Antigen Mass May Influence Trastuzumab Concentrations in Cerebrospinal Fluid After Intrathecal Administration.
Adult
Aged
Antigens
/ immunology
Antineoplastic Agents, Immunological
/ administration & dosage
Breast Neoplasms
/ drug therapy
Female
Humans
Injections, Spinal
Meningeal Carcinomatosis
/ drug therapy
Middle Aged
Receptor, ErbB-2
/ immunology
Survival Rate
Tissue Distribution
Trastuzumab
/ administration & dosage
Young Adult
Journal
Clinical pharmacology and therapeutics
ISSN: 1532-6535
Titre abrégé: Clin Pharmacol Ther
Pays: United States
ID NLM: 0372741
Informations de publication
Date de publication:
07 2021
07 2021
Historique:
received:
08
09
2020
accepted:
25
01
2021
pubmed:
7
2
2021
medline:
28
7
2021
entrez:
6
2
2021
Statut:
ppublish
Résumé
Intravenous administration of monoclonal antibodies leads to low concentrations in the central nervous system, which is a serious concern in neuro-oncology, especially in leptomeningeal carcinomatosis of HER2-overexpressing breast cancer. Case reports of i.t. administrations of trastuzumab have shown promising results in these patients but dosing regimens are empirical in absence of pharmacokinetic (PK) study. With a population PK approach, we described the fate of trastuzumab after i.t. administration in 21 women included in a phase I-II clinical trial. Trastuzumab was administered by i.t. route every week for 8 weeks and both cerebrospinal fluid (CSF) and serum were sampled to measure trough concentrations. Some patients showed noticeable CSF concentration fluctuations predicted using a target-mediated drug disposition. This target was latent and produced with a delayed feedback. Apparent volumes of distribution were close to physiological volumes (V
Substances chimiques
Antigens
0
Antineoplastic Agents, Immunological
0
ERBB2 protein, human
EC 2.7.10.1
Receptor, ErbB-2
EC 2.7.10.1
Trastuzumab
P188ANX8CK
Types de publication
Clinical Trial, Phase I
Clinical Trial, Phase II
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
210-219Informations de copyright
© 2021 The Authors. Clinical Pharmacology & Therapeutics © 2021 American Society for Clinical Pharmacology and Therapeutics.
Références
Gauthier, H. et al. Survival of breast cancer patients with meningeal carcinomatosis. Ann. Oncol. Off. J. Eur. Soc. Med. Oncol. 21, 2183-2187 (2010).
Hall Thomas, K. & Ramirez, R.A. Leptomeningeal disease and the evolving role of molecular targeted therapy and immunotherapy. Ochsner J. 17, 362-378 (2017).
Chamberlain, M.C. Neoplastic meningitis. Neurol. 12, 179-187 (2006).
European Medicines Agency. Roche Registration GmbH Herceptin: European Public Assessment Report - Product Information. (European Medicines Agency, Amsterdam, The Netherlands, 2000). https://www.ema.europa.eu/en/medicines/human/EPAR/herceptin. Accessed May 25, 2018.
Reiber, H. Knowledge-base for interpretation of cerebrospinal fluid data patterns. Essentials in neurology and psychiatry. Arq. Neuropsiquiatr. 74, 501-512 (2016).
Stemmler, H.J. et al. Application of intrathecal trastuzumab (Herceptin) for treatment of meningeal carcinomatosis in HER2-overexpressing metastatic breast cancer. Oncol. Rep. 15, 1373-1377 (2006).
Zhang, Y. & Pardridge, W.M. Mediated efflux of IgG molecules from brain to blood across the blood-brain barrier. J. Neuroimmunol. 114, 168-172 (2001).
Noguchi, Y., Kato, M., Ozeki, K. & Ishigai, M. Pharmacokinetics of an intracerebroventricularly administered antibody in rats. mAbs 9, 1210-1215 (2017).
Zagouri, F. et al. Intrathecal administration of trastuzumab for the treatment of meningeal carcinomatosis in HER2-positive metastatic breast cancer: a systematic review and pooled analysis. Breast Cancer Res. Treat. 139, 13-22 (2013).
Kadoch, C. et al. Complement activation and intraventricular rituximab distribution in recurrent central nervous system lymphoma. Clin. Cancer Res. Off. J. Am. Assoc. Cancer Res. 20, 1029-1041 (2014).
Bonneau, C. et al. Phase I feasibility study for intrathecal administration of trastuzumab in patients with HER2 positive breast carcinomatous meningitis. Eur. J. Cancer Oxf. Engl. 1990, 75-84 (2018).
