Оценка эффективности и безопасности липосомальных антрациклинов: данные клинических исследований I–II фаз

1. Allen TM, Martin FJ. Advantages of liposomal delivery systems for anthracyclines. Semin Oncol 31: 5–15, 2004 (suppl 13).
2. Vail DM, Amantea MA, Colbern GT et al. Pegylated liposomal doxorubicin: Proof of principle using preclinical animal models and pharmacokinetic studies. Semin Oncol 31: 16–35, 2004 (suppl 13).
3. Krown SE, Northfelt DW, Osoba D et al. Use of liposomal anthracyclines in Kaposi’s sarcoma. Semin Oncol 31: 36–52, 2004 (suppl 13).
4. Markman M, Gordon AN, McGuire WP et al. Liposomal anthracycline treatment for ovarian cancer. Semin Oncol 31: 91–105, 2004 (suppl 13).
5. Robert NJ, Vogel CL, Henderson IC et al. The role of the liposomal anthracyclines and other systemic therapies in the management of advanced breast cancer. Semin Oncol 31: 106–146, 2004 (suppl 13).
6. Hussein MA, Anderson KC: Role of liposomal anthracyclines in the treatment of multiple myeloma. Semin Oncol 31: 147–160, 2004 (suppl 13).
7. Ewer MS, Martin FJ, Henderson IC et al. Cardiac safety of liposomal anthracyclines. Semin Oncol 31: 161–181, 2004 (suppl 13).
8. Garnick MB, Weiss GR, Steele GDJr et al. Clinical evaluation of longterm, continuous-infusion doxorubicin. Cancer Treat Rep 67: 133–142, 1983.
9. Greidanus J, Willemse PH, Uges DR et al. Continuous infusion of low-dose doxorubicin, epirubicin and mitoxantrone in cancer chemotherapy: A review. Pharm Weekbl Sci 10: 237–245, 1988.
10. de Vries EG, Greidanus J, Mulder NH et al. A phase I and pharmacokinetic study with 21-day continuous infusion of epirubicin. J Clin Oncol 5: 1445–1451, 1987.
11. Uziely B, Jeffers S, Isacson R et al. Liposomal doxorubicin: Antitumor activity and unique toxicities during two complementary phase I studies. J Clin Oncol 13: 1777–1785, 1995.
12. Jahanzeb M, Vogel C, Elkrish M et al. Stealth liposomal doxorubicin (Doxil) causes a mild and delayed leukopenia compared to standard doxorubicin in patients with solid tumors. Proc Am Soc Clin Oncol 16: 239, 1997 (abstr 843).
13. Gabizon A, Uziely B, Lotem M et al. Doxil in patients with pretreated metastatic breast cancer (MBC): A dose-schedule finding study with pharmacokinetics. Proc Am Soc Clin Oncol 16: 147, 1997 (abstr 516).
14. 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 11: 339–342, 2000.
15. Hamilton A, Biganzoli L, Coleman R et al. EORTC 10968: a phase I clinical and pharmacokinetic study of polyethylene glycol liposomal doxorubicin (Caelyx, Doxil) at a 6-week interval in patients with metastatic breast cancer. European Organization for Research and Treatment of Cancer. Ann Oncol 13: 910–918, 2002.
16. Marina NM, Cochrane D, Harney E et al. Dose escalation and pharmacokinetics of pegylated liposomal doxorubicin (Doxil) in children with solid tumors: A pediatric oncology group study. Clin Cancer Res 8: 413–418, 2002.
17. Bogner JR, Kronawitter U, Rolinski B et al. Liposomal doxorubicin in the treatment of advanced AIDS-related Kaposi sarcoma. J Acquir Immune Defic Syndr 7: 463–468, 1994.
18. James ND, Coker RJ, Tomlinson D et al. Liposomal doxorubicin (Doxil): An effective new treatment for Kaposi’s sarcoma in AIDS. Clin Oncol (R Coll Radiol) 6: 294–296, 1994.
19. 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 15: 987–993, 1997.
20. 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 18: 3093–3100, 2000.
21. Forbes C, Wilby J, Richardson G et al. A systematic review and economic evaluation of pegylated liposomal doxorubicin hydrochloride for ovarian cancer. Health Technol Assess 6: 1–119, 2002.
22. Gordon AN, Teitelbaum A: Overall survival advantage for pegylated liposomal doxorubicin compared to topotecan in recurrent epithelial ovarian cancer. Eur J Cancer Suppl 1: S51, 2003 (abstr 157).
23. O’Byrne KJ, Bliss P, Graham JD et al. A phase III study of Doxil/Caelyx versus paclitaxel in platinum-treated, taxane-naive relapsed ovarian cancer. Proc Am Soc Clin Oncol 21: 808, 2002 (abstr 808).
24. Israel VP, Garcia AA, Roman L et al. Phase II study of liposomal doxorubicin in advanced gynecologic cancers. Gynecol Oncol 78: 143–147, 2000.
25. Arcuri C, Sorio R, Lucenti A et al. A phase II study of Doxil/Caelyx (D) in relapsed epithelial ovarian cancer (OC) patients. Proc Am Soc Clin Oncol 20: 1908, 2001 (abstr 2511).
26. Gonzalez de Sande L, Oramas J, Castellano D et al. Analysis of the efficacy and toxicity of Caelyx in the treatment of heavily pretreated patients with recurrent advanced ovarian cancer: A phase II study. Proc Am Soc Clin Oncol 20: 221A, 2001 (abstr 881).
27. 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 15: 3185–3191, 1997.
28. Lyass O, Uziely B, Ben-Yosef R et al. Correlation of toxicity with pharmacokinetics of pegylated liposomal doxorubicin (Doxil) in metastatic breast carcinoma. Cancer 89: 1037–1047, 2000.
29. Rivera E, Valero V, Esteva FJ et al. Lack of activity of stealth liposomal doxorubicin in the treatment of patients with anthracycline-resistant breast cancer. Cancer Chemother Pharmacol 49: 299–302, 2002.
30. O’Brien ME, Wigler N, Inbar M et al. Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCl (Caelyx/Doxil) versus conventional doxorubicin for firstline treatment of metastatic breast cancer. Ann Oncol 15: 440–449, 2004.
31. Holder L, Overmoyer B, Silverman P et al. Doxil and oral cyclophosphamide as first-line therapy for patients with metastatic breast cancer (MBC): Preliminary results of a pilot trial. Proc Am Soc Clin Oncol 17: 146A, 1998 (abstr 556).
32. Silverman P, Overmoyer B, Holder L et al. Doxil and intravenous cyclophosphamide as first-line therapy for patients with metastatic Liposomal anthracyclines: Phase I-II trials 83 breast cancer (MBC): Interim results of an ongoing pilot trial. Proc Am Soc Clin Oncol 18: 115a, 1999 (abstr 435).
