692P - Regorafenib in patients with refractory metastatic pancreatic cancer. An open-label phase II study (RESOUND)

Date 08 October 2016
Event ESMO 2016 Congress
Session Poster Display
Topics Pancreatic Cancer
Presenter Silvia Bozzarelli
Citation Annals of Oncology (2016) 27 (6): 207-242. 10.1093/annonc/mdw371
Authors S. Bozzarelli1, L. Rimassa1, L. Giordano1, S. Sala1, M.C. Tronconi1, M. Baretti1, N. Personeni1, T. Pressiani1, A. Santoro2
  • 1Humanitas Cancer Center, Humanitas Clinical and Research Center, 20089 - Rozzano/IT
  • 2Humanitas Cancer Center, Humanitas Clinical And Research Center, Humanitas University, 20089 - Rozzano/IT

Abstract

Background

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

Methods

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

Results

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%).

Conclusions

Although the primary endpoint was not achieved in this cohort of pts with mPC, SD was observed in 25% of pts.

Clinical trial identification

NCT01892527

Legal entity responsible for the study

Humanitas Clinical and Research Centre

Funding

Bayer

Disclosure

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.