索托拉西比与多西他赛在第二线和超越多年非小细胞肺癌（NSCLC）患者中的现实比较有效性（NSCLC）
Real-world comparative effectiveness of sotorasib versus docetaxel in second line and beyond among patients with advanced non-small cell lung cancer (NSCLC)
影响因子:4.40000
分区:医学2区 / 肿瘤学3区 呼吸系统3区
发表日期:2024 Nov
作者:
Melissa Johnson, Diana Younan, Shia T Kent, Marco Mesa-Frias, M Alan Brookhart, Akhila Balasubramanian, Alexander Spira
摘要
为了评估在现实世界中使用经过预处理的KRAS G12C氧化剂的高级NSCLC患者的单药治疗或联合疗法的比较有效性，在这项研究中使用了基于美国的电子健康记录的De-nisidified数据库。在5月28日，2021年至2022年9月30日之间启动Sotorasib的KRAS G12C熔化的高级NSCLC的患者，以及2022年1月1日至9月30日（增强样本量）之间的索托拉西比，并在2019年1月1日至9月30日之间进行了研究，最少有12个月的随访机会。通过重叠加权倾向评分方法平衡治疗组。使用Kaplan-Meier估计值计算2L和2L+设置中的中位OS。危险比（HRS）是通过COX比例危害模型估算的。术语后，Sotorasib和Docetaxel队列的临床特征在倾向评分加权后平衡。在基线时，大多数患者年龄在65岁以上，ECOG性能状态为0-1，来自社区实践环境，在初始诊断时具有先进的阶段，并且先前进行了抗PD-（L）1治疗和/或基于铂金的化学疗法。在2L设置中，Sotorasib（n = 102）和多西他赛（n = 58）患者的OS（95％CI）分别为10.2（7.6-16.3）和6.0（4.2-11.0）月，分别为0.62（95％CI），为0.62（0.41-0.93）。在2L+设置中，Sotorasib（n = 164）和Docetaxel（n = 116）的中值OS（95％CI）分别为10.2（8.0-14.6）和7.2（5.1-10.6）月，分别为0.65（0.49-0.87）。在先前抗PD-（L）1治疗的患者中，Sotorasib组与多西他赛的死亡率HR（95％CI）分别为0.61（0.39-0.94）和0.65（0.48-0.89），分别为2L和2L+设置。来自其他亚组的发现与主要分析相一致。在现实世界中对经过预处理的KRAS G12C熔化晚期NSCLC患者的比较分析，Sotorasib单一疗法与多西他单一疗法或联合治疗相比表现出更长的中位OS。
Abstract
To evaluate the comparative effectiveness of sotorasib monotherapy versus docetaxel as monotherapy or combination therapy in patients with pretreated KRAS G12C-mutated advanced NSCLC in the real-world.A US-based electronic health record-derived de-identified database was used in this study. Patients with pretreated KRAS G12C-mutated advanced NSCLC who initiated sotorasib between May 28, 2021, and September 30, 2022, and docetaxel between January 1, 2019, and September 30, 2022 (to enhance sample size), were included, with a minimum of 12-month opportunity for follow-up. Treatment groups were balanced via overlap weighting propensity score methods. Median OS in the 2L and 2L+ settings were calculated using Kaplan-Meier estimates. Hazard ratios (HRs) were estimated via Cox proportional hazard models.Overall, the clinical characteristics in sotorasib and docetaxel cohorts were balanced after propensity score weighting. At baseline, most patients were > 65 years of age, had ECOG performance status of 0-1, were from the community practice setting, had advanced stage at initial diagnosis, and had prior anti-PD-(L)1 treatment and/or platinum-based chemotherapy. In the 2L setting, the median OS (95 % CI) for sotorasib (N=102) and docetaxel (N=58) patients was 10.2 (7.6-16.3) and 6.0 (4.2-11.0) months, respectively, with a corresponding mortality HR (95 % CI) of 0.62 (0.41-0.93). In the 2L+ setting, the median OS (95 % CI) for sotorasib (N=164) and docetaxel (N=116) was 10.2 (8.0-14.6) and 7.2 (5.1-10.6) months, respectively, with a corresponding mortality HR (95 % CI) of 0.65 (0.49-0.87). In patients with prior anti-PD-(L)1 treatment, the mortality HR (95 % CI) in the sotorasib group versus docetaxel was 0.61 (0.39-0.94) and 0.65 (0.48-0.89) in the 2L and 2L+ settings, respectively. Findings from other subgroups were consistent with the primary analyses.In this real-world comparative analysis of patients with pretreated KRAS G12C-mutated advanced NSCLC, sotorasib monotherapy demonstrated a longer median OS compared to docetaxel monotherapy or combination therapy.