33. Srimuninnimit V, Sinlaratana 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 21: 70A, 2002 (abstr 279).
34. 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 82: 323–328, 2001.
35. Kim RJ, Peterson G, Kulp B et al. Skin toxicity associated with pegylated liposomal doxorubicin (40 mg/m2) in the treatment of gynecologic cancers. Proc Am Soc Clin Oncol 23: 467, 2004 (abstr 5080).
36. Markman M, Kennedy A, Webster K et al. Phase 2 trial of liposomal doxorubicin (40 mg/m(2)) in platinum/paclitaxel-refractory ovarian and fallopian tube cancers and primary carcinoma of the peritoneum. Gynecol Oncol 78: 369–372, 2000.
37. Herraez AC, Gonzalez A, Cervantes A et al. Predictors of response to pegylated liposomal doxorubicin in platinum pre-treated ovarian cancer (PPOC). A GEICO study (Spanish Group for Research and Treatment of Ovarian Cancer). Proc Am Soc Clin Oncol 22: 483a, 2003 (abstr 1942).
38. Cowens JW, Creaven PJ, Greco WR et al. Initial clinical (phase I) trial of TLC D-99 (doxorubicin encapsulated in liposomes). Cancer Res 53: 2796–2802, 1993.
39. Shapiro CL, Ervin T, Welles L et al. 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: 1435–1441, 1999.
40. Conley BA, Egorin MJ, Whitacre MY et al. Phase I and pharmacokinetic trial of liposome-encapsulated doxorubicin. Cancer Chemother Pharmacol 33: 107–112, 1993.
41. Lowe ES, Adamson PC, Widemann BC et al. Phase I trial and pharmacokinetic study of liposomal doxorubicin (TLC-D99, Myocet) in children with refractory solid tumors. Proc Am Soc Clin Oncol 21: 434a, 2002 (abstr 434).
42. Casper ES, Schwartz GK, Sugarman A et al. Phase I trial of doseintense liposome-encapsulated doxorubicin in patients with advanced sarcoma. J Clin Oncol 15: 2111–2117, 1997.
43. Myocet (liposome encapsulated doxorubicin citrate complex) package leaflet. Stevenage, Herts, Medeus Pharma UK Ltd, 2004.
44. Doxil (doxorubicin HCl liposome injection) prescribing information. Bridgewater, NJ, Ortho Biotech Products, LP, 2001.
45. DaunoXome (daunorubicin citrate liposome injection) prescribing information. San Dimas, CA, Gilead Sciences, Inc, 2002.
46. Presant CA, Scolaro M, Kennedy P et al. Liposomal daunorubicin treatment of HIV-associated Kaposi’s sarcoma. Lancet 341: 1242–1243, 1993.
47. Gill PS, Espina BM, Muggia F et al. Phase I/II clinical and pharmacokinetic evaluation of liposomal daunorubicin. J Clin Oncol 13: 996–1003, 1995.
48. Guaglianone P, Chan K, DelaFlor-Weiss E et al. Phase I and pharmacologic study of liposomal daunorubicin (DaunoXome). Invest New Drugs 12: 103–110, 1994.
49. Steele JP, O’Doherty CA, Evans M et al. Phase I/II trial of liposomal daunorubicin in malignant mesothelioma. Proc Am Soc Clin Oncol 17: 502A, 1998 (abstr 1933).
50. O’Byrne KJ, Thomas AL, Sharma RA et al. A phase I dose-escalating study of DaunoXome, liposomal daunorubicin, in metastatic breast cancer. Br J Cancer 87: 15–20, 2002.
51. Bieker R, Lerchenmuller C, Wehmeyer J et al. Phase I study of liposomal daunorubicin in relapsed and refractory acute myeloid leukemia. Oncol Rep 10: 915–920, 2003.
52. Cortes J, O’Brien S, Estey E et al. Phase I study of liposomal daunorubicin in patients with acute leukemia. Invest New Drugs 17: 81–87, 1999.
53. Fassas A, Buffels R, Anagnostopoulos A et al. 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: 308–315, 2002.
54. Lowis S, Lewis I, Elsworth A et al. 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: 109A, 2002 (abstr 435).
55. Delgado G, Potkul RK, Treat JA et al. A phase I/II study of intraperitoneally administered doxorubicin entrapped in cardiolipin liposomes in patients with ovarian cancer. Am J Obstet Gynecol 160: 812-817; discussion 817–819, 1989.
56. Rahman A, Treat J, Roh JK et al. A phase I clinical trial and pharmacokinetic evaluation of liposome-encapsulated doxorubicin. J Clin Oncol 8: 1093–1100, 1990.
57. Vaughn DJ, Treat JA, Drobins P et al. A phase I study of a new liposome encapsulated doxorubicin (LED) formulation in advanced malignancies. Proc Am Soc Clin Oncol 18: 231A, 1999 (abstr 892).
58. Flaherty KT, Malkowicz SB, Vaughn DJ: Phase I study of weekly liposome-encapsulated doxorubicin in patients with advanced, androgen-independent prostate cancer. Am J Clin Oncol 27: 136–139, 2004.
59. Owen RR, Sells RA, Gilmore IT et al. A phase I clinical evaluation of liposome-entrapped doxorubicin (Lip-Dox) in patients with primary and metastatic hepatic malignancy. Anticancer Drugs 3: 101–107, 1992.
60. Gabizon A, Peretz T, Sulkes A et al. Systemic administration of doxorubicin-containing liposomes in cancer patients: A phase I study. Eur J Cancer Clin Oncol 25: 1795–1803, 1989.
61. Booser DJ, Perez-Soler R, Cossum P et al. Phase I study of liposomal annamycin. Cancer Chemother Pharmacol 46: 427–432, 2000.
62. Hong RL, Tseng YL: Phase I and pharmacokinetic study of a stable, polyethylene-glycolated liposomal doxorubicin in patients with solid tumors: The relation between pharmacokinetic property and toxicity. Cancer 91: 1826–1833, 2001.
63. Matsumura Y, Gotoh M, Muro K et al. Phase I and pharmacokinetic study of MCC-465, a doxorubicin (DXR) encapsulated in PEG immunoliposome, in patients with metastatic stomach cancer. Ann Oncol 15: 517–525, 2004.
64. Venook AP, Amantea M, Bonmen E et al. Pegylated liposome-encapsulated doxorubicin (DOXIL) in patients with hepatocellular carcinoma (HCC). Proc Am Soc Clin Oncol 15: 473, 1996 (abstr).
