Real-world evidence of nanoliposomal irinotecan and fluorouracil with folinic acid in patients with unresectable or recurrent pancreatic cancer: Final results of a multicenter observational study.

• DOI: 10.1200/jco.2025.43.4_suppl.721
• Publication Date: 2025-01-27T14:31:24Z
• Authors: Yudai Shinohara; Tsuyoshi Shirakawa; Mototsugu Shimokawa; Taiga Otsuka; Hozumi Shimokawa; Junichi Nakazawa; Futa Koga; Hisanobu Oda; Shigeyuki Takeshita; Shiho Arima; Shuji Arita; Yasunori Kawaguchi; Kazuo Nishikawa; Hiroki Taguchi; Kenichi Jikuya; Tatsunori Sakai; Yujiro Ueda; Takahiro Sakae; Toshihiko Mizuta; Kenji Mitsugi
• Keywords: Folinic acid

721 Background: Nanoliposomal irinotecan (NAL-IRI) and fluorouracil with folinic acid (NFF) is the standard regimen after gemcitabine-based therapy for unresectable or recurrent pancreatic cancer (urPC). However, we have almost no prospective data on its efficacy safety in real-world, so conducted this study to investigate them both retrospectively prospectively (NAPOLEON-2 study). We previously reported retrospective ASCO-GI 2023, here report final results of part. Methods: collected urPC patients treated NFF who had received at least one previous chemotherapy line 17 hospitals Japan from June 2021 October 2023. The primary endpoint was overall survival (OS). Secondary endpoints were response rate (ORR), disease control (DCR), progression-free (PFS), dose intensity (DI) adverse events (AEs). In addition, OS PFS among therapeutic lines also analyzed. Results: A total 150 enrolled. median follow-up period 7.2 months (95% confidence interval [CI], 6.3–8.8); age, 72 years (range, 45–85), 81 female (54%). Eastern Cooperative Oncology Group performance status 0/1/2/3 46/93/10/1 patients, respectively. Sixteen (11%) locally advanced disease; 134 (89%) metastatic 77 (51%) liver metastasis; 47 (31%) peritoneal metastasis. All therapy. administered as 2nd/3rd/4th-or-later-line 87/53/10 7.8 CI, 6.6–9.2); PFS, 3.7 2.8–4.9); rate, 11%; 56%. relative 72.7% NAL-IRI 79.4% fluorouracil. initial reduced 84 (56%), mainly owing decreased organ function (17%), followed by age (12%), worsened (10%), UGT1A1 examination (5%). Dosage reduction during treatment (independent reduction) performed 74 (49%), neutropenia (22%) anorexia (11%). Frequent Grade 3/4 (27%), (19%), leukopenia (16%). 5 infection observed only patient. 2nd-line group, compared 3rd-or-later-line 7.4 vs (hazard ratio [HR], 0.97; 95% 0.68–1.39; p=0.88) 3.3 4.2 (HR, 1.04; 0.74–1.45; p=0.84), Conclusions: appropriate manageable toxicity profiles, consistent our report. can be a candidate 2nd-or-later-line regimens real-world. Clinical trial information: UMIN000043939 .