度伐利尤单抗联合化疗作为局部晚期非小细胞肺癌患者新辅助治疗方案的疗效与安全性

Efficacy and safety of durvalumab plus chemotherapy as neoadjuvant regimen in the treatment of locally advanced non-small cell lung cancer patients

目的评估度伐利尤单抗联合化疗作为局部晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)患者新辅助治疗方案的疗效与安全性。方法纳入38例可手术局部晚期NSCLC患者,接受度伐利尤单抗联合紫杉醇/卡铂两周期新辅助治疗,后行手术切除。术后恢复后行度伐利尤单抗单药或联合紫杉醇/卡铂辅助治疗至少两周期或以上,记录临床应答率、病理应答率、无疾病生存期(disease-free survival,DFS)、总体生存期(overall survival,OS)和不良事件。结果新辅助治疗后,患者临床完全应答、部分应答、疾病稳定和疾病进展占比分别为0.00%、65.78%、31.58%和2.63%,临床客观应答率为65.78%。显著病理缓解和完全病理缓解分别为57.89%和23.68%。截至最后随访日期,3名患者(7.89%)疾病复发,2名(5.26%)死亡。平均DFS为15.4个月(95%CI:14.4~16.3个月),平均OS为15.8个月(95%CI:15.1~16.5个月)。最常见不良事件为脱发(47.37%)、恶心呕吐(42.11%)、疲乏(39.47%)、贫血(34.21%)、中性粒细胞减少(28.95%)、白细胞减少(21.05%)和便秘(21.05%)。绝大部分不良事件均是1~2级,仅有少量3~4级。结论度伐利尤单抗联合化疗新辅助治疗局部晚期NSCLC患者可实现较高的病理应答率及生存获益,并且耐受性较好。

Objective To evaluate the efficacy and safety of durvalumab combined with chemotherapy as neoadjuvant therapy for patients with locally advanced non-small cell lung cancer(NSCLC).Methods Thirty-eight patients with operable locally advanced NSCLC were enrolled and received two cycles of neoadjuvant therapy with durvalumab combined with paclitaxel/carboplatin,followed by surgical resection.After postoperative recovery,durvalumab alone or in combination with paclitaxel/carboplatin were administered as adjuvant therapy for at least two cycles.Clinical response rate,pathological response rate,disease-free survival(DFS),overall survival(OS)and adverse events were assessed.Results After neoadjuvant therapy,the proportions of clinical complete response,partial response,stable disease and disease progression were 0.00%,65.78%,31.58%and 2.63%,respectively.The objective response rate(ORR)was 65.78%.Significant pathological response and complete pathological response were 57.89%and 23.68%,respectively.Up to the last follow-up date,three patients(7.89%)relapsed and two patients(5.26%)died.The mean DFS was 15.4 months(95%CI:14.4-16.3 months),and the mean OS was 15.8 months(95%CI:15.1-16.5 months).The most common adverse events were alopecia(47.37%),nausea and vomiting(42.11%),fatigue(39.47%),anemia(34.21%),neutropenia(28.95%),leukopenia(21.05%)and constipation(21.05%).Most of the adverse events were grade 1-2,and only a few were grade 3-4.Conclusion Durvalumab combined with neoadjuvant chemotherapy can achieve a higher pathological response rate and survival benefit in patients with locally advanced NSCLC,and is well tolerated.