Modelling and Simulation in the Development and Use of Anti-cancer Agents: an Underused Tool?

Overview

Journal J Pharmacokinet Pharmacodyn

Publisher Springer

Specialty Pharmacology

Date 2005 Oct 14

PMID 16222783

Citations 6

Authors

Ferdinand Rombout

Leon Aarons

Mats Karlsson

Anthony Man

France Mentre

Peter Nygren

Amy Racine

Hans Schaefer

Jean-Louis Steimer

Inaki Troconiz

Achiel Van Peer

Affiliations

Soon will be listed here.

Abstract

To help identify the role of modelling and simulation in the development of anti-cancer agents, their main advantages and the obstacles to their rational use, an expert meeting was organized by COST B15. This manuscript presents a synthesis of views expressed at that meeting and indicates future directions. The manuscript also shows some examples where modelling and simulation have proven to be of relevant value in the drug development process for anti-cancer agents.

Citing Articles

Revisiting Dosing Regimen Using Pharmacokinetic/Pharmacodynamic Mathematical Modeling: Densification and Intensification of Combination Cancer Therapy.

Meille C, Barbolosi D, Ciccolini J, Freyer G, Iliadis A Clin Pharmacokinet. 2016; 55(8):1015-25.

PMID: 26946136 DOI: 10.1007/s40262-016-0374-7.

Optimal chemotherapy for leukemia: a model-based strategy for individualized treatment.

Jayachandran D, Rundell A, Hannemann R, Vik T, Ramkrishna D PLoS One. 2014; 9(10):e109623.

PMID: 25310465 PMC: 4195683. DOI: 10.1371/journal.pone.0109623.

Modeling NSCLC progression: recent advances and opportunities available.

Suleiman A, Nogova L, Fuhr U AAPS J. 2013; 15(2):542-50.

PMID: 23404126 PMC: 3675755. DOI: 10.1208/s12248-013-9461-y.

Refinement of the population pharmacokinetic model for the monoclonal antibody matuzumab: external model evaluation and simulations.

Kuester K, Kovar A, Lupfert C, Brockhaus B, Kloft C Clin Pharmacokinet. 2009; 48(7):477-87.

PMID: 19691369 DOI: 10.2165/11313400-000000000-00000.

Semi-mechanistic model for neutropenia after high dose of chemotherapy in breast cancer patients.

Ramon-Lopez A, Nalda-Molina R, Valenzuela B, Perez-Ruixo J Pharm Res. 2009; 26(8):1952-62.

PMID: 19488837 DOI: 10.1007/s11095-009-9910-6.

References

Cole B, Gelber R, Kirkwood J, Goldhirsch A, Barylak E, Borden E . Quality-of-life-adjusted survival analysis of interferon alfa-2b adjuvant treatment of high-risk resected cutaneous melanoma: an Eastern Cooperative Oncology Group study. J Clin Oncol. 1996; 14(10):2666-73. DOI: 10.1200/JCO.1996.14.10.2666. View

Thall P, Russell K . A strategy for dose-finding and safety monitoring based on efficacy and adverse outcomes in phase I/II clinical trials. Biometrics. 1998; 54(1):251-64. View

Lovejoy E, Clarke A, Harrison D . Animal models and the molecular pathology of cancer. J Pathol. 1997; 181(2):130-5. DOI: 10.1002/(SICI)1096-9896(199702)181:2<130::AID-PATH754>3.0.CO;2-F. View

Buchdunger E, Matter A, Druker B . Bcr-Abl inhibition as a modality of CML therapeutics. Biochim Biophys Acta. 2001; 1551(1):M11-8. DOI: 10.1016/s0304-419x(01)00022-1. View

Buyse M, Piedbois P . On the relationship between response to treatment and survival time. Stat Med. 1996; 15(24):2797-812. DOI: 10.1002/(SICI)1097-0258(19961230)15:24<2797::AID-SIM290>3.0.CO;2-V. View

Gieschke R, Reigner B, Blesch K, Steimer J . Population pharmacokinetic analysis of the major metabolites of capecitabine. J Pharmacokinet Pharmacodyn. 2002; 29(1):25-47. DOI: 10.1023/a:1015716617967. View

Brown J, Giaccia A . The unique physiology of solid tumors: opportunities (and problems) for cancer therapy. Cancer Res. 1998; 58(7):1408-16. View

Ratain M . Body-surface area as a basis for dosing of anticancer agents: science, myth, or habit?. J Clin Oncol. 1998; 16(7):2297-8. DOI: 10.1200/JCO.1998.16.7.2297. View

Yang J, Liu A, Dougherty C, Chen X, Guzman R, Nandi S . Beware of contaminating mouse cells in human xenografts from nude mice. Anticancer Res. 2000; 20(3A):1635-9. View

10.

Mauro M, ODwyer M, Heinrich M, Druker B . STI571: a paradigm of new agents for cancer therapeutics. J Clin Oncol. 2002; 20(1):325-34. DOI: 10.1200/JCO.2002.20.1.325. View

11.

Gasparini M, Eisele J . A curve-free method for phase I clinical trials. Biometrics. 2000; 56(2):609-15. DOI: 10.1111/j.0006-341x.2000.00609.x. View

12.

Avvisati G, Coco F, Mandelli F . Acute promyelocytic leukemia: clinical and morphologic features and prognostic factors. Semin Hematol. 2001; 38(1):4-12. View

13.

Von Hoff D . There are no bad anticancer agents, only bad clinical trial designs--twenty-first Richard and Hinda Rosenthal Foundation Award Lecture. Clin Cancer Res. 1998; 4(5):1079-86. View

14.

Sandberg J, Parker V, Blanchard K, Sweedler D, Powell J, Kachensky A . Pharmacokinetics and tolerability of an antiangiogenic ribozyme (ANGIOZYME) in healthy volunteers. J Clin Pharmacol. 2001; 40(12 Pt 2):1462-9. View

15.

Bruno R, Hille D, Riva A, Vivier N, ten Bokkel Huinnink W, Van Oosterom A . Population pharmacokinetics/pharmacodynamics of docetaxel in phase II studies in patients with cancer. J Clin Oncol. 1998; 16(1):187-96. DOI: 10.1200/JCO.1998.16.1.187. View

16.

Weisenthal L . Antineoplastic drug screening belongs in the laboratory, not in the clinic. J Natl Cancer Inst. 1992; 84(7):466-9. DOI: 10.1093/jnci/84.7.466. View

17.

Relling M, Hancock M, Rivera G, Sandlund J, Ribeiro R, Krynetski E . Mercaptopurine therapy intolerance and heterozygosity at the thiopurine S-methyltransferase gene locus. J Natl Cancer Inst. 1999; 91(23):2001-8. DOI: 10.1093/jnci/91.23.2001. View

18.

Nelson A, Fingleton B, Rothenberg M, Matrisian L . Matrix metalloproteinases: biologic activity and clinical implications. J Clin Oncol. 2000; 18(5):1135-49. DOI: 10.1200/JCO.2000.18.5.1135. View

19.

Dix S, Wingard J, Mullins R, Jerkunica I, Davidson T, GILMORE C . Association of busulfan area under the curve with veno-occlusive disease following BMT. Bone Marrow Transplant. 1996; 17(2):225-30. View

20.

Moine P, Mazoit J . Streptococcus pneumoniae pneumonia in mice: optimal amoxicillin dosing predicted from a pharmacokinetic-pharmacodynamic model. J Pharmacol Exp Ther. 1999; 291(3):1086-92. View