Dr. Katz on Neoadjuvant mFOLFIRINOX in Pancreatic Cancer

Matthew H. G. Katz, MD, CMQ, FACS, FASCO, professor, chair, the Department of Surgical Oncology, the Division of Surgery, The University of Texas MD Anderson Cancer Center, discusses the efficacy of mFOLFIRINOX, a chemotherapy regimen consisting of oxaliplatin, irinotecan, leucovorin, and fluorouracil, prior to pancreatectomy in patients with borderline resectable pancreatic cancer.

The phase 2 A021501 trial (NCT02839343) aimed to investigate the efficacy of mFOLFIRINOX and the efficacy of mFOLFIRINOX followed by hypofractionated radiation therapy, with a primary end point of 18-month overall survival (OS) compared with a preselected historical OS control rate of 50%. Accrual to the radiation therapy arm closed early due to futility. The neoadjuvant mFOLFIRINOX alone arm demonstrated a Kaplan-Meier–estimated 18-month survival rate of 66.7%, exceeding the control rate.

The chemotherapy-alone arm was associated with a median OS of 29.8 months, Katz says. This arm of the A021501 trial showed a survival rate superior to the historical control rate, confirming that neoadjuvant mFOLFIRINOX should be further studied in pancreatic cancer, such as in combination with novel therapeutics, Katz explains.

Since the radiation arm did not fully accrue, it could not be statistically evaluated, so the role of neoadjuvant radiation therapy in pancreatic cancer is still unclear, Katz concludes.