多斯塔利单抗和真实世界治疗在铂后晚期/复发子宫内膜癌患者中的结果:GARNET试验与基于美国电子健康记录的外部控制臂

IF 2.3 Q2 ECONOMICS
Scott Goulden, Qin Shen, Robert Coleman, Cara Mathews, Matthias Hunger, Ankit Pahwa, Rene Schade
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引用次数: 0

摘要

背景:晚期或复发子宫内膜癌(EC)患者在铂基化疗后治疗选择有限,预后较差。单臂I期GARNET试验(NCT02715284)先前报道了dostarlimumab对错配修复缺陷/微卫星不稳定性-高度晚期或复发性EC的疗效。目的:本研究的目的是比较dostarlimumab (GARNET A1队列安全人群)与接受非抗程序性死亡(PD)-1/PD配体(L)1/2治疗的等效现实世界外部对照组的总生存期(OS)和描述治疗停止时间(TTD)(使用来自全国电子健康记录衍生的去识别数据库的数据构建,并应用GARNET资格标准)。方法:根据文献回顾和临床专家确定的预后因素构建倾向评分,用于治疗加权逆概率(IPTW)。构建Kaplan-Meier曲线,估计OS/TTD(采用Cox回归模型估计OS校正后的风险比)。结果:与现实治疗相比,dostarlimumab与52%的死亡风险降低相关(风险比,0.48;95%可信区间[CI], 0.35-0.66)。dostarlimumab经iptws调整后的中位OS (N=143)不可估计(95% CI, 19.4 -不可估计),而现实世界治疗(N= 185)的中位OS为13.1个月(95% CI, 8.3-15.9)。dostarlimumab组的中位TTD为11.7个月(95% CI, 6.0-38.7),真实队列组的中位TTD为5.3个月(95% CI, 4.1-6.0)。讨论:与先前的分析一致,在使用稳定IPTW调整缺乏随机化后,接受dostarlimab治疗的患者的生存期明显长于美国现实世界队列中的患者。此外,患者在接受多司达单抗治疗时,TTD时间较长,这表明患者具有良好的耐受性。结论:晚期或复发性EC患者在GARNET中接受dostarlimumab治疗的死亡风险明显低于接受现实世界非抗pd -(L)1/2治疗的患者。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Outcomes for Dostarlimab and Real-World Treatments in Post-platinum Patients With Advanced/Recurrent Endometrial Cancer: The GARNET Trial Versus a US Electronic Health Record-Based External Control Arm
Background: Patients with advanced or recurrent endometrial cancer (EC) have limited treatment options following platinum-based chemotherapy and poor prognosis. The single-arm, Phase I GARNET trial (NCT02715284) previously reported dostarlimab efficacy in mismatch repair–deficient/microsatellite instability–high advanced or recurrent EC. Objectives: The objective of this study was to compare overall survival (OS) and describe time to treatment discontinuation (TTD) for dostarlimab (GARNET Cohort A1 safety population) with an equivalent real-world external control arm receiving non-anti-programmed death (PD)-1/PD-ligand (L)1/2 treatments (constructed using data from a nationwide electronic health record–derived de-identified database and applied GARNET eligibility criteria). Methods: Propensity scores constructed from prognostic factors, identified by literature review and clinical experts, were used for inverse probability of treatment weighting (IPTW). Kaplan-Meier curves were constructed and OS/TTD was estimated (Cox regression model was used to estimate the OS-adjusted hazard ratio). Results: Dostarlimab was associated with a 52% lower risk of death vs real-world treatments (hazard ratio, 0.48; 95% confidence interval [CI], 0.35-0.66). IPTW-adjusted median OS for dostarlimab (N=143) was not estimable (95% CI, 19.4–not estimable) versus 13.1 months (95% CI, 8.3-15.9) for real-world treatments (N = 185). Median TTD was 11.7 months (95% CI, 6.0-38.7) for dostarlimab and 5.3 months (95% CI, 4.1-6.0) for the real-world cohort. Discussion: Consistent with previous analyses, patients treated with dostarlimab had significantly longer OS than patients in the US real-world cohort after adjusting for the lack of randomization using stabilized IPTW. Additionally, patients had a long TTD when treated with dostarlimab, suggesting a favorable tolerability profile. Conclusion: Patients with advanced or recurrent EC receiving dostarlimab in GARNET had significantly lower risk of death than those receiving real-world non-anti-PD-(L)1/2 treatments.
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CiteScore
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