Radiotherapy Department, The Third Affiliated Hospital of Guangxi Medical University, Dan-Cun Road No.13, Nanning, 530000, Guangxi, China.
Sci Rep. 2024 Oct 31;14(1):26200. doi: 10.1038/s41598-024-78159-y.
The use of immune checkpoint inhibitors (ICIs) as neoadjuvant therapy is a promising novel approach in resectable non-small-cell lung cancer (NSCLC). This study aimed to investigate the prognostic value of PD-L1 in patients with NSCLC receiving neoadjuvant immune checkpoint inhibitor plus chemotherapy (CT).
Several databases (PubMed, Embase, and cochrane central register of controlled trials [CENTRAL]) were systematically searched. Randomized controlled trials (RCTs) investigating pathological and survival outcomes with neoadjuvant ICI + CT versus CT alone in NSCLC were analyzed.
Overall, eight RCTs (n = 3,404) were included. The analyses showed neoadjuvant ICI + CT significantly improved complete pathological response (pCR) and event-free survival (EFS) in either tumor PD-L1 < 1%, ≥ 1%, 1-49%, or ≥ 50% population (both p < 0.0001) compared with neoadjuvant CT alone. The overall survival (OS) data are not yet mature among all included RCTs, and only three RCTs presented OS data by PD-L1 status of patients. The pooled OS favored neoadjuvant ICI + CT in the PD-L1 ≥ 1% population (hazard ratio [HR], 0.45; 95% CI, 0.31-0.65; p < 0.0001), but not in the PD-L1 < 1% population (HR, 0.89; 95% CI, 0.66-1.19; p = 0.43).
Compared with neoadjuvant CT alone, neoadjuvant ICI + CT significantly enhanced pCR and EFS for patients with resectable NSCLC regardless of the expression of PD-L1. It seems that only patients with PD-L1 positive tumors may achieve a better OS, but it's currently inconclusive due to immature data, so future research with long-term follow-up is still needed.
免疫检查点抑制剂（ICIs）作为新辅助治疗在可切除非小细胞肺癌（NSCLC）中是一种很有前途的新方法。本研究旨在探讨 PD-L1 在接受新辅助免疫检查点抑制剂联合化疗（CT）的 NSCLC 患者中的预后价值。
系统检索了多个数据库（PubMed、Embase 和 Cochrane 对照试验中心注册库[CENTRAL]）。分析了新辅助 ICI+CT 与单独 CT 治疗 NSCLC 的病理和生存结果的随机对照试验（RCT）。
共有 8 项 RCT（n=3404）纳入分析。结果表明，与单独新辅助 CT 相比，新辅助 ICI+CT 显著提高了肿瘤 PD-L1<1%、≥1%、1-49%或≥50%人群的完全病理缓解（pCR）和无事件生存（EFS）（均 p<0.0001）。所有纳入的 RCT 中总生存（OS）数据尚未成熟，只有 3 项 RCT 按患者的 PD-L1 状态提供了 OS 数据。荟萃分析结果表明，在 PD-L1≥1%的人群中，新辅助 ICI+CT 有利于 OS（风险比[HR]，0.45；95%CI，0.31-0.65；p<0.0001），但在 PD-L1<1%的人群中，新辅助 ICI+CT 并不有利于 OS（HR，0.89；95%CI，0.66-1.19；p=0.43）。
与单独新辅助 CT 相比，新辅助 ICI+CT 显著提高了可切除 NSCLC 患者的 pCR 和 EFS，无论 PD-L1 的表达如何。似乎只有 PD-L1 阳性肿瘤的患者才能获得更好的 OS，但由于数据不成熟，目前还没有定论，因此仍需要进行长期随访的进一步研究。
