Ncog-44. Neurologic Assessment in Neuro-oncology (nano) Scale in a Phase Ii Study of Pembrolizumab or Pembrolizumab Plus Bevacizumab in Patients With Recurrent Glioblastoma
Year: 2020
Type: article
Abstract: PURPOSE The neurologic assessment in neuro-oncology (NANO) scale was developed as a standardized metric to objectively measure neurologic function in brain tumor patients to complement radiographic assessment in defining overall outcome. A multicenter, phase 2 study of pembrolizumab with or without bevacizumab in patients with recurrent glioblastoma incorporated the NANO scale as an exploratory endpoint. METHODS Neurologic examination was evaluated at baseline and MRI assessments using the NANO scale until patients came off study. Statistical descriptive data analysis was performed using R (version 3.4.3). Correlation analysis utilized Fisher’s exact test. RESULTS NANO compliance rate was 94% in 80 patients accrued on the study. Of the 80 patients, 7 were missing NANO at baseline visit and were excluded from analysis for NANO response criteria. Fifteen patients did not have end of treatment NANO evaluation. Of 73 patients, 35 (48%) had a normal neurologic examination at baseline by NANO. Strength and language accounted for the majority of changes in neurologic function over the course of study treatment. Eighteen patients (25%) had neurologic progression by NANO, of whom 2 did not have concurrent radiographic progression. Three patients (pembrolizumab plus bevacizumab cohort) had a neurologic response associated with stable disease on MRI. NANO assessment prior to initiation of cycle 3 correlated with RANO response (p=0.011), change in KPS (p=0.002) and dexamethasone requirement (p=0.007) while those with NANO progression at this assessment had worse overall survival (291 vs 324 days), but this trend did not achieve statistical significance (p=0.2). CONCLUSIONS Evaluation of neurologic function by NANO scale was feasible in a multicenter prospective study in patients with GBM with a high compliance rate. The NANO scale objectively tracked stable neurologic function in most patients throughout the trial period and was associated with a trend for survival.
Source: Neuro-Oncology
Authors: Lakshmi Nayak, Annette Molinaro, Katherine Peters, Jennifer Clarke, Justin Jordan, John de Groot, Phioanh Nghiemphu, Thomas Kaley, Howard Colman, Christine McCluskey, Sarah Gaffey, Timothy Smith, David Cote, Mariano Severgnini, Jennifer Yearley, Qing Zhao, Wendy Blumenschein, Gabriel Duda, Alona Muzikansky, Rakesh Jain, Patrick Wen, David Reardon
Institutions: Dana-Farber Cancer Institute, University of California, San Francisco, Duke Medical Center, Massachusetts General Hospital, The University of Texas MD Anderson Cancer Center, University of California, Los Angeles, Memorial Sloan Kettering Cancer Center, Huntsman Cancer Institute, Brigham and Women's Hospital, Merck & Co., Inc., Rahway, NJ, USA (United States), Harvard University, Center for Neuro-Oncology
Language: English
Subfield: Genetics
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W3112113244