Abstract 252P
Background
The FOLFOXIRI regimen is a standard first-line treatment for unresectable pancreatic ductal adenocarcinoma (UPDA). Capecitabine, an oral prodrug of fluorouracil, offers a convenient and safe alternative. This study aims to evaluate the efficacy and safety of the XELOXIRI regimen (capecitabine, oxaliplatin, and irinotecan) in Chinese patients with UPDA.
Methods
This retrospective study analyzed consecutive patients receiving XELOXIRI biweekly as first-line chemotherapy for UPDA : capecitabine 1000 mg/m2 orally twice daily on days 1 to 7, combined with intravenous oxaliplatin 85 mg/m2 and irinotecan 150 mg/m2 on day 1. The primary endpoint was objective response rate (ORR). Secondary endpoints included overall survival (OS), progression-free survival (PFS), and adverse events (AEs).
Results
Thirty-seven patients were included with a median age of 60 years (range, 43-71), including 23 males and 14 females. Fifteen had unresectable locally advanced disease at diagnosis, while 22 had unresectable metastatic disease. As of June 30, 2024, the median follow-up was 27.5 months. The median treatment duration was 5 cycles (range, 3-10). Disease progression was observed in 27 patients, with 20 deaths. Fourteen patients achieved partial response, fifteen had stable disease, and eight experienced progressive disease. The ORR was 37.8%, and the disease control rate was 78.4%. Five patients underwent radical surgery following XELOXIRI, with one achieving a pathological complete response. Median OS for the entire population was 12.2 months (95% CI: 9.8-NA), and median PFS was 6.4 months (95% CI: 5.3-10.6). Among those undergoing radical surgery, median OS was not reached, and median PFS was 11.5 months (95% CI: 5.5-NA). Treatment-related AEs (TRAEs) of any grade occurred in 34 patients (91.9%), with Grade 3 or higher TRAEs observed in 17 patients (46.0%), including neutropenia (21.6%), thrombocytopenia (8.1%), nausea and vomiting (8.1%), elevated transaminase (2.7%), and anemia (2.7%). All Grade 4 TRAEs were neutropenia, with no Grade 5 TRAEs or deaths.
Conclusions
The XELOXIRI regimen demonstrates significant efficacy and manageable toxicity in treating UPDA, providing a convenient alternative to FOLFOXIRI.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Beijing Weiai Public Welfare Foundation.
Disclosure
All authors have declared no conflicts of interest.