Pharmacokinetic/pharmacodynamic modeling of antitumor agents encapsulated into liposomes

Advanced Drug Delivery Reviews

Volumn 40, Issue 1-2, 1999, Pages 39-61

  Harashima, H ^a   Tsuchihashi, M ^a   Iida, S ^a   Doi, H ^a   Kiwada, H ^a  

^a UNIVERSITY OF TOKUSHIMA   (Japan)

Author keywords

[No Author keywords available]

Indexed keywords

ENCAPSULATION; HEMODYNAMICS; MATHEMATICAL MODELS; ONCOLOGY; PHARMACOKINETICS;

LIPOSOMES;

CONTROLLED DRUG DELIVERY;

ANTINEOPLASTIC AGENT; DOXORUBICIN; DRUG CARRIER; LIPOSOME;

ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; BLOOD FLOW VELOCITY; CELL KILLING; COMPARTMENT MODEL; COMPUTER SIMULATION; DRUG BLOOD LEVEL; DRUG DISPOSITION; DRUG RELEASE; ENCAPSULATION; HUMAN; MATHEMATICAL MODEL; NONHUMAN; PERITONEUM TUMOR; PHARMACODYNAMICS; PRIORITY JOURNAL; REVIEW; VALIDATION PROCESS;

EID: 0032850129     PISSN: 0169409X     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0169-409X(99)00039-3     Document Type: Article

References (64)

