卡瑞利珠单抗联合放化疗对复发或转移性宫颈癌疗效及安全性研究

Efficacy and safety of Camrelizumab combined with salvage chemoradiotherapy for patients with postoperative pelvic recurrence or/and para-aotric lymph node metastasis of cervical cancer

目的:观察程序性死亡因子受体-1抑制剂卡瑞利珠单抗联合挽救性放化疗在术后盆腔复发或(和)腹主动脉旁淋巴结转移性宫颈癌疗效及安全性。方法:选取2020年1月至2022年2月中南大学湘雅医学院附属湖南省肿瘤医院妇瘤科收治的40例宫颈癌术后盆腔复发或盆腔放疗后腹主动脉旁淋巴结转移患者,根据意向性治疗方案将患者分为治疗组及观察组,每组各20例。观察组采用常规挽救性放化疗,治疗组在观察组基础上联合卡瑞利珠单抗免疫治疗并进行免疫维持。主要研究终点为无进展生存(PFS),次要研究终点为完全缓解率(CRR)及总生存(OS)。随访截止到2022年6月30日。结果:放化疗结束后3个月评价,治疗组的完全缓解(CR)率(65.00%)明显高于观察组(30.00%)(P<0.05)。治疗组的中位PFS(mPFS)未达到,明显长于观察组(15个月)(P<0.05)。观察组中有6例患者出现进展,主要表现为远处转移,其中5例患者死亡。不良反应主要为反应性皮肤毛细血管内皮增生症(RCCEP)及甲状腺功能异常。未观察到4级不良反应及治疗相关死亡事件的发生。结论:卡瑞利珠单抗联合挽救性放化疗治疗术后盆腔复发或(和)腹主动脉旁淋巴结转移宫颈癌显示出显著的疗效及良好的安全性。可作为此类区域复发性宫颈癌的治疗新的模式。

Objective:To analyze the efficacy and safety of programmed death receptor 1(PD-1)inhibitor Camrelizumab combined with salvage chemoradiotherapy for patients with postoperative pelvic recurrence or/and para-aotric lymph node metastasis of cervical cancer.Methods:A total of 40 patients with postoperative pelvic recurrence of cervical cancer and/or para-aotric lymph node metastasis after pelvic radiotherapy from January 2020 to February 2022 were selected as the study objects.According to the intentional treatment plan,they were divided into treatment group and observation group(20 cases in each group).The observation group received conventional salvage chemoradiotherapy,while the treatment group received Camrelizumab combined with salvage chemoradiotherapy.The primary endpoints were progression-free survival(PFS),and the secondary endpoints were complete response rate(CRR)and overall survival(OS).The last follow-up was conducted on June 30,2022.Results:Three months after the end of treatment,the CR rate of the treatment group was higher than that of the observation group(65%vs 30%,P<0.05).The median progression-free survival(mPFS)in the treatment group was not achieved,which was significantly longer than the median PFS in the observation group by 15 months(P<0.05).Six patients in the observation group progressed,mainly with distant metastases.Five of the patients died.The main adverse reactions were Reactive cutaneous capillary endothelial proliferation(RCCEP)and thyroid dysfunction.No grade 4 adverse events and treatment-related deaths were observed.Conclusions:Carerizumab combined with salvage chemoradiotherapy in the treatment of postoperative pelvic recurrence or/and para-aotric lymph node metastatic cervical cancer shows significant efficacy and good safety.It may be used as a new treatment model for locoregionally recurrent cervical cancer.