65. Hong RL, Tseng YL, Chang FH: Pegylated liposomal doxorubicin in treating a case of advanced hepatocellular carcinoma with severe hepatic dysfunction and pharmacokinetic study. Ann Oncol 11: 349–353, 2000.
66. Hong RL, Tseng YL: A phase II and pharmacokinetic study of pegylated liposomal doxorubicin in patients with advanced hepatocellular carcinoma. Cancer Chemother Pharmacol 51: 433–438, 2003.
67. Halm U, Etzrodt G, Schiefke I et al. A phase II study of pegylated liposomal doxorubicin for treatment of advanced hepatocellular carcinoma. Ann Oncol 11: 113–114, 2000.
68. Ruff P, Moodley SD, Rapoport BL et al. Long term follow-up of pegylated liposomal doxorubicin (Caelyx): A well tolerated and effective agent in advanced hepatocellular carcinoma (HCC). Proc Am Soc Clin Oncol 20: 1268A, 2001 (abstr 667).
69. Miller RL, Bowen KE, Chun HG: A phase II study of liposomal doxorubicin (LD, Doxil) in patients with advanced hepatocellular carcinoma (HCC) or cholangiocarcinoma (CC). Proc Am Soc Clin Oncol 21: 667, 2002 (abstr 2324).
70. Dangoor A, Ranson M, Lee SM et al. Treatment of inoperable hepatocellular carcinoma (HCC) with pegylated liposomal doxorubicin: A phase II study. Proc Am Soc Clin Oncol 22: 361, 2003 (abstr 1450).
71. Hengge UR, Brockmeyer NH, Baumann M et al. Liposomal doxorubicin in AIDS-related Kaposi’s sarcoma. Lancet 342: 497, 1993.
72. Hengge UR, Brockmeyer NH, Rasshofer R et al. Fatal hepatic failure with liposomal doxorubicin. Lancet 341: 383–384, 1993.
73. Iannitti D, Rathore R, Safran H et al. TLC D-99 can be safely administered to patients with advanced hepatobiliary carcinomas and severe hepatobiliary dysfunction. Proc Am Soc Clin Oncol 19: 1214, 2000 (abstr 2285).
74. Daniele B, De Vivo R, Perrone F et al. Phase I clinical trial of liposomal 84 D.S. Alberts et al.daunorubicin in hepatocellular carcinoma complicating liver cirrhosis. Anticancer Res 20: 1249–1251, 2000.
75. Alberts DS, Garcia DJ: Safety aspects of pegylated liposomal doxorubicin in patients with cancer. Drugs 54: 30–35, 1997 (suppl 4).
76. Bischoff J, Hesse S, Stemmler H et al. A phase I study of PEG liposomal doxorubicin (PLD) plus docetaxel (D) in metastatic breast cancer (MBC). Proc Am Soc Clin Oncol 22: 71, 2003 (abstr 282).
77. 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 14: 1430–1437, 2003.
78. Hamilton AL, Pavlick A, Volm M et al. Pegylated liposomal doxoru117. Vail DM, Chun R, Thamm DH et al. Efficacy of pyridoxine to ameliorate the cutaneous toxicity associated with doxorubicin containing pegylated (Stealth) liposomes: A randomized, double-blind clinical trial using a canine model. Clin Cancer Res 4: 1567–1571, 1998.
118. Colbern GT, Musterer R, Hiller AJ et al. Treatment of palmar-plantar erythrodysesthesia with pyridoxine or ergotamine: Effect on efficacy of Doxil in lewis lung carcinoma. Proc Am Soc Clin Oncol 17: 238A, 1998 (abstr 913).
119. Eng C, Mauer AM, Fleming GF et al. Phase I study of pegylated liposomal doxorubicin, paclitaxel, and cisplatin in patients with advanced solid tumors. Ann Oncol 12: 1743–1747, 2001.
120. Dingeldein GC, Hoffmann M, Huebner G et al. Phase I/II study with liposomal-encapsulated doxorubicin in VAD-protocol for patients with multiple myeloma. Blood 98: 308b, 2001 (abstr 4985).
121. Drinkard LC, Blumenschein GR, DiStefano A et al. A phase I trial of liposomal doxorubicin (Doxil) given on day one followed by docetaxel (Taxotere) given on day five in patients with advanced solid tumors. Proc Am Soc Clin Oncol 18: 209A, 1999 (abstr 801).
122. Titgan MA: Prevention of palmar-plantar erythrodysesthesia associated with liposome-encapsulated doxorubicin (Doxil) by oral dexamethasone. Proc Am Soc Clin Oncol 16: 82a, 1997 (abstr 288).
123. Coleman RL, Lin WM, Miller DS et al. Oral dexamethasone (DMS) attenuates Doxil-induced palmar plantar erythema (PPE) in patients with recurrent gynecologic malignancies. Proc Am Soc Clin Oncol 20: 206A, 2001 (abstr 883).
124. Rossi J-F, Jourdan E, Legouffe E et al. Intermediate analysis of a prospective randomised comparison of standard VAD protocol (vincristine, doxorubicin and dexamethasone) and pegylated liposomal doxorubicin (Doxil/CAELYX) plus dexamethasone as a first-line treatment in multiple myeloma (MM). Blood 102: 447A, 2003 (abstr 1631).
125. Hussein MA, Elson P, Tso EA et al. Doxil (D), vincristine (V), Decadron (d) and thalidomide (T) (DVd-T) for relapsed/refractory multiple myeloma (RMM). Blood 100: 237A, 2003 (abstr 831).
126. Kollmannsberger C, Mayer F, Harstrick A et al. Reduction of skin toxicity of pegylated liposomal doxorubicin (PLD) by concomitant administration of dexamethasone and pyridoxine in patients (pts) with anthracycline-sensitive malignancies - A phase I/II trial. Ann Oncol 11: 136, 2000 (suppl 4) (abstr 623P).
127. Colbern G, Steinmetz K, Musterer R et al. Amifostine reduces severity and incidence of Doxil-induced palmar/plantar erythrodysesthesia in rats but does not reduce Doxil antitumor efficacy or alter pharmacokinetics in mice. Proc Am Soc Clin Oncol 19: 209a, 2000 (abstr 815).
128. Lyass O, Lotem M, Edelmann D et al. Protective effect of amifostine (AMF) on Doxil/Caelyx-induced palmar-plantar erythrodysesthesia (PPE) in patients with advanced cancer. Proc Am Soc Clin Oncol 20: 99B, 2001 (abstr 2148).
129. Koukourakis MI, Romanidis K, Froudarakis M et al. Concurrent administration of Docetaxel and Stealth liposomal doxorubicin with radiotherapy in non–small cell lung cancer: Excellent tolerance using subcutaneous amifostine for cytoprotection. Br J Cancer 87: 385–392, 2002.
