Pegylated liposomal doxorubicin in the treatment of breast cancer

Clinical Breast Cancer

Volumn 4, Issue 5, 2003, Pages 318-328

  O'Shaughnessy, Joyce A ^a  

^a BAYLOR UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

Cardiac toxicity; Liposomal anthracyclines; Metastatic breast cancer; Safety

Indexed keywords

ANASTROZOLE; ANTHRACYCLINE DERIVATIVE; AROMATASE INHIBITOR; CAPECITABINE; CYCLOPHOSPHAMIDE; DAUNORUBICIN; DOCETAXEL; DOXORUBICIN; EPIDERMAL GROWTH FACTOR RECEPTOR 2; EPIRUBICIN; EXEMESTANE; FLUOROURACIL; GEMCITABINE; GONADORELIN AGONIST; IDARUBICIN; LETROZOLE; LIPOSOME; MACROGOL; MEGESTROL ACETATE; METHOTREXATE; MITOMYCIN C; NAVELBINE; PACLITAXEL; PLATINUM DERIVATIVE; PYRIDOXINE; TAMOXIFEN; TAXANE DERIVATIVE; TRASTUZUMAB; UNCLASSIFIED DRUG; UNINDEXED DRUG;

ADJUVANT CHEMOTHERAPY; ADVANCED CANCER; ALOPECIA; ANEMIA; ANTINEOPLASTIC ACTIVITY; BLOOD TOXICITY; BONE MARROW SUPPRESSION; BREAST CANCER; CANCER COMBINATION CHEMOTHERAPY; CANCER LOCALIZATION; CARDIOTOXICITY; CLINICAL STUDY; CLINICAL TRIAL; CONGESTIVE HEART FAILURE; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG ERUPTION; DRUG FORMULATION; DRUG HALF LIFE; DRUG INDICATION; DRUG RESEARCH; DRUG RESPONSE; DRUG SAFETY; DRUG TARGETING; ERYTHEMA; EXTRAVASATION; FATIGUE; HAND FOOT SYNDROME; HUMAN; HYPERGLYCEMIA; HYPERTHERMIC THERAPY; METASTASIS; MONOTHERAPY; MUCOSA INFLAMMATION; NAUSEA AND VOMITING; NEUTROPENIA; REVIEW; SKIN MANIFESTATION; SKIN TOXICITY; STOMATITIS; SURVIVAL TIME; THROMBOCYTOPENIA; TREATMENT PLANNING;

EID: 0942277118     PISSN: 15268209     EISSN: None     Source Type: Journal    
DOI: 10.3816/CBC.2003.n.037     Document Type: Review

References (81)

