背景:自2018年进口PD-1抑制剂pembrolizumab在中国上市以来,中国开启了恶性肿瘤免疫治疗的时代,几种国产PD-1抑制剂陆续上市。了解国产与进口PD-1抑制剂对晚期非小细胞肺癌患者的疗效和安全性是否存在差异,我们在中国的两家三级医院进行了这项回顾性研究.
方法:通过电子病历系统筛选符合纳入标准的接受tislelizumab或camrelizumab或pembrolizumab治疗的晚期NSCLC患者。共筛查259例患者,但是由于基线不平衡,我们进行了倾向评分匹配,最终包括三组149例患者:pembrolizumab(n=38),tislelizumab(n=38),和camrelizumab(n=73),在倾向评分匹配治疗后,每组的基线特征都非常平衡。
结果:结果显示,中位无进展期为11.3mvs10.1mvs8.9m;p=0.754;客观缓解率为63.2%vs50%vs57.5%;pembrolizumab的P=0.510,tislelizumab,和carrelizumab,分别。PD-L1表达亚组之间的中位PFS没有显着差异。在安全方面,任何级别的卡雷珠单抗的皮肤毒性均高于其他两组(p=0.034),且3级以上不良反应发生率在三组间差异无统计学意义。
结论:在这项现实世界的研究中,国产tislelizumab的疗效和安全性,camrelizumab,和进口pembrolizumab具有可比性.
BACKGROUND: Since the imported PD-1 inhibitor
pembrolizumab was listed in China in 2018, China has opened up the era of immunotherapy for malignant tumors, with several domestically produced PD-1 inhibitors coming onto the market one after another. To find out whether there are differences in the efficacy and safety of domestic and imported PD-1 inhibitors in patients with advanced non-small cell lung cancer, we conducted this retrospective study in two tertiary hospitals in China.
METHODS: Patients with advanced NSCLC treated with tislelizumab or camrelizumab or
pembrolizumab who met the inclusion criteria were screened through the electronic medical record system. A total of 259 patients were screened, but due to the unbalanced baseline, we performed propensity score matching and finally included 149 patients in three groups:
pembrolizumab (n = 38), tislelizumab (n = 38), and camrelizumab (n = 73), which had very balanced baseline characteristics in each group after propensity score matching treatment.
RESULTS: The results showed that the median progression-free period was 11.3 m vs 10.1 m vs 8.9 m; p = 0.754; and the objective response rate was 63.2% vs 50% vs 57.5%; P = 0.510 for
pembrolizumab, tislelizumab, and carrelizumab, respectively. There was no significant difference in median PFS between PD-L1 expression subgroups. In terms of safety, only skin toxicity of any grade of carrelizumab was higher than that of the other two groups (p = 0.034), and the incidence of grade ≥ 3 adverse reactions was not statistically significant among the three groups.
CONCLUSIONS: In this real-world study, the efficacy and safety of the domestically produced tislelizumab, camrelizumab, and the imported
pembrolizumab were comparable.