Cardiac safety of liposomal anthracyclines

Seminars in Oncology

Volumn 31, Issue SUPPL. 13, 2004, Pages 161-181

  Ewer, Michael S ^a,f   Martin, Francis J ^b   Henderson, I Craig ^c   Shapiro, Charles L ^d   Benjamin, Robert S ^a   Gabizon, Alberto A ^e  

^a UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^b ALZA CORPORATION   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d OHIO STATE UNIVERSITY   (United States)

^e SHAARE ZEDEK MEDICAL CENTER   (Israel)

^f Houston TX 77030 ^*  (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTHRACYCLINE DERIVATIVE; CISPLATIN; CYCLOPHOSPHAMIDE; DAUNORUBICIN; DOCETAXEL; DOXORUBICIN; DOXORUBICINOL; EPIRUBICIN; FLUOROURACIL; MITOXANTRONE; PACLITAXEL; RAZOXANE; TAXANE DERIVATIVE; TRASTUZUMAB;

ALOPECIA; ANTINEOPLASTIC ACTIVITY; BONE MARROW TOXICITY; BREAST CANCER; CANCER SURVIVAL; CARDIOMYOPATHY; CARDIOTOXICITY; CARDIOVASCULAR RISK; CHEMOTHERAPY INDUCED EMESIS; CLINICAL TRIAL; DIARRHEA; DISEASE SEVERITY; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG SAFETY; ELECTRON MICROSCOPY; ENCAPSULATION; HUMAN; INCIDENCE; MUSCLE ATROPHY; MYELOID LEUKEMIA; NAUSEA; PRIORITY JOURNAL; REVIEW; RISK ASSESSMENT;

EID: 11144284578     PISSN: 00937754     EISSN: None     Source Type: Journal    
DOI: 10.1053/j.seminoncol.2004.08.006     Document Type: Article

References (133)

1. J.H. Silber, G. Barber Doxorubicin-induced cardiotoxicity N Engl J Med 333 1995 1359 1360
2. L. Paz-Ares, N. Dobbs, C. Twelves Doxorubicin-induced cardiotoxicity N Engl J Med 333 1995 1360
3. L. Samuel Doxorubicin-induced cardiotoxicity Postgrad Med J 71 1995 318
4. V.J. Ferrans, J.R. Clark, J. Zhang Pathogenesis and prevention of doxorubicin cardiomyopathy Tsitologiia 39 1997 928 937
5. M.E. Billingham, J.W. Mason, M.R. Bristow Anthracycline cardiomyopathy monitored by morphologic changes Cancer Treat Rep 62 1978 865 872
6. M. Billingham, M. Bristow Evaluation of anthracycline cardiotoxicity predictive ability and functional correlation of endomyocardial biopsy Cancer Treat Symp 3 1984 71 76
7. M.S. Ewer, N. Jaffe, H. Ried Doxorubicin cardiotoxicity in children Comparison of a consecutive divided daily dose administration schedule with single dose (rapid) infusion administration Med Pediatr Oncol 31 1998 512 515
8. L.C. Kremer, E.C. van Dalen, M. Offringa Anthracycline-induced clinical heart failure in a cohort of 607 children Long-term follow-up study J Clin Oncol 19 2001 191 196
9. D.D. Von Hoff, M.W. Layard, P. Basa Risk factors for doxorubicin-induced congestive heart failure Ann Intern Med 91 1979 710 717
10. N. Andrieu-Abadie, J.P. Jaffrezou, S. Hatem L-carnitine prevents doxorubicin-induced apoptosis of cardiac myocytes Role of inhibition of ceramide generation Faseb J 13 1999 1501 1510
11. G. Falcone, W. Filippelli, B. Mazzarella Cardiotoxicity of doxorubicin Effects of 21-aminosteroids Life Sci 63 1998 1525 1532
12. E.H. Herman, J. Zhang, B.B. Hasinoff Comparison of the protective effects against chronic doxorubicin cardiotoxicity and the rates of iron (III) displacement reactions of ICRF-187 and other bisdiketopiperazines Cancer Chemother Pharmacol 40 1997 400 408
13. G. Link, R. Tirosh, A. Pinson Role of iron in the potentiation of anthracycline cardiotoxicity Identification of heart cell mitochondria as a major site of iron-anthracycline interaction J Lab Clin Med 127 1996 272 278
