Evidence map›Paper›PMID 32506369›Full record

Trial reportJournal of neuro-oncology2020

Cerebrospinal fluid circulating tumor cells as a quantifiable measurement of leptomeningeal metastases in patients with HER2 positive cancer.

Rachna Malani, Martin Fleisher, Priya Kumthekar, Xuling Lin, Antonio Omuro, Morris D Groves, Nancy U Lin, Michelle Melisko, Andrew B Lassman, Suriya Jeyapalan and 7 more

3 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Journal of neuro-oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 59 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
59citing papers in PubMed, 1 pooled it
6.5field-weighted citation impact, top 2% of its field
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.

NCT01325207 phase1 / phase2completednot on this map

Phase I/II Dose Escalation Trial to Assess Safety of Intrathecal Trastuzumab for the Treatment of Leptomeningeal Metastases in HER2 Positive Breast Cancer

TypeinterventionalSponsorNorthwestern UniversityRan2011 to 2019Enrolled34ConditionsBreast CancerArmsTrastuzumab
NCT06330337 phase3recruitingnot on this mapstarted 2024, after this paper: background citation

Specific Model Electroacupuncture Stimulation Promotes Paclitaxel Delivery Across the BBB for Postoperative Glioma Patients: A Randomized Controlled Study

TypeinterventionalSponsorThe Third Affiliated hospital of Zhejiang Chinese Medical UniversityRan2024 to 2027Enrolled58ConditionsGliomaArmsTemozolomide(TMZ) injection or oral administration, Albumin-Bound Paclitaxel(ABX) intravenous drip, Specific mode electroacupuncture stimulation(SMES) intervention
NCT06818331 phase2recruitingnot on this mapstarted 2025, after this paper: background citation

Evaluation of Clinical Efficacy and Safety of Specific Mode Electroacupuncture Stimulation for Paclitaxel Across BBB Delivery in Patients With Postoperative Recurrence of Malignant Glioma: A Single-arm Trial

TypeinterventionalSponsorThe Third Affiliated hospital of Zhejiang Chinese Medical UniversityRan2025 to 2028Enrolled20ConditionsGliomaArmsSMES+PTX, Paclitaxel, Specific mode electroacupuncture stimulation
3 · Its place in the literature

Who cites it

59 citing papers in PubMed, 1 synthesis or guideline pooled it, 79 citations in OpenAlex.

  1. Guideline
  2. Trial
  3. Review
  4. Review
  5. Review
  6. Article
  7. Article
  8. Article
  9. Article
  10. Review
  11. Leptomeningeal carcinomatosis in gastric cancer: A Review.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2025
    Review
  12. Leptomeningeal Disease: Current Approaches and Future Directions.Current neurology and neuroscience reports · 2025
    Review
  13. Review
  14. Review
  15. Article
  16. Article
  17. Review
  18. Article
  19. Review
  20. Review
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

17 authors at 7 institutions in 2 countries.

Rachna Malani *Department of Neurology, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY, 10065, USA.ORCID http://orcid.org/0000-0003-2038-8738
Martin Fleisher *Department of Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, 10065, USA.
Priya Kumthekar *Department of Neurology, Northwestern University, Evanston, IL, 60208, USA.
Xuling LinDepartment of Neurology, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY, 10065, USA.
Antonio OmuroDepartment of Neurology, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY, 10065, USA.
Morris D GrovesDepartment of Neurology, Texas Oncology, Austin, TX, 78705, USA.
Nancy U LinDepartment of Neurology, Dana Farber Cancer Institute, Boston, MA, 02215, USA.
Michelle MeliskoDepartment of Medicine, UCSF, San Francisco, CA, 94143, USA.
Andrew B LassmanDepartment of Neurology and Herbert Irving Comprehensive Cancer Center, New-York Presbyterian Hospital/Columbia University Irving Medical Center, New York, NY, 10032, USA.
Suriya JeyapalanDepartment of Neurology, Tufts University, Medford, MA, 02155, USA.
Andrew SeidmanDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, 10065, USA.
Anna SkakodubDepartment of Neurology, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY, 10065, USA.
Adrienne BoireDepartment of Neurology, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY, 10065, USA.
Lisa M DeAngelisDepartment of Neurology, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY, 10065, USA.
Marc RosenblumDepartment of Pathology, Memorial Sloan Kettering Cancer Center, New York, NY, 10065, USA.
Jeffrey Raizer *Department of Neurology, Northwestern University, Evanston, IL, 60208, USA.
Elena Pentsova *Department of Neurology, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY, 10065, USA. pentsove@mskcc.org.
Memorial Sloan Kettering Cancer Center · USNorthwestern University · USDana-Farber Cancer Institute · USNewYork–Presbyterian Hospital · USTexas Oncology · USTufts University · USUniversity of California, San Francisco · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
NCATS NIH HHS UL1 TR001863NCI NIH HHS P30 CA008748NIH HHS P30-CA008748
6 · The paper itself

Abstract

purposeThe CellSearch® system has been used to identify circulating tumor cells (CTCs) in cerebrospinal fluid (CSF) to diagnose leptomeningeal metastasis (LM) in patients with epithelial cancers. Using this system, we prospectively explored sequential CSF CTC enumeration in patients with LM from HER2+ cancers receiving intrathecal (IT) trastuzumab to capture dynamic changes in CSF CTC enumeration.

methodsCSF from patients enrolled in an IRB-approved phase I/II dose escalation trial of IT trastuzumab for LM in HER2+ cancer (NCT01325207) was obtained on day 1 of each cycle and was evaluated by the CellSearch® platform for CTC enumeration. The results were correlated with CSF cytology from the same sample, along with clinical and radiographic response.

resultsFifteen out of 34 patients with HER2+ LM were enrolled in CSF CTC analysis; 14 were women. Radiographic LM was documented in 14 (93%) patients; CSF cytology was positive in 6 (40%) and CSF CTCs were identified in 13 (87%). Median CSF CTC was 22 CTCs (range 0-200 +) per 3 ml. HER2/neu expression analysis of CTCs was performed in 8 patients; 75% had confirmed expression of HER2/neu positivity in CSF and HER2/neu expression was absent in 25%. Four of 10 patients received 7 or more cycles of IT trastuzumab; in 3 of these patients, increase in CSF CTCs enumeration from baseline was detected 2-3 months prior to changes seen on MRI, and while CSF cytology remained negative.

conclusionOur study demonstrates that enumeration of CSF CTCs may provide dynamic, quantitative assessment of tumor burden in the central nervous system compartment during treatment for LM and prior to changes on MRI or CSF cytology.

trial registrationClinicaltrials.gov: NCT01325207; registered March 29th, 2011.

Indexed as

Antineoplastic Agents, ImmunologicalBiomarkers, TumorBreast NeoplasmsErb-b2 Receptor Tyrosine KinasesFemaleFollow-Up StudiesHumansInjections, SpinalMeningeal CarcinomatosisNeoplastic Cells, CirculatingPrognosisSurvival RateTrastuzumabAntineoplastic Agents, ImmunologicalBiomarkers, TumorERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesTrastuzumabBiomarkerCerebrospinal fluidCirculating tumor cellsLeptomeningeal metastasesLiquid biomarkers

Identifiers

PMID32506369
PMCPMC7438284
OpenAlexW3033298905

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.