1. Woodle M.C., Lasic D.D. Sterically stabilized liposomes. Biochim. Biophys. Acta. 1113:1992;171-199.
2. Oku N. Long-circulating liposomes. Crit. Rev. Ther. Drug Carrier Syst. 11:1994;231-270.
3. Papahadjopoulos D., Allen T.M., Gabizon A., Mayhew E., Matthay K., Huang S.K., Lee K.-D., Woodle M.C., Lasic D.D., Redemann C., Martin F.J. Sterically stabilized liposomes: Improvements in pharmacokinetics and antitumor therapeutic efficacy. Proc. Natl. Acad. Sci. USA. 88:1991;11460-11464.
4. Huang S.K., Mayhew R., Gilani S., Lasic D.D., Martin F.J., Papahadjopoulos D. Pharmacokinetics and therapeutics of sterically stabilized liposomes in mice bearing C-26 colon carcinoma. Cancer Res. 52:1992;6774-6781.
5. Vaage J., Mayhew E., Lasic D., Martin F. Therapy of primary and metastatic mouse mammary carcinomas with doxorubicin encapsulated in long circulating liposomes. Int. J. Cancer. 51:1992;942-948.
6. Gabizon A.A. Selective tumor localization and improved therapeutic index of anthracyclines encapsulated in long-circulating liposomes. Cancer Res. 52:1992;891-896.
7. Vaage J., Donovan D., Mayhew E., Abra R., Huang A. Therapy of human ovarian carcinoma xenografts using doxorubicin encapsulated in sterically stabilized liposomes. Cancer. 72:1993;3671-3675.
8. Williams S.S., Alosco T.R., Mayhew E., Lasic D.D., Martin F.J., Bankert R.B. Arrest of human lung tumor xenograft growth in severe combined immunodeficient mice using doxorubicin encapsulated in sterically stabilized liposomes. Cancer Res. 53:1993;3964-3967.
9. Fischl M.A., Krown S.E., O'Boyle K.P., Mitsuyasu R., Miles S., Wernz J.C., Volberding P.A., Kahn J., Groopinan J.E., Feinberg J., Woody M. And the AIDS Clinical Trials Group. Weekly doxorubicin in the treatment of patients with AIDS-related Kaposi's sarcoma. J. Acquir. Immune Defic. Syndr. 6:1993;259-264.
10. Harrison M., Tomlinson D., Stewart S. Liposomal-entrapped doxorubicin: An active agent in AIDS-related Kaposi's sarcoma. J. Clin. Oncol. 13:1995;914-920.
11. Uziely B., Jeffers S., Isacson R., Kutsch K., Wei-Tsao D., Yehoshua Z., Libson E., Muggia F.M., Gabizon A. Liposomal doxorubicin: Antitumor activity and unique toxicities during two complementary phase I studies. J. Clin. Oncol. 13:1995;1777-1785.
12. Goebel F.-D., Goldstein D., Goos M., Jablonowski H., Stewart J.S. For the international SL-DOX study group. Efficacy and safety of Stealth liposomal doxorubicin in AIDS-related Kaposi's sarcoma. Br. J. Cancer. 73:1996;989-994.
13. Urakami Y., Harashima H., lidda S., Nagayasu A., Kiwada H. Kinetic study on the optimization of tumor delivery of antitumor agents by liposomes: Simulation study based on the physiological modeling. Drug Deliv. Syst. 12:1997;403-408.
14. Aroesty J., Lincoln T., Shapiro N., et al. Tumor growth and chemotherapy: mathematical methods, computer simulations, and experimental foundations. Math. Biosci. 17:1973;243-300.
15. Skipper H.E., Schabel F.M. Jr., Mellett L.B., Montgomery J.A., Wilkoff L.J., Lloyd H.H., Brockman R.W. Implications of biochemical, cytokinetic, pharmacologic and toxicologic relationships in the design of optimal therapeutic schedules. Cancer Chemother. Rep. 54:1970;431-450.
16. Shimoyama M., Kimura K. Quantitative clonal growth of mammalian cells: its application for quantitative study of cytocidal action of mitomycin-C. Gann. 63:1972;773-783.
17. Jusko W.J. Pharmacodynamics of chemotherapeutic effects: Dose-time-response relationships for phase-nonspecific agents. J. Pharm. Sci. 60:1971;892-895.
18. Ozawa S., Sugiyama Y., Mltsuhashi Y., Kobayashi T., Inaba M. Cell killing action of cell cycle phase-non-specific antitumor agents is dependent on concentration-time product. Cancer Chemother. Pharmacol. 21:1988;185-190.
19. Ozawa S., Sugiyama Y., Mitsuhashi J., Inaba M. Kinetic analysis of cell killing effect induced by cytosine arabinoside and cisplatin in relation to cell cycle phase specificity in human colon cancer and Chinese hamster cells. Cancer Res. 49:1989;3823-3828.
20. Jusko W.J. A pharmacodynamic model for cell-cycle-specific chemotherapeutic agents. J. Pharamcokin. Biopharm. 1:1973;175-200.
21. Rahman A., Carmichael D., Harris M., Roh J.K. Comparative pharmacokinetics of free doxorubicin and doxorubicin entrapped in cardiolipin liposomes. Cancer Res. 46:1986;2295-2299.
