Mixture therapy with liposomal irinotecan, 5-fluorouracil, leucovorin, and oxaliplatin (NALIRIFOX) outperformed therapy with nab-paclitaxel and gemcitabine (Gem-NabP) in sufferers with metastatic pancreatic ductal adenocarcinoma within the NAPOLI-3 trial.
NALIRIFOX improved each progression-free survival (PFS) and general survival (OS), in contrast with Gem-NabP, for sufferers who had no prior therapy within the metastatic setting.
These outcomes have been offered on the 2023 ASCO Gastrointestinal Cancers Symposium by Zev A. Wainberg, MD, of UCLA Santa Monica Medical Heart.
Proceed Studying
The part 3 NAPOLI-3 trial (ClinicalTrials.gov Identifier: NCT04083235) included 770 sufferers with pancreatic ductal adenocarcinoma not beforehand handled within the metastatic setting. Sufferers have been randomly assigned to obtain NALIRIFOX (n=383) or Gem-NabP (n=387) till illness development or toxicity.
The median age was 64 years within the NALIRIFOX arm and 65 years within the Gem-NabP arm. Greater than half of sufferers have been males (53.3% and 59.4%, respectively), most have been White (82.2% and 83.7%), and most had liver metastasis (80.2% and 80.4%).
The target response charge was larger within the NALIRIFOX arm than within the Gem-NabP arm (41.8% and 36.2%, respectively). The entire response charge was 0.3% in each arms.
About half of sufferers in every arm obtained subsequent anticancer remedy (50.5% within the NALIRIFOX arm and 54.4% within the Gem-NabP arm).
Sufferers within the NALIRIFOX arm had considerably longer PFS and OS. The median OS was 11.1 months within the NALIRIFOX arm and 9.2 months within the Gem-NabP arm (hazard ratio [HR], 0.83; 95% CI, 0.70-0.99; P =.04). The median PFS was 7.4 months and 5.6 months, respectively (HR, 0.69; 95% CI, 0.58-0.83; P <.0001). In subgroup analyses, NALIRIFOX was usually favored over Gem-NabP for each survival outcomes. PFS was considerably higher with NALIRIFOX throughout all subgroups besides amongst sufferers with 2 metastatic websites or with an ECOG efficiency standing of 1. The speed of treatment-related adversarial occasions (TRAEs) was 95.1% within the NALIRIFOX arm and 92.9% within the Gem-NabP arm. The speed of grade 3 or larger TRAEs was 70.8% and 68.1%, respectively. The speed of deadly TRAEs was 1.6% and a pair of.1%, respectively. The two regimens had completely different security profiles, with NALIRIFOX recipients usually experiencing extra non-hematologic toxicities (eg, diarrhea, nausea, vomiting, and hypokalemia) and Gem-NabP recipients reporting extra hematologic toxicities (eg, neutropenia, anemia, and thrombocytopenia). “These outcomes help the NALIRIFOX routine as a brand new reference routine for the first-line therapy of sufferers with metastatic pancreatic most cancers and hopefully one thing we are able to construct off of sooner or later,” Dr Wainberg concluded. Disclosures: This analysis was supported by Ipsen. Some research authors declared affiliations with biotech, pharmaceutical, and/or system corporations. Please see the unique reference for a full checklist of disclosures. Reference Wainberg ZA, Melisi D, Macarulla T, et al. NAPOLI-3: A randomized, open-label part 3 research of liposomal irinotecan + 5-fluorouracil/leucovorin + oxaliplatin (NALIRIFOX) versus nab-paclitaxel + gemcitabine in treatment-naïve sufferers with metastatic pancreatic ductal adenocarcinoma. ASCO GI 2023. January 19-21, 2023. Summary LBA661.