Comparison of conventional versus liposomal irinotecan in combination with fluorouracil for advanced pancreatic cancer: a single-institution experience
The majority of pancreatic cancers are diagnosed at an advanced stage, when surgical options are limited and treatment relies on systemic chemotherapy. In the NAPOLI-1 trial, liposomal irinotecan in combination with fluorouracil (nal-iri/5FU) was shown to improve overall survival when compared to fluorouracil alone for metastatic pancreatic cancer. Other retrospective studies have shown the combination of fluorouracil and conventional irinotecan (FOLFIRI) to be a viable option, though no randomized trials have compared nal-iri/5FU to FOLFIRI. The purpose of this single-center, retrospective, cohort study was to determine if nal-iri/5FU and FOLFIRI are similarly effective for the treatment of advanced pancreatic cancer. Due to the potential for treatment bias, inverse probability of treatment weighting was utilized to correct for baseline differences between the groups. The primary outcome of progression-free survival was similar at 4.1 months for nal-iri/5FU and 3.1 months for FOLFIRI. Overall survival and adverse effect frequency were also similar. Pegfilgrastim was used in 16% and 15% of patients, respectively, and nal-iri/5FU patients required significantly less atropine during treatment (36 vs. 70%). A cost analysis was conducted and concluded that the treatment with nal-iri/5FU was nearly 30 times more expensive than FOLFIRI treatment. Together, these data suggest a potential role for FOLFIRI for the treatment of advanced pancreatic cancer in the absence of clear benefits in effectiveness, toxicity, or cost for nal-iri/5FU.
KeywordsMetastatic pancreatic adenocarcinoma Nanoliposomal irinotecan FOLFIRI Cost-effective
Compliance with ethical standards
Conflict of interest
Anne Noonan served as a paid member of the Data Safety Monitoring Board for Helsinn in 2015–2016 and a paid advisory board member for QED Therapeutics and Exelixis in 2019. No other authors have any potential conflicts to declare.
- 5.Onivyde (irinotecan liposome) [package insert]. Basking Ridge: Ipsen Biopharmaceuticals, Inc.; 2017.Google Scholar
- 6.Wang-Gillam A, Li CP, Bodoky G, Dean A, Shan YS, Jameson G, et al. Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial. Lancet. 2016;387(10018):545–57.CrossRefPubMedGoogle Scholar
- 7.Gill S, Ko YJ, Cripps C, Beaudoin A, Dhesy-Thind S, Zulfiqar M, et al. PANCREOX: a randomized phase III study of fluorouracil/leucovorin with or without oxaliplatin for second-line advanced pancreatic cancer in patients who have received gemcitabine-based chemotherapy. J Clin Oncol. 2016;34(32):3914–20.CrossRefPubMedGoogle Scholar
- 8.Oettle H, Riess H, Stieler JM, Heil G, Schwaner I, Seraphin J, et al. Second-line oxaliplatin, folinic acid, and fluorouracil versus folinic acid and fluorouracil alone for gemcitabine-refractory pancreatic cancer: outcomes from the CONKO-003 trial. J Clin Oncol. 2014;32(23):2423–9.CrossRefPubMedGoogle Scholar
- 9.Gebbia V, Maiello E, Giuliani F, Borsellino N, Arcara C, Colucci G. Irinotecan plus bolus/infusional 5-Fluorouracil and leucovorin in patients with pretreated advanced pancreatic carcinoma: a multicenter experience of the Gruppo Oncologico Italia Meridionale. Am J Clin Oncol. 2010;33(5):461–4.CrossRefPubMedGoogle Scholar
- 15.ASP drug pricing files. Centers for Medicare and Medicaid Services. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/2019ASPFiles.html. Accessed 10 Apr 2019.
- 16.Fryar CD, Kruszon-Moran D, Gu Q, Ogden CL. Mean body weight, height, waist circumference, and body mass index among adults: United States, 1999–2000 through 2015–2016. Natl Health Stat Rep. 2018;122:1–16.Google Scholar
- 21.Fleeman N, Abdulla A, Bagust A, Beale S, Richardson M, Stainthorpe A, et al. Pegylated liposomal irinotecan hydrochloride trihydrate for treating pancreatic cancer after gemcitabine: an evidence review group perspective of a NICE single technology appraisal. Pharmacoeconomics. 2018;36(3):289–99.CrossRefPubMedGoogle Scholar