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Background <p>Leptomeningeal metastasis (LM) is an almost universally fatal complication of solid tumors. Intrathecal pemetrexed (IP) has preliminary activity; however, robust efficacy and safety data are lacking.</p> Methods <p>Data of 112 patients with newly diagnosed, cytologically and/or radiologically confirmed LM from solid tumors between May 2021 and June 2024 were retrospectively analyzed. All patients received IP as first-line intrathecal therapy. The efficacy and safety of IP were evaluated, and prognostic factors associated with overall survival in the entire cohort and a non-small-cell lung cancer (NSCLC) subgroup were identified.</p> Results <p>The primary tumor types were NSCLC (63.4%), small-cell lung cancer (14.3%), breast cancer (9.8%), and colorectal cancer (5.4%). The median overall survival (mOS) for the entire cohort was 8.0 months (95% confidence interval [CI], 6.5–9.5), with an overall clinical response rate of 75% (84/112). In the NSCLC subgroup, the mOS was 6.0 months (95% CI, 3.6–8.4). Multivariable analysis identified three independent predictors of improved survival: &gt;6 IP administrations (hazard ratio [HR], 0.38; 95% CI, 0.23–0.62; <i>P</i> &lt; 0.001), achievement of a clinical response (HR, 0.53; 95% CI, 0.32–0.88), and negative cerebrospinal fluid cytology after treatment (HR, 0.44; 95% CI, 0.28–0.70; <i>P</i> &lt; 0.001). Importantly, among patients with NSCLC who received &gt; 6 IP cycles, the mOS was 16 months. Treatment-related adverse events were predominantly grades 1–2. The most common symptoms were myelosuppression (41.1%) and elevated hepatic transaminase levels (36.6%).</p> Conclusions <p>Intrathecal pemetrexed could confer clinically meaningful survival benefits with acceptable toxicity in patients with solid tumor LM.</p>

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Real-world evidence for first-line intrathecal pemetrexed in leptomeningeal metastases from solid tumors: a retrospective cohort study

  • 期刊论文

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  • 发表日期：

    2026年4月2日

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  • Zhuo Wang,
  • Yin Cao,
  • Qiang Wang,
  • Libo Wang,
  • Meichen Gu,
  • Jincai Lv,
  • Fuxue Huang,
  • Ying Li,
  • Pengyu Chang,
  • Lihua Dong

摘要

Background

Leptomeningeal metastasis (LM) is an almost universally fatal complication of solid tumors. Intrathecal pemetrexed (IP) has preliminary activity; however, robust efficacy and safety data are lacking.

Methods

Data of 112 patients with newly diagnosed, cytologically and/or radiologically confirmed LM from solid tumors between May 2021 and June 2024 were retrospectively analyzed. All patients received IP as first-line intrathecal therapy. The efficacy and safety of IP were evaluated, and prognostic factors associated with overall survival in the entire cohort and a non-small-cell lung cancer (NSCLC) subgroup were identified.

Results

The primary tumor types were NSCLC (63.4%), small-cell lung cancer (14.3%), breast cancer (9.8%), and colorectal cancer (5.4%). The median overall survival (mOS) for the entire cohort was 8.0 months (95% confidence interval [CI], 6.5–9.5), with an overall clinical response rate of 75% (84/112). In the NSCLC subgroup, the mOS was 6.0 months (95% CI, 3.6–8.4). Multivariable analysis identified three independent predictors of improved survival: >6 IP administrations (hazard ratio [HR], 0.38; 95% CI, 0.23–0.62; P < 0.001), achievement of a clinical response (HR, 0.53; 95% CI, 0.32–0.88), and negative cerebrospinal fluid cytology after treatment (HR, 0.44; 95% CI, 0.28–0.70; P < 0.001). Importantly, among patients with NSCLC who received > 6 IP cycles, the mOS was 16 months. Treatment-related adverse events were predominantly grades 1–2. The most common symptoms were myelosuppression (41.1%) and elevated hepatic transaminase levels (36.6%).

Conclusions

Intrathecal pemetrexed could confer clinically meaningful survival benefits with acceptable toxicity in patients with solid tumor LM.