Regorafenib is an oral multikinase inhibitor approved for the treatment of metastatic colorectal cancer and GIST, but clinical activity was observed also in other cancers
This is a single-stage, phase II trial that includes patients (pts) with various types of metastatic cancers refractory to standard treatments. Here we present the results of the pancreatic cohort (mPC). Main inclusion criteria: >1 measurable lesion (RECIST 1.1), ECOG PS
From Jan. 2015 to Jan. 2016, 20 pts were enrolled. Of these 80% received >2 chemotherapy lines (range 1-3). 2–month PFR was 25% (5/20 pts, all stable disease, SD). At a median follow up of 5.3 mos, median PFS and OS were 1.6 mos (range 0.7-5.9) and 3.0 mos (range 1.1-6.1) respectively. Reasons for treatment discontinuation were radiological disease progression (55%), adverse events (AEs) or clinical deterioration (45%). Dose reductions or delays for AEs were required in 35% and 65% of pts respectively. Main G3-4 AEs were hand-foot skin reaction (20%) and hepatic toxicity (10%), and G1-2 AEs were anorexia (60%), fatigue, anemia, diarrhea and fever (40%), hypophosphatemia and hypertension (30%).
Although the primary endpoint was not achieved in this cohort of pts with mPC, SD was observed in 25% of pts.
Clinical trial identification
Legal entity responsible for the study
Humanitas Clinical and Research Centre
L. Rimassa: Member of Advisory Board: Eli Lilly, Merck, Bayer, Amgen, Arqule. A. Santoro: Member of Advisory Board: Bayer. All other authors have declared no conflicts of interest.