The effectiveness and safety of nanoliposomal irinotecan with fluorouracil and folinic acid (NFF) in patients with unresectable or recurrent pancreatic cancer with or without prior biliary drainage (BD) or on-treatment biliary tract infection (BTI) in the real world are unclear. Pancreatic cancer can lead to BTIs, and having a BTI during chemotherapy may require antibiotics or biliary intervention, interrupt treatment, and reduce the intensity of the chemotherapy dose. Therefore, we analyzed the clinical outcomes of this condition in a multicenter, prospective study (NAPOLEON-2).

We evaluated 150 patients with unresectable or recurrent pancreatic cancer who received NFF as second- or later-line therapy. The patients were categorized into the pre-treatment BD group (37 patients) and the non-BD group (113 patients). The primary endpoint was overall survival (OS). Secondary endpoints were progression-free survival (PFS), the objective response rate (ORR), the disease control rate (DCR), relative dose intensity, and adverse events (AEs). BTI was estimated using landmark analysis at 2 and 3 months to reduce immortal bias.

There was no difference in OS between the two groups (hazard ratio, 1.25; 95% confidence interval, 0.83–1.89), and PFS was not different between the groups. The ORR was 11% in both groups, and the DCR was 58% in the non-BD group and 51% in the BD group. Hematological AEs of grade ≥ 3 were observed in 34% of patients in the non-BD group and 38% in the BD group, while nonhematological AEs of grade ≥ 3 were observed in 40% and 68%, respectively. The BTI rate was higher in the BD group than in the non-BD group (32% vs. 4%). On-treatment BTI showed no clinically meaningful difference in OS at the 2- and 3-month landmark analyses.

BD has little effect on survival in patients treated with NFF. Physicians need to pay attention to BTI in NFF treatment.