152P - Interim analysis of the NAPOLEON-2 study: Safety evaluation of nanoliposomal irinotecan with fluorouracil and folinic acid for unresectable pancreatic cancer patients with prior biliary drainage

Background

Nanoliposomal irinotecan with fluorouracil and folinic acid (Nal-IRI/FU/LV; NFF) is a standard treatment after gemcitabine-based chemotherapy for unresectable pancreatic cancer (uPC) patients (pts). However, there has been no data comparing safety between prior biliary drainage (BD) and non-BD (NBD). Therefore, we conducted such a study and report the results of the interim sub-analysis.

Methods

As part of a pre-planned interim analysis of a multicenter prospective observational study from June 2021, we analyzed the patient characteristics and clinical outcomes of uPC pts associated with safety; adverse events (AEs), dose modification, and relative dose intensity between patients in the BD and NBD groups. This analysis was conducted on attaining 50% of the target cases.

Results

The median follow-up period was 5.3 months. Of the 75 pts, NFF was administered to the 19 pts in the BD group and the 56 pts in the NBD group. The BD group was significantly younger (p=0.049), included more locally advanced disease (p=0.04) and pancreatic head cases (p<0.01), and the duration of their previous treatment was shorter (p=0.02) compared with the NBD group. The median relative dose intensities in the BD and NBD groups of Nal-IRI were 78.1% and 69.8% (p=0.21) and of FU 89.9% and 80.4% (p=0.23), respectively. For the initial dose, 42% and 59% of pts in the BD and NBD groups needed Nal-IRI dose reduction, respectively (p=0.53). The rates of dose reduction during NFF did not differ in Nal-IRI or in FU, and those of discontinuation of NFF due to AEs were similar in the two groups (7% vs 8%). The rate of grade 3/4 non-hematological AEs was higher in the BD group (63% vs 30%; p=0.01), whereas that of hematological AEs was equivalent (32% vs 32%; p=0.96). Frequent grade 3/4 AEs in the BD group were neutropenia (26%), anemia (16%), and fatigue (15%). Additionally, biliary tract infections were observed only in the BD group (16%, p<0.01).

Conclusions

NFF more frequently caused severe non-hematological AEs and biliary tract infections in the BD group. Therefore, more attention should be paid to pts with prior BD for safety.

Clinical trial identification

Editorial acknowledgement

We thank Robert Blakytny, DPhil, from Edanz for editing a draft of this abstract.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.