Abstract：
UNASSIGNED: Optimal treatment for stage IIIA/N2 non-small cell lung cancer (NSCLC) is controversial. We aimed to assess the efficacy and safety of adjuvant pembrolizumab for stage IIIA/N2 NSCLC completely resected after neoadjuvant concurrent chemoradiation therapy (CCRT).
UNASSIGNED: In this open-label, single-center, single-arm phase 2 trial, patients with stage IIIA/N2 NSCLC received adjuvant pembrolizumab for up to two years after complete resection following neoadjuvant CCRT. The primary endpoint was disease-free survival (DFS). Secondary endpoints included overall survival (OS) and safety. As an exploratory biomarker analysis, we evaluated the proliferative response of blood CD39+PD-1+CD8+ T cells using fold changes in the percentage of proliferating Ki-67+ cells from days 1 to 7 of cycle 1 (Ki-67D7/D1).
UNASSIGNED: Between October 2017 and October 2018, 37 patients were enrolled. Twelve (32%) and three (8%) patients harbored EGFR and ALK alterations, respectively. Of 34 patients with programmed cell death ligand 1 assessment, 21 (62%), 9 (26%), and 4 (12%) had a tumor proportion score of <1%, 1-50%, and ≥50%, respectively. The median follow-up was 71 months. The median DFS was 22.4 months in the overall population, with a five-year DFS rate of 29%. The OS rate was 86% at two years and 76% at five years. Patients with tumor recurrence within six months had a significantly lower Ki-67D7/D1 among CD39+PD-1+CD8+ T cells than those without (p=0.036). No new safety signals were identified.
UNASSIGNED: Adjuvant pembrolizumab may offer durable disease control in a subset of stage IIIA/N2 NSCLC patients after neoadjuvant CCRT and surgery.
UNASSIGNED: In this open-label, single-center, single-arm phase 2 trial, patients with stage IIIA/N2 NSCLC received adjuvant pembrolizumab for up to two years after complete resection following neoadjuvant CCRT. The primary endpoint was disease-free survival (DFS). Secondary endpoints included overall survival (OS) and safety. As an exploratory biomarker analysis, we evaluated the proliferative response of blood CD39+PD-1+CD8+ T cells using fold changes in the percentage of proliferating Ki-67+ cells from days 1 to 7 of cycle 1 (Ki-67D7/D1).
UNASSIGNED: Between October 2017 and October 2018, 37 patients were enrolled. Twelve (32%) and three (8%) patients harbored EGFR and ALK alterations, respectively. Of 34 patients with programmed cell death ligand 1 assessment, 21 (62%), 9 (26%), and 4 (12%) had a tumor proportion score of <1%, 1-50%, and ≥50%, respectively. The median follow-up was 71 months. The median DFS was 22.4 months in the overall population, with a five-year DFS rate of 29%. The OS rate was 86% at two years and 76% at five years. Patients with tumor recurrence within six months had a significantly lower Ki-67D7/D1 among CD39+PD-1+CD8+ T cells than those without (p=0.036). No new safety signals were identified.
UNASSIGNED: Adjuvant pembrolizumab may offer durable disease control in a subset of stage IIIA/N2 NSCLC patients after neoadjuvant CCRT and surgery.
摘要：
■IIIA/N2期非小细胞肺癌（NSCLC）的最佳治疗方法存在争议。我们旨在评估pembrolizumab对新辅助同步放化疗（CCRT）后完全切除的IIIA/N2期非小细胞肺癌的疗效和安全性。
■在此开放标签中，单中心,单臂第二阶段试验，IIIA/N2期NSCLC患者在新辅助CCRT后完全切除后接受帕姆单抗辅助治疗长达两年.主要终点是无病生存期（DFS）。次要终点包括总生存期(OS)和安全性。作为一项探索性生物标志物分析，我们使用第1周期第1天至第7天增殖Ki-67+细胞百分比的倍数变化(Ki-67D7/D1)评估了血液CD39+PD-1+CD8+T细胞的增殖反应.
■在2017年10月至2018年10月期间，共纳入37例患者。12例（32%）和3例（8%）患者存在EGFR和ALK改变，分别。34例程序性细胞死亡配体1评估患者，21（62%），9（26%），和4（12％）的肿瘤比例得分<1％，1-50%,且≥50%,分别。中位随访时间为71个月。在总人口中，平均DFS为22.4个月，五年DFS率为29%。两年的OS率为86％，五年为76％。6个月内肿瘤复发的患者在CD39+PD-1+CD8+T细胞中的Ki-67D7/D1显著低于没有肿瘤复发的患者(p=0.036)。没有发现新的安全信号。
在新辅助CCRT和手术后，辅助派姆单抗可能在IIIA/N2期非小细胞肺癌患者的一部分中提供持久的疾病控制。
■在此开放标签中，单中心,单臂第二阶段试验，IIIA/N2期NSCLC患者在新辅助CCRT后完全切除后接受帕姆单抗辅助治疗长达两年.主要终点是无病生存期（DFS）。次要终点包括总生存期(OS)和安全性。作为一项探索性生物标志物分析，我们使用第1周期第1天至第7天增殖Ki-67+细胞百分比的倍数变化(Ki-67D7/D1)评估了血液CD39+PD-1+CD8+T细胞的增殖反应.
■在2017年10月至2018年10月期间，共纳入37例患者。12例（32%）和3例（8%）患者存在EGFR和ALK改变，分别。34例程序性细胞死亡配体1评估患者，21（62%），9（26%），和4（12％）的肿瘤比例得分<1％，1-50%,且≥50%,分别。中位随访时间为71个月。在总人口中，平均DFS为22.4个月，五年DFS率为29%。两年的OS率为86％，五年为76％。6个月内肿瘤复发的患者在CD39+PD-1+CD8+T细胞中的Ki-67D7/D1显著低于没有肿瘤复发的患者(p=0.036)。没有发现新的安全信号。
在新辅助CCRT和手术后，辅助派姆单抗可能在IIIA/N2期非小细胞肺癌患者的一部分中提供持久的疾病控制。