14. C. Hershko, A. Pinson, G. Link Prevention of anthracycline cardiotoxicity by iron chelation Acta Haematol 95 1996 87 92
15. L. Gille, H. Nohl Analyses of the molecular mechanism of adriamycin-induced cardiotoxicity Free Radic Biol Med 23 1997 775 782
16. I.A. Al-Nasser In vivo prevention of adriamycin cardiotoxicity by cyclosporin A or FK506 Toxicology 131 1998 175 181
17. J. Serrano, C.M. Palmeira, D.W. Kuehl Cardioselective and cumulative oxidation of mitochondrial DNA following subchronic doxorubicin administration Biochim Biophys Acta 1411 1999 201 205
18. A. Maeda, M. Honda, T. Kuramochi Doxorubicin cardiotoxicity Diastolic cardiac myocyte dysfunction as a result of impaired calcium handling in isolated cardiac myocytes Jpn Circ J 62 1998 505 511
19. A. Bordoni, P. Biagi, S. Hrelia The impairment of essential fatty acid metabolism as a key factor in doxorubicin-induced damage in cultured rat cardiomyocytes Biochim Biophys Acta 1440 1999 100 106
20. G. Minotti, R. Ronchi, E. Salvatorelli Doxorubicin irreversibly inactivates iron regulatory proteins 1 and 2 in cardiomyocytes Evidence for distinct metabolic pathways and implications for iron-mediated cardiotoxicity of antitumor therapy Cancer Res 61 2001 8422 8428
21. S.M. Swain, F.S. Whaley, M.S. Ewer Congestive heart failure in patients treated with doxorubicin A retrospective analysis of three trials Cancer 97 2003 2869 2879
22. O. Hequet, Q.H. Le, I. Moullet Subclinical late cardiomyopathy after doxorubicin therapy for lymphoma in adults J Clin Oncol 22 2004 1864 1871
23. C.L. Shapiro, P.H. Hardenbergh, R. Gelman Cardiac effects of adjuvant doxorubicin and radiation therapy in breast cancer patients J Clin Oncol 16 1998 3493 3501
24. C.L. Shapiro, A. Recht Side effects of adjuvant treatment of breast cancer N Engl J Med 344 2001 1997 2008
25. Herceptin (trastuzumab) prescribing information 2003 Genentech, Inc South San Francisco, CA
26. L. Gianni, P. Dombernowsky, G. Sledge Cardiac function following combination therapy with paclitaxel and doxorubicin An analysis of 657 women with advanced breast cancer Ann Oncol 12 2001 1067 1073
27. M.S. Ewer, H.R. Gibbs, J. Swafford Cardiotoxicity in patients receiving transtuzumab (Herceptin) Primary toxicity, synergistic or sequential stress, or surveillance artifact? Semin Oncol 26 1999 96 101
28. A.C. Wolff Liposomal anthracyclines and new treatment approaches for breast cancer Oncologist 8 suppl 2 2003 25 30
29. C,E. Geyer Jr, J. Bryant, E. Romond Cardiac safety analysis of the first stage of NSABP B-31, a randomized trial comparing the safety and efficacy of Adriamycin and cyclophosphamide (AC) followed by Taxol to that of AC followed by Taxol plus Herceptin in patients (Pts) with operable, node-positive (N+), HER-2 overexpressing breast cancer (HER2+BC) Breast Cancer Res Treat 82 suppl 1 2003 s13 (abstr)
30. L. Gianni, E. Munzone, G. Capri Paclitaxel by 3-hour infusion in combination with bolus doxorubicin in women with untreated metastatic breast cancer High antitumor efficacy and cardiac effects in a dose-finding and sequence-finding study J Clin Oncol 13 1995 2688 2699
31. P. Valagussa, G. Capri, A. Moliterni Cardiac safety of doxorubicin (A) and paclitaxel (T) at 5-year follow-up in women with breast cancer Proc Am Soc Clin Oncol 20 2001 134a (abstr)
