Is There Room for Liposomal Irinotecan in Biliary Tract Cancer? A Meta-analysis of Randomised Trials.

Clin Oncol (R Coll Radiol)

Digestive Molecular Clinical Oncology Research Unit, University of Verona, Verona, Italy; Investigational Cancer Therapeutics Clinical Unit, Azienda Ospedaliera Universitaria Integrata, Policlinico "G.B. Rossi", Verona, Italy.

Published: February 2024

AI Article Synopsis

  • - The study investigates the effectiveness of combining nanoliposomal irinotecan (nal-IRI) with 5-fluorouracil/leucovorin (5-FU/LV) for treating advanced biliary tract cancer, compared to the standard FOLFOX regimen.
  • - A systematic review and meta-analysis were conducted using data from major medical databases, focusing on outcomes like progression-free survival and overall survival from randomized trials.
  • - Results indicated that the nal-IRI combination significantly reduced disease progression risk and improved overall survival and response rates compared to 5-FU/LV alone, suggesting its potential as a more effective treatment option.

Article Abstract

Aims: The combination of 5-fluorouracil/leucovorin (5-FU/LV) plus oxaliplatin (FOLFOX) is widely acknowledged as the standard regimen for second-line treatment in patients with advanced biliary tract cancer. Nanoliposomal irinotecan (nal-IRI) has demonstrated its activity in patients with advanced pancreatic cancer. Recent studies have investigated the activity of nal-IRI in combination with 5-FU/LV for biliary tract cancer. However, the results have been contradictory. We conducted a meta-analysis to assess survival outcomes and response rates in randomised trials investigating the activity of nal-IRI in previously treated biliary tract cancer patients.

Materials And Methods: We systematically collected potentially relevant findings from PubMed/Medline, the Cochrane library and EMBASE. Abstracts presented at major international oncological meetings were also reviewed. We extracted hazard ratios and 95% confidence intervals for progression-free survival and overall survival, as well as odds ratios and 95% confidence intervals for objective response rate. The outcomes of the accessible randomised studies evaluating the activity of nal-IRI plus 5-FU/LV were analysed.

Results: The combination therapy exhibited a statistically significant decrease in the risk of progression (hazard ratio 0.70; 95% confidence interval 0.50-0.97) when compared with 5-FU/LV alone. Additionally, the dual regimen yielded longer overall survival and a higher objective response rate.

Conclusion: Our meta-analysis showed that nal-IRI plus 5-FU/LV had a superior activity in comparison with 5-FU/LV. Further investigations are required to elucidate the role of nal-IRI in this setting and to identify subgroups of patients who could derive the greatest benefit from its administration.

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http://dx.doi.org/10.1016/j.clon.2023.12.005DOI Listing

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