淋巴结转移的局部晚期宫颈癌行PD-1抑制剂联合同步放化疗的疗效及安全性研究

Efficacy and safety of programmed cell death-1 inhibitor combined with concurrent chemoradiotherapy for locally advanced cervical cancer patients with lymph node metastases

目的:探讨程序性细胞死亡受体-1(PD-1)抑制剂联合同步放化疗在淋巴结转移的局部晚期宫颈癌中的疗效及安全性。方法:收集2020年4月至2022年3月59例于湖南省肿瘤医院就诊的FIGO分期(2009年)ⅡB~ⅣA期宫颈癌合并盆腔淋巴结伴或不伴腹主动脉旁淋巴结转移患者的临床病理资料,分为对照组30例和治疗组29例,对照组行适形调强放疗+三维后装放疗±同步顺铂化疗(30~40 mg/m2、1次/周),治疗组在放化疗期间联合PD-1抑制剂卡瑞利珠单抗或信迪利单抗并行免疫维持。观察两组放疗的客观缓解率(objective response rate,ORR)、疾病控制率(disease control rate,DCR)、疾病进展(progressive disease,PD)率、无进展生存(progression-free survival,PFS)率及不良反应发生情况。结果:治疗组ORR(96.6%vs.70.0%)和DCR(96.6%vs.73.3%)均高于照组,两者比较差异均具有统计学意义(均P<0.05)。治疗组PD率低于对照组(3.4%vs.26.7%),两者比较差异具有统计学意义(P=0.014)。治疗组和对照组1年PFS率分别为85.3%和58.0%,两者比较差异具有统计学意义(P=0.009)。结论:PD-1抑制剂联合同步放化疗可提高淋巴结转移的局部晚期宫颈癌患者疗效。

Objective:To determine the efficacy and safety of programmed cell death-1(PD-1)inhibitor combined with concurrent chemoradiotherapy in locally advanced cervical cancer patients with lymph node metastases.Methods:A total of 59 stageⅡB-ⅣA cervical cancer patients with pelvic and/or para-aortic lymph node metastases admitted in Hunan Cancer Hospital from April 2020 to March 2022 were enrolled and assigned into control(30 cases)and treatment(29 cases)groups.Patients in the control group received conformal intensity-modulated radiotherapy plus 3D brachytherapy±cisplatin(30-40 mg/m2,weekly).Patients in the treatment group received chemoradiotherapy plus PD-1 inhibitor camrelizumab or sintilimab,followed by PD-1 inhibitor as maintenance.Objective response rate(ORR),disease control rate(DCR),progression-free survival(PFS),and adverse effect occurrence in both groups were observed.Results:The ORR(96.6%vs.70%)and DCR(96.6%vs.73.3%)in the treatment group were significantly higher than those in the control group,the difference was statistically significant(P<0.05).The rate of progressive disease(PD)in the treatment group was significantly lower than that in the control group(3.4%vs.26.7%),the difference was statistically significant(P=0.014).The one-year PFS rate of the treatment group was significantly higher than that of the control group(85.3%vs.58.0%),the difference was statistically significant(P=0.009).Conclusions:PD-1 inhibitor combined with concurrent chemoradiotherapy improves the outcome of locally advanced cervical cancer patients with lymph node metastases.