Abstract 346P
Background
While nano-liposomal irinotecan, fluorouracil, and folinic acid (NFF) is a standard treatment for unresectable or recurrent pancreatic cancer (urPC) after gemcitabine-based chemotherapy, clinical data on the efficacy and safety are limited. We initiated the NAPOLEON-2 study and reported an interim analysis of its prospective portion, focusing on safety (ESMO-Asia 2023). We report our final analysis of the efficacy and safety of 2nd-line NFF.
Methods
We prospectively collected data of urPC patients treated with NFF who had received one chemotherapy line in 17 hospitals in Japan from June 2021 to October 2023. The primary endpoint was overall survival (OS). Secondary endpoints were the overall response rate (ORR), disease control rate (DCR), progression-free survival (PFS), dose intensity (DI) and adverse events (AEs).
Results
NFF as 2nd-line therapy was administered to 87 patients. The median follow-up period was 6.4 months. The median age was 72 (47–83) years, and 36 patients were female (41%). Eleven patients had locally advanced cancer. The liver (55%), peritoneum (31%), and lungs (29%) were the most common metastatic sites. All patients had previously received gemcitabine. The median OS and PFS were 7.3 months (95% confidence interval [CI], 6.4–9.4) and 3.3 months (95%CI, 2.8–5.0), respectively. The ORR and DCR were 12% and 58%, respectively. The initial doses of nanoliposomal irinotecan (NAL-IRI) and fluorouracil (FU) were reduced in 54 and 32 cases, respectively, mainly due to organ function (13%) and age (17%). Grade 3/4 hematological and non-hematological AEs occurred in 28 and 38 cases, respectively. Neutropenia (25%) and anorexia (21%) were common grade 3/4 AEs. The median relative DI was 70% in the NAL-IRI group and 78% in the FU group. Dose reduction during treatment was observed in 43 and 47 cases in the NAL-IRI and FU groups, respectively, mainly due to neutropenia (20%) and anorexia (15%).
Conclusions
NFF as 2nd-line therapy had appropriate efficacy and manageable toxicity profiles, consistent with our previous report. NFF may be an appropriate 2nd-line regimen in clinical practice.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.