Dr. Ulahannan on the PRODIGE 35 Trial in Pancreatic Cancer

Susanna Ulahannan, MD, assistant professor, Section of Hematology/Oncology, associate director, Oklahoma TSET Phase I Program, Stephenson Cancer Center, The University of Oklahoma, discusses the phase II PRODIGE 35/PANOPTIMOX trial in pancreatic cancer.

In the phase II trial, patients with metastatic disease were randomized to 3 treatment arms in the maintenance setting. They compared continuous FOLFIRINOX in arm A with 8 cycles of FOLFIRINOX and then 5-fluorouracil leucovorin (LV5FU2) as maintenance in arm B, explains Ulahannan. When patients progressed, they went back and gave them FOLFIRINOX again.

Arm C was a gemcitabine-based therapy alternating with FOLFIRI. The randomization showed that alternating gemcitabine with FOLFIRI was inferior. The results showed that arm B was comparable to arm A. Median overall survival (OS) in arms A, B, and C were 10.1 months (95% CI, 8.5-12.2), 11.0 months (95% CI, 8.7-13.1), and 7.3 months (95% CI, 5.7-9.5), respectively. OS rates at 18 months were 18.5%, 28%, and 13.9%, respectively, demonstrating a P value >.05 favoring the use of FOLFIRINOX and LV5FU2 as maintenance therapy.

This is a phase II trial, so it needs phase III data to confirm the results, states Ulahannan. Nonetheless, physicians now have some randomized data to support the use of this maintenance approach in patients who otherwise experience a lot of toxicity.