肿瘤电场治疗仪治疗复发脑胶质母细胞瘤的前瞻性单中心单臂探索性研究

Application of a tumor electric field treatment system in patients with recurrent glioblastoma:results from a prospective,single-center,single-arm pilot study

目的:评价肿瘤电场治疗仪用于治疗复发胶质母细胞瘤患者的初步安全性和有效性。方法:选取2020年4月至2020年8月期间中南大学湘雅医院和解放军总医院6例受试者,均为男性,中位年龄53(48~68)岁。入组复发胶质母细胞瘤受试者并收集临床资料,通过观察受试者治疗期间不良事件的发生率、肿瘤进展时间(time to progression,TTP)和总生存时间(overall survival,OS)评估治疗的安全性和有效性。结果:入组6例受试者中位随访时间10.9(8.4~22.7)个月,所有受试者发生肿瘤进展,5例随访至死亡,截至随访截止1例生存。中位肿瘤进展时间(median time to progression,m TTP)为4.7个月(95%CI:3.62~5.78),中位无进展生存时间(median progression-free survival,mPFS)为4.7个月(95%CI:3.62~5.78),中位总生存时间(median overall survival,mOS)为10.9个月(95%CI:8.86~12.94)。客观缓解率(CR+PR)33.3%;疾病控制率(SD+PR+CR)83.3%。治疗相关的不良事件主要为头皮皮疹,发生率为66.7%,经调整电极片黏贴位置、保持创口干燥、涂抹类固醇类软膏或抗生素软膏后均可有效缓解。结论:肿瘤电场治疗仪用于治疗复发胶质母细胞瘤的受试者在电场治疗过程中呈现良好的初步安全性和有效性。

Objective:To evaluate preliminary safety and effectiveness of a tumor electric field treatment system in patients with recurrent glioblastoma.Methods:In total,six patients were enrolled from April 2020 to August 2020 in Xiangya Hospital and Chinese PLA General Hospital.The median age was 53(48-68)years.Patients with recurrent glioblastoma were enrolled,and their clinical data were collected.The safety and effectiveness of the treatment system were evaluated by assessing the incidence of adverse events,time to progression(TTP),and overall survival(OS).Results:In total,the median follow-up time was 10.9(8.4-22.7)months.Progressive disease was observed in all patients,five patients were followed up to death,and one patient is still alive.The median time to tumor progression(mTTP)was 4.7 months(95%CI:3.62-5.78),median progression-free survival(mPFS)was 4.7 months(95%CI:3.62-5.78),and median OS was 10.9 months(95%CI:8.86-12.94).The objective response rate(CR+PR)was 33.3%;the disease control rate(SD+PR+CR)was 83.3%.The most common treatmentrelated adverse event was scalp rash,with an incidence rate of 66.7%,which could be effectively relieved by adjusting the sticking position of the transducer arrays,keeping the wound dry,and applying steroid or antibiotic ointment.Conclusions:This study showed the preliminary safety and effectiveness of tumor electric field therapy in patients with recurrent glioblastoma.