为了评估 sotorasib 单药治疗与多西紫杉醇作为单药治疗或联合治疗在现实世界中对经治疗的 KRAS G12C 突变晚期 NSCLC 患者的比较疗效。本研究使用了美国电子健康记录衍生的去识别化数据库。纳入已接受过治疗的 KRAS G12C 突变晚期 NSCLC 患者，这些患者在 2021 年 5 月 28 日至 2022 年 9 月 30 日期间开始使用 sotorasib，并在 2019 年 1 月 1 日至 2022 年 9 月 30 日期间开始使用多西他赛（以增加样本量），其中至少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。 2L 和 2L 设置中的中位 OS 是使用 Kaplan-Meier 估计值计算的。通过Cox比例风险模型估计风险比（HR）。总体而言，索托拉西和多西他赛队列的临床特征在倾向评分加权后得到平衡。基线时，大多数患者年龄 > 65 岁，ECOG 体能状态为 0-1，来自社区实践环境，初次诊断时已处于晚期阶段，并且之前接受过抗 PD-(L)1 治疗和/或以铂类为基础的化疗。在 2L 治疗中，索托拉西 (N=102) 和多西他赛 (N=58) 患者的中位 OS (95% CI) 分别为 10.2 (7.6-16.3) 和 6.0 (4.2-11.0) 个月，死亡率相应较高HR (95% CI) 为 0.62 (0.41-0.93)。在 2L 治疗中，索托拉西 (N=164) 和多西他赛 (N=116) 的中位 OS (95% CI) 分别为 10.2 (8.0-14.6) 和 7.2 (5.1-10.6) 个月，相应的死亡率 HR (95% CI) 为 0.65 (0.49-0.87)。在既往接受过抗 PD-(L)1 治疗的患者中，在 2L 和 2L 设置中，索托拉西组与多西他赛组的死亡率 HR (95% CI) 分别为 0.61 (0.39-0.94) 和 0.65 (0.48-0.89) 。其他亚组的结果与主要分析一致。在这项对预先治疗的 KRAS G12C 突变晚期 NSCLC 患者的现实世界比较分析中，与多西他赛单药治疗或联合治疗相比，sotorasib 单药治疗显示出更长的中位 OS。版权所有 © 2024 Elsevier B.V. All保留权利。

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.Copyright © 2024 Elsevier B.V. All rights reserved.