32. P. Dombernowsky, J. Gehl, M. Boesgaard Doxorubicin and paclitaxel, a highly active combination in the treatment of metastatic breast cancer Semin Oncol 23 1996 23 27
33. M.R. Moore, J. Srinivasiah, B.A. Feinberg Phase II randomized trial of doxorubicin plus paclitaxel (AT) versus doxorubicin HCl liposome injection (Doxil) plus paclitaxel (DT) in metastatic breast cancer Proc Am Soc Clin Oncol 17 1998 160a (abstr 614)
34. L. Gianni, L. Vigano, A. Locatelli Human pharmacokinetic characterization and in vitro study of the interaction between doxorubicin and paclitaxel in patients with breast cancer J Clin Oncol 15 1997 1906 1915
35. J. Suzuki, A. Yanagisawa, T. Shigeyama Early detection of anthracycline-induced cardiotoxicity by radionuclide angiocardiography Angiology 50 1999 37 45
36. W.I. Ganz, K.S. Sridhar, S.S. Ganz Review of tests for monitoring doxorubicin-induced cardiomyopathy Oncology 53 1996 461 470
37. M.S. Ewer, M.K. Ali, S.P. Chawla A comparison of resting and exercise ejection fractions with cardiac biopsy grades in patients receiving Adriamycin Proc Am Soc Clin Oncol 4 1985 27 (abstr)
38. I.C. Henderson, L.J. Sloss, N. Jaffe Serial studies of cardiac function in patients receiving adriamycin Cancer Treat Rep 62 1978 923 929
39. B.V. Jensen, T. Skovsgaard, S.L. Nielsen Functional monitoring of anthracycline cardiotoxicity A prospective, blinded, long-term observational study of outcome in 120 patients Ann Oncol 13 2002 699 709
40. B. Mackay, M.S. Ewer, C.H. Carrasco Assessment of anthracycline cardiomyopathy by endomyocardial biopsy Ultrastruct Pathol 18 1994 203 211
41. M.S. Ewer, M.K. Ali, B. Mackay A comparison of cardiac biopsy grades and ejection fraction estimations in patients receiving Adriamycin J Clin Oncol 2 1984 112 117
42. B. MacKay, L.M. Keyes, R.S. Benjamin Cardiac biopsy Tex Soc Electron Microsc J 11 1980 7 15
43. T. Nousiainen, E. Jantunen, E. Vanninen Natriuretic peptides as markers of cardiotoxicity during doxorubicin treatment for non-Hodgkin's lymphoma Eur J Haematol 62 1999 135 141
44. E.H. Herman, S.E. Lipshultz, N. Rifai Use of cardiac troponin T levels as an indicator of doxorubicin-induced cardiotoxicity Cancer Res 58 1998 195 197
45. J. Lekakis, V. Prassopoulos, P. Athanassiadis Doxorubicin-induced cardiac neurotoxicity study with iodine 123-labeled metaiodobenzylguanidine scintigraphy J Nucl Cardiol 3 1996 37 41
46. R.A. Valdes Olmos, I. Carrio, C.A. Hoefnagel High sensitivity of radiolabelled antimyosin scintigraphy in assessing anthracycline related early myocyte damage preceding cardiac dysfunction Nucl Med Commun 23 2002 871 877
47. S.S. Legha, R.S. Benjamin, B. Mackay Adriamycin therapy by continuous intravenous infusion in patients with metastatic breast cancer Cancer 49 1982 1762 1766
48. F.M. Torti, M.R. Bristow, A.E. Howes Reduced cardiotoxicity of doxorubicin delivered on a weekly schedule. Assessment by endomyocardial biopsy Ann Intern Med 99 1983 745 749
49. K.K. Jain, E.S. Casper, N.L. Geller A prospective randomized comparison of epirubicin and doxorubicin in patients with advanced breast cancer J Clin Oncol 3 1985 818 826
