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Background <p>The effectiveness and safety of<!--Query ID="Q1" Text="Please check if article title was captured correctly. " Resolved="yes"--> 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).</p> Methods <p>We evaluated 150 patients with unresectable <!--Query ID="Q2" Text="Please check if the authors and their affiliation are presented and indicated correctly. " Resolved="yes"-->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.</p> Results <p>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.</p> Conclusions <p>BD has little effect on survival in patients treated with NFF. Physicians need to pay attention to BTI in NFF treatment.</p>

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Effect of biliary drainage and biliary tract infection in unresectable pancreatic cancer treated with nanoliposomal irinotecan with fluorouracil and folinic acid: a multicenter, prospective cohort study (NAPOLEON-2)

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  • 发表日期：

    2026年5月26日

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  • Wataru Yoshioka,
  • Tsuyoshi Shirakawa,
  • Mototsugu Shimokawa,
  • Taiga Otsuka,
  • Futa Koga,
  • Noriko Oza,
  • Hirokazu Takahashi,
  • Masayuki Kitsuka,
  • Junichi Nakazawa,
  • Hozumi Shimokawa,
  • Yudai Shinohara,
  • Hisanobu Oda,
  • Shigeyuki Takeshita,
  • Shiho Arima,
  • Shuji Arita,
  • Yasunori Kawaguchi,
  • Kazuo Nishikawa,
  • Satoshi Otsu,
  • Hiroki Taguchi,
  • Kenichi Jikuya,
  • Tatsunori Sakai,
  • Yujiro Ueda,
  • Takahiro Sakae,
  • Norimasa Araki,
  • Hironori Sawase,
  • Yasushi Ide,
  • Machiko Kawahira,
  • Kenta Nio,
  • Toshihiko Mizuta,
  • Kenji Mitsugi

摘要

Background

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).

Methods

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.

Results

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.

Conclusions

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