Dr Shameem on Deciding on NALIRIFOX vs FOLFIRINOX in Superior Pancreatic Cancer

“When I consider dose reduction, it gives me comfort to know that I know what I’m doing is what the [NAPOLI 3] trial did, [which demonstrated] efficacy [of a given agent in a given population].”

Raji Shameem, MD, a medical oncologist and hematologist at Orlando Health Cancer Institute, mentioned scientific concerns for choosing NALIRIFOX (liposomal irinotecan [Onivyde], 5-fluorouracil, leucovorin, and oxaliplatin) vs FOLFIRINOX (leucovorin, fluorouracil, irinotecan, and oxaliplatin) for the frontline remedy of sufferers with superior pancreatic most cancers.

He emphasised the significance of aligning dosing methods with these utilized in pivotal trials, noting that trial-based protocols for dose reductions present a framework that ensures remedy efficacy is maintained and minimizes the dangers related to empiric, untested modifications. Findings from the section 3 PRODIGE 24 trial (NCT01526135), which evaluated modified FOLFIRINOX (mFOLFIRINOX) in sufferers with resected pancreatic adenocarcinoma, demonstrated efficacy in a comparatively youthful affected person inhabitants, as all sufferers within the mFOLFIRINOX arm of this trial have been youthful than 80 years of age, he mentioned.

In distinction, the section 3 NAPOLI-3 trial (NCT04083235) of NALIRIFOX in sufferers with beforehand untreated metastatic pancreatic most cancers enrolled a broader inhabitants with out age restrictions, with the oldest enrolled affected person being 85 years of age, and roughly 6% of members 75 years of age or older, he defined. According to Shameem, this distinction between the trials is especially related in follow settings with a excessive proportion of older sufferers, because it offers reassurance that efficacy and security outcomes with NALIRIFOX have been noticed throughout a extra inclusive age vary.

Regarding affected person choice, Shameem underscored efficiency standing as a important determinant. He famous that though each NALIRIFOX and FOLFIRINOX are affordable for sufferers with good efficiency standing, the usage of regimens composed of a number of medication in sufferers with an ECOG efficiency standing of two or larger might result in extra toxicity with out proportional scientific profit. He added that this consideration is especially necessary in older sufferers, the place the steadiness between tolerability and efficacy have to be fastidiously assessed.

According to Shameem, the enrollment of older adults within the NAPOLI-3 trial helps the real-world applicability of NALIRIFOX, significantly in older populations typically underrepresented in pancreatic most cancers trials. He burdened that chronological age shouldn’t be the only issue guiding remedy choice and that trial knowledge demonstrating the security and efficacy of NALIRIFOX in older sufferers present further confidence for oncologists contemplating intensive regimens on this group.