Using pharmacokinetic and pharmacodynamic modeling and simulation to evaluate importance of schedule in topotecan therapy for pediatric neuroblastoma

Clinical Cancer Research

Volumn 14, Issue 1, 2008, Pages 318-325

  Panetta, John C ^a,b   Schaiquevich, Paula ^a   Santana, Victor M ^a,b   Stewart, Clinton F ^a,b  

^a ST JUDE CHILDREN S RESEARCH HOSPITAL   (United States)

^b UNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

COTRIMOXAZOLE; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; TOPOTECAN;

ADOLESCENT; AREA UNDER THE CURVE; ARTICLE; BONE MARROW SUPPRESSION; CHILD; CLINICAL ARTICLE; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG EFFICACY; HUMAN; INFANT; MATHEMATICAL MODEL; NEUROBLASTOMA; NEUTROPENIA; NEUTROPHIL COUNT; NEWBORN; PHARMACODYNAMICS; PNEUMOCYSTOSIS; PRIORITY JOURNAL; SIMULATION; THROMBOCYTOPENIA; TUMOR GROWTH; TUMOR VOLUME;

ADOLESCENT; ANTINEOPLASTIC AGENTS; AREA UNDER CURVE; CHILD; CHILD, PRESCHOOL; CLINICAL TRIALS, PHASE II AS TOPIC; DRUG ADMINISTRATION SCHEDULE; HISTORY, ANCIENT; HUMANS; INFANT, NEWBORN; MODELS, THEORETICAL; NEUROBLASTOMA; TOPOTECAN;

EID: 40749102939     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-07-1243     Document Type: Article

References (35)

