A multicenter retrospective study of GEM+nab-PTX or FOLFIRINOX in metastatic pancreatic cancer patients: NAPOLEON study

Abstract

Abstract Background Gemcitabine plus nab-paclitaxel (GnP) and FOLFIRINOX (FFX) are both considered as standard chemotherapy for patients with metastatic pancreatic cancer (mPC). However, there are no prospective clinical trials that directly compare these two therapies. We investigate and compare them to support the treatment selection for mPC. Methods: We retrospectively analyzed the patients with mPC who had received GnP or FFX as first-line chemotherapy at 14 institutions in Kyushu. In this study, patient characteristics and clinical outcomes; overall survival (OS), progression-free survival (PFS), overall response rate (ORR), disease control rate (DCR) and adverse events (AEs) were compared. Results: A total of 211 pts were included; GnP 119 pts (73 males and 46 females) and FFX 92 pts (55 males and 37 females). The median age of the FFX group was younger than that of GnP (GnP 68 vs. FFX 61 years). There was neither significant difference in the OS (median: 10.2 vs. 11.1 months, HR 0.98, 95%CI 0.72-1.34, p = 0.91) nor the PFS (median: 5.5 vs. 5.7 months, HR 1.05, 95%CI 0.79-1.40, p = 0.75) between the GnP and FFX group, respectively. Moreover, neither significant difference in the ORR (29% vs. 27%, p = 0.72) nor the DCR (81% vs. 79%, p = 0.25) was seen. There were no significant differences in grade 3/4 neutropenia (55% vs. 58%) and febrile neutropenia (10% vs. 13%). Grade 3/4 peripheral sensory neuropathy (12% vs. 3%) and fatigue (4% vs. 0%) were more frequent with GnP. All grades of rash and alopecia were more frequent with GnP. Otherwise, grade 3/4 anorexia (6% vs. 20%), diarrhea (0% vs. 11%) and nausea (3% vs. 11%) were more with FFX. 64% of the patients with FFX received GnP as second-line, but the rate of patients with FFX followed by GnP was only 10%. Conclusions: There was no significant difference in the effectiveness between GnP and FFX statistically. We need to select the appropriate treatment for each patient, considering that the toxicity profiles differ.