度伐利尤单抗联合顺铂和多西他赛新辅助治疗局部晚期非小细胞肺癌的疗效评估

Efficacy of durvalumab combined with cisplatin and docetaxel as neoadjuvant therapy in the treatment of locally advanced non-small cell lung cancer patients

目的探索度伐利尤单抗联合顺铂和多西他赛新辅助治疗局部晚期非小细胞肺癌的疗效与安全性。方法本前瞻性、单臂临床研究纳入25例2020年1月至2021年3月局部晚期非小细胞肺癌患者,术前接受度伐利尤单抗联合顺铂和多西他赛新辅助治疗2周期,术后接受度伐利尤单抗单药或联合顺铂和多西他赛辅助治疗。患者出院后,前半年每1~2个月复查1次,之后每3~6个月复查1次。主要观察指标为病理缓解率;次要观察指标为临床应答率、无疾病生存期(disease-free survival,DFS)及总体生存期(overall survival,OS)。结果所有入组患者的平均年龄为(59.84±7.14)岁,其中男性18例(72.00%)、女性7例(28.00%)。主要观察指标结果表明,56%的患者达到显著病理缓解,其中24%实现完全病理缓解。次要观察指标表明,0、60%、36%和4%的患者分别实现临床完全应答、部分应答、疾病稳定和疾病进展,总体客观应答率为60%。患者1年DFS为79%,1年OS为90%。东部肿瘤协作组体力状态评分、TNM分期与DFS及OS均不相关。最常见不良事件为脱发(48%)、疲乏(40%)及恶心呕吐(36%)。其中大部分不良事件为轻度1~2级,少量为3~4级。结论度伐利尤单抗联合顺铂和多西他赛新辅助治疗局部晚期非小细胞肺癌患者具有较好疗效。

Objective To explore the efficacy and safety of durvalumab combined with cisplatin and docetaxel as neoadjuvant therapy in the treatment of locally advanced non-small cell lung cancer(NSCLC)patients.Methods This prospective,single-arm clinical study included twenty-five patients with locally advanced NSCLC from January 2020 to March 2021 who received durvalumab combined with cisplatin and docetaxel neoadjuvant therapy for 2 cycles before surgery.Then they received durvalumab monotherapy or combined with cisplatin and docetaxel adjuvant therapy after surgery.After discharge,patients were followed up every 1 to 2 months for the first six months and every 3 to 6 months thereafter.The primary outcome was pathological remission rate.Secondary outcome measures were clinical response rate,disease-free survival(DFS),and overall survival(OS).Results The mean age of all enrolled patients was(59.84±7.14)years,including 18 males(72.00%)and 7 females(28.00%).The primary outcome indicated that 56% patients achieved significant pathological response,among which 24% achieved complete pathological response.The secondary outcome showed that 0,60%,36% and 4% patients achieved clinical complete response,partial response,disease stability and disease progression,and the overall objective response rate was 60%.The 1-year DFS was 79%,and the 1-year OS was 90%.There was no correlation of Eastern Cooperative Oncology Group performance status and TNM stage with DFS or OS.Besides,The most common adverse events were alopecia(48%),fatigue(40%),nausea and vomiting(36%).Most of the adverse events were at grade 1 to 2,only a few were at grade 3 to 4.Conclusion Durvalumab combined with cisplatin and docetaxel exhibits good efficacy profile as neoadjuvant therapy in locally advanced NSCLC patients.