Surgical Outcomes With Neoadjuvant Durvalumab Plus Chemotherapy Followed by Adjuvant Durvalumab in Resectable NSCLC.

Here, we report surgical outcomes from AEGEAN.

在这里，我们报告了AEGEAN研究的手术结果。

Methods

Patients with treatment-naive R-NSCLC (stage II-IIIB [N2]) and Eastern Cooperative Oncology Group performance status 0 or 1 were randomized (1:1) to platinum-based chemotherapy plus durvalumab or placebo intravenously (every 3 wk, 4 cycles) before surgery, followed by durvalumab or placebo (every 4 wk, 12 cycles).

对于治疗前的R-NSCLC（II-IIIB期[N2]）患者，且东部肿瘤协作组表现状态为0或1，按1:1的比例随机分配接受铂类为基础的化疗联合durvalumab或安慰剂静脉注射（每3周一次，共4个周期）术前治疗，随后接受durvalumab或安慰剂（每4周一次，共12个周期）。

Surgical outcomes were summarized for the mITT population using descriptive statistics.

使用描述性统计方法总结了mITT人群的手术结果。

Results

A total of 737 out of 740 mITT patients received treatment, 366 and 371 in the durvalumab and placebo arms, respectively; 80.6% and 80.7% underwent surgery, 77.6% and 76.7% completed surgery, and of the 295 and 302 patients who underwent surgery, 17.3% and 22.2% had delayed surgery.

共有740名mITT患者中有737名接受了治疗，其中durvalumab组和安慰剂组分别有366名和371名患者；80.6%和80.7%的患者接受了手术，77.6%和76.7%的患者完成了手术，而在接受手术的295名和302名患者中，分别有17.3%和22.2%的患者手术延迟。

The median time from last neoadjuvant dose to surgery was 34.0 days in both arms.

从最后一次新辅助治疗剂量到手术的中位时间在两组中均为34.0天。

Of the patients who underwent surgery, similar proportions had open (49.2% versus 50.7%) and minimally invasive (49.2% versus 47.0%) procedures; lobectomy was the most common procedure (88.1% versus 85.4%).

在接受手术的患者中，开放手术（49.2%对比50.7%）和微创手术（49.2%对比47.0%）的比例相似；肺叶切除术是最常见的手术类型（88.1%对比85.4%）。

R0 resection rates were numerically higher in the durvalumab versus placebo arm (94.7% versus 91.3%).

在durvalumab组与安慰剂组中，R0切除率数值上更高（94.7%对比91.3%）。

The median time from surgery to first adjuvant dose was 50.0 versus 52.0 days.

从手术到首次辅助剂量的中位时间是50.0天对比52.0天。

In exploratory analyses, a numerically higher proportion of patients in the durvalumab versus placebo arm with baseline N2 nodal status had downstaging from N2 to N0 (47.3% versus 40.2%) or, with baseline N1 nodal status, from N1 to N0 (53.6% versus 46.2%) after surgery.

在探索性分析中，与安慰剂组相比，基线时N2淋巴结状态的患者在手术后接受durvalumab治疗的患者中，从N2降至N0的比例在数值上更高（47.3%对比40.2%），同样，基线时N1淋巴结状态的患者，在手术后从N1降至N0的比例也更高（53.6%对比46.2%）。

Similar proportions had surgical complication(s) (59.1% versus 60.1%), primarily grade 1 or 2 (53.0% versus 51.8%, modified safety analysis set).

相似比例的患者出现了手术并发症（59.1%对比60.1%），主要是1级或2级（53.0%对比51.8%，改良安全分析集）。

Conclusions

The addition of durvalumab to neoadjuvant chemotherapy had no detrimental effect on the feasibility, approach, type, or timing of surgery and was associated with a tolerable surgical safety profile, versus neoadjuvant chemotherapy alone.

在新辅助化疗中加入durvalumab对手术的可行性、方法、类型或时机没有不良影响，并且与仅使用新辅助化疗相比，手术安全性是可以接受的。

clinical_trial_information

ClinicalTrials.Gov Identifier: NCT03800134.

临床试验注册号：NCT03800134。