奥希替尼联合替雷利珠单抗治疗晚期非小细胞肺癌效果及患者生存情况

Efficacy of osimertinib combined with tislelizumab in treatment of advanced non-small cell lung cancer and the survival status of patients

目的探讨奥希替尼联合替雷利珠单抗治疗晚期非小细胞肺癌(NSCLC)的临床效果及患者生存情况。方法前瞻性选择南京鼓楼医院集团宿迁医院2019年2月至2022年1月晚期NSCLC患者108例,采用随机数字表法分为奥希替尼联合替雷利珠单抗治疗组(研究组)和奥希替尼治疗组(对照组),每组54例。3周为1个周期,两组均治疗3个周期后观察疗效。对比两组临床疗效、肿瘤标志物水平、免疫功能、不良反应;随访1年,采用Kaplan-Meier法分析两组总生存(OS)和无进展生存(PFS),比较采用log-rank检验。结果治疗3个周期后,研究组疾病控制率比对照组高[81.48%(44/54)比59.26%(32/54),χ^(2)=6.40,P=0.011],研究组客观缓解率比对照组高[57.41%(31/54)比37.04%(20/54),χ^(2)=4.50,P=0.034]。治疗前,两组间细胞角蛋白19片段抗原21-1(CYFRA21-1)、鳞状细胞癌抗原(SCC-Ag)、组织多肽抗原(TPA)水平差异均无统计学意义(均P>0.05),治疗后两组均较治疗前降低(均P<0.05),且研究组较对照组更低(均P<0.05)。治疗前,两组CD3+T细胞、CD4+T细胞、CD8+T细胞比例差异均无统计学意义(均P>0.05),治疗后两组CD3+T细胞、CD4+T细胞比例均较治疗前升高(均P<0.05),且研究组较对照组更高(均P<0.001),治疗后两组CD8+T细胞比例均较治疗前降低(P<0.05),且研究组较对照组更低(P<0.001)。两组中性粒细胞减少、白细胞减少、免疫相关性肺炎、肝功能损害发生率差异均无统计学意义(均P>0.05)。随访1年,研究组失访1例,对照组失访2例,随访率为97.22%(105/108);研究组死亡9例,OS率为83.02%,对照组死亡20例,OS率为61.54%。研究组OS、PFS均优于对照组[中位OS时间:11个月(95%CI 6~11个月)比8个月(95%CI 3~11个月),χ^(2)=12.32,P<0.001;中位PFS时间:9个月(95%CI 4~11个月)比5个月(95%CI 4~11个月),χ^(2)=6.84,P<0.001]。结论奥希替尼联合替雷利珠单抗可降低晚期NSCLC患者肿瘤标志物水平,改善患者免疫功能,近期疗效良好,未增加不良反应,且可使患者生存获益。

ObjectiveTo investigate the clinical efficacy of osimertinib combined with tislelizumab in the treatment of advanced non-small cell lung cancer(NSCLC)and the survival status of patients.MethodsA total of 108 patients with advanced NSCLC in Suqian Hospital of Nanjing Drum Tower Hospital Group from February 2019 to January 2022 were prospectively selected,and they were divided into osimertinib combined with tislelizumab treatment group(study group)and osimertinib treatment group(control group)by random number table method,with 54 cases in each group.Three weeks were 1 cycle.The curative effect was observed after 3 cycles of treatment in both groups.The clinical efficacy,levels of tumor markers,immune function and adverse reactions were compared between the two groups.After 1 year of follow-up,the overall survival(OS)and progression-free survival(PFS)of the two groups were analyzed by Kaplan-Meier method and compared by log-rank test.ResultsAfter 3 cycles of treatment,the disease control rate of the study group was higher than that of the control group[81.48%(44/54)vs.59.26%(32/54),χ^(2)=6.40,P=0.011],and the objective remission rate of the study group was higher than that of the control group[57.41%(31/54)vs.37.04%(20/54),χ^(2)=4.50,P=0.034].Before treatment,the differences in the levels of cytokeratin 19 fragment antigen 21-1(CYFRA21-1),squamous cell carcinoma antigen(SCC-Ag)and tissue polypeptide antigen(TPA)between the two groups were not statistically significant(all P>0.05),and after treatment,the levels of tumor markers were lower than those before treatment in both groups(all P<0.05),and they were lower in the study group than those in the control group(all P<0.05).Before treatment,there were no statistically significant differences in the proportions of CD3+T cells,CD4+T cells and CD8+T cells between the two groups(all P>0.05),and after treatment,the proportions of CD3+T cells and CD4+T cells were higher than those before treatment in both groups(both P<0.05),and they were higher in the study group than those in the control group(both P<0.001),and the proportion of CD8+T cells before treatment in both groups was lower than that after treatment(P<0.05),and it was lower in the study group than that in the control group(P<0.001).The differences in the incidence of neutropenia,leukopenia,immune-associated pneumonia,and liver function injury between the two groups were not statistically significant(all P>0.05).At 1 year of follow-up,there was 1 case of loss of follow-up in the study group and 2 cases of loss of follow-up in the control group,with a follow-up rate of 97.22%(105/108);there were 9 deaths in the study group with an OS rate of 83.02%and 20 deaths in the control group with an OS rate of 61.54%.OS and PFS in the study group were better than those in the control group[median OS time:11 months(95%CI 6-11 months)vs.8 months(95%CI 3-11 months),χ^(2)=12.32,P<0.001;median PFS time:9 months(95%CI 4-11 months)vs.5 months(95%CI 4-11 months),χ^(2)=6.84,P<0.001].ConclusionsOsimertinib combined with tislelizumab can reduce the level of tumor markers and improve immune function in patients with advanced NSCLC with good short-term efficacy,and it doesn't increase the adverse effects and can result in a survival benefit.