130. Lin E, Morris JS, Ayers GD: Effect of celecoxib on capecitabine-induced hand-foot syndrome and antitumor activity. Oncology (Huntingt) 16: 31-37, 2002.
131. Lopez AM, Wallace L, Dorr RT et al. Topical DMSO treatment for pegylated liposomal doxorubicin-induced palmar-plantar erythrodysesthesia. Cancer Chemother Pharmacol 44: 303–306, 1999.
132. Owainati A, Zalupski M, Shields A et al. Phase I study of liposomal doxorubicin (Doxil) and cyclophosphamide in solid tumors. Proc Am Soc Clin Oncol 17: 249A, 1998 (abstr 954).
133. Szelenyi H, Siehl J, Menssen HD et al. Cyclophosphamide, liposomal doxorubicin and dexamethasone (CLAD) is safe and efficacious in multiple myeloma. Eur J Cancer 35: 337–344, 1999 (suppl 4).
134. Leighl NB, Burkes RL, Dancey JE et al. A phase I study of pegylated liposomal doxorubicin hydrochloride (Caelyx) in combination with cyclophosphamide and vincristine as second-line treatment of patients with small-cell lung cancer. Clin Lung Cancer 5: 107–112, 2003.
135. Guastalla JP, Geay JF, Hardy-Bessard AC et al. Phase I study of pegylated liposomal doxorubicin as the anthracycline in FAC regimen for first-line treatment of metastatic breast cancer (MBC): FCC regimen. Proc Am Soc Clin Oncol 22: 62, 2003 (abstr 248).
136. Israel VK, Jeffers S, Bernal G et al. Phase I study of Doxil (liposomal doxorubicin) in combination with paclitaxel. Proc Am Soc Clin Oncol 17: 245A, 1998 (abstr 938).
137. 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. Proc Am Soc Clin Oncol 18: 220A, 1999 (abstr 848).
138. Rose P, Greer B, Markman M et al. A phase I study of paclitaxel, carboplatin, and liposomal doxorubicin in ovarian, peritoneal, and tubal carcinoma: A Gynecologic Oncology Group study. Proc Am Soc Clin Oncol 19: 387A, 2000 (abstr 1531).
139. Lum BL, Advani R, Fisher GA et al. A phase I trial of Doxil, paclitaxel, and valspodar (PSC 833) in refractory malignancies. Proc Am Soc Clin Oncol 20: 72A, 2001 (abstr 285).
140. 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 86: 1379–1384, 2002.
141. Hirsch R, Jahanzeb M, Marrs N et al. Phase I study of Doxil in combination with escalating doses of Taxotere in the treatment of patients with advanced malignancies. Proc Am Soc Clin Oncol 18: 213A, 1999 (abstr 820).
142. Tauer K, Hussein A, Birch R et al. A phase I study of taxotere (T) and Doxil (D) in refractory cancer. Proc Am Soc Clin Oncol 19: 230A, 2000 (abstr 901).
143. Sparano JA, Malik U, Rajdev L et al. Phase I trial of pegylated liposomal doxorubicin and docetaxel in advanced breast cancer. J Clin Oncol 19: 3117–3125, 2001.
144. Pavlick AC, Chodkiewicz C, Liebes L et al. A phase I and pharmacokinetic study of docetaxel combined with Doxil (pegylated liposomal doxorubicin) without and with granulocyte colony stimulating factor. Anticancer Drugs 15: 119–125, 2004.
145. Schwonzen M, Kurbacher CM, Mallmann P: Liposomal doxorubicin and weekly paclitaxel in the treatment of metastatic breast cancer. Anticancer Drugs 11: 681–685, 2000.
146. Tolis C, Briasoulis E, Tzamakou E et al. Phase I trial and interaction pharmacokinetics of pegylated-liposomal doxorubicin (Caelyx; Doxil) and weekly Taxol. Proc Am Soc Clin Oncol 19: 206a, 2000 (abstr 803).
147. Mavroudis D, Kouroussis C, Kakolyris S et al. Phase I study of paclitaxel (taxol) and pegylated liposomal doxorubicin (caelyx) administered every 2 weeks in patients with advanced solid tumors. Oncology 62: 216–222, 2002.
148. Lortholary A, Delozier T, Bourgeois H et al. A phase I study of paclitaxel in combination with pegylated liposomal doxorubicin (PLD) as second-line chemotherapy in metastatic breast cancer (MBC). Proc Am Soc Clin Oncol 22: 52, 2003 (abstr 206).
149. Gasparini G, Morabito A, Fanelli M et al. Phase I-II study of liposomial doxorubicin and docetaxel as first-line treatment in patients with advanced breast cancer. Proc Am Soc Clin Oncol 21: 54B, 2002 (abstr 2029).
150. 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 98: 610–617, 2003.
151. Androulakis N, Kouroussis C, Mavroudis D et al. Phase I study of weekly paclitaxel and liposomal doxorubicin in patients with advanced solid tumours. Eur J Cancer 38: 1992–1997, 2002.
152. Laufman LR, Spiridonidis CH, Jones JJ et al. Phase I trial of Doxil and vinorelbine in patients with advanced malignancies. Cancer Invest 22: 344–352, 2004.
153. Burstein HJ, Ramirez MJ, Petros WP et al. Phase I study of Doxil and vinorelbine in metastatic breast cancer. Ann Oncol 10: 1113–1116, 1999.
154. Jahanzeb M, Hirsch R, Marrs N et al. Phase I study of Doxil in combination with escalating doses of Navelbine for the treatment of patients with advanced malignancies. Proc Am Soc Clin Oncol 18: 215a, 1999 (abstr 827).
155. Gebbia V, Mauceri G, Fallica G et al. Pegylated liposomal doxorubicin 86 D.S. Alberts et al. with vinorelbine in metastatic breast carcinoma. A phase I-II clinical investigation. Oncology 63: 23–30, 2002.
156. Tambaro R, Greggi S, Iaffaioli RV et al. An escalating dose finding study of liposomal doxorubicin and vinorelbine for the treatment of refractory or resistant epithelial ovarian cancer. Ann Oncol 14: 1406–1411, 2003.
157. Bartlett N, Niedzwiecki D, Johnson J et al. A phase I/II study of gemcitabine, vinorelbine, and liposomal doxorubicin for relapsed Hodgkin’s disease: Preliminary results of CALGB 59804. Proc Am Soc Clin Oncol 22: 566, 2003 (abstr 2275).
158. Layman R, Silverman P, Remick S et al. Phase I trial of combination pegylated liposomal doxorubicin (PLD), vinorelbine, and gemcitabine. Proc Am Soc Clin Oncol 22: 155, 2003 (abstr 619).
