目的:分析针对鼻咽癌(NPC)的抗PD-1免疫检查点抑制剂的疗效和不良反应。
方法:在研究的第一阶段,将40例接受抗PD-1免疫检查点抑制剂联合放化疗治疗的III/IVa期NPC患者作为一线治疗(观察组),70例接受单纯放化疗治疗的NPC患者(对照组).在研究的第二阶段,88例使用免疫检查点抑制剂治疗的NPC患者根据免疫疗法的行数进行分组,次数,以及应用程序的类型。
结果:第一阶段近期疗效观察表明,观察组和对照组对鼻咽癌原发灶的客观缓解率(ORR)分别为75.0%和40.0%;观察组的死亡率远低于对照组。一线治疗的总体评价与观察对照组如下:ORR(67.5%vs.38.6%);PFS中位数(17.52vs.17.21个月);和中位OS(18.68vs.18.14个月),分别为(p<0.05)。研究的第二阶段的ORR为53.4%,免疫治疗的疗效与分期有关,定时,和频率。
结论:抗PD-1免疫检查点抑制剂联合放化疗作为鼻咽癌的一线治疗可以显著改善患者的预后。定时,频率,免疫疗法的类型对免疫疗法的疗效有影响。治疗期间发生的不良反应是可以耐受和可控的。
OBJECTIVE: To analyze the efficacy and adverse effects of anti-PD-1 immune checkpoint inhibitors aimed at nasopharyngeal carcinoma (NPC).
METHODS: During the first stage of the study, using 40 patients with stage III/IVa NPC treated with anti-PD-1 immune checkpoint inhibitors in combination with chemoradiotherapy as a first-line treatment (observation group) and 70 patients with NPC treated with chemoradiotherapy alone (control group). In the second stage of the study, 88 patients with NPC treated with immune checkpoint inhibitors were grouped according to the number of lines of immunotherapy, the number of times, and the types of application.
RESULTS: Observation of the short-term effects in the first stage indicated that the objective response rate (ORR) of the observation group and the control group against primary foci of NPC was 75.0% versus 40.0%; the mortality rate of the observation group was much lower than that of the control group. The overall first-line treatment evaluation of the observation vs. control groups were as follows: ORR (67.5% vs. 38.6%); median PFS (17.52 vs. 17.21 months); and median OS (18.68 vs. 18.14 months), respectively (p < 0.05). The second stage of the study had an ORR of 53.4%, and the efficacy of immunotherapy was related to staging, timing, and frequency.
CONCLUSIONS: Anti-PD-1 immune checkpoint inhibitors combined with chemoradiotherapy as the first-line treatment for nasopharyngeal carcinoma may improve patient outcomes significantly. Timing, frequency, and the type of immunotherapy exerted an effect on the efficacy of immunotherapy. Adverse effects that occurred during treatment were tolerable and controllable.