So today I called for Progression Free Survival (PFS) to be renamed as Progression Free Duration (PFD) because “improved PFS” incorrectly sends out a signal to patients that survival is prolonged— when in reality it may or may not be prolonged & can even be worse. @TheLancetOncol
Simply points for #IMW2019 attendees to keep in mind.
- Ph II studies are a hypothesis — not proof
- “Activity” is not = clinical benefit.
- Clinical benefit = improved OS or validated PRO; plus safety
- PFS, MRD-, CR = Surrogate end points @TheLancetthelancet.com/journals/lance…
Survival with TKI's 2-fold worse in patients who have the highest out of pocket cost! Seen in patients with Medicare! Congratulations on great study Dr. Goulart, @ScottDRamsey @junger47 #ASCOQLTY19