Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

Glioma trials should track living well, not just longer

Key clinical point: Members of a neuro-oncology working group have published a report on their work to date focused on standardizing clinical outcome assessments (COAs) that they say should be used as clinical trial endpoints and in clinical care.

Major finding: Symptoms that should be measured include pain, difficulty communicating, perceived cognition, seizures, and symptomatic adverse events. Functional issues should be measured, including physical functioning (weakness or walking), and role functioning related to work or social/leisure activities.

Study details: Report on the work of the Fast Track COA Group, which includes members of previous neuro-oncology working groups, the Food and Drug Administration, and observers from the European Medicines Agency.

Disclosures: Dr. Armstrong reported employment as a senior investigator and deputy chief of the neuro-oncology branch of the Center for Cancer Research at the NCI. His coauthors reported disclosures related to several companies and interests, including AbbVie, AstraZeneca, Bristol-Myers Squibb, Genentech, Merck, Taiho, and Tocagen.

Citation:

Armstrong TS et al. Lancet Oncol. 2020;21(2):e97-103.