Multicenter retrospective analysis of original versus modified FOLFIRINOX in metastatic pancreatic cancer: Results of the NAPOLEON study

Nakazawa J. · Tsuruta N. · Shimokawa M. · Kawahira M. · Arima S. · Ido A. · Koga F. · Ueda Y. · Komori A. · Otsu S. · Fukahori M. · Makiyama A. · Taguchi H. · Honda T. · Shibuki T. · Nio K. · Ide Y. · Ureshino N. · Mizuta T. · Otsuka T. · Shirakawa T. · Mitsugi K.

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Article / Publication Details Abstract

Introduction: Original FOLFIRINOX (oFFX) is more toxic than other regimens for patients with metastatic pancreatic cancer (mPC); therefore, a modified FFX (mFFX) regimen with a reduced dosage has been used in Japanese clinical practice. However, very few studies have compared these two regimens. Methods: This study was conducted as part of a multicenter retrospective study of 318 patients with mPC across 14 centers in Japan (NAPOLEON study). To control for potential bias and confounders, we conducted a propensity score-adjusted analysis of patient characteristics and clinical outcomes. Results: oFFX and mFFX were administered to 48 and 54 patients. More patients with younger age and poorer performance status were included in the oFFX group. The overall survival (OS; median, 11.6 vs. 11.3 months; hazard ratio (HR), 0.91; 95% confidence interval (CI), 0.60-1.40; p=0.67), progression-free survival (PFS) (median, 6.3 vs. 5.7 months; HR, 0.85; 95% CI, 0.56-1.28; p=0.44), and overall response rate (29 vs. 26%, p=0.71) were not significantly different for the oFFX and mFFX groups. Thrombopenia and liver dysfunction were significantly more frequent with oFFX than with mFFX. The median received dose intensity of CPT-11 was higher with oFFX than with mFFX (299 vs. 270 mg/m2/week, p

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