1. Jemal A, Murray T, Samuels A, et al. Cancer statistics, 2002. CA Cancer J Clin 2002; 53:5-23.
2. Winer EP, Morrow M, Osborne CK, et al. Malignant tumors of the breast. In: DeVita VT, Hellman S, Rosenberg RA, eds. Cancer: principles and practice of oncology. Philadelphia, PA: Lippincott Williams & Wilkins, 2001:1651-1717.
3. Lindley C. Breast cancer. In: DiPiro JT, Talbert RL, Yee GC, et al., eds. Pharmacotherapy: a pathophysiologic approach. Stamford, CT: Appleton & Lange, 1997:2467-2497.
4. Klijn JG, Blamey RW, Boccardo F, et al. Combined tamoxifen and luteinizing hormone-releasing hormone (LHRH) agonist versus LHRH agonist alone in premenopausal advanced breast cancer: a meta-analysis of four randomized trials. J Clin Oncol 2001; 19:343-353.
5. Mouridsen H, Gershanovich M, Sun Y, et al. Phase III study of letrozole versus tamoxifen as first-line therapy of advanced breast cancer in postmenopausal women: analysis of survival and update of efficacy from the International Letrozole Breast Cancer Group. J Clin Oncol 2003; 21:2101-2109.
6. Bonneterre J, Thurlimann B, Robertson JF, et al. Anastrozole versus tamoxifen as first-line therapy for advanced breast cancer in 668 postmenopausal women: results of the Tamoxifen or Arimidex Randomized Group Efficacy and Tolerability study. J Clin Oncol 2000; 18:3748-3757.
7. Nabholtz JM, Buzdar A, Pollak M, et al. Anastrozole is superior to tamoxifen as first-line therapy for advanced breast cancer in postmenopausal women: results of a North American multicenter randomized trial. Arimidex Study Group. J Clin Oncol 2000; 18:3758-3767.
8. Paridaens R, Dirix L, Lohrisch C, et al. Mature results of a randomized phase II multicenter study of exemestane versus tamoxifen as first-line hormone therapy for postmenopausal women with metastatic breast cancer. Ann Oncol 2003; 14:1391-1398.
9. Buzdar A, Douma J, Davidson N, et al. Phase III, multicenter, double-blind, randomized study of letrozole, an aromatase inhibitor, for advanced breast cancer versus megestrol acetate. J Clin Oncol 2001; 19:3357-3366.
10. Kaufmann M, Bajetta E, Dirix LY, et al. Exemestane is superior to megestrol acetate after tamoxifen failure in postmenopausal women with advanced breast cancer: results of a phase III randomized double-blind trial. The Exemestane Study Group. J Clin Oncol 2000; 18:1399-1411.
11. Buzdar AU, Jonat W, Howell A, et al. Anastrozole versus megestrol acetate in the treatment of postmenopausal women with advanced breast carcinoma: results of a survival update based on a combined analysis of data from two mature phase III trials. Arimidex Study Group. Cancer 1998; 83:1142-1152.
12. Sledge GW, Neuberg D, Bernardo P, et al. Phase III trial of doxorubicin, paclitaxel, and the combination of doxorubicin and paclitaxel as front-line chemotherapy for metastatic breast cancer: an inter-group trial (E1193). J Clin Oncol 2003; 21:588-592.
13. Nabholtz JM, Senn HJ, Bezwoda WR, et al. Prospective randomized trial of docetaxel versus mitomycin plus vinblastine in patients with metastatic breast cancer progressing despite previous anthracycline-containing chemotherapy. 304 Study Group. J Clin Oncol 1999; 17:1413-1424.
14. Bishop JF, Dewar J, Toner GC, et al. Initial paclitaxel improves outcome compared with CMFP combination chemotherapy as frontline therapy in untreated metastatic breast cancer. J Clin Oncol 1999; 17:2355-2364.
15. Mackey JR, Paterson A, Dirix LY, et al. Final results of the phase III randomized trial comparing docetaxel (T), doxorubicin (A) and cyclophosphamide (C) to FAC as first line chemotherapy (CT) for patients (pts) with metastatic breast cancer (MBC). Proc Am Soc Clin Oncol 2002; 21:35a (Abstract #137).
