Corticosteroid use endpoints in neuro-oncology: Response Assessment in Neuro-Oncology Working Group
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AbstractBackground:
Corticosteroids are the mainstay of treatment for peritumor edema but are often associated with significant side effects. Therapies that can reduce corticosteroid use would potentially be of significant benefit to patients. However, currently there are no standardized endpoints evaluating corticosteroid use in neuro-oncology clinical trials.
Methods:
The Response Assessment in Neuro-Oncology (RANO) Working Group has developed consensus recommendations for endpoints evaluating corticosteroid use in clinical trials in both adults and children with brain tumors.
Results:
Responders are defined as patients with a 50% reduction in total daily corticosteroid dose compared with baseline or reduction of the total daily dose to ≤2 mg of dexamethasone (or equivalent dose of other corticosteroid); baseline dose must be at least 4 mg of dexamethasone daily (or equivalent dose of other corticosteroids) for at least one week. Patients must have stable or improved Neurologic Assessment in Neuro-Oncology (NANO) score or Karnofsky performance status score or Eastern Cooperative Oncology Group (ECOG) (Lansky score for children age <16 y), and an improved score on a relevant clinical outcome assessment tool. These criteria must be sustained for at least 4 weeks after baseline assessment to be considered a response, and are confirmed 4 weeks after that (ie, 8 wk after baseline assessment) to be considered a sustained response.
Conclusions:
This RANO proposal for corticosteroid use endpoints in neuro-oncology clinical trials may need to be refined and will require prospective validation in clinical studies
All Author(s) ListArvold ND, Armstrong TS, Warren KE, Chang SM, DeAngelis LM, Blakeley J, Chamberlain MC, Dunbar E, Loong HH, Macdonald DR, Reardon DA, Vogelbaum MA, Yuan Y, Weller M, van den Bent M, Wen PY
Journal nameNeuro-Oncology
Year2018
Month7
Volume Number20
Issue Number7
Place of PublicationEngland
Pages897 - 906
ISSN1522-8517
eISSN1523-5866
LanguagesEnglish-United Kingdom
KeywordsNeuro-Oncology

Last updated on 2021-05-12 at 00:30