ArticleNeuro-oncology2025
Intrathecal sintilimab for leptomeningeal metastases of non-small cell lung cancer failed from targeted therapy and intrathecal chemotherapy (LMIS study).
Article in Neuro-oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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Who cites it
5 citing papers in PubMed.
- Increasing incidence and improved survival of leptomeningeal metastasis in advanced lung cancer: a 10-year real-world cohort study.Translational lung cancer research · 2026Article
- Article
- CSF proteomics identifies ADGRG1 as a predictive biomarker of intrathecal immune checkpoint inhibitor response in leptomeningeal metastasis.Journal for immunotherapy of cancer · 2026Article
- Point/Counterpoint: Intrathecal therapy for patients with leptomeningeal metastases from solid tumors.Neuro-oncology · 2025Article
- PD-L1 expression in cerebrospinal fluid for leptomeningeal metastasis from solid tumors: preliminary assessment of clinical implications.Frontiers in immunology · 2025Article
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16 authors.
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Abstract
backgroundLeptomeningeal metastases (LMs) are serious complications of non-small cell lung cancer (NSCLC). This study aimed to investigate the safety and efficacy of intrathecal immune checkpoint inhibitors (ICIs) in treating NSCLC-LM.
methodsWe conducted this prospective phase 1 study (ChiCTR2200062245) using a traditional "3+3" design with intrathecal sintilimab (dose escalation 10, 20, 30, and 40 mg) for NSCLC-LM patients who had progressed from targeted therapy and intrathecal pemetrexed. The primary study endpoints were safety and recommended dose, and the secondary endpoints included clinical response rate, progression-free survival (PFS), intracranial progression-free survival (iPFS), and overall survival (OS).
resultsNo dose-limiting toxicity was found at 10, 20, 30, and 40 mg for intrathecal sintilimab. Therefore, sintilimab 40 mg was recommended for intrathecal injection. A total of 19 patients were enrolled in this study. The median age at diagnosis of LM was 53 years. The overall incidence of adverse events (AEs) was 68.4%, and rash (n = 4, 21.1%) was the most common AEs, which returned to normal after symptomatic treatment. As 1 patient was lost to follow-up and 18 patients could be evaluated for efficacy, the clinical response rate was 38.9% (7/18). Median PFS was 3.5 months (95% CI: 2.7-4.2 months), median iPFS was 3.5 months (95% CI: 1.3-5.6 months), and median OS was 11.5 months (95% CI: 0.0-25.4 months).
conclusionsIntrathecal ICIs for NSCLC-LM patients are safe, and the recommended dose of sintilimab is 40 mg. Intrathecal sintilimab for NSCLC-LM failed from multi-line therapies, showed potential effectiveness in some patients, and is worthy of further study.
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