Tatiana Prowell, Associate Professor of Oncology at Johns Hopkins School of Medicine and Breast Cancer Scientific Liaison at the U.S. Food & Drug Administration, shared a post on X:
“Things to consider when evaluating PFS benefit:
Is this an add-on (A+B vs A) or a replacement design (A vs B) where A is std of care.
If add-on, PFS benefit must be larger to offset added tox/cost of a combo & result in benefit/risk.”
“In contrast, if a replacement trial shows superiority, a smaller PFS benefit may be meaningful, especially if there is another advantage such as more favourable toxicity profile, greater patient convenience, etc.
HOWEVER…”
“You must ask:
What is the absolute benefit in PFS & how does it compare to imaging interval? (Note scans may get less frequent w/ time in trials so on that too dep on mPFS).
If mPFS diff is < time btwn scans, hard to know if real.”
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