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Leptomeningeal metastasis (LM) is a fatal complication of advanced non-small cell lung cancer (NSCLC). The aim of this retrospective study is to investigate the effectiveness and safety of furmonertinib in patients with advanced EGFR-mutated (EGFRm) NSCLC and LM. Between February 2020 and March 2023, 31 patients with EGFR mutation-positive NSCLC with LM treated with furmonertinib for at least 8 weeks are eligible for this study. The objective was to assess confirmed objective response rate (ORR), disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS) and safety. Other efficacy assessments included baseline changes in cerebrospinal fluid (CFS) cytology and neurologic examination. Measurable lesions were assessed according to RECIST version 1.1 (RECIST 1.1). LM was assessed according to Neuro-Oncology LM (RANO-LM) criteria. The median PFS (mPFS) for the 31 patients was 11.70 months (95% CI 9.48-13.92months) and the median OS (mOS) was 18.40 months (95% CI 12.49-24.21months). The 1-year survival rate was 67%. The LM ORR and DCR were 75% and 95%, respectively, with a median DoR of 12.00 months (95% CI 7.40-16.60 months). The overall ORR and DCR were 22.6% and 93.5%, respectively, with a median DoR of 7.20 months (95% CI 3.60-10.80 months). Neurologic function improved in 18 (75.0%) of the 24 patients with abnormal baseline assessments. Logistic regression analysis showed that the therapeutic dose of furmonertinib was a positive predictor of OS in NSCLC patients harboring EGFR mutations with LM HR: 2.679 (1.004-7.147), P=0.049. The most common adverse events (AEs) are diarrhea, decreased appetite and rash. And are usually grade 1 to 2. Our study provides real-world clinical evidence that furmonertinib shows a clinically meaningful therapeutic effect with a tolerable safety profile in patients with EGFRm NSCLC and LM. Our findings also suggest that the furmonertinib therapeutic dose may be an effective strategy for prolonging overall survival outcomes in these patients.
Han et al. (Fri,) studied this question.