Polyethylene glycol-liposomal doxorubicin: A review of its use in the management of solid and haematological malignancies and AIDS-related Kaposi's sarcoma

Drugs

Volumn 62, Issue 14, 2002, Pages 2089-2126

  Sharpe, Miriam ^a   Easthope, Stephanie E ^a   Keating, Gillian M ^a   Lamb, Harriet M ^a  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

ALPHA INTERFERON; ALTRETAMINE; ANTHRACYCLINE ANTIBIOTIC AGENT; BLEOMYCIN; CARBOPLATIN; CYCLOPHOSPHAMIDE; DAUNORUBICIN; DEXAMETHASONE; DOCETAXEL; DOXORUBICIN; EPIRUBICIN; FLUOROURACIL; GEMCITABINE; IFOSFAMIDE; MACROGOL; METHOTREXATE; METHYLPREDNISOLONE; MITOMYCIN; MITOMYCIN C; MITOXANTRONE; NAVELBINE; PACLITAXEL; PLATINUM; PYRIDOXINE DERIVATIVE; TAXANE DERIVATIVE; TOPOTECAN; UNCLASSIFIED DRUG; UNINDEXED DRUG; VINBLASTINE; VINCRISTINE;

ACQUIRED IMMUNE DEFICIENCY SYNDROME; ALLERGIC REACTION; ALOPECIA; ANAPHYLAXIS; ANEMIA; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; ASTHENIA; ASTHMA; BACKACHE; BONE MARROW SUPPRESSION; BREAST CANCER; CARDIOTOXICITY; CHILL; CLINICAL TRIAL; CONSTIPATION; DIARRHEA; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG EFFICACY; DRUG FORMULATION; DRUG HALF LIFE; DYSPEPSIA; DYSPNEA; FACE EDEMA; FEBRILE NEUTROPENIA; FEVER; HAND FOOT SYNDROME; HEMATOLOGIC MALIGNANCY; HUMAN; HYPERTENSION; HYPOTENSION; KAPOSI SARCOMA; LEUKOPENIA; METASTASIS; MULTIPLE MYELOMA; NAUSEA; NEUTROPENIA; NONHODGKIN LYMPHOMA; PHARYNGITIS; PRURITUS; RASH; REVIEW; SOLID TUMOR; STOMATITIS; TACHYCARDIA; THORAX PAIN; THROMBOCYTOPENIA; URTICARIA; VERTIGO;

EID: 0036402578     PISSN: 00126667     EISSN: None     Source Type: Journal    
DOI: 10.2165/00003495-200262140-00012     Document Type: Review

References (142)

1. Coukell A, Spencer CM. Polyethylene glycol-liposomal doxorubicin: A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy in the management of AIDS-related Kaposi's sarcoma, Drugs 1997 Mar; 53 (3): 520-38
2. Riggs CE. Bennett JP. Clinical pharmacology of individual antineoplastic agents. In: Moossa AR, Schimpff SC, Robson MC, editors. Comprehensive Textbook of Oncology, 2nd ed. v. 1. Baltimore, Maryland, USA: Williams & Wilkins, 1991: 537-65
3. Balmer C, Valley AW. Basic principles of cancer treatment and cancer chemotherapy, In: DiPiro JT, Talbert RL, Hayes PE, et al., editors. Pharmacotherapy: A Pathophysiologic Approach, 2nd ed. Norwalk. Connecticut, USA: Appleton & Lange, 1993; 1879-929
4. Waterhouse DN, Tardi PG, Mayer LD. et al. A comparison of liposomal formulations of doxorubicin with drug administered in free form: Changing toxicity profiles. Drug Saf 2001; 24 (12): 903-20
5. Olson RD, Mushlin PS. Doxorubicin cardiotoxicity: Analysis of prevailing hypotheses. FASEB J 1990 Oct; 4 (13): 3076-86
6. Speyer J, Wasserheit C. Strategies for reduction of anthracycline cardiac toxicity. Semin Oncol 1998; 25 (5): 525-37
7. Green M. Anthracycline cardiotoxicity, no longer an issue? Ann Oncol 1998; 9: 691-3
8. Gabizon A, Martin F. Polyethylene glycol-coated (pegylated) liposomal doxorubicin. Rationale for use in solid tumours. Drugs 1997: 54 Suppl. 4: 15-21
9. Lasic DD. Doxorubicin in sterically stabilized liposomes. Nature 1996 Apr 11; 380: 561-2
10. Lasic DD, Martin FJ, Gabizon A. et al. Sterically stabilized liposomes: A hypothesis on the molecular origin of the extended circulation times. Biochim Biophys Acta 1991; 1070: 187-92
11. Meriwether WD, Bachur NR. Inhibition of DNA and RNA metabolism by daunorubicin and adriamycin in L1210 mouse leukemia. Cancer Res 1972 Jun; 32 (6): 1137-42
12. Reinert KE. Anthracycline-binding induced DNA stiffening, bending and elongation; stereochemical implications from viscometric investigations. Nucleic Acids Res 1983 May 25; 11 (10): 3411-30
