160P - Interim analysis of the NAPOLEON-2 study: Safety evaluation of nano-liposomal irinotecan with fluorouracil and folinic acid for advanced pancreatic cancer

Background

Nano-liposomal irinotecan with fluorouracil and folinic acid (NFF) is a standard treatment for advanced pancreatic cancer after gemcitabine-based chemotherapy. However, there are limited clinical data on its efficacy and safety. We therefore initiated the NAPOLEON-2 study. Imajima et al. have reported the final results of the retrospective portion of the study (ASCO GI, 2023). Here, we report on the pre-planned interim analysis of the prospective portion, focusing on safety.

Methods

This study is an ongoing multicenter observational study that took place in June 2021, with a target number of 150 cases. The primary endpoint was overall survival, with secondary endpoints including response rate, disease control rate, progression-free survival, dose intensity, and adverse events (AEs). According to the protocol regulation, an interim analysis was conducted once reaching half the number of target cases to verify the validity of further enrollment.

Results

The median follow-up period was 5.3 months. The median age was 71 years (range, 45–83), and the study included seven locally advanced cancer cases. Liver (43), peritoneum (28), and lung (21) were the most common metastatic sites. NFF was administered as a 2nd/3rd/4th- or later-line therapy to 44/25/6 cases, respectively. All patients had previously received gemcitabine-based therapy. For the initial dose, nano-liposomal irinotecan (NAL-IRI) or fluorouracil (FU) was reduced in 41 and 26 cases, respectively, mainly because of organ function (17%) and age (15%). Grade 3/4 hematological or non-hematological AEs occurred in 24 and 29 cases, respectively. Frequently observed grade 3/4 AEs were neutropenia (26%) and anorexia (16%). The median relative dose intensity was 71.5% for NAL-IRI and 82.9% for FU. Dose reduction during treatment was observed in 35 cases with NAL-IRI and 34 cases with FU, mainly from neutropenia (19%) and anorexia (13%).

Conclusions

These results reproduced the retrospective portion in the safety of NFF, validating this interim analysis. NFF was safely administered in practical clinical settings, so we determined that enrollment should be continued.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.