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用zolbetuximab联合CAPOX一线治疗Claudin 18.2阳性胃或胃食管交界腺癌:一项成本效益分析。

First-line treatment with zolbetuximab plus CAPOX for ClDN18.2-positive gastric or gastroesophageal junction adenocarcinoma: a cost-effectiveness analysis.

作者信息

Lei Jianying, Zhang Jiahao, You Caicong, Fu Wu, Liu Maobai, Li Na

机构信息

Department of Pharmacy, Fujian Medical University Union Hospital, Fuzhou, China.

The School of Pharmacy, Fujian Medical University, Fuzhou, China.

出版信息

Therap Adv Gastroenterol. 2024 Nov 22;17:17562848241297052. doi: 10.1177/17562848241297052. eCollection 2024.

Abstract

BACKGROUND

Patients with HER2-negative locally advanced or unresectable metastatic gastric cancer and gastroesophageal junction (G/GEJ) adenocarcinoma have limited first-line treatment options and a poor prognosis. The GLOW clinical trial showed that zolbetuximab plus capecitabine plus oxaliplatin (CAPOX) significantly prolonged these patients' overall survival (OS) and progression-free survival (PFS).

OBJECTIVES

This study evaluated the cost-effectiveness of zolbetuximab plus CAPOX as a first-line treatment for HER2-negative locally advanced or unresectable metastatic G/GEJ adenocarcinoma in the United States and China.

DESIGN

The cost-effective analysis.

METHODS

Based on the GLOW clinical trial data (NCT03653507), we constructed a 10-year Markov model to assess the cost-effectiveness of the zolbetuximab or placebo plus CAPOX treatment regimen. Only direct medical costs were considered. The primary outcomes of the model were quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios (ICERs). One-way and probabilistic sensitivity analyses were employed to assess the robustness of the model.

RESULTS

In the United States, zolbetuximab plus CAPOX added 0.24 QALYs and resulted in an incremental cost of $196,791.11 compared with placebo plus CAPOX, which had an ICER of $821,515.65 per QALY gained. For China, the zolbetuximab group gained 0.23 QALYs at an incremental cost of $62,822.69, resulting in an ICER of $273,568.01/QALY. One-way sensitivity analysis revealed that the results were most sensitive to the price of zolbetuximab. Zolbetuximab plus CAPOX had 0% cost-effectiveness at the willingness-to-pay thresholds of $150,000/QALY in the United States and $38,188/QALY in China.

CONCLUSION

Zolbetuximab plus CAPOX may be a cost-effective option for patients with locally advanced, unresectable, or metastatic G/GEJ adenocarcinoma when the price of zolbetuximab reduced by 83.37% ($367.7/100 mg) in the United States and 82.25% ($110.8/100 mg) in China.

摘要

背景

人表皮生长因子受体2(HER2)阴性的局部晚期或不可切除的转移性胃癌及胃食管交界(G/GEJ)腺癌患者的一线治疗选择有限,预后较差。GLOW临床试验表明,zolbetuximab联合卡培他滨加奥沙利铂(CAPOX)显著延长了这些患者的总生存期(OS)和无进展生存期(PFS)。

目的

本研究评估了zolbetuximab联合CAPOX作为HER2阴性局部晚期或不可切除的转移性G/GEJ腺癌一线治疗方案在美国和中国的成本效益。

设计

成本效益分析。

方法

基于GLOW临床试验数据(NCT03653507),构建了一个10年的马尔可夫模型,以评估zolbetuximab或安慰剂联合CAPOX治疗方案的成本效益。仅考虑直接医疗成本。该模型的主要结果是质量调整生命年(QALY)和增量成本效益比(ICER)。采用单向和概率敏感性分析来评估模型的稳健性。

结果

在美国,与安慰剂联合CAPOX相比,zolbetuximab联合CAPOX增加了0.24个QALY,增量成本为196,791.11美元,每获得一个QALY的ICER为821,515.65美元。在中国,zolbetuximab组增加了0.23个QALY,增量成本为62,822.69美元,ICER为273,568.01美元/QALY。单向敏感性分析显示,结果对zolbetuximab的价格最为敏感。在美国,当支付意愿阈值为150,000美元/QALY,在中国为38,188美元/QALY时,zolbetuximab联合CAPOX的成本效益为0%。

结论

当zolbetuximab在美国的价格降低83.37%(367.7美元/100毫克),在中国降低82.25%(110.8美元/100毫克)时,zolbetuximab联合CAPOX对于局部晚期、不可切除或转移性G/GEJ腺癌患者可能是一种具有成本效益的选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b704/11583495/9eb13b0e651a/10.1177_17562848241297052-fig1.jpg

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