22. Butler T.P., Grantham F.H., Gullino P.M. Bulk transfer of fluid in the interstitial compartment of mammary tumors. Cancer Res. 35:1975;3084-3088.
23. Jam R.K. Determination of tumor blood flow: A review. Cancer Res. 48:1988;2641-2658.
24. Eskey C.J., Wolmark N., McDowell C.L., Domach M.M., Jam R.K. Residence time distributions of various tracers in tumors: Implications for drug delivery and blood flow measurement. J. Natl. Cancer Inst. 86:1994;293-299.
25. Huang S.K., Lee K.-D., Hong K., Friend D.S., Papahadjopoulos D. Microscopic localization of sterically stabilized liposomes in colon carcinoma-bearing mice. Cancer Res. 52:1992;5135-5143.
26. Yuan F., Leunig M., Huang S.K., Berk D.A., Papahadjopoulos D., Jam R.K. Microvascular permeability and interstitial penetration of sterically stabilized (Stealth) liposomes in a human tumor xenograft. Cancer Res. 54:1994;3352-3356.
27. Evans W.E., Relling M.V. Clinical pharmacokinetics-pharmacodynamics of antitumor drugs. Clinical pharmacokinet. 16:1989;327-336.
28. Yamaoka K., Tanigawara Y., Nakagawa T., Uno T. A pharmacokinetic analysis program (MULTI) for microcomputer. J. Pharmacobiodyn. 4:1981;879-890.
29. Yamaoka K., Nakagawa T.A. Nonlinear least squares program based on differential equations. MULTI(RUNGE), for microcomputers. J. Pharmacobiodyn. 6:1983;595-606.
30. Mayer L.D., Bally M.B., Cullis P.R., Wilson S.L., Emerman J.T. Comparison of free and liposome encapsulated doxorubicin tumor drug uptake and antitumor efficacy in the SCL115 murine mammary tumor. Cancer Lett. 53:1990;183-190.
31. Harashima H., Yamane C., Kume Y., Kiwada H. Kinetic analysis of AUC-dependent saturable clearance of liposomes: Mathematical description of AUC dependency. J. Pharmacokinet. Biopharm. 21:1993;299-308.
32. Jam R.K. Transport of molecules in the tumor interstitium: A review. Cancer Res. 47:1987;3039-3051.
33. Smith K.A., Hill S.A., Begg A.C., Denekamp J. Validation of the fluorescent dye Hoechst 33342 as a vascular space marker in tumors. Br. J. Cancer. 57:1988;247-253.
34. Nakai D., Fuse E., Suzuki H., Inaba M., Sugiyama Y. Evaluation of the efficacy of targeting of antitumor drugs: Simulation analysis based on pharmacokinetic/pharmacodynamic consideration. J. Drug Target. 3:1996;443-453.
35. Eichholtz-Wirth H. Dependence of the cytostatic effect of adriamycin on drug concentration and exposure time in vitro. Br. J. Cancer. 41:1980;886-891.
36. Milano G., Cassuto-Viguier E., Fischel J.L., Formento P., Renee N., Frenay M., Thyss A., Namer M. Doxorubicin weekly low dose administration: in vitro cytotoxicity generated by the typical pharmacokinetic profile. Eur. J. Cancer. 28A:1992;1881-1885.
37. Horoqitz A.T., Barenholz Y., Gabizon A.A. In vitro cytotoxicity of liposome-encapsulated doxorubicin: dependence on liposome composition and drug release. Biochim. Biophys. Acta. 1109:1992;203-209.
38. Saikawa A., Nomura T., Yamashita F., Takakura Y., Sezaki H., Hashida M. Pharmacokinetic analysis of drug disposition after intratumoral injection in a tissue-isolated tumor perfusion system. Pharm. Res. 13:1996;1438-1444.
39. Wu N.Z., Da D., Rudoll T.L., Needham D., Whorton A.R., Dewhirst M.W. Increased microvascular permeability contributes to preferential accumulation of Stealth liposomes in tumor tissue. Cancer Res. 53:1993;3765-3770.
40. Uchiyama K., Nagayasu A., Yamagiwa Y., Nishida T., Harashima H., Kiwada H. Effects of the size and fluidity of liposomes on their accumulation in tumors: A presumption of their interaction with tumors. Int. J. Pharm. 121:1995;195-203.
41. Yuan F., Dellian M., Fukumura D., Leunig M., Berk D.A., Torchilin V.P., Jam R.K. Vascular permeability in a human tumor xenograft: Molecular size dependence and cutoff size. Cancer Res. 55:1995;3752-3756.
42. Suzuki S., Watanabe S., Uno S., Tanaka M., Masuko T., Hashimoto Y. Endocytosis does not necessarily augment the cytotoxicity of adriamycin encapsulated in immunoliposomes. Biochim Biophys. Acta. 1224:1994;445-453.
43. Horowitz A.T., Barenholz Y., Gabizon A.A. In vitro cytotoxicity of liposome-encapsulated doxorubicin: dependence on liposome composition and drug release. Biochim. Biophys. Acta. 1109:1992;203-209.
