Background: Nanoliposomal irinotecan combined with fluorouracil plus leucovorin (nal-IRI + 5-FU/LV) is a standard second-line treatment for patients with advanced pancreatic cancer. Despite its efficacy, the prognostic factors for treatment efficacy remain unclear in clinical practice.
Objectives: To investigate prognostic factors for survival with nal-IRI + 5-FU/LV.
Design: Single-centre retrospective cohort.
Methods: We included 204 patients who were treated with nal-IRI + 5-FU/LV at our institution between July 2020 and March 2022. These patients had unresectable or recurrent pancreatic adenocarcinoma refractory to a gemcitabine-containing regimen. A Cox regression hazard model was used to explore prognostic factors for overall survival (OS).
Results: Of the 204 eligible patients, 127 (64%) had received only one prior treatment. Most patients (90%) had metastatic disease, with 93, 61 and 55 patients having metastases to the liver, lungs and peritoneum, respectively. Among them, 18 patients had peritoneal metastasis without ascites. The median OS and progression-free survival (PFS) were 8.7 (95% confidence interval (CI), 7.5-9.8) and 3.6 (95% CI, 3.0-4.2) months, respectively. An Eastern Cooperative Oncology Group performance status (PS) of 0, serum albumin (Alb) level ⩾3.5 g/dL, C-reactive protein (CRP) level <0.5 mg/dL, carbohydrate antigen 19-9 (CA 19-9) level <1000 U/mL and peritoneum metastasis without ascites were independent prognostic factors for OS. The hazard ratios for these factors were 2.08, 1.96, 2.34, 2.22 and 1.92 with p-values of ⩽0.001, 0.001, <0.001, <0.001 and 0.043, respectively. Peritoneal metastasis, with or without ascites, was associated with 2-year OS rates compared to those without: 14.5% versus 6.0%, and 27.8% versus 6.5% (p-value = 0.053 and 0.010, respectively).
Conclusion: A PS of 0, Alb >3.5 g/dL, CRP <0.5 mg/dL, CA 19-9 <1000 U/mL and the presence of peritoneal metastasis, especially without ascites, were favourable prognostic factors for survival in patients with advanced pancreatic cancer treated with nal-IRI + 5-FU/LV.
Keywords: long survivor; nanoliposomal irinotecan; pancreatic cancer; peritoneal metastasis; predictive factor; prognostic factor.
Study identifying factors that may associate with survival in patients with advanced pancreatic cancer who received nanoliposomal irinotecan with fluorouracil and leucovorin (NAPOLI-1) Why was the study done? Pancreatic cancer is often diagnosed late and is hard to treat and NAPOLI-1 is one of the treatments available for advanced stages; however, most patients do not survive for long. The researchers wanted to learn more about the factors, which could potentially improve survival outcomes for patients. What did the researchers do? They reviewed medical records of 204 patients who were treated with NAPOLI-1 between July 2020 and March 2022. These patients had advanced pancreatic cancer that was either unresectable or metastatic and had progressed following prior treatments. The researchers examined whether the characteristics of patients associated with their survival time. What did they find? Only 17 patients (8.3%) survived for more than two years. Some characteristics of patients were associated with longer survival: they had good physical function call Performance status (PS), low levels of a blood marker called C-reactive protein (CRP), low levels of another marker called carbohydrate antigen (CA) 19-9, and high levels of a blood marker called albumin. Additionally, patients with cancer that had spread to the peritoneum (the lining of the abdominal cavity) but without fluid collection in the abdominal cavity had better outcomes if they met these conditions. What do the results mean? The findings suggest that certain factors, such as lower CRP and CA 19-9 levels, high Albumin, and disease spread to peritoneum, may improve the chances of surviving longer for patients on the NAPOLI-1 regimen. This information could help doctors identify which patients are more likely to benefit from this treatment.
© The Author(s), 2025.