摘要
[目的]评估非小细胞肺癌(non-small cell lung cancer,NSCLC)合并Kirsten大鼠肉瘤病毒癌基因同源物12号外显子甘氨酸突变为半胱氨酸(Kirsten rat sarcoma viral oncogene exon 12 glycine mutation to cysteine,KRAS G12C)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月在博鳌恒大国际医院治疗的53例局部进展期或远处转移伴有KRAS G12C突变的NSCLC患者临床资料。Sotorasib 960 mg每日1次口服,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,通过客观缓解率(objective response rate,ORR)、疾病控制率(disease control rate,DCR)、中位无进展生存期、中位总生存期评估有效性,并评估药物的安全性。分析不同性别、年龄、骨转移、脑转移、吸烟史、合并丝氨酸/苏氨酸激酶11突变、合并Kelch样ECH关联蛋白1突变、合并肿瘤蛋白53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个月未行疗效评价,49例可评价疗效的患者治疗时间1.0~16.3个月,中位治疗时间为4.7个月,ORR为51.0%,DCR为87.8%,中位无进展生存期为6.5个月,中位总生存期为10.7个月。亚组分析发现,骨转移患者ORR为33.3%,无骨转移患者ORR为64.3%(χ2=4.601,P=0.032)。药物不良反应总发生率为17.0%,1~2级不良反应发生率为9.4%,3~4级不良反应发生率为7.6%。其中肝功损害发生率为9.5%(1~2级为5.7%,3~4级为3.8%),发热(3级)3.8%,四肢疼痛和呕吐(1级)均为1.9%。[结论]Sotorasib治疗NSCLC伴有KRAS G12C突变的患者是安全的。与文献报道相比,ORR较高,中位无进展生存期和中位总生存期近似。骨转移是该药物疗效的负相关因素。
[Objective]To investigate the efficacy and safety of Sotorasib targeted therapy for non-small cell lung cancer(NSCLC)with KRAS G12C mutation.[Methods]Clinical data of 53 with locally advanced or metastatic NSCLC harboring KRAS G12C mutation admitted at Boao Evergrande International Hospital from September 2021 to June 2023 were retrospectively analyzed.Patients were orally administered Sotora-sib at a dose of 960 mg q.d,until disease progression or intolerance.All patients were followed up until September 2023,the treatment response was assessed every 1~3 months after treatment.The efficacy was evaluated with indicators of objective response rate(ORR),disease control rate(DCR),median progression-free survival(mPFS),and median overall survival(mOS),and the drug safety was also assessed.The im-pact of gender,age,bone metastasis,brain metastasis,smoking history,serine/threonine kinase muta-tion,Kelch-like ECH-associated protein 1 mutation,tumor protein 53 mutation,and PD-L1 expression on ORR was analyzed.[Results]Among the 53 patients,49 patients who received treatment for 1.0 to 16.3 month with a median of 4.7 months,were included in the analysis.The ORR was 51.0%,DCR was 87.8%,mPFS was 6.5 months,and mOS was 10.7 months.Subgroup analysis showed that ORR of patients with bone metastasis was 33.3%and that was 64.3%for those without bone metastasis(χ2=4.601,P=0.045).The overall incidence of adverse reaction was 17.0%,with grades 1~2 accounting for 9.4%and grades 3~4 accounting for 7.6%.The incidence of hepatic impairment was 9.5%,fever(grade 3)was 3.8%,limb pain and vomiting(grade 1)were all 1.9%.[Conclusion]Sotorasib treatment for NSCLC patients harboringKRAS G12C mutation is safe.The ORR was higher than that reported in literature,and the mOS and mPFS were comparable.Bone metastasis is a negative predictor of drug efficacy.
作者
包小云
吕庄
栾天燕
高苗苗
BAO Xiaoyun;LV Zhuang;LUAN Tianyan;GAO Miaomiao(Boao Evergrande International Hospital,Qionghai 571434,China;Branch of the First Affiliated Hospital of Xinjiang Medical University,Changji 831100,China)
出处
《肿瘤学杂志》
CAS
2024年第9期733-737,共5页
Journal of Chinese Oncology
