首页|奥希替尼联合赛沃替尼二线治疗EGFR-TKI治疗期间T790M突变的转移性NSCLC的临床疗效

奥希替尼联合赛沃替尼二线治疗EGFR-TKI治疗期间T790M突变的转移性NSCLC的临床疗效

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目的 探讨奥希替尼联合赛沃替尼二线治疗表皮生长因子受体-酪氨酸激酶抑制剂(EGFR-TKI)治疗期间T790M突变的转移性非小细胞肺癌(NSCLC)的效果及安全性。方法 选取2021年1月至2022年1月安康市人民医院接收的EGFR-TKI治疗期间T790M突变的转移性NSCLC患者94例。采用随机数字表法将患者分为研究组(47例)和对照组(47例)。治疗期间研究组失访7例,最终入组40例;对照组失访9例,最终入组38例。对照组男24例,女14例;年龄(60。32±5。71)岁;体重指数(BMI)(18。06±1。61)kg/m2;采用奥希替尼治疗。研究组男27例,女13例;年龄(61。05±6。64)岁;BMI(18。13±1。54)kg/m2;在对照组基础上,采用赛沃替尼治疗。治疗3个月后,比较两组的疗效和不良反应;比较两组治疗前后的血清癌胚抗原(CEA)、细胞角质蛋白19片段抗原21-1(CYFRA21-1)、血管内皮生长因子(VEGF)、基质金属蛋白酶-9(MMP-9)水平。治疗后随访2年,记录两组的中位无进展生存期(PFS)和中位总生存期(OS)。采用独立样本t检验、配对t检验、x2检验、Kaplan-Meier分析、Log-rank检验。结果 治疗后,研究组 CEA[(65。30±14。29)μg/L]、CYFRA21-1[(1。62±0。69)μg/L]、VEGF[(381。04±27。64)ng/L]、MMP-9[(151。98±25。47)μg/L]水平均低于对照组[(73。59±16。03)μg/L、(2。57±0。76)μg/L、(396。61±26。51)ng/L、(169。07±26。54)μg/L],差异均有统计学意义(均 P<0。05)。研究组的疾病控制率[85。00%(34/40)]、客观缓解率[62。50%(25/40)]均高于对照组[65。79%(25/38)、39。47%(15/38)],差异均有统计学意义(均P<0。05)。两组药物不良反应总发生率比较,差异无统计学意义(P>0。05)。两组PFS、OS比较,差异均有统计学意义(均P<0。05)。结论 奥希替尼联合赛沃替尼二线治疗EGFR-TKI治疗期间T790M突变的转移性NSCLC,有助于提高疾病控制率,延长患者的生存期,且安全性良好。
Clinical efficacy of Osimertinib combined with Savolitinib as second-line therapy for T790M mutation-positive metastatic NSCLC during EGFR-TKI treatment
Objective To investigate the efficacy and safety of Osimertinib combined with Savolitinib as second-line therapy for T790M mutation-positive metastatic non-small cell lung cancer(NSCLC)during treatment with epidermal growth factor receptor-tyrosine kinase inhibitor(EGFR-TKI).Methods A total of 94 patients with metastatic NSCLC with T790M mutation during EGFR-TKI treatment in Ankang People's Hospital from January 2021 to January 2022 were selected.The patients were divided into a study group(47 cases)and a control group(47 cases)by the random number table method.During the treatment period,7 cases were lost to follow-up and 40 cases were enrolled in the study group.In the control group,9 cases were lost to follow-up,and 38 cases were enrolled.In the control group,there were 24 males and 14 females,aged(60.32±5.71)years,with a body mass index(BMI)of(18.06±1.61)kg/m2.There were 27 males and 13 females in the study group,aged(61.05±6.64)years,with a BMI of(18.13±1.54)kg/m2.The control group was treated with Osimertinib,and the study group was treated with Savolitinib on the basis of the control group.After 3 months of treatment,the efficacy and adverse reactions of the two groups were compared.The serum levels of carcinoembryonic antigen(CEA),cytokeratin 19 fragment antigen 21-1(CYFRA21-1),vascular endothelial growth factor(VEGF),and matrix metalloproteinase-9(MMP-9)were compared between the two groups before and after treatment.The median progression-free survival(PFS)and median overall survival(OS)were recorded after 2 years of follow-up.Independent sample t test,paired t test,x2 test,Kaplan-Meier analysis,and Log-rank test were used.Results After treatment,the levels of CEA[(65.30±14.29)μg/L],CYFRA21-1[(1.62±0.69)μg/L],VEGF[(381.04±27.64)ng/L],and MMP-9[(151.98±25.47)μg/L]in the study group were lower than those in the control group[(73.59±16.03)μg/L,(2.57±0.76)μg/L,(396.61±26.51)ng/L,and(169.07±26.54)μg/L],with statistically significant differences(all P<0.05).The disease control rate[85.00%(34/40)]and objective response rate[62.50%(25/40)]of the study group were higher than those of the control group[65.79%(25/38)and 39.47%(15/38)],with statistically significant differences(both P<0.05).There was no statistically significant difference in the total incidence of adverse drug reactions between the two groups(P>0.05).There were statistically significant differences in the PFS and OS between the two groups(both P<0.05).Conclusion Osimertinib combined with Savolitinib as second-line therapy for metastatic NSCLC with T790M mutation during EGFR-TKI treatment helps to improve the disease control rate and prolong the patients'survival,with good safety.

Metastatic non-small cell lung cancerEpidermal growth factor receptor-tyrosine kinase inhibitorT790M mutationOsimertinibSavolitinib

汪定军、石蕾、张娟

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安康市人民医院呼吸内科,安康 725000

安康市人民医院肿瘤内科,安康 725000

安康市中心血站业务管理科,安康 725000

转移性非小细胞肺癌 表皮生长因子受体-酪氨酸激酶抑制剂 T790M突变 奥希替尼 赛沃替尼

陕西省重点研发计划

2021SF-034

2024

国际医药卫生导报
中华医学会,国际医药卫生导报社

国际医药卫生导报

影响因子:0.781
ISSN:1007-1245
年,卷(期):2024.30(16)