16. O'Shaughnessy J, Miles D, Vukelja S, et al. Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: phase III trial results. J Clin Oncol 2002; 20:2812-2823.
17. 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. J Clin Oncol 1997; 15:3185-3191.
18. Honig SF. Treatment of metastatic disease: hormonal and chemotherapy In: Harris JR, Lippman ME, Morrow M, et al., eds. Diseases of the breast. Philadelphia, PA: Lippincott-Raven, 1996:669-734.
19. Adriamycin RDF/Adriamycin PFS (doxorubicin hydrochloride for injection) [package insert]. Kalamazoo, MI: Pharmacia & Upjohn Company; 2002.
20. Swain SM, Whaley FS, Ewer MS. Congestive heart failure in patients treated with doxorubicin: a retrospective analysis of three trials. Cancer 2003; 97:2869-2879.
21. Maluf FC, Spriggs D. Anthracyclines in the treatment of gynecologic malignancies. Gynecol Oncol 2002; 85:18-31.
22. Hortobagyi GN. Anthracyclines in the treatment of cancer. An overview. Drugs 1997; 54(suppl 4):1-7.
23. Stewart CF, Ratain MJ. Topoisomerase interactive agents. In: DeVita VT, Hellman S, Rosenberg RA, eds. Cancer: principles and practice of oncology. Philadelphia, PA: Lippincott Williams & Wilkins, 2001:415-431.
24. Weiss RB. The anthracyclines: will we ever find a better doxorubicin? Semin Oncol 1992; 19:670-686.
25. Gabizon AA. Liposomal anthracyclines. Hematol Oncol Clin North Am 1994; 8:431-450.
26. Gabizon A, Martin F. Polyethylene glycol-coated (pegylated) liposomal doxorubicin. Rationale for use in solid tumours. Drugs 1997; 54(suppl 4): 15-21.
27. 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; 54:987-992.
28. Gabizon AA. Pegylated liposomal doxorubicin: metamorphosis of an old drug into a new form of chemotherapy. Cancer Invest 2001; 19:424-436.
29. Gabizon A, Price DC, Huberty J, et al. Effect of liposome composition and other factors on the targeting of liposomes to experimental tumors: biodistribution and imaging studies. Cancer Res 1990; 50:6371-6378.
30. Gabizon AA. Liposomal drug carrier systems in cancer chemotherapy: current status and future prospects. J Drug Target 2002; 10:535-538.
31. Jain RK. Delivery of molecular and cellular medicine to solid tumors. J Control Release 1998; 53:49-67.
32. Martin F. Clinical pharmacology and anti-tumor efficacy of Doxil (pegylated liposomal doxorubicin). In: Lasic DD, Papahadjopoulos D, eds. Medical applications of liposomes. New York, NY: Elsevier, 1998:638.
33. Gabizon A, Papahadjopoulos D. Liposome formulations with prolonged circulation time in blood and enhanced uptake by tumors. Proc Natl Acad Sci U S A 1988; 85:6949-6953.
34. Gabizon A, Goren D, Horowitz AT, et al. Long-circulating liposomes for drug delivery in cancer therapy: a review of biodistribution studies in tumor-bearing animals. Adv Drug Deliv Rev 1997; 24:337-344.
35. Vaage J, Donovan D, Uster P, et al. Tumour uptake of doxorubicin in polyethylene glycol-coated liposomes and therapeutic effect against a xenografted human pancreatic carcinoma. Br J Cancer 1997; 75:482-486.
36. Harrington KJ, Mohammadtaghi S, Uster PS, et al. Effective targeting of solid tumors in patients with locally advanced cancers by radiolabeled pegylated liposomes. Clin Cancer Res 2001; 7:243-254.
37. 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; 17:3512-3521.
38. Koukourakis MI, Koukouraki S, Giatromanolaki A, et al. High intratumoral accumulation of stealth liposomal doxorubicin in sarcomas-rationale for combination with radiotherapy. Acta Oncol 2000; 39:207-211.
39. 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; 36:55-63.
40. Martin FJ. Pegylated liposomal doxorubicin: scientific rationale and preclinical pharmacology. Oncology 1997; 11:11-32.
