Liposomal doxorubicin: Antitumor activity and unique toxicities during two complementary phase I studies

Journal of Clinical Oncology

Volumn 13, Issue 7, 1995, Pages 1777-1785

  Uziely, Beatrice ^b   Jeffers, Susan ^b   Isacson, Rut ^b   Kutsch, Kimberlea ^b   Wei Tsao, Denise ^b   Yehoshua, Zohar ^b   Libson, Eugene ^b   Muggia, Franco M ^b   Gabizon, Alberto ^a  

^a HADASSAH HEBREW UNIVERSITY MEDICAL CENTER   (Israel)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

DOXORUBICIN; LIPOSOME; MACROGOL;

ADULT; AGED; ALOPECIA; ANTINEOPLASTIC ACTIVITY; ARTICLE; BONE MARROW SUPPRESSION; BREAST CARCINOMA; CLINICAL TRIAL; DESQUAMATION; DOSE RESPONSE; DYSESTHESIA; FEMALE; HEAD AND NECK CARCINOMA; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; MAJOR CLINICAL STUDY; MALE; MAXIMUM PERMISSIBLE DOSE; OVARY CARCINOMA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PROSTATE CARCINOMA; SKIN TOXICITY; SOLID TUMOR; STOMATITIS;

EID: 0029038996     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.1995.13.7.1777     Document Type: Article

References (35)

1. DelaFlor-Weiss E, Uziely B, Muggia FM: Protracted drug infusions in cancer treatment: An appraisal of 5-fluouracil, doxorubicin, and platinums. Ann Oncol 4:723-733, 1993
2. Gabizon A, Barenholz Y, Bialer M: Prolongation of the circulation time of doxorubicin encapsulated in liposomes containing a polyethyleneglycol-derivatized phospholipid: Pharmacokinetic studies in rodents and dogs. Pharm Res 10:703-708, 1993
3. 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 54:987-992, 1994
4. Huang L (Forum Editor): Covalently attached polymers and glycans to alter the biodistribution of liposomes. J Liposome Res 2:289-454, 1992
5. Lasic DD, Martin FJ (eds): Stealth Liposomes. Boca Raton, FL, CRC Press, 1995
6. Gabizon AA: Selective tumor localization and improved therapeutic index of anthracyclines encapsulated in long-circulating liposomes. Cancer Res 52:891-896, 1992
7. Papahadjopoulos D, Allen TM, Gabizon A, et al: Sterically stabilized liposomes: Improvements in pharmacokinetics and antitumor therapeutic efficacy. Proc Natl Acad Sci USA 88:11460-11464, 1991
8. 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 54:2186-2191, 1994
9. Huang SK, Lee K-D, Hong K, et al: Microscopic localization of sterically-stabilized liposomes in colon carcinoma-bearing mice. Cancer Res 52:5135-5143, 1992
10. Wu NZ, Da D, Rudoll TL, et al: Increased microvascular permeability contributes to preferential accumulation of stealth liposomes in tumor tissue. Cancer Res 53:3765-3770, 1993
11. Yuan F, Leunig M, Huang SK, et al: Microvascular permeability and interstitial penetration of sterically stabilized (stealth) liposomes in a human tumor xenograft. Cancer Res 54:3352-3356, 1994
12. Mayhew EG, Lasic DD, Babbar S, et al: Pharmacokinetics and antitumor activity of epirubicin encapsulated in long-circulating liposomes. Int J Cancer 51:302-309, 1992
13. 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 51:942-948, 1992
14. Huang SK, Mayhew E, Gilani S, et al: Pharmacokinetics and therapeutics of sterically stabilized liposomes in mice bearing C-26 colon carcinoma. Cancer Res 52:6774-6781, 1992
15. Gabizon A, Pappo O, Goren D, et al: Preclinical studies with doxorubicin encapsulated in polyethylene-glycol coated liposomes. J Liposome Res 3:517-528, 1993
16. Williams SS, Alosco Tr, Mayhew E, et al: Arrest of human lung tumor xenograft growth in severe combined immunodeficient mice using doxorubicin encapsulated in sterically stabilized liposomes. Cancer Res 53:3964-3967, 1993
17. Vaage J, Donovan D, Mayhew E, et al: Therapy of human ovarian carcinoma xenografts using doxorubicin encapsulated in sterically stabilized liposomes. Cancer 72:3671-3675, 1993
18. Vaage J, Barbera-Guillem E, Abra R, et al: Tissue distribution and therapeutic effects of intravenous free and liposomal doxorubicin against human prostatic carcinoma xenografts. Cancer 73:1478-1484, 1994
19. Simpson JK, Miller RF, Spittle MF: Liposomal doxorubicin for treatment of AIDS-related Kaposi's sarcoma. Clin Oncol 5:372-373, 1993
20. Lokich JJ, Moore C: Chemotherapy-associated palmar-plantar erythrodysesthesia syndrome. Ann Intern Med 101:798-800, 1984
21. 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
22. Owen RR, Sell RA, Gilmore IT, et al: A phase I clinical evaluation of liposome-entrapped doxorubicin (Lip-Dox) in patients with primary and metastatic hepatic malignancy. Anti-Cancer Drugs 3:101-107, 1992
23. 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
24. Conley BA, Egorin MJ, Whitacre MY, et al: Phase I and pharmacokinetic trial of liposome-encapsulated doxorubicin. Cancer Chemother Pharmacol 33:107-112, 1993
25. Von Hoff DD, Layard MW, Basa P, et al: Risk factors for doxorubicin-induced congestive heart failure. Ann Intern Med 91:710-717, 1979
26. Brenner DE: Liposomal encapsulation: Making old and new drugs do new tricks. J Natl Cancer Inst 81:1436-1438, 1989
27. De Vries EG, Mulder NH, Daemen T: Current state of liposome-complexed drugs in the treatment of cancer patients. Ann Oncol 3:419-421, 1992
28. Gabizon AA: Liposomal anthracyclines. Hematol Oncol Clin North Am 8:431-450, 1994
29. 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
30. Pestalozzi R, Schwendener R, Sauter C: Phase I/II study of liposome-complexed mitoxantrone in patients with advanced breast cancer. Ann Oncol 3:445-449, 1992
31. 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
32. Samuels BL, Vogelzang NJ, Ruane M, et al: Continuous venous infusion of doxorubicin in advanced sarcomas. Cancer Treat Rep 71:971-972, 1987
33. Legha SS, Benjamin RS, Mackay B, et al: Reduction of doxorubicin cardiotoxicity by prolonged continuous infusion. Ann Intern Med 96:133-139, 1982
34. Hortobagyi GN, Frye D, Buzdar AU, et al: Decreased cardiac toxicity of doxorubicin administered by continuous intravenous infusion in combination chemotherapy for metastatic breast carcinoma. Cancer 63:37-45, 1989
35. Zalupski M, Metch B, Balcerzak S, et al: Phase III comparison of doxorubicin and dacarbazine given by bolus versus infusion in patients with soft tissue sarcoma: A Southwest Oncology Group study. J Natl Cancer Inst 83:926-932, 1991