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Sotorasib治疗53例中国患者疗效观察

Observations on the Efficacy of Sotorasib Treatment in 53 Chinese Patient

投稿时间：2024-01-18 修订日期：2024-02-28

DOI：

中文关键词: Sotorasib AMG510 KRAS G12C突变中国NSCLC人群

英文关键词:Sotorasib AMG510 KRAS G12C mutation Chinese NSCLC population

基金项目:

作者	单位	邮编
包小云^*	博鳌恒大国际医院	571434

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中文摘要:

[目的] 探讨53例中国非小细胞肺癌（NSCLC）合并KRAS G12C突变患者使用Sotorasib靶向治疗的有效性和安全性。[方法] 回顾性分析2021年9月至2023年6月在海南省博鳌恒大国际医院治疗的53例具有局部进展期或远处转移伴有KRAS G12C突变的NSCLC的患者。口服Sotorasib 960mg每日服用一次至疾病进展或不可耐受，治疗后每1-3个月评价治疗效果。随访至2023年9月，通过客观有效率（ORR）、疾病控制率（DCR）、中位无进展生存期（mPFS）、中位总生存期（mOS）评估有效性，并评估药物的安全性。比较不同性别、年龄及有无骨转移、脑转移、吸烟史、合并STK11突变、合并KEAP1突变、合并TP53突变、PD-L1表达对ORR的影响。[结果] 53例患者中，4例患者因治疗时间＜1月未行疗效评价，49例行疗效评价的患者治疗时间1.0～16.3个月，中位治疗时间为4.7个月，ORR 51.0%，DCR 87.8%，mPFS 6.5个月，mOS 10.7个月。分组分析发现骨转移患者ORR 33.3%，无骨转移患者ORR 64.3%。骨转移患者ORR更低，差异具有统计学意义（Fisher精确检验 P=0.045）。药物不良反应总发生率为17.0 %，分级1-2级9.4%，3-4级7.6%。其中肝功损害9.5%（1-2级5.7%，3-4级3.8%）、发热（3级3.8%）、四肢疼痛和呕吐均为1.9%(1级)。[结论] Sotorasib治疗中国人群NSCLC伴有KRAS G12C 突变的患者是安全的，ORR高于国外人群，mOS和mPFS与国外人群近似。骨转移是该药物疗效的负相关因素。

英文摘要:

[Aim] To investigate the efficacy and safety of Sotorasib targeted therapy in 53 Chinese patients with non-small cell lung cancer (NSCLC) harboring KRAS G12C mutation. [Methods] A retrospective analysis was conducted on 53 patients with locally advanced or metastatic NSCLC harboring KRAS G12C mutation, treated at Boao Evergrande International Hospital in Hainan Province from September 2021 to June 2023. Patients were orally administered Sotorasib at a dose of 960 mg once daily until disease progression or intolerance. Treatment response was assessed every 1-3 months post-treatment. Follow-up was conducted until September 2023. The efficacy was evaluated by objective response rate (ORR), disease control rate (DCR), median progression-free survival (mPFS), and median overall survival (mOS), and the safety of the drug was assessed. The impact of different factors including gender, age, presence of bone metastasis, brain metastasis, smoking history, coexistence of STK11 mutation, KEAP1 mutation, TP53 mutation, and PD-L1 expression on ORR was compared. [Results] Among the 53 patients, 4 patients were not evaluated for treatment response due to treatment duration less than 1 month, and 49 patients underwent treatment response evaluation with treatment duration ranging from 1.0 to 16.3 months and a median treatment duration of 4.7 months. The ORR was 51.0%, DCR was 87.8%, mPFS was 6.5 months, and mOS was 10.7 months. Subgroup analysis showed an ORR of 33.3% in patients with bone metastasis and 64.3% in patients without bone metastasis. The ORR was significantly lower in patients with bone metastasis (p=0.045). The overall incidence of adverse drug reactions was 17.0%, with grades 1-2 accounting for 9.4% and grades 3-4 accounting for 7.6%. Hepatic impairment occurred in 9.5% (grades 1-2: 5.7%, grades 3-4: 3.8%), fever (grade 3: 3.8%), limb pain, and vomiting were all 1.9% (grade 1). [Conclusion] Sotorasib treatment in Chinese NSCLC patients harboring KRAS G12C mutation is safe, with a higher ORR than that reported in foreign populations, and similar mOS and mPFS compared to foreign populations. Bone metastasis is a negative predictor of drug efficacy.

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