13. Hortobágyi GN. Anthracyclines in the treatment of cancer. Drugs 1997; 54 Suppl. 4: 1-7
14. Beyer U, Rothen-Rutishauser B, Unger C, et al. Differences in the intracellular distribution of acid-sensitive doxorubicin-protein conjugates in comparison to free and liposomal formulated doxorubicin as shown by confocal microscopy. Pharm Res 2001; 18 (1): 29-38
15. Stürzl M, Zietz C, Eisenburg B, et al. Liposomal doxorubicin in the treatment of AIDS-associated Kaposi's sarcoma: Clinical, histological and cell biological evaluation. Res Virol 1994 May-Aug; 145 (3-4): 261-9
16. Vaage J, Donovan D, Mayhew E. et al. Therapy of human ovarian carcinoma xenografts using doxorubicin encapsulated in sterically stabilized liposomes. Cancer 1993 Dec 15; 72: 3671-5
17. Wiles ME, Bell C. L: Landfair D, et al. Anthracycline efficacy in vitro: Cytotoxicity of liposomal/nonliposomal daunorubicin and doxorubicin for multiple tumor cell types [in ENGLISH]. Drug Delivery: Journal of Delivery and Targeting of Therapeutic Agents 1997; 4 (4): 255-62
18. Pratt G, Wiles ME. Rawstron AC. et al. Liposomal daunorubicin: In vitro and in vivo efficacy in multiple myeloma. Hematol Oncol 1998 Jun: 16: 47-55
19. Gabizon A, Chemla M, Tzemach D, et al. Liposome longevity and stability in circulation: Effects on the in vivo delivery to tumors and therapeutic efficacy of encapsulated anthracyclines. J Drug Target 1996; 3: 391-8
20. Cabanes A, Tzemach D, Goren D. et al. Comparative study of the antitumor activity of free doxorubicin and polyethylene glycol-coated liposomal doxorubicin in a mouse lymphoma model. Clin Cancer Res 1998 Feb: 4: 499-505
21. Vaage J, Donovan D, Mayhew E. et al. Therapy of mouse mammary carcinomas with vincristine and doxorubicin encapsulated in sterically stabilized liposomes. Int J Cancer 1993;54: 959-64
22. Vaage J, Mayhew E, Lasic D. et al. Therapy of primary and metastatic mouse mammary carcinomas with doxorubicin encapsulated in long circulating liposomes. Int J Cancer 1992; 51: 942-8
23. Vaage J, Donovan D, Loftus T, et al. Chemoprevention and therapy of mouse mammary carcinomas with doxorubicin encapsulated in sterically stabilized liposomes. Cancer 1994 May 1; 73: 2366-71
24. Vaage J, Donovan D, Loftus T, et al. Prevention of metastasis from mouse mammary carcinomas with liposomes carrying doxorubicin. Br J Cancer 1995; 72 (5): 1074-5
25. Vaage J, Donovan D, Loftus T, et al. Prophylaxis and therapy of mouse mammary carcinomas with doxorubicin and vincristine encapsulated in sterically stabilised liposomes. Eur J Cancer 1995; 31A (3): 367-72
26. Lyass O, Uziely B, Ben-Yosef R, et al. Correlation of toxicity with pharmacokinetics of pegylated liposomal doxorubicin (Doxil) in metastatic breast carcinoma. Cancer 2000; 89 (5): 1037-47
27. Amantea MA, Gabizon A. Pharmacokinetics (PKs) of Caelyx®/Doxil® (Stealth® liposomal doxorubicin) in patients with either breast or prostate cancer [abstract]. Ann Oncol 1998; 9 Suppl. 2: 171
28. Gabizon A, Uziely B, Lotem M, et al. Doxil® in patients with pretreated metastatic breast cancer (MBC): A dose-schedule finding study with pharmacokinetics [abstract]. 33rd Proc Am Soc Clin Oncol 1997 May 17; 16: 147
29. Symon Z, Peyser A, Tzemach D, et al. Selective delivery of doxorubicin to patients with breast carcinoma metastases by stealth liposomes, Cancer 1999 Jul 1; 86: 72-8
30. Czejka M, Braunsdorier M, Strauch S, et al. Pegylated liposomal doxorubicin (Caelyx®), administered intravenously at conventional dosages, penetrates into the brain [abstract no. 448]. Clin Cancer Res 1999 Nov; 5 Suppl.: 3819s