44. Forssen E.A., Male-Brune R., Adler-Moore J.P., Lee M.J.A., Schmidt P.G., Krasieva T.B., Shimizu S., Tromberg B.J. Fluorescence imaging studies for the disposition of daunorubicin liposomes (DaunoXome) within tumor tissue. Cancer Res. 56:1996;2066-2075.
45. Lefrak E.A., Pitha J., Rosenheim S., Gottlieb J.A. A clinicopathologic analysis of adriamycin cardiotoxicity. Cancer. 32:1973;302-314.
46. Bielack S.S., Erttman R., Winkler K., Landbeck G. Doxorubicin: effect of different schedules on toxicity and anti-tumor efficacy. Eur. J. Cancer Clin. Oncol. 25:1989;873-882.
47. van Hoesel Q.G.C.M., Steerenberg P.A., Crommelin D.J.A., van Dijk A., van Oort W., Klein S., Douze J.M.C., de Wildt D.J., Hilen F.C. Reduced cardiotoxicity and nephrotoxicity with preservation of antitumor activity of doxorubicin entrapped in stable liposomes in the LOU/M Wsl rat. Cancer Res. 44:1984;3698-3705.
48. Gabizon A., Shiota R., Papahadjopoulos D. Pharmacokinetics and tissue distribution of doxorubicin encapsulated in stable liposomes with long circulation times. J. Natl. Cancer Inst. 81:1989;1484-1488.
49. Harashima H., Midori Y., Ohshima S., Yachi K., Kikuchi H., Kiwada H. Kinetic analysis of tissue distribution of doxorubicin incorporated in liposomes in rats (II). Biopharm. Drug Disposit. 14:1993;595-608.
50. Harasym T.O., Cullis P.R., Bally M.B. Intratumor distribution of doxorubicin following u.v. administration of drug encapsulated in egg phosphatidylcholine/cholesterol liposomes. Cancer Chemother. Pharmacol. 40:1997;309-317.
51. Mayhew E., Cimino M., Kiemperer J., Lazo R., Wiernikowski J., Arbuck S. Free and liposomal doxorubicin treatment of intraperitoneal colon 26 tumor: Therapeutic and pharmacologic studies. Selective Cancer Therapeutic. 6:1990;193-209.
52. Inaba M., Johnson R.K. Uptake and retention of adriamycin and daunorubicin by sensitive and anthracycline-resistant subline of P388 leukemia. Biochem. Pharmacol. 27:1978;2123-2130.
53. Bally M.B., Masin D., Nayar R., Cullis P.R., Mayer L.D. Transfer of liposomal drug carriers from the blood to the peritoneal cavity of normal and ascitic tumor-bearing mice. Cancer Chemother. Pharmacol. 34:1994;137-146.
54. 14C]adriamycin following intraperitoneal administration to rats. Cancer Res. 41:1981;1311-1317.
55. Flessner M.F., Dedrick R.L., Schultz J.S. Exchange of macromolecules between peritoneal cavity and plasma. Am. J. Physiol. 248:1984;H15-H25.
56. Park J.W., Hong K., Carter P., Asgan H., Guo L.Y., Keller G.A., Wirth C., Shalaby R., Kotts C., Wood W.I., Papahadjopoulos D., Benz C.C. Development of antip185HER2 immunoliposomes for cancer therapy. Proc. Natl. Acad. Sci. USA. 92:1995;1327-1331.
57. Kirpotin D., Park J.W., Hong K., Zalipsky S., Li W.L., Carter P., Benz C.C., Papahadjopoulos D. Sterically stabilized antiHER2 immunoliposomes: Design and targeting to human breast cancer cells in vitro. Biochemistry. 36:1997;66-75.
58. Suzuki S., Inoue K., Hongoh A., Hashimoto Y., Yamazoe Y. Modulation of doxorubicin resistance in a doxorubicin-resistant human leukaemia cell by an immunoliposome targeting transferring receptor. Br. J. Cancer. 76:1997;83-89.
59. Maruyama K., et al. Immunoliposomes bearing polyethyleneglycol-coupled Fab′ fragment show prolonged circulation time and high extravasation into targeted solid tumors in vivo. FEBS Lett. 413:1997;177-180.
60. de Menezes D.E.L., M Pilarski L., Allen T.M. In vitro and in vivo targeting of immunoliposomal doxorubicin to human B-cell lymphoma. Cancer Res. 58:1998;3320-3330.
61. Mayer L.D., Tai L.C.L., Bally M.B., Mitilenes G.N., Ginsberg R.S., Cullis P.R. Characterization of liposomal systems containing doxorubicin entrapped in response to pH gradients. Biochim. Biophys. Acta. 1025:1990;143-151.
62. Piscitelli S.C., Rodvold K.A., Rushing D.A., Tewksbury D.A. Pharmacokinetics and pharmacodynamics of doxorubicin in patients with small cell lung cancer. Clin. Pharmacol. Ther. 53:1993;555-561.
63. Gabizon A.A. Liposomal anthracyclines. New Drug Therapy. 8:1994;431-451.
64. Harashima H., Komatsu S., Kojima S., Yanagi C., Morioka Y., Naito M., Kiwada H. Species difference in the disposition of liposomes among mice, rats and rabbits: Allometric relationship and species dependent hepatic uptake clearance. Pharm. Res. 13:1996;1049-1054.