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Background Advanced pancreatic ductal adenocarcinoma (aPDAC) remains a challenging, non-curable disease. FOLFIRINOX regimen is the standard in first-line chemotherapy (L1) in this setting. FOLFOXIRI, a similar schedule with a lower dose of irinotecan and no bolus 5-fluorouracil, has demonstrated efficacy and good tolerance in metastatic colorectal cancer. We aimed to compare clinical outcomes of this two regimens in patients with aPDAC in routine clinical practice. Methods Analyses were derived from all consecutive aPDAC patients treated in L1, between 2011 and 2017 in two French institutions, with FOLFOXIRI (n = 165) or standard (n = 124) regimens. FOLFOXIRI consisted of irinotecan (165 mg/m2), oxaliplatin (85 mg/m2), leucovorin (200 mg/m2) and 5-fluorouracil (3200 mg/m2 as a 48-hour continuous infusion) every two weeks. One hundred pairs of patients were selected through propensity score matching (PSM) analysis and clinical outcomes of the two treatments were compared. Results After a median follow up of 44.1 months, median overall survival (OS) was 11.1 months (95% confidence interval [CI], 9.8 to 13.1) in the FOLFOXIRI group and 11.6 months (95% CI, 10.8 to 15.5) in the FOLFIRINOX group. Median progression free survival (PFS) was 5.8 months (95% CI, 3.9 to 6.9) in the FOLFOXIRI group and 6.7 months (95% CI, 6.0 to 7.7) in the FOLFIRINOX group. After PSM, the survival of patients remained similar between the two regimens in OS (hazard ratio [HR], 0.79; 95% CI, 0.58 to 1.08; P = 0.137) and PFS (HR, 0.80; 95% CI, 0.60 to 1.08; P = 0.139). The objective response rate was 33.3% in the FOLFOXIRI group versus 47.2% in the FOLFIRINOX group, while disease-control rates were 62.8% and 75.3%, respectively (P = 0.129). The grade 3 or 4 toxicities were occurring in 29.0% of patients in FOLFOXIRI group versus 21.3% in FOLFIRINOX group (P = 0.216). FOLFOXIRI was associated with a higher incidence of grade 3 or 4 digestive adverse events compared to FOLFIRINOX group (11.0% versus 5.0%, respectively) but was similar to the safety profile of FOLFIRINOX previously reported in the PRODIGE 4/ACCORD 11 trial. Conclusions FOLFOXIRI is feasible in L1 in patients with aPDAC but does not confer any therapeutic benefit as compared with FOLFIRINOX regimen. Legal entity responsible for the study Besancon University Hospital. Funding Has not received any funding. Disclosure All authors have declared no conflicts of interest. |
