Posted by Michael Wonder on 10 Dec 2022
You're cured till you're not: should disease-free survival be used as a regulatory or clinical endpoint for adjuvant therapy of cancer?
9 December 2022 - Recent commentary reviewing the use of biologics or other novel molecules tested in the adjuvant setting for a range of solid tumours has suggested that a significant improvement in disease-free survival is not a pivotal clinical endpoint, which of its own account, justifies a subsequent change in practice.
As a corollary, such a view implies that disease-free survival is also not an appropriate regulatory endpoint for the registration of adjuvant therapies administered after surgery or by inference for the approval of neo-adjuvant therapy (with or without adjuvant treatment).