31. Stewart S, Harrington KJ. The biodistribution and pharmacokinetics of stealth liposomes in patients with solid tumors. Oncology USA 1997; 11 (10 Suppl. 11): 33-7
32. Amantea MA, Forrest A, Northfelt DW, et al. Population pharmacokinetics and pharmacodynamics of pegylated-liposomal doxorubicin in patients with AIDS-related Kaposi's sarcoma. Clin Pharmacol Ther 1997 Mar; 61: 301-11
33. Weger M, Czejka M, Linkesch W, et al. A phase I pharmacokinetic study of Doxil® (liposomal doxorubicin in combination with vinorelbine, cyclophosphamide, and prednisone in NHL patients [abstract no. 894]. 35th ASCO; 1999 May 15-18; Atlanta, Georgia: 232
34. Gautier M, Petros W, Peterson B, et al. Doxil, vincristine and dexamethasone: A new regimen for elderly patients with multiple myeloma [abstract no. 101]. 35th ASCO; 1999 May 15-18; Atlanta, Georgia: 28a
35. Venook AP, Amantea M, Bonnem E, et al. Pegylated liposome-encapsulated doxorubicin (Doxil®) in patients with hepatocellular carcinoma [abstract no. 1494]. 32nd ASCO; 1996 May 18-21; Philadelphia, PA: 473
36. Schering-Plough Ltd. Caelyx Prescribing Information. Bruxelles, Belgium, Jul 2001
37. Gabizon A, Catane R, Uziely B, et al. Prolonged circulation time and enhanced accumulation in malignant exudates of doxorubicin encapsulated in polyethylene-glycol coated liposomes. Cancer Res 1994 Feb 15; 54: 987-92
38. Northfelt DW, Martin FJ, Working P, et al. Doxorubicin encapsulated in liposomes containing surface-bound polyethylene glycol: Pharmacokinetics, tumor localization, and safety in patients with AIDS-related Kaposi's sarcoma. J Clin Pharmacol 1996 Jan; 36 (1): 55-63
39. Gabizon A, Huang A, Martin F, etal. Doxorubicin encapsulated in polyethylene glycol-coated liposomes: Initial clinical-pharmacokinetic studies in solid tumors. In: Lasic D, Martin F, editors. Stealth Liposomes. Boca Raton, Florida, USA: CRC Press, 1995: 245-55
40. Guyton AC. Textbook of Medical Physiology. 6th ed. Philadelphia: W.B. Saunders Company, 1981
41. Allen TM. Liposomes: Opportunities in drug delivery. Drugs 1997; 54 Suppl. 4: 8-14
42. Brown JM, Giaccia AJ. The unique physiology of solid tumors: Opportunities (and problems) for cancer therapy. Cancer Res 1998; 58 (7): 1408-16
43. ALZA Pharmaceuticals Inc. Doxil® Prescribing Information. Mountain View, California, USA, Jul 2000
44. Harrington KJ, Gooden CSR, Mohammedtaghi S, et al. Biodistribution and pharmacokinetics of In-111 labeled Stealth® liposomes in patients with solid tumours [abstract no. 1511]. 32nd ASCO; 1996 May 18-21; Philadelphia, PA: 477
45. Gabizon AA. Liposomal anthracyclines. New Drug Therapy 1994; 8 (2): 431-50
46. Northfelt DW. Stealth® liposomal doxorubicin (SLD) delivers more doxorubicin (DOX) to AIDS-Kaposi's sarcoma (AIDS-KS) lesions than to normal skin [abstract no. 5]. Proc Am Soc Clin Oncol 1994 Mar; 13: 51
47. Working PK. Newman MS. Huang SK. et al. Pharmacokinetics, biodistribution and therapeutic efficacy of doxorubicin encapsulated in Stealth® liposomes (Doxil®). J Liposome Res 1994; 4 (1): 667-87
48. Working PK, Dayan AD. Pharmacological-toxicological expert report. Caelyx™. (Stealth® liposomal doxorubicin HCl). Hum Exp Toxicol 1996; 15 (9): 752-85
49. Huang SK, Lee K-D, Hong K, et al. Microscopic localization of sterically stabilized liposomes in colon carcinoma-bearing mice. Cancer Res 1992 Oct 1; 52: 5135-43
50. Harrington K, Stewart S, Harrison D, et al. Phase II pilot study of Caelyx (doxorubicin HCI, pegylated liposomal) in patients with inoperable head and neck squamous cell cancer [abstract]. Br J Cancer 1998; 78 Suppl. 2: 34
