{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,21]],"date-time":"2026-04-21T06:36:55Z","timestamp":1776753415096,"version":"3.51.2"},"reference-count":11,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,4,21]],"date-time":"2026-04-21T00:00:00Z","timestamp":1776729600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Pharmacol."],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Liposomal irinotecan (nal-IRI) and conventional irinotecan (IRI) represent two formulations with distinct pharmacokinetic properties, yet their comparative safety profiles remain incompletely characterized. This study aimed to systematically evaluate their adverse event (AE) patterns through integrated pharmacovigilance and clinical analyses.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We conducted a dual-approach investigation combining: (1) a single-center retrospective study of 308 pancreatic cancer patients (nal-IRI = 131; IRI = 177) treated between December 2023-September 2024, and (2) disproportionality analysis of FAERS database reports (2004\u20132024) using reporting odds ratios (RORs) and proportional reporting ratios (PRRs).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The retrospective study demonstrated significantly higher incidence of grade 3\u20134 leukopenia with nal-IRI (9.16% vs. 3.39%, p &amp;lt; 0.05) and earlier onset of hematologic\/hepatic toxicities (median time difference: 20\u201330\u00a0days, p &amp;lt; 0.05). No significant differences were observed in non-hematologic toxicities between groups. FAERS analysis revealed distinct AE patterns: nal-IRI reports were predominantly associated with fatal outcomes (43.76%) and cholangitis (PRR = 996.70) in pancreatic cancer patients, while IRI showed conventional chemotherapy toxicities in colorectal cancer patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>These findings suggest that nal-IRI and IRI exhibit distinct safety profiles, which are partly attributable to differences in their liposomal pharmacokinetics, but also reflect the underlying disease characteristics and prognostic profiles of their respective patient populations. These findings emphasize the need for enhanced monitoring during initial nal-IRI treatment cycles and suggest differential safety management strategies for the two formulations. Future multicenter studies with pharmacokinetic assessments are warranted to further elucidate these differences.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fphar.2026.1745317","type":"journal-article","created":{"date-parts":[[2026,4,21]],"date-time":"2026-04-21T05:37:05Z","timestamp":1776749825000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Distinct safety profiles of liposomal and conventional irinotecan: insights from clinical experience and real-world data"],"prefix":"10.3389","volume":"17","author":[{"given":"Han","family":"Shan","sequence":"first","affiliation":[{"name":"Department of Pharmacy, Fudan University Shanghai Cancer Center","place":["Shanghai, China"]},{"name":"Department of Oncology, Shanghai Medical College, Fudan University","place":["Shanghai, China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shuohan","family":"Huang","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Fudan University Shanghai Cancer Center","place":["Shanghai, China"]},{"name":"Department of Oncology, Shanghai Medical College, Fudan University","place":["Shanghai, China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Qiong","family":"Du","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Fudan University Shanghai Cancer Center","place":["Shanghai, China"]},{"name":"Department of Oncology, Shanghai Medical College, Fudan University","place":["Shanghai, China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mengmeng","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Fudan University Shanghai Cancer Center","place":["Shanghai, China"]},{"name":"Department of Oncology, Shanghai Medical College, Fudan University","place":["Shanghai, China"]}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1965","published-online":{"date-parts":[[2026,4,21]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"997","DOI":"10.1002\/cpt.720","article-title":"Population pharmacokinetics of liposomal Irinotecan in patients with cancer","volume":"102","author":"Adiwijaya","year":"2017","journal-title":"Clin. Pharmacol. Ther."},{"key":"B2","doi-asserted-by":"publisher","first-page":"104398","DOI":"10.1016\/j.phrs.2019.104398","article-title":"Irinotecan: 25 years of cancer treatment","volume":"148","author":"Bailly","year":"2019","journal-title":"Pharmacol. Res."},{"key":"B3","doi-asserted-by":"publisher","first-page":"111","DOI":"10.1007\/s40487-022-00215-2","article-title":"Liposomal Irinotecan shows a larger therapeutic index than non-liposomal Irinotecan in patient-derived xenograft models of pancreatic cancer","volume":"11","author":"Barbier","year":"2023","journal-title":"Oncol. Ther."},{"key":"B4","doi-asserted-by":"publisher","first-page":"1550","DOI":"10.1002\/psp4.12725","article-title":"Population pharmacokinetics of liposomal Irinotecan in patients with cancer and exposure-safety analyses in patients with metastatic pancreatic cancer","volume":"10","author":"Brendel","year":"2021","journal-title":"CPT Pharmacometrics Syst. Pharmacol."},{"key":"B5","doi-asserted-by":"publisher","first-page":"255","DOI":"10.1007\/s40265-024-02133-1","article-title":"Liposomal irinotecan: a review as first-line therapy in metastatic pancreatic adenocarcinoma","volume":"85","author":"Brown","year":"2025","journal-title":"Drugs"},{"key":"B6","doi-asserted-by":"publisher","first-page":"1589","DOI":"10.1007\/s40262-023-01279-7","article-title":"Irinotecan-induced toxicity: a pharmacogenetic study beyond UGT1A1","volume":"62","author":"de With","year":"2023","journal-title":"Clin. Pharmacokinet."},{"key":"B7","doi-asserted-by":"publisher","first-page":"1007","DOI":"10.1007\/s40265-020-01336-6","article-title":"Liposomal irinotecan: a review in metastatic pancreatic adenocarcinoma","volume":"80","author":"Frampton","year":"2020","journal-title":"Drugs"},{"key":"B8","doi-asserted-by":"publisher","first-page":"113851","DOI":"10.1016\/j.addr.2021.113851","article-title":"Liposome composition in drug delivery design, synthesis, characterization, and clinical application","volume":"176","author":"Large","year":"2021","journal-title":"Adv. Drug Deliv. Rev."},{"key":"B9","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1080\/14740338.2024.2430306","article-title":"Increased reporting of accidental overdose with glucagon-like peptide-1 receptor agonists: a population-based study","volume":"25","author":"McIntyre","year":"2024","journal-title":"Expert Opin. Drug Saf."},{"key":"B10","doi-asserted-by":"publisher","first-page":"2224","DOI":"10.1111\/cas.15377","article-title":"Liposomal irinotecan (onivyde): exemplifying the benefits of nanotherapeutic drugs","volume":"113","author":"Milano","year":"2022","journal-title":"Cancer Sci."},{"key":"B11","doi-asserted-by":"publisher","first-page":"318","DOI":"10.1016\/j.clcc.2024.05.009","article-title":"Treatment of metastatic biliary cancers with irinotecan and 5-Fluorouracil based chemotherapy after platinum\/gemcitabine progression: a systematic review and meta-analysis","volume":"23","author":"Voutsadakis","year":"2024","journal-title":"Clin. Colorectal Cancer"}],"container-title":["Frontiers in Pharmacology"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fphar.2026.1745317\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,21]],"date-time":"2026-04-21T05:37:08Z","timestamp":1776749828000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fphar.2026.1745317\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,4,21]]},"references-count":11,"alternative-id":["10.3389\/fphar.2026.1745317"],"URL":"https:\/\/doi.org\/10.3389\/fphar.2026.1745317","relation":{},"ISSN":["1663-9812"],"issn-type":[{"value":"1663-9812","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,4,21]]},"article-number":"1745317"}}