Department of Medicine, University of California, San Francisco, California, USA.
Department of Medicine, Division of Oncology, Stanford Cancer Institute, Stanford University School of Medicine, Stanford, California, USA.
Cancer. 2024 Sep 1;130(17):2897-2903. doi: 10.1002/cncr.35357. Epub 2024 May 8.
Emerging data supporting the rise of perioperative immune checkpoint inhibitors (ICIs) as a standard of care in the treatment of early stage, surgically resectable non-small cell lung cancer (NSCLC) dominated the NSCLC news in 2023. Adjuvant pembrolizumab became the second adjuvant ICI to receive US Food and Drug Administration approval in early 2023 after the 2021 approval of adjuvant atezolizumab and the 2022 approval of neoadjuvant nivolumab with chemotherapy. Subsequently in 2023, multiple phase 3 trials examining perioperative ICIs were positive and demonstrated clinically meaningful outcomes by prolonging event-free survival, improving pathologic complete response rates, and trending toward improved overall survival in most. Perioperative pembrolizumab became the first ICI to attain US Food and Drug Administration approval in this setting through the KEYNOTE-671 trial (ClinicalTrials.gov identifier NCT03425643), which also demonstrated a definitive overall survival benefit in the entire study population. However, questions remain regarding patient selection for either approach and how we can optimize biomarkers to determine who needs adjuvant therapy after surgery.
2023 年，非小细胞肺癌（NSCLC）领域的新闻主要围绕围手术期免疫检查点抑制剂（ICIs）作为早期可手术切除 NSCLC 治疗标准的地位不断提升这一新兴数据展开。辅助帕博利珠单抗于 2021 年辅助阿替利珠单抗和 2022 年化疗联合新辅助纳武利尤单抗获得美国食品和药物管理局（FDA）批准后，于 2023 年初成为第二个获得 FDA 批准的辅助 ICI。随后，2023 年多项围手术期 ICI 的 III 期临床试验结果均为阳性，通过延长无事件生存期、提高病理完全缓解率，并在大多数情况下有改善总生存期的趋势，显示出具有临床意义的结果。围手术期帕博利珠单抗通过 KEYNOTE-671 试验（ClinicalTrials.gov 标识符 NCT03425643）成为首个在该治疗环境下获得 FDA 批准的 ICI，该试验也在整个研究人群中显示出明确的总生存获益。然而，对于这两种治疗方法，患者选择和如何优化生物标志物以确定谁需要手术后辅助治疗仍存在疑问。
