Researchers participating in HCRN GI14-198, recently reported findings in the European Journal of Cancer. The study was a phase II randomized, double-blind study of mFOLFIRINOX plus ramucirumab versus mFOLFIRINOX plus placebo in advanced pancreatic cancer patients.

Vascular endothelial growth factor receptor (VEGFR)-mediated signaling contributes to andgiogenesis and therapy resistance in pancreatic ductal adenocarcinoma (PDAC). Ramucirumab (RAM) is a VEGFR2 monoclonal antibody. Investigators conducted a randomized phase II trial to compare progression-free survival between mFOLFIRINOX with or without RAM in first line therapy of metastatic PDAC.

This phase II randomized, multi-center, placebo controlled, double-blinded, trial randomly assigned to recurrent/metastatic PDAC patients to either mFOLFIRINOX/RAM (Arm A) or mFOLFIRINOX/placebo (Arm B). The primary endpoint is PFS at 9 months, and the secondary endpoints include overall survival , response rate and toxicity evaluation.

The investigators found that the addition of RAM to FOLFIRINOX did not significantly impact progression free survival or overall survival. The combination was well tolerated.

Read the abstract

Authors: Walid L. Shaib, Rupji Manali, Yuan Liu, Bassel El-Rayes, Patrick Loehrer, Bert O’Neil, Steven Cohen, Tina Khair, Erwin Robin, Timothy Huyck, Tanios Bekaii-Saab

Institutions:  Community Healthcare System, Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Mayo Clinic – Arizona, Nebraska Methodist Hospital, Pennsylvania Cancer Specialists & Research Institute, Thomas Jefferson University Kimmel Cancer Center, University of Louisville James Graham Brown Cancer Center, Winship Cancer Institute of Emory University.