Efficacy of liposomal-irinotecan (nal-IRI) plus 5-fluorouracil/folinic acid (5-FU/LV) versus oxaliplatin plus fluoropyrimidines in previous gemcitabine treated pancreatic adenocarcinoma (PAC) patients (pts).
383 Background: The chemotherapy regimens nal-IRI plus 5-FU/LV as well as oxaliplatin plus fluoropyrimidines are used after previous gemcitabine based chemotherapy in the 2nd line treatment of metastatic PAC. We aimed to compare the clinical efficacy of these two treatment options. Methods: In this single institutional retrospective cohort analysis all pts with advanced PAC that were treated between 01/2012-08/2018 with nal-IRI plus 5-FU/LV or oxaliplatin plus fluoropyrimidines after previous 1st line gemcitabine based chemotherapy were analysed for clinical parameters, median progression free survival (mPFS) and overall survival (mOS). Survival analyses were performed by Kaplan-Meier method. Results: Characteristics of pts were well matched (Table). mPFS in pts (n=30) that received nal-IRI plus 5-FU/LV in the 2nd line treatment after gemcitabine based chemotherapy was 4.49 months while treatment with oxaliplatin plus fluoropyrimidines (n=31) resulted in a mPFS of 3.44 months (p=0.007, HR 0.47, 95% CI 0.27-0.81). Furthermore, pts with a CA 19-9 level >1000 kU/l at the beginning of 2nd line treatment had a significantly improved mPFS and mOS, when treated with nal-IRI plus 5-FU/LV compared to oxaliplatin plus fluoropyrimidines (mPFS 4.94 months versus 3.44 months, p=0.0186, HR 0.42, 95% CI 0.18-0.98; mOS 9.31 months versus 6.16 months, p=0.0386, HR 0.43, 95% CI 0.18-1.02). Conclusions: The efficacy of nal-IRI plus 5-FU/LV in our study is encouraging and outperforms oxaliplatin-based chemotherapy in the 2nd line treatment setting for PAC pts pretreated with gemcitabine. Prospective randomized trials are urged to validate our observation. [Table: see text]