159. Yeung AW, Wong A, Ali M: Phase I trial of Doxil and topotecan in solid tumors. Proc Am Soc Clin Oncol 17: 255A, 1998 (abstr 979).
160. Hamilton A, Hochster H, Rosenthal M et al. Continuous infusion topotecan (TP-CI) with Doxil (Dx): A phase I study of dual topoisomerase inhibition. Proc Am Soc Clin Oncol 19: 200a, 2000 (abstr 777).
161. Mirchandani D, Hochster H, Hamilton A et al. Efficacy of Doxil and topotecan in platinum-pretreated epithelial ovarian cancer in a phase I study. Gynecol Oncol 80: 315, 2001(abstr).
162. Hochster H, Rosenthal M, Chachoua A et al. Prolonged topotecan infusion combined with Doxil – A well tolerated regimen. Proc Am Soc Clin Oncol 18: 214a, 1999 (abstr 822).
163. Dunphy FR, Cantrell C, Dunleavy T et al. Phase I and pharmacokinetic (PK) study of Doxil (D) and irinotecan (I) in advanced cancer patients. Proc Am Soc Clin Oncol 20: 102A, 2001 (abstr 404).
164. Mendelson DS, Brewer M, Goermar N et al. Phase I study of liposomal lurtotecan (OSI-211) in combination with liposomal doxorubicin every 3 weeks in patients (pts) with advanced solid tumors. Proc Am Soc Clin Oncol 22: 155, 2003 (abstr 622).
165. Ryan CW, Fleming GF, Janisch L et al. A phase I study of liposomal doxorubicin (Doxil) with topotecan. Am J Clin Oncol 23: 297-300, 2000.
166. Geertsen PF, Stroyer 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 platinumpaclitaxel containing chemotherapy (abstr 2522). Proc Am Soc Clin Oncol 20: 193B, 2001 (abstr 2522).
167. Klein P, Wasserheit C, Hochster H et al. Apparent protection of Doxil skin and oral toxicities when combined with cisplatin (CDDP): Results of a phase I study (abstr 835). Proc Am Soc Clin Oncol 18: 217A, 1999 (abstr 835).
168. Uys A, Rapoport BL, Mahomed R: Phase I trial of pegylated-liposomal doxorubicin (Caelyx, Doxil) and carboplatin in patients with advanced malignancy. Proc Am Soc Clin Oncol 21: 81B, 2002 (abstr 2138).
169. Gonzalez-Billalabeitia E, Mendiola C, Mellado B et al. A phase I/II clinical study of pegylated liposomal doxorubicin plus carboplatin in advanced ovarian cancer. Proc Am Soc Clin Oncol 22: 478a, 2003 (abstr 1919).
170. Goncalves A, Braud AC, Viret F et al. Phase I study of pegylated liposomal doxorubicin (Caelyx) in combination with carboplatin in patients with advanced solid tumors. Anticancer Res 23: 3543-3548, 2003.
171. Recchia F, De Filippis S, Saggio G et al. Phase I study of liposomal doxorubicin and oxaliplatin as salvage chemotherapy in advanced ovarian cancer. Anticancer Drugs 14: 633-638, 2003.
172. Tobias D, Runowicz C, Mandeli J et al. A phase I trial of gemcitabine and Doxil for recurrent epithelial ovarian cancer. Proc Am Soc Clin Oncol 19: 392a, 2000 (abstr 1551).
173. D’Agostino G, Ferrandina G, Garganese G et al. Phase I study of gemcitabine and liposomal doxorubicin in relapsed ovarian cancer. Oncology 62: 110–114, 2002.
174. 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 19: 1716–1722, 2001.
175. Wong Z-W, Khoo K-S, Shah VA et al. Phase I/II study of pegylated liposomal doxorubicin (PLD) and gemcitabine (G) as first-line therapy for metastatic breast cancer (MBC). Proc Am Soc Clin Oncol 21: 49B, 2002 (abstr 2008).
176. Fracasso PM, Blum KA, Tan BR et al. Phase I study of pegylated liposomal doxorubicin and gemcitabine in patients with advanced malignancies. Cancer 95: 2223-2229, 2002.
177. 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 344: 783–792, 2001.
178. 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.
179. Chia SK, Clemons M, Martin LA et al. A multi-centre phase II trial of pegylated liposomal doxorubicin and trastuzumab in HER-2 overexpressing metastatic breast cancer (MBC). Proc Am Soc Clin Oncol 23: 34, 2004 (abstr 630).
180. Kim E, Gaiotti DA, Volm MD et al. Reversible cardiotoxicity from pegylated liposomal doxorubicin plus trastuzumab (Herceptin): results from 2 prospective studies. 27th Annual San Antonio Breast Cancer Symposium, San Antonio, TX, 2004.
181. Volm M, Oratz R, Pavlick A et al. A phase I study of liposomal doxorubicin and temozolomide in patients with advanced cancer. Proc Am Soc Clin Oncol 19: 223a, 2000 (abstr 872).
182. Awada A, Dubuisson M, Sales F et al. A phase I study of a prolonged schedule of temozolomide (Temodar) plus liposomal doxorubicin (Caelyx) in advanced solid cancers: Final results of a promising combination. Proc Am Soc Clin Oncol 21: 79B, 2002 (abstr 2130).
183. O’Donnell A, Judson I, Verrill M et al. A phase one dose escalation and pharmacokinetic study of temozolomide and liposomal doxorubicin (Caelyx). Proc Am Soc Clin Oncol 21: 84B, 2002 (abstr 2150).
184. Fracasso PM, Tan BR, Picus J et al. A phase I accelerated dose escalation and pharmacokinetic study of Doxil and valspodar (PSC 833) in patients with advanced malignancies. Proc Am Soc Clin Oncol 20: 74A, 2001 (abstr 286).
185. Lum BL, Cho CD, Fisher GA et al. A phase I trial of pegylated liposomal doxorubicin (Doxil) and oral valspodar (PSC-833), a modulator of multidrug resistance, in advanced solid malignancies. Proc Am Soc Clin Oncol 21: 114A, 2002 (abstr 455).
186. Rose PG, Rodriguez M, Walker J et al. A phase I trial of prolonged oral etoposide and liposomal doxorubicin in ovarian, peritoneal, and tubal carcinoma: A gynecologic oncology group study. Gynecol Oncol 85: 136–139, 2002.
187. Dees EC, O’Neil B, Humes E et al. Phase I clinical trial of the proteasome inhibitor bortezomib in combination with pegylated liposomal doxorubicin in patients with refractory solid tumors. Proc Am Soc Clin Oncol 22: 217, 2003 (abstr 868).
