Evidence map›Paper›PMID 40437572›Full record

Trial reportBMC medicine2025

Intrathecal pemetrexed efficacy and cerebrospinal fluid tumor marker response in refractory leptomeningeal metastasis of non-small-cell lung cancer: a single-arm phase II trial.

Qingsheng Xu, Kaiyuan Huang, Luqing Tong, Danfang Yan, Yilei Zhao, Hanjin Yang, Weili Jin, Luyuan Zhang, Jinquan Cai, Qun Chen

Abstract readAdaptive Clinical TrialClinical Trial, Phase II
In one paragraph

Trial report in BMC medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Qingsheng Xu *Department of Neurosurgery, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.
Kaiyuan Huang *Department of Neurosurgery, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.
Luqing TongDepartment of Neurosurgery, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.
Danfang YanDepartment of Radiation Oncology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.
Yilei ZhaoDepartment of Radiology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.
Hanjin YangDepartment of Pathology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.
Weili JinThe Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.
Luyuan ZhangDepartment of Neurosurgery, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.
Jinquan CaiDepartment of Neurosurgery, The Second Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China. caijinquan666777@126.com.
Qun ChenDepartment of Neurosurgery, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China. chenqun1318013@zju.edu.cn.

Funding

Medical and Health Research Project of Zhejiang Province no.2022510274National Natural Science Foundation of China no. 82301455National Natural Science Foundation of China no. 82373130Zhejiang Provincial Natural Science Foundation of China under Grant LMS25H160020Zhejiang Provincial Natural Science Foundation of China under Grant no. LGF22H160002
6 · The paper itself

Abstract

backgroundThe treatments for refractory leptomeningeal metastasis (RLM) of non-small cell lung cancer (NSCLC) are limited, and response assessment is complex and challenging. This clinical trial aimed to evaluate the efficacy of intrathecal pemetrexed (IP) and response assessment using cerebrospinal fluid (CSF) tumor marker in RLM.

methodsThis was a single-center, single-arm, phase II adaptive clinical trial. Patients with RLM of NSCLC were eligible for inclusion. Patients were assigned to receive 30 mg of IP every 3 weeks for a total of 6 cycles. The primary endpoint was overall survival (OS). The secondary endpoints included progression-free survival (PFS) evaluated according to EANO-ESMO response assessment, disease control rate, the concordance of CSF tumor marker response with EANO-ESMO response assessment, and safety.

resultsA total of 29 patients were enrolled in the trial. The median PFS was 10.03 months (95% CI, 6.42-13.64), and the median OS was 20.37 months (95% CI, 14.86-25.88), respectively. A ± 35% threshold for CSF tumor marker level change (TML) yielded the optimal predictive performance, with AUCs of 0.890 (95% CI, 0.833-0.947), 0.911 (95% CI, 0.870-0.951), and 0.784 (95% CI, 0.717-0.850) for EANO-ESMO response, progression, and stable, respectively. Most patients (93.1%) experienced grade 1-2 treatment-related adverse events.

conclusionsOur therapeutic regimen of IP provided a practical, survival-extending, and tolerant option for RLM patients. CSF tumor marker response was correlated with EANO-ESMO response assessment, offering an effective tool for response monitoring of RLM.

trial registrationChinese Clinical Trial Register (ChiCTR) ChiCTR2200057235. Registered on March 1, 2022. Date of the first patient enrollment: April 29, 2022.

Indexed as

Biomarkers, TumorCarcinoma, Non-Small-Cell LungLung NeoplasmsMeningeal CarcinomatosisMeningeal NeoplasmsPemetrexedAdultAgedFemaleHumansInjections, SpinalMaleMiddle AgedTreatment OutcomeBiomarkers, TumorPemetrexedIntrathecal pemetrexedNon-small-cell lung cancerRefractory leptomeningeal metastasisResponse assessmentTumor marker in cerebrospinal fluid

Identifiers

PMID40437572
PMCPMC12121236

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.