Abstract 259P
Background
This study aims to evaluate the efficacy and safety of liposomal irinotecan-based regimens in Chinese patients with unresectable advanced pancreatic cancer in real-world.
Methods
This study is an observational real-world study. Cohort 1 is a concurrent controlled study with data from patients treated with liposomal irinotecan-based regimens (experimental group) compared with those treated with albumin-bound paclitaxel plus gemcitabine (AG regimen, control group). Cohort 2 observes second-line patients who receiving liposomal irinotecan-based regimens. The primary endpoint is progression-free survival (PFS), and secondary endpoints include objective response rate (ORR) , overall survival (OS), and safety.
Results
As of July 1, 2024, we analyzed 168 subjects' data, with 63 in Cohort 1 (45 in the experimental group and 18 control group) and 105 in Cohort 2. Baseline characteristics were generally balanced between the two groups in Cohort 1. The most common treatment regimens in the experimental group were liposomal irinotecan plus oxaliplatin plus fluoropyrimidines (55.6%) and liposomal irinotecan plus fluoropyrimidines (26.7%). 12 subjects in the experimental group and 15 in the control group had at least one tumor assessment, ORR was 26.7% and 8.3% respectively. Neither group reached median PFS nor OS. The incidence rates of adverse events (AEs) in the experimental group and the control group were 51.6% and 44.4%, and the incidence rates of ≥ grade 3 AEs were 6.7% and 5.6% respectively. In Cohort 2, 35 subjects underwent at least once imaging evaluation, 5 (14.3%) of them achieved partial response. 15 subjects experienced disease progression or death, resulting in a median PFS of 4.24 months (95% CI: NA). Five patients died, with median OS not reached yet. During treatment, 91 patients (86.7%) experienced AEs, and 28 (26.7%) experienced ≥ grade 3 AEs. There were no unexpected AEs or Grade 5 treatment-related AEs.
Conclusions
This study demonstrated that liposomal irinotecan-based regimens showing promising efficacy and manageable safety profiles for unresectable advanced pancreatic cancer in Chinese patients. Further research and ongoing follow-up are recommended.
Clinical trial identification
ChiCTR2300078041.
Editorial acknowledgement
Legal entity responsible for the study
Fudan University Shanghai Cancer Center.
Funding
CSPC Ouyi Pharmaceutical Co., Ltd.
Disclosure
All authors have declared no conflicts of interest.