Abstract 570P
Background
There are no validated tools for the clinical neurological assessment of patients with leptomeningeal metastases (LM). However, clinical examination during the course of the disease guides medical management and is part of response assessment in clinical trials. Because neuroimaging may not always be obtained owing to rapid clinical deterioration, clinical neurological assessment of LM is essential, and standardization Is important to minimize rater disagreement.
Methods
The RANO-LM group launched a 2-steps process, aiming at improving and standardizing the clinical assessment of patients with LM. We report here on the first step: the establishment of a consensus scorecard. The task force had 9 virtual meetings to define general recommendations on neurological assessment and selected domains of interest that should be tested.
Results
Fourteen domains of neurological symptoms and signs were selected: level of consciousness, cognition, nausea and vomiting, vision, eye movement, facial strength, hearing, swallowing, dysarthria, limb strength, ataxia, walking, bladder bowel functions. For each item, a clear instruction on how to perform the assessment is provided with scoring criteria between 0 and 2. The general clinical status of the patient and use of steroids, pain medications, and anti-emetics should be documented. Neurological sequelae from previous brain metastases or cancer treatment should be rated at the baseline evaluation; it should be specified when symptoms or signs may be related to a condition other than LM.
Conclusions
A revised NANO-LM consensus scorecard for clinical assessment has been established. An international prospective validation study of the proposal is currently ongoing (NCT06417710).
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
University Hospital Zurich.
Funding
Has not received any funding.
Disclosure
E. Le Rhun: Financial Interests, Personal, Advisory Board: Leo Pharma, Seattle Genetics, Bayer, Pierre Fabre, Janssen, Roche; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Other, Consulting: Pfizer, Servier; Financial Interests, Institutional, Funding: BMS; Non-Financial Interests, Personal, Officer, Brain Tumor Group secretary: EORTC; Non-Financial Interests, Personal, Other, Board member: EANO. L. Nayak: Financial Interests, Personal, Research Grant: Bristol Myers Squibb, ONO, Merck, Kazia, Zeneca. F; Financial Interests, Personal, Advisory Board: ONO, BraveBio, Genmab, Miltenyi, Curis, Kite/Gilead. M.J. Lim Fat: Financial Interests, Personal, Advisory Board: Novocure, Servier. R. Rudà: Financial Interests, Institutional, Research Grant: Bayer; Financial Interests, Personal, Advisory Board: Novocure, Servier, Genenta, CureVac. P. Forsyth: Financial Interests, Personal, Advisory Board: NIH/NCI, Pfizer, DOD, Bristol Myers Squibb, Genentech. B. O'Brien: Financial Interests, Personal, Advisory Board: Plus Therapeutics. M. Preusser: Financial Interests, Personal, Advisory Board: Bayer, Bristol Myers Squibb, Novartis, Gerson Lehrman Group (GLG), CMC Contrast, GSK, Mundipharma, Roche, BMJ Journals, MedMedia, AstraZeneca, AbbVie, Lilly, Medahead, Daiichi Sankyo, Sanofi, Merck Sharp & Dome, Tocagen, Adastra, Gan & Lee Pharmaceuticals, Janssen, Servier, Miltenyi, Böhringer-Ingelheim, Telix, Medscape. P. Kumthekar: Financial Interests, Personal, Advisory Board: Enclear Therapies, Affinia Therapeutics, Biocept, Janssen, Bioclinica, Novocure, Mirati, Servier, Roche, Telix Pharmaceuticals, PlusTherapeutics, Belay Diagnostics, Biodexa; Financial Interests, Personal, Speaker’s Bureau: Seagen. D. Brandsma: Financial Interests, Institutional, Research Grant: Gilead Sciences; Financial Interests, Personal, Advisory Board: Boehringer Ingelheim , Lilly Pharmaceuticals. M. Weller: Financial Interests, Personal, Advisory Board: Merck (EMD), Novartis, Neurosense; Financial Interests, Personal, Other, IDMC: Orbus, Philogen, Curevac; Financial Interests, Personal, Invited Speaker: Novocure; Financial Interests, Institutional, Research Grant: Quercis, Versameb; Non-Financial Interests, Personal, Leadership Role: EORTC. All other authors have declared no conflicts of interest.