41. Doxil (doxorubicin HCI liposome injection) [package insert]. Raritan, NJ: Ortho Biotech Products L.P.; 2001.
42. 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; 89:1037-1047.
43. 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. Proc Am Soc Clin Oncol 2002; 21:45a (Abstract #177).
44. Keller AM, Mennel RG, Nabholtz JM, 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. Proc Am Soc Clin Oncol 2001; 20:190b (Abstract #115).
45. Overmoyer B, Silverman P, Holder L, et al. Doxil and intravenous cyclophosphamide as first-line therapy for patients with metastatic breast cancer (MBC): interim results of an ongoing pilot trial. Breast Cancer Res Treat 1998; 50:324 (Abstract #536).
46. Jones V, Finucane D, Rodriguez R, et al. Phase II study of weekly paclitaxel (Taxol) and liposomal doxorubicin (Doxil) in patients with locally advanced and metastatic breast cancer. Proc Am Soc Clin Oncol 2000; 19:116a (Abstract #451).
47. Vorobiof DA, Chasen MR, McMichael GB, et al. Multicentre phase II study with pegylated liposomal doxorubicin (PLD) and paclitaxel (T) as first line therapy in patients (pts) with advanced breast cancer (ABC). Proc Am Soc Clin Oncol 2003; 22:49 (Abstract #195).
48. Rigatos SK, Tsavdaridis D, Athanasiadis A, et al. Paclitaxel and liposomal doxorubicin (Caelyx) combination in advanced breast cancer patients: a phase II study. Oncol Rep 2003; 10:1817-1819.
49. 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; 19:3117-3125.
50. Fracasso PM, Rodriguez LC, Herzog TJ, et al. Phase I dose and sequencing study of pegylated liposomal doxorubicin and docetaxel in patients with advanced malignancies. Cancer 2003; 98:610-617.
51. Alexopoulous A, Ardavanis A, Stavrakakis J, et al. Pegylated liposomal doxorubicin (PLD) and docetaxel (D) as first-line treatment in metastatic breast cancer (MBC). Proc Am Soc Clin Oncol 2003; 22:58 (Abstract #232).
52. Athanassiou A, Potamianou A, Ziras N, et al. A phase II trial of docetaxel (D) and liposomal doxorubicin (LD) as 1st line treatment in metastatic breast cancer (MBC). Proc Am Soc Clin Oncol 2003; 22:74 (Abstract #297).
53. 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; 19:1716-1722.
54. Rivera E, Valero V, Arun B, et al. Phase II study of pegylated liposomal doxorubicin in combination with gemcitabine in patients with metastatic breast cancer. J Clin Oncol 2003; 21:3249-3254.
55. Ning S, Macleod K, Abra RM, et al. Hyperthermia induces doxorubicin release from long-circulating liposomes and enhances their anti-tumor efficacy. Int J Radiat Oncol Biol Phys 1994; 29:827-834.
56. Huang SK, Stauffer PR, Hong K, et al. Liposomes and hyperthermia in mice: increased tumor uptake and therapeutic efficacy of doxorubicin in sterically stabilized liposomes. Cancer Res 1994; 54:2186-2191.
57. Kouloulias VE, Dardoufas CE, Kouvaris JR, et al. Liposomal doxorubicin in conjunction with reirradiation and local hyperthermia treatment in recurrent breast cancer: a phase I/II trial. Clin Cancer Res 2002; 8:374-382.
58. Park JW, Stauffer P, Diederich C, et al. Hyperthermia (HT) + Doxil significantly enhances drug delivery and efficacy in metastatic breast cancer of the chest wall (CW): a phase I/II study. Proc Am Soc Clin Oncol 2001; 20:47a (Abstract #184).
59. Dvorak J, Zoul Z, Melichar B, et al. Pegylated liposomal doxorubicin in combination with hyperthermia for treatment of skin metastases of breast carcinoma: a case report. Onkologie 2001; 24:166-168.
60. Dvorak J, Zoul Z, Melichar B, et al. Pegylated liposomal doxorubicin in combination with hyperthermia in the treatment of a case of advanced hepatocellular carcinoma. J Clin Gastroenterol 2002; 34:96-98.
