Neurologic assessment in neuro-oncology (NANO) scale in a prospective phase II trial of anti-PD1 antibody, pembrolizumab with or without bevacizumab in patients with recurrent glioblastoma.

Authors

null

Lakshmi Nayak

Dana-Farber Cancer Institute, Boston, MA

Lakshmi Nayak , Timothy Smith , Sarah C. Gaffey , Katherine B. Peters , Jennifer Leigh Clarke , Justin T Jordan , John Frederick De Groot , Phioanh Leia Nghiemphu , Thomas Joseph Kaley , Howard Colman , Terri Armstrong , Martin J. Taphoorn , Victoria Caruso , Myriam Bednarek Debruyne , Chinmay Bhavsar , Annette M Molinaro , Mariano Severgnini , Patrick Y. Wen , David A. Reardon

Organizations

Dana-Farber Cancer Institute, Boston, MA, Brigham and Women's Hospital, Boston, MA, Dana-Farber/Brigham and Women's Cancer Center, Harvard Medical School, Boston, MA, Duke University Medical Center, Durham, NC, University of California, San Francisco, San Francisco, CA, Massachusetts General Hospital, Boston, MA, The University of Texas MD Anderson Cancer Center, Department of Neuro-Oncology, Houston, TX, University of California, Los Angeles, Los Angeles, CA, Memorial Sloan Kettering Cancer Center, New York, NY, Hunstman Cancer Institute, Salt Lake City, UT, National Cancer Institute, Bethesda, MD, Haaglanden Medical Center, The Hague, Netherlands, UC San Francisco, San Francisco, CA, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA

Research Funding

Pharmaceutical/Biotech Company

Background: The neurologic assessment in neuro-oncology (NANO) scale was developed as a standardized metric to objectively measure neurologic function in patients (pts) with brain tumors to complement radiographic assessment in defining overall outcome. The scale has been incorporated in various prospective studies to assess pts and to determine its utility. Methods: A multicenter, open label, phase II trial of pembrolizumab with and without bevacizumab in pts with recurrent glioblastoma (GBM) incorporated NANO scale as an exploratory endpoint. Neurologic examination by NANO was documented at baseline and each cycle until pts came off study. Statistical analyses including descriptive data analysis and generalized linear models were performed using R (version 3.4.3). Results: Eighty pts received treatment on study and underwent NANO evaluations. NANO compliance rate was 94%; of a total 388 expected NANO evaluations, 24 were missing. Of 80 pts, 7 missing NANO at baseline visit were excluded from analysis. Fifteen pts did not have end of treatment NANO evaluation. Of 73 pts, 35 (48%) had a normal neurologic examination at baseline by NANO. Two NANO domains (strength and language) accounted for the majority of variability in neurologic function over the course of study treatment. There was a significant correlation between NANO at each cycle and Karnofsky performance status score (p= 0.02). Nineteen pts were on dexamethasone at baseline; 42 required it during study. Corticosteroid requirement (OR = 1.9, p< 0.001) and an increase in corticosteroid dose (OR = 2.6, p< 0.001) were associated with higher risk of NANO progression (PD). Eighteen pts (25%) met NANO criteria for PD, including 2 without PD on MRI. Three pts (4%) had a neurologic response per NANO criteria associated with stability on MRI. Conclusions: Evaluation of neurologic function by NANO was feasible in a multicenter prospective study in GBM pts with a high compliance rate. NANO was able to objectively track neurologic function throughout the trial including preservation of baseline status in non-progressors. Clinical trial information: NCT02337491

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Abstract Details

Meeting

2018 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Central Nervous System Tumors

Track

Central Nervous System Tumors

Sub Track

Central Nervous System Tumors

Clinical Trial Registration Number

NCT02337491

Citation

J Clin Oncol 36, 2018 (suppl; abstr 2037)

DOI

10.1200/JCO.2018.36.15_suppl.2037

Abstract #

2037

Poster Bd #

195

Abstract Disclosures