50. Phase III randomized study of fluorouracil, epirubicin, and cyclophosphamide v fluorouracil, doxorubicin, and cyclophosphamide in advanced breast cancer: an Italian multicentre trial. Italian Multicentre Breast Study with Epirubicin J Clin Oncol 6 1988 976 982
51. R. Lahtinen, J. Kuikka, T. Nousiainen Cardiotoxicity of epirubicin and doxorubicin A double-blind randomized study Eur J Haematol 46 1991 301 305
52. H.D. Homesley, D.S. Harry, R.V. O'Toole Randomized comparison of cisplatin plus epirubicin or doxorubicin for advanced epithelial ovarian carcinoma. A multicenter trial Am J Clin Oncol 15 1992 129 134
53. I.C. Henderson, J.C. Allegra, T. Woodcock Randomized clinical trial comparing mitoxantrone with doxorubicin in previously treated patients with metastatic breast cancer J Clin Oncol 7 1989 560 571
54. J.M. Bennett, H.B. Muss, J.H. Doroshow A randomized multicenter trial comparing mitoxantrone, cyclophosphamide, and fluorouracil with doxorubicin, cyclophosphamide, and fluorouracil in the therapy of metastatic breast carcinoma J Clin Oncol 6 1988 1611 1620
55. S.M. Swain Adult multicenter trials using dexrazoxane to protect against cardiac toxicity Semin Oncol 25 1998 43 47
56. A.J. Weiss, G.E. Metter, W.S. Fletcher Studies on adriamycin using a weekly regimen demonstrating its clinical effectiveness and lack of cardiac toxicity Cancer Treat Rep 60 1976 813 822
57. B.L. Lum, J.M. Svec, F.M. Torti Doxorubicin Alteration of dose scheduling as a means of reducing cardiotoxicity Drug Intell Clin Pharm 19 1985 259 264
58. T. Umsawasdi, M. Valdivieso, D.J. Booser Weekly doxorubicin versus doxorubicin every 3 weeks in cyclophosphamide, doxorubicin, and cisplatin chemotherapy for non-small cell lung cancer Cancer 64 1989 1995 2000
59. R.S. Benjamin, S.P. Chawla, M.S. Ewer Adriamycin cardiotoxicity-An assessment of approaches to cardiac monitoring and cardioprotection M.P. Hacker J.S. Lazo T.R. Tritton Organ Directed Toxicities of Anticancer Drugs 1987 Martinus Nijhoff Publishing Boston, MA Proceedings of the First International Symposium on the Organ Directed Toxicities of Anticancer Drugs, Burlington, VT, June 4-6
60. S.S. Legha, R.S. Benjamin, B. Mackay Reduction of doxorubicin cardiotoxicity by prolonged continuous intravenous infusion Ann Intern Med 96 1982 133 139
61. E.S. Casper, J.J. Gaynor, S.I. Hajdu A prospective randomized trial of adjuvant chemotherapy with bolus versus continuous infusion of doxorubicin in patients with high-grade extremity soft tissue sarcoma and an analysis of prognostic factors Cancer 68 1991 1221 1229
62. M. Zalupski, B. Metch, S. Balcerzak Phase III comparison of doxorubicin and dacarbazine given by bolus versus infusion in patients with soft-tissue sarcomas A Southwest Oncology Group study J Natl Cancer Inst 83 1991 926 932
63. S.E. Lipshultz, A.L. Giantris, S.R. Lipsitz Doxorubicin administration by continuous infusion is not cardioprotective the Dana-Farber 91-01 Acute Lymphoblastic Leukemia protocol J Clin Oncol 20 2002 1677 1682
64. D.R. Budman, D.A. Berry, C.T. Cirrincione Dose and dose intensity as determinants of outcome in the adjuvant treatment of breast cancer. The Cancer and Leukemia Group B J Natl Cancer Inst 90 1998 1205 1211
65. J. Speyer, C. Wasserheit Strategies for reduction of anthracycline cardiac toxicity Semin Oncol 25 1998 525 537
66. Zinecard (dexrazoxane for injection) prescribing information 2002 Pharmacia & Upjohn Company Kalamazoo, MI
