Multicenter retrospective analysis for efficacy and safety of liposomal irinotecan (nal-IRI) plus 5-FU/leucovorin (5-FU/LV) after progression on gemcitabine-based therapy in Korean patients (pts) with metastatic pancreatic ductal adenocarcinoma (mPDAC): A study by Korean Cancer Study Group (KCSG).

Abstract

344 Background: Nal-IRI plus 5-FU/LV has demonstrated efficacy in mPDAC pts who previously received gemcitabine-based therapy in the pivotal NAPOLI-1 trial. Real-world data are helpful to measure the clinical outcomes and safety profile of this regimen in daily practice setting. Methods: Between January 2017 and April 2018, a Named Patient Program (NPP) was activated to provide controlled, pre-approval access of nal-IRI in Korea. This analysis is multicenter retrospective study for patients who received nal-IRI plus 5-FU/LV under the NPP. Results: A total of 86 patients entered into this NPP among 10 Korean institutions. Median age was 61 years (range, 37-79) and 52 pts (60%) were male. Liver (n=49, 57%), peritoneum (30, 35%), and lung (27, n=31%) were the most common metastatic sites. All patients had ECOG performance status 0-1 and previously received gemcitabine-based therapy. Prior to nal-IRI plus 5-FU/LV, 35 (41%) and 51 (59%) patients received <2 and ≥ 2 lines of chemotherapy for unresectable/metastatic disease, respectively. Best response was complete response (n=2, 2%), partial response (7, 8%), stable disease (38, 44%), and progressive disease (32, 37%), indicating overall response rates of 10% and disease control rate of 55%. With median follow-up duration of 6.4 months, median progression-free survival (PFS) was 3.5 months (95% CI, 1.3-5.7) and median overall survival (OS) was not yet reached. The 6-month PFS and OS rates were 37.5% and 65.1%, respectively. Most common grade 3-4 toxicities were neutropenia (n=32, 37%), nausea (9, 10%), vomiting (8, 9%), anemia (7, 8%), and diarrhea (4, 5%). Febrile neutropenia occurred in 7 patients (8%). Conclusions: Nal-IRI plus 5-FU/LV was well tolerated and effective for mPDAC patients who progressed on gemcitabine-based therapy. Despite heavily pretreated patients were included, efficacy and safety outcomes in our cohort were consistent with the results of previous NAPOLI-1 trial.