BACKGROUND: The 5-fuorouracil, oxaliplatin and irinotecan (FOLFOXIRI) regimen is the standard first-line treatment for advanced pancreatic cancer (APC). Capecitabine, an oral prodrug of 5-fluorouracil, offers a more convenient and potentially safer alternative. We evaluated the efficacy and safety of the XELOXIRI regimen (capecitabine, oxaliplatin, irinotecan) in Chinese patients with APC. METHODS: This real-world study evaluated consecutive patients treated with the XELOXIRI regimen as first-line chemotherapy for APC at a national cancer center in China from August 2019 to June 2024. Treatment efficacy was assessed using the objective response rate (ORR), overall survival (OS), and progression-free survival (PFS), and safety was assessed using adverse events (AEs). RESULTS: Fifty-six patients were enrolled (median age, 60 years [range, 33-71]
35 males, 21 females). Seventeen had locally advanced unresectable disease and 39 had metastatic disease. After a median follow-up of 19.8 months, the ORR was 33.9% (95% confidence interval [CI]: 21.8-47.8), disease control rate was 82.1% (95% CI: 69.6-91.1), and median response duration was 6.2 months (95% CI: 3.6-NA). Six patients with locally advanced disease and one with lung metastasis underwent R0 resection, with one achieving a pathological complete response. Median OS for the entire cohort was 16.2 months (95% CI: 10.6-23.2) and median PFS was 6.3 months (95% CI: 5.3-9.0). OS rates at 6, 12, and 18 months were 92.2%, 56.7%, and 35.6%, respectively
PFS rates were 53.9%, 20.2%, and 6.7%. For those who underwent R0 resection, median OS was not reached and median PFS was 12.3 months (95% CI: 11.9-NA).Treatment-related AEs (TRAEs)occurred in 94.6% of patients, with Grade 3 or higher TRAEs in 44.6%. No Grade 5 TRAEs or treatment-related deaths were observed. CONCLUSION: The XELOXIRI regimen demonstrated promising efficacy and manageable toxicity in the treatment of APC, providing a practical alternative to FOLFOXIRI, with similar outcomes and easier administration.