67. S.M. Swain, F.S. Whaley, M.C. Gerber Cardioprotection with dexrazoxane for doxorubicin-containing therapy in advanced breast cancer J Clin Oncol 15 1997 1318 1332
68. S.M. Swain, F.S. Whaley, M.C. Gerber Delayed administration of dexrazoxane provides cardioprotection for patients with advanced breast cancer treated with doxorubicin-containing therapy J Clin Oncol 15 1997 1333 1340
69. A. Noori, J. Lindenfeld, E. Wolfel Beta-blockade in adriamycin-induced cardiomyopathy J Card Fail 6 2000 115 119
70. H. Matsui, I. Morishima, Y. Numaguchi Protective effects of carvedilol against doxorubicin-induced cardiomyopathy in rats Life Sci 65 1999 1265 1274
71. M. Ryberg, D. Nielsen, T. Skovsgaard Epirubicin cardiotoxicity An analysis of 469 patients with metastatic breast cancer J Clin Oncol 16 1998 3502 3508
72. T.M. Allen, F.J. Martin Advantages of liposomal delivery systems for anthracyclines Semin Oncol 31 suppl 13 2004 5 15
73. A. Rahman, N. More, P.S. Schein Doxorubicin-induced chronic cardiotoxicity and its protection by liposomal administration Cancer Res 42 1982 1817 1825
74. A. Rahman, A. Kessler, N. More Liposomal protection of adriamycin-induced cardiotoxicity in mice Cancer Res 40 1980 1532 1537
75. E.H. Herman, A. Rahman, V.J. Ferrans Prevention of chronic doxorubicin cardiotoxicity in beagles by liposomal encapsulation Cancer Res 43 1983 5427 5432
76. A. Rahman, A. Fumagalli, A. Goodman Potential of liposomes to ameliorate anthracycline-induced cardiotoxicity Semin Oncol 11 1984 45 55
77. A. Rahman, G. White, N. More Pharmacological, toxicological, and therapeutic evaluation in mice of doxorubicin entrapped in cardiolipin liposomes Cancer Res 45 1985 796 803
78. P.C. Gokhale, B. Radhakrishnan, S.R. Husain An improved method of encapsulation of doxorubicin in liposomes Pharmacological, toxicological and therapeutic evaluation Br J Cancer 74 1996 43 48
79. E.A. Forssen, Z.A. Tokes Use of anionic liposomes for the reduction of chronic doxorubicin-induced cardiotoxicity Proc Natl Acad Sci U S A 78 1981 1873 1877
80. E.A. Forssen, Z.A. Tokes Attenuation of dermal toxicity of doxorubicin by liposome encapsulation Cancer Treat Rep 67 1983 481 484
81. Q.G. van Hoesel, P.A. Steerenberg, D.J. Crommelin 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
82. A. Gabizon, A. Dagan, D. Goren Liposomes as in vivo carriers of adriamycin Reduced cardiac uptake and preserved antitumor activity in mice Cancer Res 42 1982 4734 4739
83. F. Olson, E. Mayhew, D. Maslow Characterization, toxicity and therapeutic efficacy of adriamycin encapsulated in liposomes Eur J Cancer Clin Oncol 18 1982 167 176
84. G. Storm, Q.G. van Hoesel, G. de Groot A comparative study on the antitumor effect, cardiotoxicity and nephrotoxicity of doxorubicin given as a bolus, continuous infusion or entrapped in liposomes in the Lou/M Wsl rat Cancer Chemother Pharmacol 24 1989 341 348
85. A. Gabizon, D. Goren, Z. Fuks Enhancement of adriamycin delivery to liver metastatic cells with increased tumoricidal effect using liposomes as drug carriers Cancer Res 43 1983 4730 4735
86. A. Gabizon, A. Meshorer, Y. Barenholz Comparative long-term study of the toxicities of free and liposome-associated doxorubicin in mice after intravenous administration J Natl Cancer Inst 77 1986 459 469