51. Koukourakis MI, Koukouraki S, Giatromanolaki A, et al. Liposomal doxorubicin and conventionally fractionated radiotherapy in the treatment of locally advanced non-small-cell lung cancer and head and neck cancer. J Clin Oncol 1999 Nov; 17: 3512-21
52. Caponigro F, Comella P, Budillon A, et al. Phase I study of Caelyx (doxorubicin HCL, pegylated liposomal) in recurrent or metastatic head and neck cancer. Ann Oncol 2000; 11: 339-42
53. Stewart JS, Lewanski C, Harrington K, et al. Comparison of pegylated liposomal doxorubicin (PLD) and pegylated liposomal cisplatinum (PLC) in patients with advanced head and neck squamous cell carcinoma (HNSCC) [abstract no. 1672]. 36th ASCO; 2000 May 20-23; New Orleans. LA: 423
54. Halm U, Etzrodt G, Schiefke I, et al. A phase II study of pegylated liposomal doxorubicin for treatment of advanced hepatocellular carcinoma. Ann Oncol 2000 Jan; 11: 113-4
55. Hubert A, Lyass O, Pode D, et al. Doxil (Caelyx): An exploratory study with pharmacokinetics in patients with hormone-refractory prostate cancer. Anticancer Drugs 2000; 11: 123-7
56. McMenemin R, Macdonald G, Moffat L, et al. A phase II study of Caelyx™ (liposomal doxorubicin) in metastatic carcinoma of the prostate: Tolerability and efficacy modification by liposomal encapsulation. Invest New Drugs 2002; 20 (3): 331-7
57. Toma S, Tucci A, Villani G, et al. Liposomal doxorubicin (Caelyx) in advanced pretreated soft tissue sarcomas: A phase II study of the Italian Sarcoma Group (ISG). Anticancer Res 2000; 20: 485-92
58. Dietrich J, Fabel-Schulte K, Hau P, et al. Liposomal doxorubicin (Caelyx) in the treatment of recurrent high-grade glioma - A phase II/III study [abstract no. 661]. Proc Am Soc Clin Oncol 2000 May 20; 19: 170
59. Dietrich J, Hau P, Fabel K, et al. Phase II clinical trial in high-grade-glioma: Stabilization of disease in patients treated with liposomal doxorubicin [abstract no. 262]. Proc Am Soc Clin Oncol 2001 May 12; 20 Pt 1: 66
60. Oh Y, Perez-Soler R, Fossella FV, et al. Phase II study of intravenous Doxil® in malignant pleural mesothelioma. Invest New Drugs 2000; 18: 243-5
61. Baas P, van Meerbeeck J, Groen H, et al. Caelyx™ in malignant mesothelioma: A phase II EORTC study. Ann Oncol 2000; 11: 697-700
62. Lorigan PC. Crosby T, Coleman RE. Current drug treatment guidelines for epithelial ovarian cancer. Drugs 1996 Apr; 51 (4): 571-84
63. Wiseman LR, Spencer CM. Paclitaxel: An update of its use in the treatment of metastatic breast cancer and ovarian and other gynaecological cancers. Drugs Aging 1998 Apr; 12 (4): 305-34
64. Gordon AN, Fleagle JT, Guthrie D, et al. Recurrent epithelial ovarian carcinoma: A randomized phase III study of pegylated liposomal doxorubicin versus topotecan. J Clin Oncol 2001 Jul 15; 19 (14): 3312-22
65. Gibbs DD, Pyle L, Allen M, et al. A phase I dose-finding study of a combination of pegylated liposomal doxorubicin (Doxil), carboplatin and paclitaxel in ovarian cancer. Br J Cancer 2002; 86 (9): 1379-84
66. Green S, Weiss GR. Southwest Oncology Group standard response criteria, endpoint definitions and toxicity criteria. Invest New Drugs 1992; 10: 239-53
67. Muggia FM, Hainsworth JD, Jeffers S, et al. Phase II study of liposomal doxorubicin in refractory ovarian cancer: Antitumor activity and toxicity modification by liposomal encapsulation. J Clin Oncol 1997 Mar; 15 (3): 987-93
68. Safra T, Groshen S, Jeffers S, et al. Treatment of patients with ovarian carcinoma with pegylated liposomal doxorubicin: Analysis of toxicities and predictors of outcome. Cancer 2001; 91: 90-100