188. Hofheinz RD, Willer A, Weisser A et al. Pegylated liposomal doxorubicin in combination with mitomycin C, infusional 5-fluorouracil and sodium folinic acid. A phase-I-study in patients with upper gastrointestinal cancer. Br J Cancer 90: 1893–1897, 2004.
189. Ferrari VD, Valcamonico F, Simoncini E et al. Pegylated liposomal doxorubicin (CAELYX), TIOthepa (TIO), folinic acid (FA) and fluorouracil (FU) in patients (pts) with advanced breast cancer (ABC). A phase I-II study. Proc Am Soc Clin Oncol 22: 66, 2003 (abstr 264).
190. Brown GL, Lewis L, Choi H et al. Phase 1-2a dose ranging study of TLK286 (a novel glutathione analog) in combination with liposomal doxorubicin in platinum refractory or resistant ovarian cancer. Proc Am Soc Clin Oncol 23: 463, 2004 (abstr 5062).
191. Orlowski RZ, Voorhees PM, Garcia R et al. Phase I study of the proteasome inhibitor bortezomib and pegylated liposomal doxorubicin in patients with refractory hematologic malignancies. Proc Am Soc Clin Oncol 22: 200, 2003 (abstr 801).
192. 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 20: 47a, 2001 (abstr 184) Liposomal anthracyclines: Phase I-II trials 87 angiosarcoma of the skin after systemic treatment with liposome-encapsulated doxorubicin and interferon-alpha. Br J Dermatol 140: 1187–1188, 1999.
230. Eiling S, Lischner S, Busch JO et al. Complete remission of a radioresistant cutaneous angiosarcoma of the scalp by systemic treatment with liposomal doxorubicin. Br J Dermatol 147: 150–153, 2002.
231. Skubitz KM: Phase II trial of pegylated-liposomal doxorubicin (Doxil) in mesothelioma. Cancer Invest 20: 693-699, 2002.
232. Baas P, van Meerbeeck J, Groen H et al. Caelyx in malignant mesothelioma: A phase II EORTC study. Ann Oncol 11: 697–700, 2000.
233. Martino R, Perea G, Caballero MD et al. Cyclophosphamide, pegylated liposomal doxorubicin (Caelyx), vincristine and prednisone (CCOP) in elderly patients with diffuse large B-cell lymphoma: Results from a prospective phase II study. Haematologica 87: 822–827, 2002.
234. Topilow AA, Mencel PJ, Nahum K et al. Cyclophosphamide/pegylated liposomal doxorubicin/vincristine/prednisone (CDOP) in the treatment of intermediate grade non-Hodgkin’s lymphoma (IG-NHL): A five-year follow-up. Proc Am Soc Clin Oncol 22: 596, 2003 (abstr 2397).
235. Tsavaris N, Kosmas C, Vadiaka M et al. Pegylated liposomal doxorubicin in the CHOP regimen for older patients with aggressive (stages III/IV) non-Hodgkin’s lymphoma. Anticancer Res 22: 1845–1848, 2002.
236. Di Bella NJ, Khan MM, Dakhil SR et al. Pegylated liposomal doxorubicin as single-agent treatment of low-grade non-Hodgkin’s lymphoma: A phase II multicenter study. Clin Lymphoma 3: 235–240, 2003.
237. Tulpule A, Khan AU, Mohrbacher AF et al. A phase II trial of pegylated liposomal doxorubicin, rituximab, cyclophosphamide, vincristine, and prednisone (DR-COP) in aggressive B-cell non-Hodgkin’s lymphoma. Proc Am Soc Clin Oncol 23: 602, 2004 (abstr 6688).
238. Richardson DS, Kelsey SM, Johnson SA et al. Early evaluation of liposomal daunorubicin (DaunoXome, Nexstar) in the treatment of relapsed and refractory lymphoma. Invest New Drugs 15: 247–253, 1997.
239. Tulpule A, Rarick MU, Kolitz J et al. Liposomal daunorubicin in the treatment of relapsed or refractory non-Hodgkin’s lymphoma. Ann Oncol 12: 457–462, 2001.
240. Fumagalli L, Zucchetti M, Vigano M et al. Treatment of HIV-associated non-Hodgkin’s lymphoma with liposomal daunorubicin substituted CHOP and HAART: Preliminary clinical results and CSF pharmacokinetic. Proc Am Soc Clin Oncol 19: 35A, 2000 (abstr 136).
241. McBride NC, Cavenagh JD, Ward MC et al. Liposomal daunorubicin (DaunoXome) in combination with cyclophosphamide, vincristine and prednisolone (COP-X) as salvage therapy in poor-prognosis non- Hodgkins lymphoma. Leuk Lymphoma 42: 89–98, 2001.
242. Mitchell P, Marlton P, Grigg A et al. A phase II trial of daunoxomesubstituted CHOP in the treatment of elderly patients with aggressive non-Hodgkin’s lymphoma. Proc Am Soc Clin Oncol 22: xxx, 2003 (abstr 2404).
243. Dabaja BS, O’Brien SM, Kantarjian HM et al. Fractionated cyclophosphamide, vincristine, liposomal daunorubicin (daunoXome), and dexamethasone (hyperCVXD) regimen in Richter’s syndrome. Leuk Lymphoma 42: 329–337, 2001.
244. Cervetti G, Caracciolo F, Cecconi N et al. Efficacy and toxicity of liposomal daunorubicin included in PVABEC regimen for aggressive NHL of the elderly. Leuk Lymphoma 44: 465–469, 2003.
245. Wollina U, Graefe T, Kaatz M: Pegylated doxorubicin for primary cutaneous T-cell lymphoma: A report on ten patients with follow-up. J Cancer Res Clin Oncol 127: 128–134, 2001.
246. Prince HM, Seymour JF, Ryan G et al. Pegylated liposomal doxorubicin in the treatment of cutaneous T-cell lymphoma. J Am Acad Dermatol 44: 149–150, 2001.
247. Wollina U, Dummer R, Brockmeyer NH et al. Multicenter study of pegylated liposomal doxorubicin in patients with cutaneous T-cell lymphoma. Cancer 98: 993–1001, 2003.
248. Odrazka K, Vanasek J, Vaculikova M et al. The role of chemotherapy in prostate cancer. Minireview. Neoplasma 47: 197–203, 2000.
249. Beedassy A, Cardi G: Chemotherapy in advanced prostate cancer. Semin Oncol 26: 428–438, 1999.
250. Yagoda A, Petrylak D: Cytotoxic chemotherapy for advanced hormone-resistant prostate cancer. Cancer 71: 1098–1109, 1993.
251. 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 20: 331–337, 2002.