87. J.A. Balazsovits, L.D. Mayer, M.B. Bally Analysis of the effect of liposome encapsulation on the vesicant properties, acute and cardiac toxicities, and antitumor efficacy of doxorubicin Cancer Chemother Pharmacol 23 1989 81 86
88. P.M. Kanter, G.A. Bullard, R.A. Ginsberg Comparison of the cardiotoxic effects of liposomal doxorubicin (TLC D-99) versus free doxorubicin in beagle dogs In Vivo 7 1993 17 26
89. P.K. Working, M.S. Newman, T. Sullivan Reduction of the cardiotoxicity of doxorubicin in rabbits and dogs by encapsulation in long-circulating, pegylated liposomes J Pharmacol Exp Ther 289 1999 1128 1133
90. J. Treat, A. Greenspan, D. Forst Antitumor activity of liposome-encapsulated doxorubicin in advanced breast cancer Phase II study J Natl Cancer Inst 82 1990 1706 1710
91. A. Gabizon, T. Peretz, A. Sulkes Systemic administration of doxorubicin-containing liposomes in cancer patients A phase I study Eur J Cancer Clin Oncol 25 1989 1795 1803
92. R.R. Owen, R.A. Sells, I.T. Gilmore A phase I clinical evaluation of liposome-entrapped doxorubicin (Lip-Dox) in patients with primary and metastatic hepatic malignancy Anticancer Drugs 3 1992 101 107
93. L. Harris, G. Batist, R. Belt Liposome-encapsulated doxorubicin compared with conventional doxorubicin in a randomized multicenter trial as first-line therapy of metastatic breast carcinoma Cancer 94 2002 25 36
94. Food and Drug Administration Center for Drug Evaluation and Research Sixty-third meeting of the oncologic drugs advisory committee, Silver Spring, MD. Available at: http://www.fda.gov/ohrms/dockets/ac/99/transcpt/3540t1.rtf. (site accessed June 22, 2002)
95. G. Batist, G. Ramakrishnan, C.S. Rao Reduced cardiotoxicity and preserved antitumor efficacy of liposome-encapsulated doxorubicin and cyclophosphamide compared with conventional doxorubicin and cyclophosphamide in a randomized, multicenter trial of metastatic breast cancer J Clin Oncol 19 2001 1444 1454
96. G. Batist, L. Harris, N. Azarnia Improved therapeutic index of TLC D-99 (liposome-encapsulated doxorubicin) compared to free doxorubicin in first-line treatment of metastatic breast cancer in patients who had received prior adjuvant doxorubicin Proc Am Soc Clin Oncol 19 2000 105a (abstr 405)
97. E. Winer, G. Batist, R. Belt Reduced cardiotoxicity of liposome-encapsulated doxorubicin (TLC D-99) compared to free doxorubicin in first-line therapy of metastatic breast cancer in patients at increased risk for anthracycline-induced cardiac toxicity Proc Am Soc Clin Oncol 19 2000 84a (abstr 323)
98. W.H. Miller Jr, A. DeMichele, K. Fox A phase I/II dose escalating trial of liposomal doxorubicin (TLC D-99, Myocet) in combination with paclitaxel (Taxol, T) for patients (pts) with metastatic breast cancer (MBC) Proc Am Soc Clin Oncol 21 2002 1937a (abstr 1937)
99. D.J. Slamon, B. Leyland-Jones, S. Shak Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2 N Engl J Med 344 2001 783 792
100. M. Theodoulou, S.M. Campos, G. Batist TLC D99 (D, Myocet) and Herceptin (H) is safe in advanced breast cancer (ABC) Final cardiac safety and efficacy analysis Proc Am Soc Clin Oncol 21 2002 55a (abstr 216)