69. Gordon AN, Granai CO, Rose PG, et al. Phase II study of liposomal doxorubicin in platinum- and paclitaxel-refractory epithelial ovarian cancer. J Clin Oncol 2000 Sep; 18 (17): 3093-100
70. Rose PG, Maxson JH, Fusco N, et al. Liposomal doxorubicin in ovarian, peritoneal, and tubal carcinoma: A retrospective comparative study of single-agent dosages. Gynecol Oncol 2001; 82: 323-8
71. Rustin GJS, Nelstrop AE, McClean P. et al. Defining response of ovarian carcinoma to initial chemotherapy according to serum CA 125. J Clin Oncol 1996 May; 14 (5): 1545-51
72. Campos SM. Penson RT, Mays AR, et al. The clinical utility of liposomal doxorubicin in recurrent ovarian cancer. Gynecol Oncol 2001; 81: 206-12
73. Israel VP, Garcia AA, Roman L, et al. Phase II study of liposomal doxorubicin in advanced gynecologic cancers. Gynecol Oncol 2000; 78: 143-7
74. Arcuri C, Sorio LR, Tognon G, et al. Efficacy and toxicity of Doxil/Caelyx (D) in patients with recurrent epithelial ovarian cancer (OC) [abstract no. C13]. Ann Oncol 2001: 12 Suppl. 4: 34
75. National Institute for Clinical Excellence. Guidance on the use of pegylated liposomal doxorubicin hydrochloride (PLDH) for the treatment of advanced ovarian cancer. Technology Appraisal Guidance - No. 45, Jul 2002. Availalbe from URL: http://www.nice.org.uk. [Accessed 26 Jul 2002]
76. Voest EE, Verhaar-Langereis MJ. A phase II study of the combination doxil and topotecan in platinum-resistant ovarian cancer [abstract no. 2479]. 37th ASCO; 2001 May 12-15; San Francisco, CA: 182
77. Geertsen PF, Strøyer I, Herrstedt J, et al. Phase I study of topotecan (T) and pegylated liposomal doxorubicin (Caelyx) in patients (pts) with progressive ovarian cancer within 12 months after first-line platinum-paclitaxel containing chemotherapy [abstract no. 2522]. 37th ASCO; 2001 May 12-15; San Francisco, CA: 193b
78. Mirchandani D, Hochster H, Hamilton A, et al. Efficacy of Doxil and topotecan in platinum-pretreated epithelial ovarian cancer in a phase I study [abstract no. 138]. Gynecol Oncol 2001 Feb; 80 (2): 315
79. Bourgeois H. Pegylated liposomal doxorubicin (Caelyx) and ifosfamide (IFO) in recurrent ovarian cancer (ROC): A phase I/II GINECO study [abstract no. 1577]. 36th ASCO; 2000 May 20-23; New Orleans, LA: 398a
80. Tobias DH, Runowicz J, Mandeli J, et al. A phase I trial of gemcitabine and doxil for recurrent epithelial ovarian cancer [abstract no. 1551]. 36th ASCO; 2000 May 20-23; New Orleans, LA: 392a
81. Alberg AJ, Lam AP, Helzlsouer KJ. Epidemiology prevention and early detection of breast cancer. Curr Opin Oncol 1999; 11: 435-41
82. Rubens RD. Key issues in the treatment of advanced breast cancer: Expectations and outcomes. Pharmacoeconomics 1996; 9 Suppl. 2: 1-7
83. Keller AM, Mennel RG, Nabholtz J, et al. Phase III trial of pegylated liposomal doxorubicin (Caelyx/Doxil) for the treatment of patients with advanced breast cancer who have failed a prior taxane-containing chemotherapy regimen [abstract no. 115 and poster]. 37th ASCO; 2001 May 12-15; San Francisco, CA: 30a
84. Smith FP, Barr F. Hendricks C. et al. Phase II study of Doxil® (pegylated liposomal doxorubicin) in doxorubicin-resistant, metastatic breast cancer [abstract 524]. 35th ASCO; 1999 May 15-18: Atlanta, Georgia: 137
85. Modiano M, Taylor C, Sharpington T, et al. Phase I study of Doxil® (pegylated liposomal doxorubicin) plus escalating doses of Taxol® in the treatment of patients with advanced breast or gynecologic malignancies [abstract]. 35th ASCO: 1999 May 15-18; Atlanta, Georgia: 220
86. Schwonzen M, Kurbacher CM, Mallmann P. Liposomal doxorubicin and weekly paclitaxel in the treatment of metastatic breast cancer. Anticancer Drugs 2000; 11: 681-5
