"Progression-free survival (PFS) is increasingly used as an important and even a primary endpoint in randomized cancer clinical trials in the evaluation of patients with solid tumors, because of both practical and clinical considerations. Although in its simplest form PFS is the time from randomization to a pre-defined endpoint, there are many factors that can influence the exact moment of when disease progression is recorded. In this overview, we review the circumstances that can devalue the use of PFS as a primary endpoint, and attempt to provide a pathway for a future desired state when PFS will become not just a secondary alternative to overall survival but rather an endpoint of choice."
https://www.ncbi.nlm.nih.gov/pmc/articl ... 458946.pdf
Overview: Progression-Free Survival as an Endpoint in Clinical Trials with Solid Tumors
Re: Overview: Progression-Free Survival as an Endpoint in Clinical Trials with Solid Tumors
The idea of using PFS instead of OS as a primary endpoint in randomized cancer clinical trials is increasingly popular with the pharma companies but I am really concern about it if it leads to approval of the drug. There are numerous cases when the PFS looks good but in reality the OS with the drug can be decreasing (when PFS is increasing), if there is an increased speed of growth after the initial response and prolonged PFS. As it stands now, the companies often happily report the interim result with the PFS increased and hide the end results with the OS decreasing - they can come out much later like 1-2 years alter than the PFS results.
Olga