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

Date

08 Oct 2016

Session

Poster Display

Presenters

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

Author affiliations

  • 1 Humanitas Cancer Center, Humanitas Clinical and Research Center, 20089 - Rozzano/IT
  • 2 Humanitas Cancer Center, Humanitas Clinical And Research Center, Humanitas University, 20089 - Rozzano/IT
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Resources

Abstract 3602

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.

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