87. Burstein HJ, Ramirez MJ, Petros WP, et al. Phase I study of Doxil and vinorelbine in metastatic breast cancer. Ann Oncol 1999 Sep; 10: 1113-6
88. Martin M, Casado A, Garcia-Carbonero I, et al. Phase II study of pegilated liposomal doxorubicin plus vinorelbine in metastatic breast cancer patients with prior anthracycline treatment [abstract no. 1965]. 38th ASCO; 2002 May 18-21; Orlando, Florida
89. Rimassa L, Salvini P, Carnaghi C, et al. Unexpected low efficacy of caelyx and vinorelbine in metastatic breast cancer (MBC) [abstract no. 446]. 36th ASCO; 2000 May 20-23; New Orleans, LA: 115
90. Rivera E, Valero V, Syrewicz L, et al. Phase I study of stealth liposomal doxorubicin in combination with gemcitabine in the treatment of patients with metastatic breast cancer. J Clin Oncol 2001 Mar 15; 19 (6): 1716-22
91. Park JW, Stauffer P, Diederich C, et al. Hyperthermia (HT) + Doxil significantly enhances drug delivery and efficacy in metastatic breast caricer of the chest wall (CW): a phase I/II study [abstract no. 184]. 37th ASCO; 2001 May 12-15; San Francisco, CA: 47a
92. Ranson MR, Carmichael J, O'Byrne K, et al. Treatment of advanced breast cancer with sterically stabilized liposomal doxorubicin: Results of a multicenter phase II trial [see comments]. J Clin Oncol 1997 Oct; 15: 3185-91
93. Sparano JA. Malik U, Rajdev L, et al. Phase I trial of pegylated liposomal doxorubicin and docetaxel in advanced breast cancer. J Clin Oncol 2001 Jun 15; 19 (12): 3117-25
94. Wigler N, Inbar M, O'Brien M, et al. Reduced cardiac toxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin (Caelyx/Doxil) vs doxorubicin for first-line treatment of metastatic breast cancer [abstract no. 177]. 38th Annual Meeting of the American Society of Clinical Oncology; 2002 May 18-21; Orlando, Florida
95. Miller AB, Hoogstraten B, Staquet M, et al. Reporting results of cancer treatment. Cancer 1981 Jan; 47: 207-14
96. Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 1982; 5: 649-55
97. Jahanzeb M, Frankel C, Elkersh M, et al. Rationale for trials studying pegylated liposomal doxorubicin in metastatic breast cancer. Oncology USA 1997; 11 (10 Suppl. 11): 45-53
98. National Cancer Institute Cancernet. Breast Cancer (PDQ®) Treatment - Health Professionals [Online]. Available from URL: http://cancernet.nci.nih.gov [Accessed 2002 Jun 21]
99. Gogas H, Papadimitriou C, Kalofonos HR, et al. Combination of liposomal doxorubicin (Caelyx) and paclitaxel in locally advanced breast cancer. A phase II study of the Hellenic Cooperative Oncology Group (HeCOG) [abstract no. 2007]. 38th ASCO; 2002 May 18-21; Orlando, Florida
100. Vorobiof DA, Rapoport BL, McMichael GB, et al. Paclitaxel (P) and pegylated liposomal doxorubicin (PLD) as first line therapy for patients (pts) with metastatic breast cancer (MBC) [abstract no. 2062]. 38th ASCO; 2002 May 18-21; Orlando, Florida
101. Betageri GV, Dipali SR. Preparation and in vitro dissolution profiles of tolazamide-polyethylene glycol solid dispersions. Drug Dev Ind Pharm 1995; 21 (11): 1347-52
102. Mitsuyasu RT. AIDS-related Kaposi's sarcoma: Current treatment options, future trends. Oncology 2000 Jun; 14 (6): 867-78
103. Mitsuyasu R, yon Roenn J, Krown R, et al. Comparison study of liposomal doxorubicin (DOX) alone or with bleomycin and vincristine (DBV) for treatment of advanced AIDS-associated Kaposi's sarcoma (AIDS-KS): AIDS clinical trial group (ACTG) protocol 286 [abstract no. 191]. 33rd ASCO; 1997 May 17-20; Denver, CO: 55a
