Irinotecan liposome in Chinese patients with advanced pancreatic cancer: A prospective, multicenter, observational real-world study.

Abstract

e16380 Background: The NAPOLI-1 study established the efficacy of irinotecan liposome combined with 5-FU/LV regimen in the second-line treatment of metastatic pancreatic cancer. However, this randomized controlled trial was conducted globally, with limited Asian participants. The aim of this study is to evaluate the efficacy and safety of the irinotecan liposome-based regimen in Chinese patients with advanced pancreatic cancer. Methods: This is a real-world observational study. Cohort 1 comprised subjects receiving first-line treatment, while Cohort 2 was designed to observe subjects receiving second-line treatment, including those administered the irinotecan liposome-containing regimen. The primary endpoint was progression-free survival (PFS), and secondary endpoints included the objective response rate (ORR) according to RECIST v1.1, overall survival (OS), and safety. In this abstract, the results from Cohort 2 were analyzed. Results: From October 11, 2023 to December 30, 2024, a total of 177 subjects were enrolled in Cohort 2, included 108 males (61.0%) and 69 females (39.0%). The median age of participants was 61.0 years, with a range from 38.0 to 83.0 years, and the median CA19-9 value was 387.0 U/ml, with a range of < 0.6 to 108,677.0. The most commonly used regimen for front-line treatment was albumin-bound paclitaxel plus gemcitabine (65.0%). The frequently utilized regimens included irinotecan liposome combined with fluorouracil (89/177, 59.3%) and irinotecan liposome combined with oxaliplatin and fluorouracil (42/177, 23.7%). The median treatment duration was 2.2 months (95%CI: 1.2 to 3.1), and the median dose of irinotecan liposome was 52.4 mg/m 2 . A total of 57 subjects received at least one imaging evaluation. The number of patients who achieved partial response (PR) and disease stability (SD) was 7 and 30, respectively, with an ORR of 12.3% (95% CI: 5.1 to 23.7) and a DCR of 64.9% (95% CI: 51.1 to 77.1). The mPFS was 6.0 months (95% CI: 4.7 to 7.4). A total of 11 patients died and the mOS has not yet been reached. Treatment-related adverse events (TRAEs) occurred in 102 patients (57.6%) during the treatment period, and 25 patients (14.1%) experienced ≥ grade 3 TRAEs. The most common (> 10%) TRAEs were: anemia (24.9%), nausea (17.5%), hypoalbuminemia (13.6%) and leucopenia (12.4%). There were no unexpected AEs. Conclusions: The results of this real-world study showed that irinotecan liposome-based regimens are effective and safe in the second-line treatment of advanced unresectable pancreatic cancer, which deserves further treatment and follow-up. Clinical trial information: ChiCTR2300078041 .