
==== Front
Neurooncol Adv
Neurooncol Adv
noa
Neuro-Oncology Advances
2632-2498
Oxford University Press US

10.1093/noajnl/vdae090.033
vdae090.033
Final Category: Biomarkers
AcademicSubjects/MED00300
AcademicSubjects/MED00310
BMRK-13 CSF TUMOR CELL (CSF-TC) DETECTION, QUANTIFICATION AND BIOMARKER ASSESSMENT HELPS IN CLINICAL MANAGEMENT OF BREAST CANCER AND NON-SMALL CELL LUNG CANCER PATIENTS HAVING LEPTOMENINGEAL DISEASE (FORESEE STUDY, NCT05414123)
Kumthekar Priya Northwestern, Chicago/IL, USA

Youssef Michael UT Southwestern.edu, Dallas/TX, USA

Yang Jonathan New York University, New York/NY, USA

Piccioni David University of San Diego Health, San Diego/CA, USA

Beruti Sue Independent Consultant, Winchester/VA, USA

Gillis Laura Independent Consultant, Winchester/VA, USA

Gordon Kelly Independent Consultanta, Brentwood/TN, USA

Blouw Barbara Plus Therapeutics, Austin/TX, USA

Moore Melissa Plus Therapeutics, Austin/TX, USA

LaFrance Norman Plus Therapeutics, Austin/TX, USA

Hedrick Marc Plus Therapeutics, Austin/TX, USA

Nagpal Seema Stanford Medicine, Stanford/CA, USA

8 2024
02 8 2024
02 8 2024
6 Suppl 1 2024 SNO/ASCO CNS Metastases Conference i11i11
© The Author(s) 2024. Published by Oxford University Press, the Society for Neuro-Oncology and the European Association of Neuro-Oncology.
2024
https://creativecommons.org/licenses/by-nc/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com

Abstract

Leptomeningeal metastases (LM) in solid tumors is difficult to diagnose and treat, and occurs when there are cancer cells in the cerebrospinal fluid (CSF)/pia and arachnoid. Current standard of care methods to diagnose or assess treatment response of LM (Clinical Evaluation, MRI and Cytology) have limited sensitivity and specificity. This creates challenges for physicians to manage LM or determine the best course of treatment. The FORESEE Study was a multi-center, prospective clinical trial evaluating a novel diagnostic platform, CNSide, that aimed to overcome these challenges. The FORESEE study enrolled patients with breast or non-Small Cell Lung Cancer (NSCLC) with suspicion of or confirmed LM. CNSide can detect and quantify tumor cells in the CSF from patients with breast cancer or NSCLC having a suspicious or confirmed LM as well as identify actionable mutations in the CSF via Fluorescent In Situ Hybridization (FISH) and next-generation sequencing. The primary end point was to determine the impact of CNSide on physician treatment decisions. Secondary endpoints included evaluating the clinical performance of CNSide vs. cytology in tumor cell detection (sensitivity, specificity, PPV and NPV). The study enrolled 40 patients (22 breast cancer and 19 NSCLC). Each patient underwent standard of care diagnostic evaluations at baseline and at three follow up timepoints through their treatment. CNSide aided clinical decision making in 93% (50/54) of the clinical decisions. At baseline, 39 patients were assessed, showing that CNSide confirmed a positive LM diagnosis in 15% (6/39), a negative LM diagnosis in 8% (3/39), progression in 15% (6/39), resolution in 15% (6/39) and no progression, or resolution in 36% (14/39) of the patients. CNSide informed the specific drug selected for treatment in 26% (10/39) patients at baseline and demonstrated clinical high utility. The FORESEE data is undergoing ongoing analysis; full analysis will be presented at the meeting.
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pmc