104. Northfelt DW, Dezube BJ, Thommes JA, et al. Pegylated-liposomal doxorubicin versus doxorubicin, bleomycin, and vincristine in the treatment of AIDS-related Kaposi's sarcoma: Results of a randomized phase III clinical trial. J Clin Oncol 1998 Jul; 16: 2445-51
105. Rizzardini G, Pastecchia C, Vigevani GM, et al. Stealth liposomal doxorubicin or bleomycin/vincristine for the treatment of AIDS-related Kaposi's sarcoma [abstract no. 17]. J Acquir Immune Defic Syndrom Hum Retrovirol 1997 Apr 1; 14 (4): A20
106. Stewart S, Jablonowski H, Goebel FD, et al. Randomized comparative trial of pegylated liposomal doxorubicin versus bleomycin and vincristine in the treatment of AIDS-related Kaposi's sarcoma. International Pegylated Liposomal Doxorubicin Study Group. J Clin Oncol 1998 Feb; 16: 683-91
107. Northfelt DW, Dezube BJ, Thommes JA, et al. Efficacy of pegylated-liposomal doxorubicin in the treatment of AIDS-related Kaposi's sarcoma after failure of standard chemotherapy. J Clin Oncol 1997 Feb: 15: 653-9
108. Hengge UR, Esser S, Rudel HP, et al. Long-term chemotherapy of HIV-associated Kaposi's sarcoma with liposomal doxorubicin. Eur J Cancer 2001; 37: 878-83
109. Krown S, Metroka C, Wernz JC. Kaposi's sarcoma in the Aquired Immune Deficiency Syndrome: A proposal for uniform evaluation, reponse, and staging criteria. J Clin Oncol 1989 Sep; 7 (9): 1201-7
110. Osoba D, Northfelt DW, Budd DW, et al. Effect of treatment on health-related quality of life in acquired immunodeficiency syndrome (AIDS)-related Kaposi's sarcoma: A randomized trial of pegylated-liposomal doxorubicin versus doxorubicin, bleomycin, and vincristine. Cancer Invest 2001; 19 (6): 573-80
111. Wu AW, Rubin HR, Mathews WC, et al. A health status questionnaire using 30 items from the medical outcomes study: Preliminary validation in persons with early HIV infection. Med Care 1991 Aug; 29 (8): 786-98
112. San Miguel JF, Creixenti JB, Garcia-Sanz R. Treatment of multiple myeloma. Haematologica 1999; 84: 36-58
113. National Cancer Institute Cancernet. Multiple Myeloma and Other Plasma Cell Neoplasms (PDQ®) Treatment - Health Professionals. Available from http://cancernet.nci.nih.gov [date last modified: Oct 2001]
114. Tsiara SN, Kapsali E, Christou L, et al. Administration of a modified chemotherapeutic regimen containing vincristine, liposomal doxorubicin and dexamethasone to multiple myeloma patients: Preliminary data. Eur J Haematol 2000; 65: 118-22
115. Hussein MA, Wood L, McLain D, et al. Phase II study of Doxil® (DO), vincristine (V) and Decadron® (D) [DVD]: In newly diagnosed multiple myeloma (MM) patients (pts) [abstract]. Blood 1998 Nov 15 Suppl. 1 (Pt 2): 278-9
116. Hussein M, Karam M, Wood L-, et al. Doxil (D), vincristine (V), and decadron (DX): A tolerable salvage regimen for relapsed refractory patients (pts) with multiple myeloma (MM) [abstract no. 4615]. Blood 1999 Nov 15; 94 (10) Suppl. 1 (Pt 2): 311b
117. National Cancer Institute CancerNet. Adult Non-Hodgkin's Lymphoma (PDQ®) Treatment - Health Professionals [Online]. Available from URL: http://cancernet.nci.nih.gov [Accessed 2002 Jun 21]
118. Moore Jr DF, Cabanillas F. Overview of prognostic factors in non-Hodgkin's lymphoma. Oncology 1998 Oct; 12 (10 Suppl. 8): 17-24
119. Dranitsaris G. Treatment of non-Hodgkin's lymphoma. Anticancer Drugs 1998; 9: 879-88
120. Niitsu N. Non-Hodgkin's lymphoma in the elderly: A guide to drug treatment. Drugs Aging 1999 Jun; 14 (6): 447-57
121. Tsavaris N, Katsikas M, Kosmas C, et al. Substitution of doxorubicin by pegylated liposomal doxorubicin (Caelyx) in the CHOP chemotherapy regimen in elderly (>75 years) patients with aggressive non-Hodgkin's lymphoma (NHL): preliminary experience [abstract]. 9th Anticancer; 1999 Feb 2-5; Paris: 251
