Zev A. Wainberg, MD, discusses recent findings from the NAPOLI 3 trial which were presented at the 2023 Gastrointestinal Cancers Symposium.
Zev A. Wainberg, MD, a professor of medicine at University of California, Los Angeles, and co-director of the UCLA GI Oncology Program, discusses the recent findings from NAPOLI 3 (NCT04083235) which were presented at the 2023 Gastrointestinal Cancers Symposium.
The randomized, open-label, pivotal phase 3 NAPOLI 3 trials is evaluating the combination of irinotecan liposome injection (Onivyde), 5-fluorouracil (5-FU), oxaliplatin, and leucovorin (NALIRIFOX) in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). Patients enrolled in the study were required to be diagnosed 6 or less weeks prior to screening, have at least 1 metastatic lesion measurable by MRI or CT scan per RECIST v1.1 criteria, and have an ECOG performance status of 0 or 1.
Recent findings revealed that treatment with NALIRIFOX improved overall survival and progression-free survival compared with nab-paclitaxel plus gemcitabine in this patient population of previously untreated patients with mPDAC.
0:08 | We presented the top-line results, which included the overall survival, which was statistically significantly improved in the group of patients who've got NALIRIFOX over nab-paclitaxel plus gemcitabine by about 2 months. The median improvement was about 2 months, the hazard ratio is .83, and the P value is .04. The statistics also showed that this progression-free survival was superior with NALIRIFOX over nab-paclitaxel plus gemcitabine. There was no statistically significant difference in response rate, although the response rate was numerically higher with NALIRIFOX, but it did not make statistical significance.
0:48 | The safety of the regimens essentially is a tradeoff, in my opinion, of toxicity between 1 regimen that causes more of the GI toxicity that have been influenced at higher rates of diarrhea and nausea, as opposed to higher rates of cytopenias, which are neutropenia, anemia and thrombocytopenia. Those were seen more commonly in the nab-paclitaxel plus gemcitabine arm. It is a tradeoff of toxicity profiles when one talks to their patients.