复发/转移宫颈癌患者应用PD-1抑制剂卡瑞利珠单抗联合阿帕替尼治疗的患者报告结局

Patient-Reported Outcomes of PD-1 Inhibitor Camrelizumab Combined with Antiangiogenic Drug Apatinib in Patients with Advanced Cervical Cancer

【目的】本科室既往一项多中心、单臂Ⅱ期临床研究报道了复发/转移宫颈癌患者接受PD-1抑制剂卡瑞利珠单抗联合抗血管生成药物阿帕替尼治疗后的有效性和安全性。本研究旨在报告该宫颈癌队列的患者报告结局(PRO)的结果。【方法】对纳入本研究的患者以面对面的方式进行问卷宫颈癌量表(FACT-Cx)的填写,评估时间包括用药前(基线)及每两个用药周期1次,直至患者出现疾病进展,未出现疾病进展者问卷收集时间截止至2020年10月12日。【结果】本研究有41例患者至少完成1份FACT-Cx问卷。患者基线、用药后前6周期及治疗6个周期后(范围7-15周期)的生活质量评分分别为114.53±18.23、124.08±15.23和132.82±21.97。结果显示,用药后前6个周期、治疗6个周期后生活质量均显著高于患者的基线生活质量水平(P<0.05)。FACT-Cx问卷的四个维度,包括生理状况维度(如精神状态、肢体疼痛等)、情感状况(如悲伤、紧张程度等)、功能状况(如日常活动能力等)及附加关注(如性功能等),在治疗6个周期后的各维度均分显著高于基线各维度的均分(P<0.05)。但社会/家庭状况维度(如家庭关系等)变化不显著。用药后前6个周期,3~4级不良反应(AEs)发生率为71.11%。而治疗6个周期后,3~4级AEs发生率显著下降至25.0%,其中高血压、疲劳等AEs发生率明显下降。【结论】复发性宫颈癌患者接受卡瑞利珠单抗联合阿帕替尼治疗后,FACT-Cx调查量表在生理状况、情感状况、功能状况及附加关注等多个维度的评分均有升高,生活质量明显提高。并且,生活质量评分在治疗6个周期后较前6个治疗周期仍有升高,提示生活质量改善时间持久。

【Objective】A previous multicenter,single-arm phaseⅡclinical study evaluated the efficacy and safety of the PD-1 inhibitor camrelizumab in combination with the antiangiogenic drug apatinib in patients with recurrent/meta⁃static cervical cancer.In the current study,we aimed to report the patient-reported outcomes(PRO)in patients with ad⁃vanced cervical cancer.【Methods】The researchers filled out quality of life questionnaire FACT-Cx with the patients face-to-face at the baseline and every two treatment cycles.The patients provided the questionnaire until disease progression.For patients who continued the study,the data cutoff date for the questionnaire was Oct12,2020.【Results】In this study,41 patients who received treatment finished at least one FACT-Cx questionnaire.The scores of FACT-Cx questionnaire at baseline,the first 6 cycles,and after 6 cycles of treatment(range,7-15cycle)were 114.53±18.23,124.08±15.23 and 132.82±21.97,respectively.The scores of questionnaire at the first 6 cycle and after 6 cycles of treatment were significant⁃ly increased when compared with those at baseline(P<0.05).With respect to each dimension of the FACT-Cx question⁃naire,physical status(such as mental state,limb pain),emotional status(such as sadness,tension),functional status(such as daily activities)and additional concerns(such as sexual function),the average scores of these dimensions was significantly higher after 6 treatment cycles than those at baseline(P<0.05).Social/family status dimensions(such as fami⁃ly relationships)did not change significantly.In the first 6 cycles,the incidence of grade 3 to 4 adverse events(AEs)was 71.11%.However,the incidence of grade 3 to 4 AEs decreased significantly to 25.0%after 6 treatment cycles,with the frequencies of hypertension and fatigue decreasing significantly.【Conclusions】Camrelizumab combined with apatinib sig⁃nificantly improves the overall quality of life of patients with recurrent/metastatic cervical cancer.The scores of FACT-Cx questionnaire in multiple dimensions,such as physiological status,emotional status,functional status,and the additional status were significantly increased.Moreover,the questionnaire scores still increase after 6 treatment cycles compared with those of the first 6 cycles,indicating that the improvement of quality of life is durable.