1. Bomgaars L, Berg SL, Blaney SM. The development of camptothecin analogs in childhood cancers. Oncologist 2001;6:506-16.
2. Furman W, Stewart CF, Poquette C, et al. The direct translation of a protracted irinotecan schedule from a xenograft model to a phase I trial in children. J Clin Oncol 1999;17:1815-24.
3. Furman WL, Crews KR, Billups C, et al. Cefixime allows greater dose escalation of oral irinotecan: a phase I study in pediatric patients with refractory solid tumors. J Clin Oncol 2006;24:563-70.
4. Bomgaars L, Kerr J, Berg S, Kuttesch J, Klenke R, Blaney SM. A phase I study of irinotecan administered on a weekly schedule in pediatric patients. Pediatr Blood Cancer 2006;46:50-5.
5. Vassal G, Doz F, Frappaz D, et al. A phase I study of irinotecan as a 3-week schedule in children with refractory or recurrent solid tumors. J Clin Oncol 2003;21:3844-52.
6. Stewart CF, Iacono LC, Chintagumpala M, et al. Results of a phase II upfront window of pharmacokinetically guided topotecan in high-risk medulloblastoma and supratentorial primitive neuroectodermal tumor. J Clin Oncol 2004;22:3357-65.
7. Stewart CF, Zamboni WC, Crom WR, et al. Topoisomerase I interactive drugs in children with cancer. Invest New Drugs 1996;14:37-47.
8. Zamboni WC, Stewart CF, Thompson J, et al. Relationship between topotecan systemic exposure and tumor response in human neuroblastoma xenografts. J Natl Cancer Inst 1998;90:505-11.
9. Houghton PJ, Chesire PJ, Myers L, Stewart CF, Synold TW, Houghton JA. Evaluation of 9-dimethylaminomethyl-10-hydroxycamptothecin against xenografts derived from adult and childhood solid tumors. Cancer Chemother Pharmacol 1992;31:229-39.
10. Houghton PJ, Stewart CF, Zamboni WC, Thompson J, Danks MK, Houghton JA. Schedule dependent efficacy of camptothecins in models of human cancer. N Y Acad Sci 1996;803:188-201.
11. Pratt CB, Stewart CF, Santana VM, et al. Phase I study of topotecan for pediatric patients with malignant solid tumors. J Clin Oncol 1994;12:539-43.
12. Blaney SM, Balis FM, Cole DE, et al. Pediatric phase I trial and pharmacokinetic study of topotecan administered as a 24-hour continuous infusion. Cancer Res 1993;53:1032-6.
13. Tubergen DG, Stewart CF, Pratt CB, et al. Phase I trial and pharmacokinetic (PK) and pharmacodynamics (PD) study of topotecan using a five-day course in children with refractory solid tumors: a pediatric oncology group study. J Pediatr Hematol Oncol 1996;18:352-61.
14. Nitschke R, Parkhurst J, Sullivan J, Harris MB, Bernstein M, Pratt C. Topotecan in pediatric patients with recurrent and progressive solid tumors: a Pediatric Oncology Group phase II study. J Pediatr Hematol Oncol 1998;20:315-8.
15. Kretschmar CS, Kletzel M, Murray K, et al. Response to paclitaxel, topotecan, and topotecan-cyclophosphamide in children with untreated disseminated neuroblastoma treated in an upfront phase II investigational window: a pediatric oncology group study. J Clin Oncol 2004;22:4119-26.
16. Furman WL, Stewart CF, Kirstein M, et al. Protracted intermittent schedule of topotecan in children with refractory acute leukemia: a pediatric oncology group study. J Clin Oncol 2002;20:1617-24.
17. Araujo RP, McElwain DL. New insights into vascular collapse and growth dynamics in solid tumors. J Theor Biol 2004;228:335-46.
18. Panetta JC. A mathematical model of breast and ovarian cancer treated with paclitaxel. Math Biosci 1997;146:89-113.
19. Panetta JC, Kirstein MN, Gajjar AJ, Nair G, Fouladi M, Stewart CF. A mechanistic mathematical model of temozolomide myelosuppression in children with high-grade gliomas. Math Biosci 2003;186:29-41.
20. Santana VM, Furman WL, Billups CA, et al. Improved response in high-risk neuroblastoma with protracted topotecan administration using a pharmacokinetically guided dosing approach. J Clin Oncol 2005;23:4039-47.
21. Stewart CF, Baker SD, Heideman RL, Jones D, Crom WR, Pratt CB. Clinical pharmacodynamics of continuous infusion topotecan in children: systemic exposure predicts hematologic toxicity. J Clin Oncol 1994;12:1946-54.
22. Zamboni WC, D'Argenio DZ, Stewart CF, et al. Pharmacodynamic model of topotecan-induced time course of neutropenia. Clin Cancer Res 2001;7:2301-8.
23. Kearns CM, Wang WC, Stute N, Ihle JN, Evans WE. Disposition of recombinant human granulocyte colony-stimulating factor in children with severe chronic neutropenia. J Pediatr 1993;123:471-9.
24. 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.
25. ADAPT II User's Guide: Pharmacokinetic/Pharmacodynamic Systems Analysis Software [computer program]. Los Angeles: Biomedical Simulations Resource; 1997.
26. Camplejohn RS, Aherne WA. In vitro labelling of childhood cancers with tritiated thymidine. Br J Cancer 1974;29:487-9.
27. Hayes FA, Green AA, Mauer AM. Correlation of cell kinetic and clinical response to chemotherapy in disseminated neuroblastoma. Cancer Res 1977;37:3766-70.
28. Minami H, Sasaki Y, Saijo N, et al. Indirect-response model for the time course of leukopenia with anticancer drugs. Clin Pharmacol Ther 1998;64:511-21.
29. Rubinow SI, Lebowitz JL. A Mathematical Model of Neutrophil Production and Control in Normal Man. J Math Biol 1975;1:187-225.
30. Mackey MC. Mathematical Models of Hematopoietic Cell Replication and Control. In: Othmer H, Adler F, Lewis M, Dallon J, editors. The Art of Mathematical Modeling: Case Studies in Ecology, Physiology, and Biofluids. New York: Prentice Hall; 1996. p.149-78.
31. Leger F, Loos WJ, Fourcade J, et al. Factors affecting pharmacokinetic variability of oral topotecan: a population analysis. Br J Cancer 2004;90:343-7.
32. Friberg LE, Karlsson MO. Mechanistic models for myelosuppression. Invest New Drugs 2003;21:183-94.
33. Erickson-Miller CL, May RD, Tomaszewski J, et al. Differential toxicity of camptothecin, topotecan and 9-aminocamptothecin to human, canine, and murine myeloid progenitors (CFU-GM) in vitro. Cancer Chemother Pharmacol 1997;39:467-72.
34. Zamboni WC, Bowman LC, Tan M, et al. Interpatient variability in bioavailability of the intravenous formulation of topotecan given orally to children with recurrent solid tumors. Cancer Chemother Pharmacol 1999;43:454-60.
35. Houghton PJ, Cheshire PJ, Hallman JD, et al. Efficacy of topoisomerase I inhibitors, topotecan and irinotecan, administered at low dose levels in protracted schedules to mice bearing xenografts of human tumors. Cancer Chemother Pharmacol 1995;36:393-403.