Immediate results of neoadjuvant chemotherapy with mFOLFIRINOX regimen in patients with resectable pancreatic cancer

The aim of the study was to evaluate of the efficacy and safety of neoadjuvant chemotherapy (nCT) with mFOLFIRINOX regimen for treating patients with resectable pancreatic cancer. 
Material and Methods. Since 2020, a prospective phase II clinical trial that tests the effectiveness of mFOLFIRINOX chemotherapy followed by radical surgery compared to surgery followed by chemotherapy has been conducted at Pavlov First Saint Petersburg State Medical University for patients with resectable pancreatic cancer. A preliminary analysis of the immediate treatment outcomes has been presented. As of September 2024, 80 patients were included in the study (standard treatment group: n=41, nCT group: n=39). Patients in the standard treatment group underwent radical surgery followed by mFOLFIRINOX aCT (oxaliplatin 85 mg/m2 IV for 120 min, irinotecan 150 mg/m2 IV for 90 min, calcium folinate 400 mg/m2 IV for 120 min, 5-fluorouracil 2400 mg/m2 IV infusion for 46 hours every 2 weeks) for 12 cycles; patients in the experimental treatment group underwent tumor verification at the first stage (endosonography-guided fine-needle aspiration biopsy with subsequent cytological examination or percutaneous biopsy), after which 6 cycles of mFOLFIRINOX nCT and radical surgery followed by mFOLFIRINOX aCT were performed for 6 cycles. The immediate surgical outcomes, complications and mortality rates were assessed. 
Results. A statistically significant superiority of the nCT group over the standard treatment group was revealed in the following indicators: frequency of portal and/or superior mesenteric vein resections – 10.2 vs 21.9 % (OR 0.44, 95 % CI [0.149–1.329] p=0.04), R0 resections – 88.5 vs 73.2 % (OR 0.6, 95 % CI [0.118–0.909], p=0.03), lymphovascular invasion – 52.6 vs 14.8 % (OR 0.28, 95 % CI [0.108–0.730] p=0.05), microvascular invasion – 55.2 vs 11.1 % (OR 0.26, 95 % CI [0.1–0.669] p=0.01), perineural invasion – 65.7 vs 37 % (OR 0.56, 95 % CI [0.327–0.969] p=0.01), frequency of negative lymph node status (pN0) – 73.1 vs 41.5 % (OR 0.61, 95 % CI [0.331–0.969] p=0.009). Conclusion. nCT is a promising and safe method that can improve immediate treatment outcomes in patients with resectable pancreatic cancer.

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