101. J. Trigo, M.A. Climent, M. Gil Cardiac safety and activity of a phase I study of 3-weekly myocet in combination with weekly herceptin and paclitaxel in HER2-positive (HER2+) locally advanced or metastatic breast cancer (LA/MBC) Proc Am Soc Clin Oncol 21 2002 61a (abstr 242)
102. J.M. Trigo, M.A. Climent, A. Lluch Liposomal doxorubicin (MYOCET) in combination with HERCEPTIN and paclitaxel is active and well tolerated in patients with HER2-positive locally advanced or metastatic breast cancer (LA/MBC) A Phase II study Breast Cancer Res Treat 82 suppl 1 2003 583 (abstr 351)
103. E.S. Casper, G.K. Schwartz, A. Sugarman Phase I trial of dose-intense liposome-encapsulated doxorubicin in patients with advanced sarcoma J Clin Oncol 15 1997 2111 2117
104. C.L. Shapiro, T. Ervin, L. Welles Phase II trial of high-dose liposome-encapsulated doxorubicin with granulocyte colony-stimulating factor in metastatic breast cancer. TLC D-99 Study Group J Clin Oncol 17 1999 1435 1441
105. M.E. Billingham, M.R. Bristow, E. Glatstein Adriamycin cardiotoxicity Endomyocardial biopsy evidence of enhancement by irradiation Am J Surg Pathol 1 1977 17 23
106. G. Berry, M. Billingham, E. Alderman The use of cardiac biopsy to demonstrate reduced cardiotoxicity in AIDS Kaposi's sarcoma patients treated with pegylated liposomal doxorubicin Ann Oncol 9 1998 711 716
107. M.H. Mustafa Decreased risk of cardiotoxicity with long-term use of Doxil/Caelyx at high lifetime cumulative doses in patients with AIDS-related Kaposi's sarcoma (KS) Proc Am Soc Clin Oncol 20 2001 291b (abstr 2915)
108. 2 Ann Oncol 11 2000 1029 1033
109. A. Gabizon, O. Lyass Cardiac safety of pegylated liposomal doxorubicin (PLD) demonstrated by endomyocardial biopsy in patients with advanced malignancies Proc Am Soc Clin Oncol 22 2003 763 (abstr 3067)
110. A.A. Gabizon, O. Lyass, G.J. Berry Cardiac safety of pegylated liposomal doxorubicin (DOXIL/CAELYX) demonstrated by endomyocardial biopsy in patients with advanced malignancies Cancer Invest 22 2004 663 669
111. J. Wolf Retrospective analysis of pegylated liposomal doxorubicin and cardiotoxicity Proc Am Soc Clin Oncol 20 2001 182b (abstr 2480)
112. F. Muggia, E. Kim, A. Downey Safety of prolonged Doxil administration in recurrent gynecologic cancers Proc Am Soc Clin Oncol 23 2004 461 (abstr 5055)
113. D. Uyar, B. Kulp, G. Peterson Cardiac safety profile of prolonged (<6 cycles) pegylated liposomal doxorubicin administration in patients with gynecologic malignancies Gynecol Oncol 94 2004 147 151
114. A.N. Gordon, J.T. Fleagle, D. Guthrie Recurrent epithelial ovarian carcinoma A randomized phase III study of pegylated liposomal doxorubicin versus topotecan J Clin Oncol 19 2001 3312 3322
115. A.M. Keller, R.G. Mennel, V.A. Georgoulias Randomized phase III trial of pegylated liposomal doxorubicin versus vinorelbine or mitomycin C plus vinblastine in women with taxane-refractory advanced breast cancer J Clin Oncol 22 2004 3893 3901
116. D.M. Vail, M.A. Amantea, G.T. Colbern Pegylated liposomal doxorubicin Proof of principle using preclinical animal models and pharmacokinetic studies Semin Oncol 31 suppl 13 2004 16 35
117. M.E. O'Brien, N. Wigler, M. Inbar Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCl (CAELYX/Doxil) versus conventional doxorubicin for first-line treatment of metastatic breast cancer Ann Oncol 15 2004 440 449
