Neo‐adjuvant FOLFIRINOX in borderline resectable and locally advanced pancreatic adenocarcinoma

Background Surgery and systemic therapy provide the best option for long‐term cancer control in localized resectable pancreas cancer. The present study assessed the efficacy and safety of neoadjuvant treatment with FOLFIRINOX in patients with borderline resectable (BR) and locally advanced (LA) pancreas cancer (PDAC). Methods This was a prospective noninterventional observational trial of neoadjuvant FOLFIRINOX in BR and LA PDAC. The primary objective was the R0/R1 surgical resection rate. Secondary objectives included progression free survival (PFS) and overall survival (OS), tolerability, and toxicity. Results Forty‐nine patients were enrolled between 2013 and 2019; the majority had LA disease (59.2%). Median age was 61 years, and median Ca 19‐9 level pretreatment was 523.4 μmol/L. Following neoadjuvant FOLFIRINOX, 11 patients (22.5%) underwent surgical resection, the majority of which were BR at diagnosis (72.7%). Median OS and PFS for the entire group were 25 (95% CI: 17.2–32.8) and 12 months (95% CI: 9.7–13.3), respectively. Median PFS in BR patients was 14 (95% CI: 10.5–17.5) compared to 12 months (95% CI: 5.2–18.8) in patients with LA patients. Median OS and PFS were not reached in patients who underwent surgical resection as compared to 22 (95% CI: 18.6–25.4) and 9 months (95% CI: 4.2–13.9) in those who did not, respectively. Grade 3/4 neutropenia, leukopenia, neuropathy, nausea/vomiting, and diarrhea occurred in 6.3%, 2.1%, 10.4%, 4.2%, and 8.3%, respectively. Conclusion Neoadjuvant FOLFIRINOX is an active regimen for patients with LA/BR PDAC with a resection rate of 22.5%. These results are in line with prior data. The manuscript herein reports on a prospective non‐interventional observational study of neo‐adjuvant FOLFIRINOX in patients with locally advanced or borderline resectable pancreatic cancer. This trial represents the first prospective trial in the Middle East of this regimen in this disease. The results of our study are promising with a resection rate of 22.4% in borderline resectable/locally advanced pancreatic cancer. In terms of efficacy, a significantly better progression free survival was achieved in patients who underwent surgical resection. Toxicity and safety results were manageable and in line with reported data. These results are comparable with the reported literature and represent true multidisciplinary care, an approach which requires emphasizing outside the western world.