TL41: Beyond RECIST, enhancing the clinical relevance of
Progression-Free Survival in oncology *James T Love, Boehringer
Ingelheim Pharmaceuticals   Keywords: oncology, PFS, RECIST
criteria, progression-free survival  Let's discuss ways to
enhance the clinical relevance of PFS. RECIST has been shown to
be a powerful tool to assess anti-cancer activity. However, some
trials have shown large effects on PFS (HR<0.50) without any
effect on survival. Oncologists have noted that patients are
often asymptomatic when they progress. Declaring progression too
early might distance progression from death. Under what
circumstances is there a place for an alternative to RECIST, or
an additional intermediate measure of progression between RECIST
and death? What do you think of changes, such as requiring an
increase above baseline, or requiring that symptoms accompany
progression of non-target or new lesions? What experience have
you had with alternative progression criteria, such as the
Immune Criteria in melanoma, the MacD