252. Harris KA, Harney E, Small EJ: Liposomal doxorubicin for the treatment of hormone-refractory prostate cancer. Clin Prostate Cancer 1: 37–41, 2002.
253. Fossa SD, Vaage S, Letocha H et al. Liposomal doxorubicin (Caelyx) in symptomatic androgen-independent prostate cancer (AIPC)–Delayed response and flare phenomenon should be considered. Scand J Urol Nephrol 36: 34–39, 2002.
254. Heidenreich A, Olbert P, Goecke J et al. A prospectively randomized phase II trial of pegylated doxorubicin in hormone refractory prostate cancer. Eur J Cancer Suppl 1: S263, 2003.
255. Martoni A, Guaraldi M, Piana E: Anthracyclines in non–small-cell lung cancer: Do they have a therapeutic role? Ann Oncol 10: S19-S23, 1999 (suppl. 5).
256. Anderson H, Hopwood P, Prendiville J et al. A randomised study of bolus vs continuous pump infusion of ifosfamide and doxorubicin with oral etoposide for small cell lung cancer. Br J Cancer 67: 1385–1390, 1993.
257. 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 7: 243–254, 2001.
258. Koletsky A, Jahanzeb M, Radice P et al. A randomized phase II trial of pegylated liposomal doxorubicin (PEG-LD) as second line treatment in non-small cell lung cancer (NSCLC) patients with prior exposure to platinum based therapy. Proc Am Soc Clin Oncol 17: 490A, 1998 (abstr 1888).
259. Numico G, Castiglione F, Granetto C et al. Single-agent pegylated liposomal doxorubicin (Caelix) in chemotherapy pretreated nonsmall cell lung cancer patients: A pilot trial. Lung Cancer 35: 59–64, 2002.
260. Clerici MP, Bollina R, Belloni P et al. Phase II trial combination of pegylated liposomal doxorubicin (Caelyx) and vinorelbine (V) or gemcitabine (G) as second line chemotherapy in patients (pts) with stage IIIb-IV non small cell lung cancer (NSCLC). Proc Am Soc Clin Oncol 22: 689, 2003 (abstr 2769).
261. O’Brien M, Hickish T, Iveson T et al. Phase II study of Caelyx (Doxil; doxorubicin HCl pegylated liposomal) in the treatment of small cell lung cancer (SCLC). Proc Am Soc Clin Oncol 17: 497A, 1998 (abstr 1913).
262. Samantas E, Kalofonos H, Linardou H et al. Phase II study of pegylated liposomal doxorubicin: Inactive in recurrent small-cell lung cancer. A Hellenic Cooperative Oncology Group Study. Ann Oncol 11: 1395–1397, 2000.
263. Thigpen JT, Blessing JA, DiSaia PJ et al. A randomized comparison of doxorubicin alone versus doxorubicin plus cyclophosphamide in the management of advanced or recurrent endometrial carcinoma: A Gynecologic Oncology Group study. J Clin Oncol 12: 1408–1414, 1994.
264. Elit L, Hirte H: Novel strategies for systemic treatment of endometrial cancer. Expert Opin Investig Drugs 9: 2831–2853, 2000.
265. Muggia FM, Blessing JA, Sorosky J et al. Phase II trial of the pegylated liposomal doxorubicin in previously treated metastatic endometrial cancer: A Gynecologic Oncology Group study. J Clin Oncol 20: 2360–2364, 2002.
266. Escobar PF, Markman M, Zanotti K et al. Phase 2 trial of pegylated liposomal doxorubicin in advanced endometrial cancer. J Cancer Res Clin Oncol 129: 651–654, 2003.
267. Hamilton AL, Wadler S, Hornreich G et al. Paclidox: a phase II study of pegylated liposomal doxorubicin (Doxil) and paclitaxel in endometrial carcinoma and sarcoma; a study of the New York Gynecologic Oncology Group (NYGOG). Proc Am Soc Clin Oncol 21: 210A, 2002 (abstr 839).
268. Maluf FC, Spriggs D: Anthracyclines in the treatment of gynecologic malignancies. Gynecol Oncol 85: 18–31, 2002.
269. Verschraegen CF, Kavanagh JJ, Loyer E et al. Phase II study of carboplatin and liposomal doxorubicin in patients with recurrent squamous cell carcinoma of the cervix. Cancer 92: 2327–2333, 2001.
270. Le LH, Swenerton KD, Elit L et al. Phase II open-label study of carboplatin and pegylated liposomal doxorubicin in uterine and cervical malignancies. Proc Am Soc Clin Oncol 22: 458, 2003 (abstr 1839).
271. Law TM, Mencel P, Motzer RJ: Phase II trial of liposomal encapsulated doxorubicin in patients with advanced renal cell carcinoma. Invest New Drugs 12: 323–325, 1994.
272. Skubitz KM: Phase II trial of pegylated-liposomal doxorubicin (Doxil) in renal cell cancer. Invest New Drugs 20: 101–104, 2002.
273. Pennington K, Gordon M, Picus J: A phase II trial of liposomal doxorbicin (Doxil) in the treatment of advanced renal cell cancer: A Hoosier Oncology Group (HOG) study. ProcAmSoc Clin Oncol 17: 339A, 1998 (abstr 1308).
274. Winquist E, Ernst DS, Jonker D et al. Phase II trial of pegylatedliposomal doxorubicin in the treatment of locally advanced unresectable or metastatic transitional cell carcinoma of the urothelial tract. Eur J Cancer 39: 1866-1871, 2003.
275. Fossa SD, Aass N, Paro G: A phase II study of DaunoXome in advanced urothelial transitional cell carcinoma. Eur J Cancer 34: 1131–1132, 1998.
276. Buentzel J, Schuth J, Glatzel M: Doxorubicin in the palliative therapy of recurrent pretreated head and neck cancer. ProcAmSoc Clin Oncol 21: 184B, 2002 (abstr 2556).
277. Djafari L, Faivre S, Domange C et al. Phase II study of pegylated liposomal doxorubicin (Caelyx/Doxil) in patients with locally recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). Proc Am Soc Clin Oncol 21: 238A, 2002 (abstr 951).
278. Siegal T, Horowitz A, Gabizon A: Doxorubicin encapsulated in sterically stabilized liposomes for the treatment of a brain tumor model: biodistribution and therapeutic efficacy. J Neurosurg 83: 1029–1037, 1995.
279. Fabel K, Dietrich J, Hau P et al. Long-term stabilization in patients with malignant glioma after treatment with liposomal doxorubicin. Cancer 92: 1936–1942, 2001.
280. Hau P, Fabel K, Baumgart U et al. Pegylated liposomal doxorubicinefficacy in patients with recurrent high-grade glioma. Cancer 100: 1199–1207, 2004.
