Evidence map›Paper›PMID 40885626›Full record

ArticleClinical lung cancer2025

Brief Report: Safety of Pulse-Dose Osimertinib for Treatment of Leptomeningeal Disease or Refractory Brain Metastases in EGFR-Mutated Nonsmall Cell Lung Cancer.

Fangdi Sun, Seema Nagpal, Surbhi Singhal, Joel W Neal, Heather A Wakelee, Nathaniel J Myall, Patrick Bolan, Jonathan W Riess, David R Gandara, Millie S Das

Abstract readClinical StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical lung cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Fangdi SunDivision of Oncology, Department of Medicine, Stanford University, Stanford, CA. Electronic address: sunf@stanford.edu.
Seema NagpalDepartment of Neuro-Oncology, Stanford University, Stanford, CA.
Surbhi SinghalDivision of Hematology/Oncology, Department of Medicine, University of California Davis, Sacramento, CA.
Joel W NealDivision of Oncology, Department of Medicine, Stanford University, Stanford, CA.
Heather A WakeleeDivision of Oncology, Department of Medicine, Stanford University, Stanford, CA.
Nathaniel J MyallDivision of Oncology, Department of Medicine, Stanford University, Stanford, CA.
Patrick BolanDivision of Oncology, Department of Medicine, Stanford University, Stanford, CA.
Jonathan W RiessDivision of Hematology/Oncology, Department of Medicine, University of California Davis, Sacramento, CA.
David R GandaraDivision of Hematology/Oncology, Department of Medicine, University of California Davis, Sacramento, CA.
Millie S DasDivision of Oncology, Department of Medicine, Stanford University, Stanford, CA; Department of Medicine, VA Palo Alto Health Care System, Palo Alto, CA.

Funding

UC Davis Paul Calabresi K12 Clinical Oncology Research Career Development ProgramK12CA138464 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI BIRKELAND, ANDREW CHARLES, LARA, PRIMO N. · 2011 to 2025
$11.4M
NCI NIH HHS K12 CA138464
6 · The paper itself

Abstract

purposeEGFR-mutated (EGFRm) NSCLC is associated with high incidence of brain metastases and leptomeningeal disease (LMD), for which effective systemic options beyond osimertinib 80 and 160 mg daily are limited. While there is some evidence for high-dose pulse administration of earlier-generation EGFR tyrosine kinase inhibitors (EGFK-TKIs), data for pulse-dose osimertinib are limited.

methodsThis multicenter retrospective case series included patients with EGFRm NSCLC with LMD or parenchymal brain metastases treated with pulse-dose osimertinib (400-560 mg once every 5-7 days) for central nervous system (CNS) progression, with or without other concurrent therapies. CNS disease control was defined as the interval from pulse-dose osimertinib initiation to radiographic progression or discontinuation for clinical progression, whichever was shorter.

resultsAmong 14 patients, EGFR mutations included exon 19 deletion in 6, L858R in 6, and other mutations in 4. All had received previous EGFR-TKI including 5 with prior osimertinib 160 mg daily. Seven received pulse-dose osimertinib as monotherapy, while the remainder received it in combination with other systemic therapy and/or CNS radiation. No treatment-related severe or unexpected side effects were reported, and only 1 patient required dose modification for adverse events. Median duration of CNS control was 4.0 months (95% CI, 1.8-NR) and median overall survival was 6.2 months (95% CI, 3.2-NR), with benefit driven by patients without previous osimertinib 160 mg daily exposure.

conclusionThough further pharmacokinetic investigation is warranted, this report provides preliminary evidence that pulse-dose osimertinib may be a safe regimen among patients with EGFRm NSCLC and refractory CNS disease.

Indexed as

AcrylamidesAniline CompoundsBrain NeoplasmsCarcinoma, Non-Small-Cell LungLung NeoplasmsMeningeal CarcinomatosisMeningeal NeoplasmsAdultAgedAged, 80 and overErbB ReceptorsFemaleFollow-Up StudiesHumansIndolesMaleAcrylamidesAniline CompoundsEGFR protein, humanErbB ReceptorsIndolesosimertinibProtein Kinase InhibitorsPyrimidinesCNS metastasesCNS progressionEGFR TKIHigh-dose pulseTyrosine kinase inhibitor

Identifiers

PMID40885626
PMCPMC12937019

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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.