Population Pharmacokinetics of Liposomal Irinotecan in Patients With Canceropen access
- Authors
- Adiwijaya, BS[Adiwijaya, B. S.]; Kim, J[Kim, J.]; Lang, I[Lang, I.]; Csoszi, T[Csoszi, T.]; Cubillo, A[Cubillo, A.]; Chen, JS[Chen, J-S]; Wong, M[Wong, M.]; Park, JO[Park, J. O.]; Kim, JS[Kim, J. S.]; Rau, KM[Rau, K. M.]; Melichar, B[Melichar, B.]; Gallego, JB[Gallego, J. B.]; Fitzgerald, J[Fitzgerald, J.]; Belanger, B[Belanger, B.]; Molnar, I[Molnar, I.]; Ma, WW[Ma, W. W.]
- Issue Date
- Dec-2017
- Publisher
- WILEY
- Citation
- CLINICAL PHARMACOLOGY & THERAPEUTICS, v.102, no.6, pp.997 - 1005
- Indexed
- SCIE
SCOPUS
- Journal Title
- CLINICAL PHARMACOLOGY & THERAPEUTICS
- Volume
- 102
- Number
- 6
- Start Page
- 997
- End Page
- 1005
- URI
- https://scholarworks.bwise.kr/skku/handle/2021.sw.skku/26281
- DOI
- 10.1002/cpt.720
- ISSN
- 0009-9236
- Abstract
- Nanoliposomal irinotecan (nal-IRI) is a liposomal formulation of irinotecan with a longer half-life (t(1/2)), higher plasma total irinotecan (tIRI), and lower SN-38 maximum concentration (C-max) compared with nonliposomal irinotecan. Population pharmacokinetic (PK) analysis of nal-IRI was performed for tIRI and total SN-38 (tSN38) using patient samples from six studies. PK-safety association was evaluated for neutropenia and diarrhea in 353 patients. PK-efficacy association was evaluated from a phase III study in pancreatic cancer NAPOLI1. Efficacy was associated with longer duration of unencapsulated SN-38 (uSN38) above a threshold and higher C-avg of tIRI, tSN38, and uSN38. Neutropenia was associated with uSN38 C-max and diarrhea with tIRI C-max. Baseline predictive factors were race, body surface area, and bilirubin. Analysis identified PK factors associated with efficacy, safety, and predictive baseline factors. The results support the benefit of nal-IRI dose of 70mg/m(2) (free-base; equivalent to 80mg/m(2) salt base) Q2W over 100mg/m(2) Q3W.
- Files in This Item
- There are no files associated with this item.
- Appears in
Collections - Medicine > Department of Medicine > 1. Journal Articles
![qrcode](https://api.qrserver.com/v1/create-qr-code/?size=55x55&data=https://scholarworks.bwise.kr/skku/handle/2021.sw.skku/26281)
Items in ScholarWorks are protected by copyright, with all rights reserved, unless otherwise indicated.