281. Hau P, Jauch T, Hirschmann B et al. Adjuvant chemotherapy with temozolomide and pegylated liposomal doxorubicin in the first-line therapy of patients with glioblastoma – A phase-II trial. Proc Am Soc Clin Oncol 23: 118, 2004 (abstr 1547).
282. Caraglia M, Addeo R, Costanzo R et al. Pegylated liposomal doxorubicin plus temozolamide in the salvage treatment of brain metastases: The update. Proc Am Soc Clin Oncol 23: 126, 2004 (abstr 1576).
283. Chua SL, Rosenthal MA, Wong SS et al. Phase 2 study of temozolomide and Caelyx in patients with recurrent glioblastoma multiforme. Neuro-oncol 6: 38–43, 2004.
284. Travitzky M, Libson E, Nemirovsky I et al. Doxil-induced regression of pleuro-pulmonary metastases in a patient with malignant meningioma. Anticancer Drugs 14: 247–250, 2003.
285. Boiardi A, Pozzi A, Salmaggi A et al. Safety and potential effectiveness of daunorubicin-containing liposomes in patients with advanced recurrent malignant CNS tumors. Cancer Chemother Pharmacol 43: 178–179, 1999.
286. Lippens RJ: Liposomal daunorubicin (DaunoXome) in children with recurrent or progressive brain tumors. Pediatr Hematol Oncol 16: 131–139, 1999.
287. Del Prete S, Caraglia M, deo R et al. Pegylated liposomal doxorubicin plus temozolamide in the salvage treatment of brain metastases: A feasibility study. Proc Am Soc Clin Oncol 22: 119, 2003 (abstr 474).
288. Ellerhorst JA, Bedikian A, Ring S et al. Phase II trial of doxil for patients with metastatic melanoma refractory to frontline therapy. Oncol Rep 6: 1097–1099, 1999.
289. Schadendorf D, Hofmann U, Allgauer T et al. Caelyx as a ’third-line’ therapy for therapy-resistant metastasized malignant melanomas. Proc Am Soc Clin Oncol 18: 553A, 1999 (abstr 2137).
290. Vorobiof DA, Rapoport BL, Mahomed R et al. Phase II study of pegylated liposomal doxorubicin in patients with metastatic malignant melanoma failing standard chemotherapy treatment. Melanoma Res 13: 201–203, 2003.
291. Thomas AL, O’Byrne K, Furber L et al. A phase II study of caelyx, liposomal doxorubicin: Lack of activity in patients with advanced gastric cancer. Cancer Chemother Pharmacol 48: 266–268, 2001.
292. Shields AF, Lange LM, Zalupski MM: Phase II study of liposomal doxorubicin in patients with advanced colorectal cancer. Am J Clin Oncol 24: 96–98, 2001.
293. Eckardt JR, Campbell E, Burris HA et al. A phase II trial of DaunoXome, liposome-encapsulated daunorubicin, in patients with metastatic adenocarcinoma of the colon. Am J Clin Oncol 17: 498–501, 1994.
294. Leung TW, Johnson PJ: Systemic therapy for hepatocellular carcinoma. Semin Oncol 28: 514–520, 2001.
295. Mathurin P, Rixe O, Carbonell N et al. Review article: Overview of medical treatments in unresectable hepatocellular carcinoma–An impossible meta-analysis? Aliment Pharmacol Ther 12: 111–126, 1998.
296. Schmidinger M, Wenzel C, Locker GJ et al. Pilot study with pegylated liposomal doxorubicin for advanced or unresectable hepatocellular carcinoma. Br J Cancer 85: 1850–1852, 2001.
297. Yeo W, Chan KK, Mukwaya G et al. Phase II studies with DaunoXome in patients with nonresectable hepatocellular carcinoma: Clinical and pharmacokinetic outcomes. Cancer Chemother Pharmacol 44: 124–130, 1999.
298. Halford S, Yip D, Karapetis CS et al. A phase II study evaluating the tolerability and efficacy of CAELYX (liposomal doxorubicin, Doxil) in the treatment of unresectable pancreatic carcinoma. Ann Oncol 12: 1399–1402, 2001.
299. Schwartz GK, Casper ES: A phase II trial of doxorubicin HCl liposome injection in patients with advanced pancreatic adenocarcinoma. Invest New Drugs 13: 77–82, 1995.
300. Koller C, Cortes J, O’Brien S et al. A pilot study of dose-intensive anthracyclines for acute lymphoblastic leukemia (ALL) using liposomal daunorubicin (LD) with hyperfractionated cyclophosphamide (CTX), vincristine (VCR), and prednisone (PDN) (HyperCVXD). Proc Am Soc Clin Oncol 17: 28A, 1998 (abstr 110).
301. Cortes J, Kantarjian H, Albitar M et al. A randomized trial of liposomal daunorubicin and cytarabine versus liposomal daunorubicin and topotecan with or without thalidomide as initial therapy for patients with poor prognosis acute myelogenous leukemia or myelodysplastic syndrome. Cancer 97: 1234–1241, 2003.
302. Litzow MR, Goloubeva O, Rowe J et al. A randomized phase II trial of gemtuzumab ozogamicin vs. Liposomal daunorubicin vs. cyclophosphamide plus topotecan, each combined with intermediate dose Ara-C for the treatment of patients with relapsed or refractory acute myelogenous leukemia. Proc Am Soc Clin Oncol 22: 587, 2003 (abstr 2359).
303. Apostolidou E, Cortes J, Tsimberidou A et al. Pilot study of gemtuzumab ozogamicin, liposomal daunorubicin, cytarabine and cyclosporine regimen in patients with refractory acute myelogenous leukemia. Leuk Res 27: 887–891, 2003.
304. Russo D, Piccaluga PP, Michieli M et al. Liposomal daunorubicin (DaunoXome) for treatment of poor-risk acute leukemia. Ann Hematol 81: 462–466, 2002.
305. Offidani M, Corvatta L, Centurioni R et al. High-dose daunorubicin as liposomal compound (Daunoxome) in elderly patients with acute lymphoblastic leukemia. Hematol J 4: 47–53, 2003.
306. 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 11: 1029–1033, 2000.
307. Winer E, Batist G, Belt R et al. Reduced cardiotoxicity of liposomeencapsulated 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: 84a, 2000 (abstr 323).

D. S. Alberts, F. M. Muggia, J. Carmichael, E. P. Winer, M. Jahanzeb, A. P. Venook, K. M. Skubitz, E. Rivera, J. A. Sparano, N. J. Dibella, S. J. Stewart, J. J. Kavanagh, A. A. Gabison