118. Wolff AC, Wang M, Sparano JA,, et al. Cardiac safety and clinical activity of pegylated liposomal doxorubicin (D) and docetaxel (T) with and without trastuzumab (H) as 1st line chemotherapy in HER2-positive and HER2-negative metastatic breast cancer (MBC): Eastern Cooperative Oncology Group (ECOG) trial E3198. 27th Annual San Antonio Breast Cancer Symposium, San Antonio, TX 2004
119. S.K. Chia, M. Clemons, L.A. Martin A multi-centre phase II trial of pegylated liposomal doxorubicin and trastuzumab in HER-2 over-expressing metastatic breast cancer (MBC) Proc Am Soc Clin Oncol 23 2004 34 (abstr 630)
120. P.S. Gill, J. Wernz, D.T. Scadden Randomized phase III trial of liposomal daunorubicin versus doxorubicin, bleomycin, and vincristine in AIDS-related Kaposi's sarcoma J Clin Oncol 14 1996 2353 2364
121. K.J. O'Byrne, A.L. Thomas, R.A. Sharma A phase I dose-escalating study of DaunoXome, liposomal daunorubicin, in metastatic breast cancer Br J Cancer 87 2002 15 20
122. A. Fassas, R. Buffels, A. Anagnostopoulos Safety and early efficacy assessment of liposomal daunorubicin (DaunoXome) in adults with refractory or relapsed acute myeloblastic leukaemia A phase I-II study Br J Haematol 116 2002 308 315
123. J. Cortes, E. Estey, S. O'Brien High-dose liposomal daunorubicin and high-dose cytarabine combination in patients with refractory or relapsed acute myelogenous leukemia Cancer 92 2001 7 14
124. R.J. Lippens Liposomal daunorubicin (DaunoXome) in children with recurrent or progressive brain tumors Pediatr Hematol Oncol 16 1999 131 139
125. S. Lowis, I. Lewis, A. Elsworth Cardiac toxicity may limit the usefulness of liposomal daunorubicin (DaunoXome) Results of a phase I study in children with relapsed or resistant tumours-A UKCCSG/SFOP study Proc Am Soc Clin Oncol 21 2002 109a (abstr 435)
126. D.H. Gallinson, Z. Li, P. Coty Cardiac toxicity of liposomal anthracyclines (LA) in Kaposi's Sarcoma patients with HIV infection Proc Am Soc Clin Oncol 22 2003 780 (abstr 3135)
127. R.M. Schiffelers, I.A. Bakker-Woudenberg, G. Storm Localization of sterically stabilized liposomes in experimental rat Klebsiella pneumoniae pneumonia Dependence on circulation kinetics and presence of poly(ethylene)glycol coating Biochim Biophys Acta 1468 2000 253 261
128. A. Gabizon, D. Goren, A.T. Horowitz Long-circulating liposomes for drug delivery in cancer therapy A review of biodistribution studies in tumor-bearing animals Adv Drug Deliv Rev 24 1997 337 344
129. P.G. Tardi, N.L. Boman, P.R. Cullis Liposomal doxorubicin J Drug Target 4 1996 129 140
130. A. Gabizon, H. Shmeeda, Y. Barenholz Pharmacokinetics of pegylated liposomal Doxorubicin Review of animal and human studies Clin Pharmacokinet 42 2003 419 436
131. D. Papahadjopoulos, T.M. Allen, A. Gabizon Sterically stabilized liposomes Improvements in pharmacokinetics and antitumor therapeutic efficacy Proc Natl Acad Sci U S A 88 1991 11460 11464
132. M. Eliskova, O. Eliska Light microscopy of the lymphatics of the human atrial wall and lymphatic drainage of supraventricular pacemakers Int Angiol 8 1989 1 6
133. F. Erdkamp, S. Chan, N. Davidson Phase III study of TLC D-99 (liposome encapsulated doxorubicin) plus cyclophosphamide vs. epirubicin (EPI) plus cyclophosphamide (CPA) in patients with metastatic breast carcinoma (MBC) Proc Am Soc Clin Oncol 18 1999 459a (abstr 459)