61. Gogas H, Papadimitriou C, Kalofonos HP, et al. Neoadjuvant chemotherapy with a combination of pegylated liposomal doxorubicin (Caelyx) and paclitaxel in locally advanced breast cancer: a phase II study by the Hellenic Cooperative Oncology Group. Ann Oncol 2002; 13:1737-1742.
62. Srimuninnimit V, Sinlarantana P, Bhothisuwan K, et al. Phase II study with the combination of pegylated liposomal doxorubicin (Caelyx) and cyclophosphamide (CC) in locally advanced breast cancer (LABC). Proc Am Soc Clin Oncol 2002; 21:70A (Abstract #279).
63. 2. Ann Oncol 2000; 11:1029-1033.
64. 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; 9:711-716.
65. Gabizon AA, Lyass O. Cardiac safety of pegylated liposomal doxorubicin demonstrated by endomyocardial biopsy in patients with advanced malignancies. Proc Am Soc Clin Oncol 2003; 22:763 (Abstract #3067).
66. 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; 82:323-328.
67. Campos SM, Penson RT, Mays AR, et al. The clinical utility of liposomal doxorubicin in recurrent ovarian cancer. Gynecol Oncol 2001; 81:206-212.
68. Edwards SJ. Prevention and treatment of adverse effects related to chemotherapy for recurrent ovarian cancer. Semin Oncol Nurs 2003; 19:19-39.
69. Nagore E, Insa A, Sanmartin O. Antineoplastic therapy-induced palmar plantar erythrodysesthesia ('hand-foot') syndrome. Incidence, recognition and management. Am J Clin Dermatol 2000; 1:225-234.
70. Colbern GT, Musterer R, Hiller AL, et al. Treatment of palmar-plantar erythrodysthesia with pyridoxine or ergotamine: effect on efficacy of Doxil in Lewis lung carcinoma. Proc Am Soc Clin Oncol 1998; 17:238a (Abstract #913).
71. Perez AT, Domenech GH, Frankel C, et al. Pegylated liposomal doxorubicin (Doxil) for metastatic breast cancer: the Cancer Research Network, Inc., experience. Cancer Invest 2002; 20(suppl 2):22-29.
72. Chanan-Khan A, Szebeni J, Savay S, et al. Complement activation following first exposure to pegylated liposomal doxorubicin (Doxil): possible role in hypersensitivity reactions. Ann Oncol 2003; 14:1430-1437.
73. Vogel CL, Cobleigh MA, Tripathy D, et al. Efficacy and safety of trastuzumab as a single agent in first-line treatment of HER2-over-expressing metastatic breast cancer. J Clin Oncol 2002; 20:719-726.
74. Cobleigh MA, Vogel CL, Tripathy D, et al. Multinational study of the efficacy and safety of humanized anti-HER2 monoclonal antibody in women who have HER2-overexpressing metastatic breast cancer that has progressed after chemotherapy for metastatic disease. J Clin Oncol 1999; 17:2639-2648.
75. Baselga J, Tripathy D, Mendelsohn J, et al. Phase II study of weekly intravenous trastuzumab (Herceptin) in patients with HER2/neu-overexpressing metastatic breast cancer. Semin Oncol 1999; 26:78-83.
76. Slamon DJ, Leyland-Jones B, Shak S, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 2001; 344:783-792.
77. Theodoulou M, Campos SM, Batist G, et al. 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 2002; 21:55a (Abstract #216).
78. Wolff AC, Bonetti M, Sparano JA, et al. Cardiac safety of trastuzumab (H) in combination with pegylated liposomal doxorubicin (D) and docetaxel (T) in HER2-positive metastatic breast cancer (MBC): preliminary results of Eastern Cooperative Oncology Group trial 3198. Proc Am Soc Clin Oncol 2003; 22:18 (Abstract #70).
79. Aramendia JM, de Romani SE, Fernandez-Hidalgo O, et al. Sequential treatment with anthracyclines and taxane with/without trastuzumab for metastatic breast cancer patients. Proc Am Soc Clin Oncol 2003; 22:84 (Abstract #336).
80. Wolff AC. Liposomal anthracyclines and new treatment approaches for breast cancer. Oncologist 2003; 8(suppl 2):25-30.
81. 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; 19:3312-3322.