122. Tulpule A, Justice g, Espina BM, et al. Pegylated liposomal doxorubicin (Doxil®) is active in the treatment of relapsed/refractory lymphomas [abstract]. Blood 1998 Nov 15 Suppl. 1 (Pt 2): 241
123. Wollina U, Graefe T, Karte K. Treatment of relapsing or recalcitrant cutaneous T-cell lymphoma with pegylated liposomal doxorubicin. J Am Acad Dermatol 2000 Jan; 42 (Pt 1): 40-6
124. Pharmacia & Upjohn. Adriamycin Prescribing Information. Kalamazoo, Michigan, USA, 1999
125. Safra T, Muggia F, Jeffers S, et al. Pegylated liposomal doxorubicin (Doxil): Reduced clinical cardiotoxicity in patients reaching or exceeding cumulative doses of 500 mg/m2, Ann Oncol 2000; 11: 1029-33
126. Berry G, Billingham M, Alderman E, et al. The use of cardiac biopsy to demonstrate reduced cardiotoxicity in AIDS Kaposi's sarcoma patients treated with pegylated liposomal doxorubicin. Ann Oncol 1998 Jul; 9: 711-6
127. Alberts DS, Garcia DJ. Safety aspects of pegylated liposomal doxorubicin in patients with cancer. Drugs 1997; 54 Suppl. 4: 30-5
128. Kollmannsberger C, Mayer F, Harstrick A. et al. Reduction of skin toxicity of pegylated liposomal doxorubicin (PLD) by concomitant administration of dexamethasone and pyridoxin in patients (pts) with anthracyclin-sensitive malignancies - A phase I/II trial [abstract no. 623P]. Ann Oncol 2000 Oct 13; 11 Suppl. 4: 136
129. Lopez AM, Wallace L, Dorr RT, et al. Topical DMSO treatment for pegylated liposomal doxorubicin-induced palmar-plantar erythrodysesthesia. Cancer Chemother Pharmacol 1999; 44: 303-6
130. Ozols RF. Update of the NCCN Ovarian Cancer Practice Guidelines. Oncology 1997 Nov; 11 (11A) NCCN Proceedings: 95-105
131. McGuire WP, Hoskins WJ, Brady MF, et al. Cyclophosphamide and cisplatin compared with paclitaxel and cisplatin in patients with stage III and stage IV ovarian cancer. N Engl J Med 1996 Jan 4; 334: 1-6
132. Bookman MA, McGuire WP, Kilpatrick D, et al. Carboplatin and paclitaxel in ovarian carcinoma: A phase I study of the Gynecologic Oncology Group. J Clin Oncol 1996 Jun; 14: 1895-902
133. Gibbs DD, Gore ME. Pursuit of optimum outcomes in ovarian cancer: Methodological approaches to therapy. Drugs 2001; 61 (8): 1103-20
134. Gibbs D, Pyle L, Allen M, et al. A phase I, dose-finding study of carboplatin (C), paclitaxel (P) and liposomal doxorubicin (LD) in advanced epithelial ovarian carcinoma (EOC) [abstract no. 1539]. Proc Am Soc Clin Oncol 2000 May 20; 19: 389a
135. Hortobagyi GN. Treatment of breast cancer. N Engl J Med 1998 Oct 1: 339 (14): 974-84
136. Fornier M, Munster P, Seidman AD. Update on the management of advanced breast cancer. Oncology 1999 May; 13 (5): 647-58
137. National Comprehensive Cancer Network. NCCN practice guidelines for breast cancer: Version 2000. Oncology 2000 Nov; 14 (11A): 33-49
138. Lebwohl DE, Canetta R. New developments in chemotherapy of advanced breast cancer. Ann Oncol 1999; 10 Suppl. 6: S139-46
139. Aapro MS. Combining new agents with anthracyclines in metastatic breast cancer: an overview of recent findings. Semin Oncol 1999 Feb; 26 (1) Suppl. 3: 17-21
140. Figgitt DP, Wiseman LR. Docetaxel: an update of its use in advanced breast cancer. Drugs 2000 Mar; 59 (3): 621-51
141. Carlson RW, Anderson BO, Bensinger W, et al. Breast Cancer Practice Guidelines [Online]. Available from: URL: http:// www. nccn. org [Accessed 2002 Mar 20]
142. Nasti G, Errante D, Santarossa S, et al. A risk and benefit assessment of treatment for AIDS-related Kaposi's sarcoma. Drug Saf 1999 May; 20 (5): 403-25