Bertelli, G., et al., Topical Dimethylsulfoxide for the Prevention of Soft Tissue Injury After Extravasation of Vesicant Cytotoxic Drugs: A Prospective Clinical Study. J. Clin. Oncol. 13: 2851, 1995. |
Blum, R.H., et al., A New Anticancer Drug with Significant Clinical Activity. Ann. Intern. Med. 80: 249, 1974. |
Comandone, A., et al., Palmar-Plantar Erythrodysestasia Syndrome Associated With 5-Fluorouracil Treatment. Anticancer Res. 13: 1781, 1993. |
Fabian, C.J., et al., Pyridoxine Therapy for Palmar-Plantar Erythrodysesthesia Associated With 5-Fluorouracil Infusion. Invest. New Drugs 8: 57, 1990. |
Frei, E., et al., Dose: A Critical Factor in Cancer Chemotherapy. Am. J. Med. 69: 585, 1980. |
Gabizon, A., et al., Liposome Formulation with Prolonged Circulation Time in Blood and Enhanced Uptake by Tumors. Proc. Natl. Acad. Sci. U S A 85: 6949, 1988. |
Gordon, K.B., et al., Hand-Foot Syndrome Associated with Liposome-Encapsulated Doxorubicin Therapy. Cancer 75: 2169,1995. |
Henderson, I.C., et al., Dose-Response in the Treatment of Breast Cancer: A Critical Review. J. Clin. Oncol. 6: 1501, 1988. |
James, N.D., et al., Liposomal Doxorubicin (Doxil): An Effective New Treatment for Kaposi's Sarcoma in AIDS. Clin. Oncol. (R. Coll. Radiol.) 6: 294, 1994. |
Larson, D.L., Treatment of Tissue Extravasation by Antitumor Agents. Cancer 49: 1796, 1982. |
Leichman, C.G., et al., Prolonged Continuous Infusion of Fluorouracil with Weekly Bolus Leucovorin: A Phase II Study in Patients with Disseminated Colorectal Cancer. J. Natl. Cancer Inst. 85: 41, 1993. |
Levine, L.E., et al., Distinctive Acral Erythema Occurring During Therapy for Severe Myelogenous Leukemia. Arch. Dermatol. 121: 102, 1985. |
Lipschultz, S.E., et al., Late Cardiac Effects of Doxorubicin Therapy for Acute Lymphoblastic Leukemia in Childhood. N. Engl. J. Med. 324: 808, 1991. |
Lokich, J.J., et al., Chemotherapy-Associated Palmar-Plantar Erythrodysesthesia Syndrome. Ann. Intern. Med. 101: 798, 1984. |
Lokich, J.J., et al., A Prospective Randomized Comparison of Continuous Infusion Fluorouracil with a Conventional Bolus Schedule in Metastatic Colorectal Carcinoma: A Mid-Atlantic Oncology Program Study. J. Clin. Oncol. 7: 425, 1989. |
Muggia, F.M., 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, 1997. |
Northfelt, D.W., et al., Doxorubicin Encapsulated In Lipsomes Containing Surface-Bound Polyethylene Glycol: Pharmacokinetics, Tumor Localization, and Safety in Patients with AIDS-Related Kaposi's Sarcoma. J. Clin. Pharmacol. 36: 55, 1996. |
Olver, I.N., et al., A Prospective Study of Topical Dimethyl Sulfoxide for Treating Anthracyline Extravasation. J. Clin. Oncol. 6: 1732, 1988. |
Papahadjopoulos, D., et al., Sterically Stabilized Liposomes: Improvements in Pharmacokinetics and Antitumor Therapeutic Efficacy. Proc. Natl. Acad. Sci. U S A 88: 11460, 1991. |
Simpson, J.K., et al., Liposomal Doxorubicin for Treatment of AIDS-Related Kaposi's Sarcoma. Clin. Oncol. (R. Coll. Radiol.) 5: 372, 1993. |
Uziely, B., et al., Liposomal Doxorubicin: Antitumor Activity and Unique Toxicities During Two Complementary Phase I Studies. J. Clin. Oncol. 13: 1777, 1995. |
Vogelzang, N.J., et al., Cancer Chemoptherapy and Skin Changes. Ann. Intern. Med. 103: 303, 1985. |
VonHoff, D.D., et al., Risk Factors for Doxorubicin-Induced Congestive Heart Failure. Ann. Intern. Med. 91: 710, 1979. |
Wiernik, P.H., et al., Hexamethylmelamine and Low or Moderate Dose Cisplatin With or Without Pyridoxine for Treatment of Advanced Ovarian Carcinoma: A Study of the Eastern Cooperative Oncology Group. Cancer Invest. 10: 1, 1992. |
FDA's List of Orphan Products Designations and Approvals, p. 24 (through Dec. 31, 1998). |
