A real-world study of the NALIRIFOX regimen in perioperative treatment of borderline resectable and locally advanced pancreatic cancer in China.

Abstract

e16450 Background: Pancreatic cancer is a highly aggressive malignancy with poor prognosis, with only approximately 10% of patients eligible for immediate surgical intervention at diagnosis. Neoadjuvant chemotherapy has demonstrated potential in improving outcomes for patients with borderline resectable pancreatic cancer (BRPC) and locally advanced pancreatic cancer (LAPC). However, no standard treatment has been established. This study aims to evaluate the efficacy and safety of the NALIRIFOX regimen (liposomal irinotecan, oxaliplatin, 5-fluorouracil [5-FU], leucovorin [LV]) in the perioperative treatment of BRPC and LAPC. Methods: This retrospective analysis included 15 patients histologically diagnosed with pancreatic head cancer treated at Chongqing People's Hospital between September 2023 and May 2024. The cohort comprised 12 patients with BRPC and 3 patients with LAPC. The median age was 59.5 years (range 41-78), with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2 (86.7% ECOG PS = 0-1). All patients received four cycles of neoadjuvant chemotherapy with NALIRIFOX regimen (liposomal irinotecan 50 mg/m 2 , oxaliplatin 60 mg/m 2 , 5-FU 2400 mg/ m 2 , LV 400mg/m 2 ), followed by surgery. Four cycles of adjuvant chemotherapy with NALIRIFOX regimen were administered after surgery. Key endpoints included tumor response, R0 resection rate, safety and survival outcomes. Results: Totally 13 patients successfully underwent laparoscopic pancreaticoduodenectomy, with 9 patients requiring portal vein reconstruction. The surgical resection rate was 86.7% (13/15) and the R0 resection rate was 92.3% (12/13). Tumor response evaluation revealed complete response (CR) in 10 patients, partial response (PR) in 3 patients, and stable disease (SD) in 2 patients, resulting in an objective response rate (ORR) of 86.7% and disease control rate (DCR) of 100% according to RECIST 1.1 criteria. 10 patients completed four cycles of adjuvant chemotherapy postoperatively. Among the 13 patients who underwent surgery, the 9-month disease free survival (DFS) rate was 92.3%, and the 1-year DFS rate was 84.6%. Adverse events (AEs) were generally manageable, with the most common grade ≥3 AEs including diarrhea (13.3%) and neutropenia (6.7%). Follow-up is ongoing. Conclusions: The NALIRIFOX regimen demonstrated significant efficacy and tolerability in perioperative treatment for patients with BRPC and LAPC, markedly improving R0 resection rate. These preliminary results are promising, although progression-free survival (PFS) and overall survival (OS) are not reached. Further studies are warranted to confirm these findings.