Population pharmacokinetic-pharmacodynamic analysis of neutropenia in cancer patients receiving PM00104 (Zalypsis®)

Clinical Pharmacokinetics

Volumn 51, Issue 11, 2012, Pages 751-764

  González Sales, Mario ^a   Valenzuela, Belén ^b   Pérez Ruixo, Carlos ^a   Fernández Teruel, Carlos ^c   Miguel Lillo, Bernardo ^c   Soto Matos, Arturo ^c   Pérez Ruixo, Juan Jose ^d  

^a Consulting Projects for Research ^*  (Spain)

^b USP Hospital San Jaime   (Spain)

^c PHARMAMAR S A   (Spain)

^d Pharmacokinetics and Drug Metabolism ^*  (Spain)

Author keywords

[No Author keywords available]

Indexed keywords

ALBUMIN; ANTINEOPLASTIC AGENT; PM 00104; UNCLASSIFIED DRUG; ZALYPSIS;

ABSOLUTE NEUTROPHIL COUNT; ADULT; ALBUMIN BLOOD LEVEL; ANTINEOPLASTIC ACTIVITY; ARTICLE; CANCER CHEMOTHERAPY; CANCER PATIENT; CELL PROLIFERATION; COMPARTMENT MODEL; DISEASE DURATION; DISEASE SEVERITY; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG ELIMINATION; FEMALE; HUMAN; INFUSION; LIVER METASTASIS; MAJOR CLINICAL STUDY; MALE; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; NEUTROPHIL COUNT; PERFORMANCE; POPULATION RESEARCH; PRIORITY JOURNAL; SOLID TUMOR; STEM CELL;

ANTINEOPLASTIC AGENTS; DOSE-RESPONSE RELATIONSHIP, IMMUNOLOGIC; HUMANS; LEUKOCYTE COUNT; MODELS, BIOLOGICAL; NEOPLASMS; NEUTROPENIA; TETRAHYDROISOQUINOLINES;

EID: 84873417516     PISSN: 03125963     EISSN: 11791926     Source Type: Journal    
DOI: 10.1007/s40262-012-0011-z     Document Type: Article

References (38)

