Nal-IRI (liposomal irinotecan) plus 5-fluorouracil and leucovorin versus 5-fluorouracil for metastatic pancreatic ductal adenocarcinoma following gemcitabine-based therapy. A systematic review and meta-analysis of randomized controlled trials.

INTRODUCTION

Pancreatic cancer has a poor prognosis. The present systematic review and meta-analysis evaluated progression free survival (PFS) and overall survival (OS) after gemcitabine-based therapy nal-IRI (liposomal irinotecan) plus 5-fluorouracil and leucovorin versus 5-fluorouracil for metastatic pancreatic ductal adenocarcinoma (PDAC) patients.

METHODS

The present systematic review and meta-analysis was registered in PROSPERO with id no. CRD42024608206. A systematic literature review was performed according to the PRISMA checklist, consulting Embase, PubMed, Scopus, and Web of Science databases.

RESULTS

Screened studies considered median values for PFS and Hazard Ratio for OS. Heterogeneity among the selected studies was statistically significant both for PFS (P < 0.001; tau2 = 0.72; I2 = 98.67%) and OS (P = 0.010; tau2 = 0.24; I2 = 87.76%). Data indicated that PFS median values were longer in the experimental group than in the control one (Z = 4.46; P < 0.001). The results for OS showing no statistically significant difference between groups (HR = 0.79; P = 0.45).

CONCLUSION

The present findings confirmed the outcomes improvements provided by nal-IRI for PDAC patients; however, our results should be interpreted cautiously. More data regarding the role of performance status, patient population, the line of treatment, and the role of eventual sequencing various regimens are awaited.