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Neoadjuvant Immunotherapy
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DOI：10.1016/j.thorsurg.2025.08.003.png)
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Abstract
En 中文
Recent research in early-stage non-small cell lung cancer (NSCLC) underscores the evolving role of immunotherapy strategies. Currently, immune checkpoint inhibitor (ICI) monotherapy without chemotherapy remains investigational and has not received FDA approval. Phase 2 neoadjuvant trials have been pivotal in identifying early surrogate markers of treatment response-such as major pathologic regression, complete pathologic response, and objective response rate-that serve as important indicators of efficacy and safety. These studies demonstrated that combination regimens, particularly chemotherapy plus ICI (CT-ICI) and dual ICI therapy, yield superior pathologic responses, positioning CT-ICI as the preferred approach in subsequent phase 3 trials. Although pathologic response metrics are valuable early indicators, they are insufficient alone for regulatory approval; long-term outcomes such as event-free, disease-free, and overall survival remain essential for FDA approval processes. Importantly, ICI monotherapy has been shown to be generally safe and well tolerated, with manageable adverse events. However, the use of chemotherapy-free dual ICI regimens continues to be investigational and has not yet achieved regulatory approval.
Keywords:
Neoadjuvant
Perioperative
Immunotherapy
Immune checkpoint inhibition
Early stage
Resectable
Lung cancer
Non-small cell lung carcinoma
Journal
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