单纯化疗的 ICER 分别为 72762.68 美元和 34813.70 美元。
在中国,对于局部晚期或转移性 HER2 阴性 GC/GEJC 患者,一线帕博利珠单抗联合化疗的疗效不如单纯化疗,但在 CPS≥10 亚组中则更为显著。