1. Rinehart KL, Holt TG, Fregeau NL, et al. Ecteinascidins 729, 743, 745, 759A, 759B, and 770: potent antitumor agents from the Caribbean tunicate Ecteinascidia turbinata. J Org Chem. 1990;55:4512-5.
2. Fontana A, Cavaliere P, Wahidulla S, et al. A new antitumor isoquinoline alkaloid from the marine nudibranch Jorunna funebris. Tetrahedron. 2000;56:7305-8.
3. Oku N, Matsunaga S, van Soest RW, et al. Renieramycin J, a highly cytotoxic tetrahydroisoquinoline alkaloid, from a marine sponge Neopetrosia sp. J Nat Prod. 2003;66:1136-9.
4. Leal JF, García-Hernández V, Moneo V, et al. Molecular pharmacology and antitumor activity of Zalypsis in several human cancer cell lines. Biochem Pharmacol. 2009;78:162-70.
5. Ocio EM, Maiso P, Chen X, et al. Zalypsis: a novel marine-derived compound with potent antimyeloma activity that reveals high sensitivity of malignant plasma cells to DNA double-strand breaks. Blood. 2009;113:3781-91.
6. Guirouilh-Barbat J, Antony S, Pommier Y. Zalypsis (PM00104) is a potent inducer of gamma-H2AX foci and reveals the importance of the C ring of trabectedin for transcription-coupled repair inhibition. Mol Cancer Ther. 2009;8:2007-14.
7. Massard C, Margetts J, Amellal N, et al. Phase I study of PM00104 (Zalypsis®) administered as a 1-hour weekly infusion resting every fourth week in patients with advanced solid tumors. Invest New Drugs. Epub 12 June 2012.
8. Friberg LE, Henningsson A, Maas H, et al. Model of chemotherapy-induced myelosuppression with parameter consistency across drugs. J Clin Oncol. 2002;20:4713-21.
9. Leger F, Loos WJ, Bugat R, et al. Mechanism-based models for topotecan-induced neutropenia. Clin Pharmcol Ther. 2004;76:567-78.
10. Latz JE, Karlsson MO, Rusthoven JJ, et al. A semimechanistic-physiologic population pharmacokinetic/pharmacodynamic model for neutropenia following pemetrexed therapy. Cancer Chemother Pharmacol. 2005;57:412-26.
11. Sandström M, Lindman H, Nygren P, et al. Model describing the relationship between pharmacokinetics and hematologic toxicity of epirubicin-docetaxel regimen in breast cancer patients. J Clin Oncol. 2005;23:413-21.
12. van Kesteren C, Zandvliet AS, Karlsson MO, et al. Semi-physiological model describing the hematological toxicity of the anti-cancer agent indisulam. Invest New Drugs. 2005;23:225-34.
13. Sandstrom M, Lindman H, Nygren P, et al. Population analysis of the pharmacokinetics and the haematological toxicity of the fluorouracil-epirubicin- cyclophosphamide regimen in breast cancer patients. Cancer Chemother Pharmacol. 2006;58:143-56.
14. Ramón-López A, Nalda-Molina R, Valenzuela B, et al. Semi-mechanistic model for neutropenia after high dose of chemotherapy in breast cancer patients. Pharm Res. 2009;26:1952-62.
15. Hing J, Perez-Ruixo JJ, Stuyckens K, et al. Mechanism-based pharmacokinetic/pharmacodynamic meta-analysis of trabectedin (ET-743, Yondelis®) induced neutropenia. Clin Pharmacol Ther. 2008;83:130-43.
16. Quartino AL, Friberg LF, Karlsson MO. A simultaneous analysis of the time-course of leukocytes and neutrophils following docetaxel administration using a semi-mechanistic myelosuppression model. Invest New Drugs. 2012;30:833-45.
17. Pérez-Ruixo C, Valenzuela B, Fernández Teruel C, González-Sales M, Miguel-Lillo B, Soto-Matos A, et al. Population pharmacokinetics of PM00104 (Zalypsis®) in cancer patients. Cancer Chemother Pharmacol. 2012;69:15-24.
18. Lindbom L, Pihlgren P, Jonsson EN. PsN-Toolkit: a collection of computer intensive statistical methods for non-linear mixed effect modeling using NONMEM. Comput Methods Programs Biomed. 2005;79:241-57.
19. Zhang L, Beal SL, Sheiner LB. Simultaneous vs. sequential analysis for population PK/PD data I: best-case performance. J Pharmacokinet Pharmacodyn. 2003;30:387-404.
20. Price TH, Chatta GS, Dale DC. Effect of recombinant granulocyte colony-stimulating factor on neutrophil kinetics in normal young and elderly humans. Blood. 1996;88:335-40.
21. Dale DC, Liles WC, Llewellyn C, et al. Effects of granulocyte-macrophage colony-stimulating factor (GM-CSF) on neutrophil kinetics and function in normal human volunteers. Am J Hematol. 1998;57:7-15.
22. Girard P. Data transformation and parameter transformations in NONMEM. http://www.page-meeting.org/page/page2002/PascalGirardPage2002.pdf. Accessed 20 Aug 2012.
23. Savic RM, Karlsson MO. Diagnosing model diagnostics. Clin Pharmacol Ther. 2007;82:17-20.
24. Kloft C, Wallin J, Henningsson A, et al. Population pharmacokinetic- pharmacodynamic model for neutropenia with patient subgroup identification: comparison across anticancer drugs. Clin Cancer Res. 2006;12:5481-90.
25. Mandema JW, Verotta D, Sheiner LB. Building population pharmacokinetic-pharmacodynamic models. I: models for covariate effects. J Pharmacokinet Biopharm. 1992;20:511-28.
26. Efron B, Tibshirani R. An introduction to the bootstrap. New York: Chapman & Hall; 1993.
27. Brendel K, Comets E, Laffont C, et al. Metrics for external model evaluation with an application to the population pharmacokinetics of gliclazide. Pharm Res. 2006;23:2036-49.
28. Joerger M, Huitema AD, Richel DJ, et al. Population pharmacokinetics and pharmacodynamics of paclitaxel and carboplatin in ovarian cancer patients: a study by the European organization for research and treatment of cancer-pharmacology and molecular mechanisms group and new drug development group. Clin Cancer Res. 2007;13:6410-8.
29. Kathman SJ, Williams DH, Hodge JP, et al. A Bayesian population PK-PD model of ispinesib-induced myelosuppression. Clin Pharmacol Ther. 2007;81:88-94.
30. Panetta JC, Schaiquevich P, Santana VM, et al. Using pharmacokinetic and pharmacodynamic modeling and simulation to evaluate importance of schedule in topotecan therapy for pediatric neuroblastoma. Clin Cancer Res. 2008;14:318-25.
31. Troconiz IF, Garrido MJ, Segura C, et al. Phase I dose-finding study and a pharmacokinetic/pharmacodynamic analysis of the neutropenic response of intravenous diflomotecan in patients with advanced malignant tumours. Cancer Chemother Pharmacol. 2006;57:727-35.
32. Lord BI, Bronchud MH, Owens S, et al. The kinetics of human granulopoiesis following treatment with granulocyte colony-stimulating factor in vivo. Proc Natl Acad Sci USA. 1989;86:9499-503.
33. Schmitz S, Franke H, Brusis J, et al. Quantification of the cell kinetic effects of G-CSF using a model of human granulopoiesis. Exp Hematol. 1993;21:755-60.
34. Yap TA, Cortes-Funes H, Shaw H, Rodriguez R, Olmos D, Lal R, et al. First-in-man phase I trial of two schedules of the novel synthetic tetrahydroisoquinoline alkaloid PM00104 (Zalypsis) in patients with advanced solid tumours. Br J Cancer. 2012;106:1379-85.
35. PharmaMar SA. A phase I multicenter, open-label, dose-escalating study of PM00104 administered as 1 and 3 hours intravenous infusion every 3 weeks in subjects with advanced solid tumors or lymphoma. [EUDRACT identifier: 2004-002585-38]. European Union Drug Regulating Authorities Clinical Trials. https://eudract.ema.europa.eu/. Accessed 4 Sep 2012.
36. PharmaMar SA. A phase I study of Zalypsis (PM00104) in subjects with advanced malignant solid tumors or lymphoma [ClinicalTrials.gov identifier NCT00359294]. US National Institutes of Health, ClinicalTrials.gov. http://www.clinicaltrials.gov. Accessed 4 Sep 2012.
37. PharmaMar SA. A phase I multicenter, open-label, dose-escalating clinical and pharmacokinetic study of PM00104 administered every 3 weeks, intravenously, over 24 hours to subjects with advanced malignant solid tumors or lymphoma. [EUDRACT identifier: 2005-002588-10]. European Union Drug Regulating Authorities Clinical Trials. https://eudract.ema.europa.eu/. Accessed 4 Sep 2012.
38. PharmaMar SA. A phase I multicenter, open-label, dose-escalating clinical and pharmacokinetic study of PM00104 administered weekly resting every fourth week, intravenously, over 1 hour, to subjects with advanced malignant solid tumors or lymphoma. [EUDRACT identifier: 2005-002587-28]. European Union Drug Regulating Authorities Clinical Trials. https://eudract.ema.europa.eu/. Accessed 4 Sep 2012.