Multicenter observational study of nanoliposomal irinotecan and fluorouracil/leucovorin in patients with unresectable or recurrent pancreatic cancer (NAPOLEON-2): Final retrospective results.

• DOI: 10.1200/jco.2023.41.4_suppl.706
• Publication Date: 2023-01-24T21:05:07Z
• Authors: Takashi Imajima; Tsuyoshi Shirakawa; Mototsugu Shimokawa; Taiga Otsuka; Taro Shibuki; Junichi Nakazawa; Shiho Arima; Keisuke Miwa; Futa Koga; Yoshihito Kubotsu; Yujiro Ueda; Ayumu Hosokawa; Shigeyuki Takeshita; Hozumi Shimokawa; Azusa Komori; Hisanobu Oda; Tatsunori Sakai; Shuji Arita; Toshihiko Mizuta; Kenji Mitsugi
• Keywords: Regimen; Folinic acid; Interim analysis

706 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). We conducted this NAPOLEON-2 study to investigate efficacy safety of NFF explore predictive prognostic factors, retrospectively prospectively, in real world. previously reported interim analysis retrospective data 6 months end collection ( Ann Oncol. 2022;33(suppl 4): S289-S290). Here, we report final 1 year collection. Methods: collected from urPC patients treated who received at least one previous chemotherapy 21 hospitals Japan June 2020 May 2021. Patient characteristics, treatment efficacy, adverse events were analyzed. Overall survival (OS) progression-free (PFS) estimated using Kaplan–Meier analysis. OS PFS among therapeutic lines also Results: was administered 161 patients. The median follow-up period 7.3 (95% confidence interval [CI], 5.6–8.9); age, 67 years (range, 38–85), 73 female (45%). Eastern Cooperative Oncology Group performance status 0/1/2/3 74/76/10/1 patients, respectively. Nineteen (12%) had locally advanced disease; 142 (88%) metastatic 89 (55%) liver metastasis; 44 (27%) peritoneal metastasis. All therapy. as 2nd/3rd/4th-or-later-line 104/41/16 8.1 CI, 7.1–9.7); PFS, 3.4 2.8–4.4); overall response rate, 5%; disease control 52%. relative dose intensity 81.6% NAL-IRI 90.7% fluorouracil. initial reduced 57 (35%), mainly owing UGT1A1 examination (8%), followed by decreased organ function worsened (6%). Dosage reduction during (independent reduction) performed (42%), neutropenia (16%) anorexia (11%). Frequent Grade 3/4 (24%), (12%), leukopenia (12%). No 5 observed. 2nd-line group, compared 3rd-or-later-line 7.6 vs 9.1 (hazard ratio [HR], 0.92; 95% 0.64–1.35; p = 0.68) 2.9 3.8 (HR, 0.89; 0.64–1.24; 0.49), Conclusions: appropriate manageable toxicity profiles, consistent our report. could be a candidate 2nd-or-later-line regimens