Abstract 160P
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.
Resources from the same session
298P - Managing locally advanced cervical cancer: Insights from a tertiary care center and a 3-year follow-up on outcomes
Presenter: Ambedkar Yadala
Session: Poster Display
Resources:
Abstract
299P - Sexual dysfunction assessment in longterm survivors of carcinoma cervix using LENT SOMA scale
Presenter: Niharika Sethi
Session: Poster Display
Resources:
Abstract
300P - Assessing ovarian function in Vietnamese cervical cancer patients who underwent ovary transposition prior to pelvic radiation therapy
Presenter: Cuong Nguyen
Session: Poster Display
Resources:
Abstract
301P - Correlation between cervical cancer recurrence after radiation therapy and vaginal microbiome
Presenter: Xiaoxian Xu
Session: Poster Display
Resources:
Abstract
302P - Expression of ERCC4 gene and its correlation with clinical and pathological parameters in cervical cancer
Presenter: Himanshu Mishra
Session: Poster Display
Resources:
Abstract
303P - Prognostic value of body composition and systemic inflammatory markers in patients with locally advanced cervical cancer following chemoradiotherapy
Presenter: Hui Guo
Session: Poster Display
Resources:
Abstract
305P - A real-world multicenter cohort study of lenvatinib (LEN) plus pembrolizumab (PEM) in Japanese patients with endometrial cancer: Interim analysis of GOGO-EM4 study
Presenter: Yoshikazu Nagase
Session: Poster Display
Resources:
Abstract
306P - Adjuvant treatment and impact on relapse in stage IA uterine papillary serous and clear cell carcinomas: A single center retrospective study
Presenter: Sachin Khurana
Session: Poster Display
Resources:
Abstract
307P - Hormonal therapy vs combination chemotherapy in metastatic leiomyosarcomas: A systematic review
Presenter: Patricia Angel
Session: Poster Display
Resources:
Abstract
309P - Expression of estrogen receptor is a negative predictive biomarker for immunotherapy with lenvatinib plus pembrolizumab for advanced endometrial cancer with pMMR
Presenter: Hiroyuki Fujii
Session: Poster Display
Resources:
Abstract