Tout, M. et al. Influence of FCGR3A-158V/F genotype and baseline CD20 antigen count on target-mediated elimination of rituximab in patients with chronic lymphocytic leukemia: a study of FILO group. Clin. Pharmacokinet. 56, 635-647 (2017).
Ternant, D. et al. Nonlinear pharmacokinetics of rituximab in non-Hodgkin lymphomas: a pilot study. Br. J. Clin. Pharmacol. 85, 2002-2010 (2019).
Friberg, L.E. & Karlsson, M.O. Mechanistic models for myelosuppression. Invest. New Drugs 21, 183-194 (2003).
Saha, N. Clinical Pharmacokinetics and Drug Interactions. In Pharm. Med. Transl. Clin. Res. 81-100 (Elsevier/Academic Press, London, 2018).
Leyland-Jones, B. Dose scheduling-Herceptin. Oncology 61(Suppl 2), 31-36 (2001).
Baselga, J. Phase I and II clinical trials of trastuzumab. Ann. Oncol. 12, S49-S55 (2001).
Grossman, S.A. & Krabak, M.J. Leptomeningeal carcinomatosis. Cancer Treat. Rev. 25, 103-119 (1999).
Rubenstein, J.L. et al. Phase I study of intraventricular administration of rituximab in patients with recurrent CNS and intraocular lymphoma. J. Clin. Oncol. Off. J. Am. Soc. Clin. Oncol. 25, 1350-1356 (2007).
Junghans, R.P. & Anderson, C.L. The protection receptor for IgG catabolism is the beta2-microglobulin-containing neonatal intestinal transport receptor. Proc. Natl. Acad. Sci. USA 93, 5512-5516 (1996).
Schlachetzki, F., Zhu, C. & Pardridge, W.M. Expression of the neonatal Fc receptor (FcRn) at the blood-brain barrier. J. Neurochem. 81, 203-206 (2002).
Thomas, V.A. & Balthasar, J.P. Understanding inter-individual variability in monoclonal antibody disposition. Antibodies Basel Switz. 8, 56 (2019).
Chang, H.-Y., Morrow, K., Bonacquisti, E., Zhang, WanYing & Shah, D.K. Antibody pharmacokinetics in rat brain determined using microdialysis. mAbs 10(6), 843-853 (2018).
Kuchimanchi, M., Monine, M., Kandadi Muralidharan, K., Woodward, C. & Penner, N. Phase II dose selection for alpha synuclein-targeting antibody cinpanemab (BIIB054) based on target protein binding levels in the brain. CPT Pharmacomet. Syst. Pharmacol. 9(9), 515-522 (2020).
Clarke, J.L., Perez, H.R., Jacks, L.M., Panageas, K.S. & DeAngelis, L.M. Leptomeningeal metastases in the MRI era. Neurology 74, 1449-1454 (2010).
Bruno, R. et al. Population pharmacokinetics of trastuzumab in patients With HER2+ metastatic breast cancer. Cancer Chemother. Pharmacol. 56, 361-369 (2005).
Mazouni, C. et al. Kinetics of serum HER-2/neu changes in patients with HER-2-positive primary breast cancer after initiation of primary chemotherapy. Cancer 109, 496-501 (2007).
Austin, C.D. et al. Endocytosis and sorting of ErbB2 and the site of action of cancer therapeutics trastuzumab and geldanamycin. Mol. Biol. Cell 15, 5268-5282 (2004).
Hommelgaard, A.M., Lerdrup, M. & van Deurs, B. Association with membrane protrusions makes ErbB2 an internalization-resistant receptor. Mol. Biol. Cell 15, 1557-1567 (2004).
Fehling-Kaschek, M., Peckys, D.B., Kaschek, D., Timmer, J. & de Jonge, N. Mathematical modeling of drug-induced receptor internalization in the HER2-positive SKBR3 breast cancer cell-line. Sci. Rep. 9, 12709 (2019).
Peckys, D.B., Korf, U., Wiemann, S. & de Jonge, N. Liquid-phase electron microscopy of molecular drug response in breast cancer cells reveals irresponsive cell subpopulations related to lack of HER2 homodimers. Mol. Biol. Cell 28, 3193-3202 (2017).
Bousquet, G. et al. Intrathecal trastuzumab halts progression of CNS metastases in breast cancer. J. Clin. Oncol. 34, e151-e155 (2016).