The Efficacy and Safety of Nab-Paclitaxel Plus Gemcitabine versus mFOLFIRINOX in the First-Line Treatment of Metastatic Pancreatic Cancer: A Retrospective Study. 

Background: Nab-paclitaxel plus Gemcitabine (AG) and modified FOLFIRINOX (FFX) are two systemic therapies that have been widely used as standard first-line chemotherapy regimens in metastatic pancreatic cancer. However, since there is no clinical trial to directly compare the efficacy and safety of the two regimens, it is not clear which regimen is more effective. In this study, we aim to examine and compare the efficacy and safety of AG and FFX as first-line chemotherapy regimens in Chinese patients with metastatic pancreatic cancer in a real-world setting. Methods We retrospectively evaluated the outcomes of 41 patients who diagnosed with metastatic pancreatic cancer and were treated with either AG ( n  = 21) or FFX ( n  = 20) as first-line chemotherapy between March 2017 and February 2022 at Zhongnan hospital of Wuhan University. Results Of 41 patients in this study, 21 were treated with AG and 20 were treated with FFX as first-line chemotherapy. No significant differences in baseline characteristics were found between the two groups. The objective response rate (ORR)was 14.3% in the AG group and 20.0% in the FFX group. The disease control rate (DCR) was 71.4% in the AG group and 60.0% in the FFX group. There was no significant difference in PFS or OS between the AG group and the FFX group.The median progression-free survival (PFS) was 5.27 months (95% confidence interval [CI], 4.08–6.46) in the AG group and 3.67 months (95% CI, 2.28–5.05, p = 0.192)in the FFX group.The median overall survival (OS) was 10.03 months (95% CI, 7.33–12.63) in the AG group and 9.02 months (95% CI,6.02–11.98, p = 0.464) in the FFX group.The second-line treatment rate was 47.1% in the AG group and 55.0% in the FFX group. Immune checkpoint inhibitors (ICIs) based regimens are common second-line treatment options whether in AG or FFX group. Significantly more grade 3–4 peripheral neuropathy occurred in the AG than the FFX groups (4 (19.0%) vs 0 (0.0%), p = 0.040*).The patients in the PNI(Prognostic nutrition index) ≥ 45 group had a significant longer median OS (PNI ≥ 45 vs PNI < 45: 10.34 vs 6.90 mo, P = 0.005). Conclusion AG and FFX showed comparable efficacy outcomes in patients with metastatic pancreatic cancer. Pancreatic cancer patients receiving first-line chemotherapy with good nutritional status are likely to have a better prognosis.