Alberts, D.S., et al., Safety Aspects of Pegylated Liposomal Doxorubicin in Patients with Cancer. Drugs , 54 (suppl. 4): 30-35, 1997. |
Brown, V.K., et al., A Note on the Toxicity and Solvent Properties of Dimethyl Sulphoxide. J. Pharmacy Pharmacol., 15: 688-692, 1963. |
Caujolle F.M.E., et al., Limits of Toxic and Teratogenic Tolerance of Dimethyl Sulfoxide. Ann. N.Y. Acad. Sci., 141: 110-125, 1967. |
David, N.A., The Pharmacology of Dimethyl Sulfoxide 6544. Ann. Rev. Pharmacology, 12: 353-374, 1972. |
Desai, M.H., et al., Prevention of Doxorubicin-Induced Skin Ulcers in the Rat and Pig with Dimethyl Sulfoxide (DMSO). Cancer Treat. Rep., 66: 1371-1374, 1982. |
Gabizon, A., et al., Clinical Studies of Liposome-Encapsulated Doxorubicin. Acta. Oncologica, 33: 779-786, 1994. |
Garnick, M., et al., Persistence of Anthracycline Levels Following Dermal and Subcutaneous Adriamycin Extravasation. Proc. AACR, 22: 173, 1981. |
Gerhards, E., et al., THe Metabolism of Dimethyl Sulfoxide and Its Metabolic Effects in Man and Animals. Ann. N.Y. Acad. Sci., 141: 65-76, 1967. |
Hucker, H.B., et al., Physiological Disposition and Metabolism of Dimethyl Sulfoxide (DMSO). Fed. Proc., 24: 546, 1965. |
Hucker, H.B., et al., Absorption, Distribution and Metabolism of Dimethylsulfoxide in the Rat, Rabbit and Guinea Pig. J. Pharmacol. Exp. Ther., 154: 176-184, 1966. |
Hucker, H.B., et al., Studies in the Absorption, Excretion and Metabolism of Dimethylsulfoxide (DMSO) in Man. J. Pharmacol. Exp. Ther., 155: 309-317, 1967. |
Klingman, A.M., Topical Pharmacology and Toxicology of Dimethyl Sulfoxide--Part I. J. Amer. Med. Assoc., 193: 140-148, 1965. |
Kolb, K.H., et al., Absorption, Distribution, and Elimination of Labeled Dimethyl Sulfoxide in Man and Animals. Ann. N.Y. Acad. Sci., 141: 85-95, 1967. |
Larson, D.L., What is the Appropriate Management of Tissue Extravasation by Antitumor Agent? Plast. Reconstruct. Surg., 75: 397-405, 1985. |
Lebredo, L., et al., DMSO Protects Against Adriamycin-Induced Tissue Necrosis. J. Surg. Res., 53: 62-65, 1992. |
MacGregor, W.S., The Chemical and Physical Properties of DMSO. Ann. N.Y. Acad. Sci., 141: 3-12, 1967. |
National Technical Information Service (NTIS): Dimethyl Sulfoxide as a Therapeutic Agent FDA contract FDA 70-22, 1972. |
Nobbs, P., et al., Soft-Tissue Injury Caused by Antineoplastic Drugs is Inhibited by Topical Dimethyl Sulphoxide and Alpha Tocopherol. Br. J. Cancer, 48: 873-876, 1983. |
Northfelt, D.W., et al., Randomized Comparative Trial of Doxil.RTM. vs. Adriamycin, Bleomycin, and Vincristine (ABV) in the Treatment of Severe AIDS-Related Kaposi's Sarcoma (AIDS-KS). 3rd Conference on Retroviruses and Opportunistic Infections, abst 379, 1996. |
Okano, T., et al., Doxorubicin-Induced Skin Ulcer in the Piglet. Cancer Treat. Rep., 67: 1075-1078, 1983. |
Porche, D.J., Liposomal Doxorubicin (Doxil.RTM.). JANAC, 7: 55-59, 1996. |
Shirley, H.H., et al., Lack of Ocular Changes with Dimethyl Sulfoxide Therapy of Scleroderma. Pharmacotherapy, 9: 165-168, 1988. |
Smith, E.R., et al., The Single--and Repeated--Dose Toxicity of Dimethyl Sulfoxide. Ann. N.Y. Acad. Sci., 141: 96-109, 1967. |
Soble, M.J., et al., Dose-Dependent Skin Ulcers in Mice Treated with DNA Binding Antitumor Antibiotics. Cancer Chemother. Pharmacol., 20: 33-36, 1987. |
Svingen, B.A., et al., Protection Against Adriamycin-Induced Skin Necrosis in the Rat by Dimethyl Sulfoxide and .alpha.-Tocopherol. Cancer Res., 41: 3395-3399, 1981. |
VanSloten Harwood, K., et al., Evaluation of Dimethethyl Sulfoxide and Local Cooling as Antidotes for Doxorubicin Extravasation in a Pig Model. Oncol. Nurs. Forum., 14: 39-44, 1987. |
Willson, J.E., et al., A Toxicologic Study of Dimethyl Sulfoxide. Toxicol. Appl. Pharmacol., 7: 104-112, 1965. |
Working, P.K., et al., Pharmacological-Toxicological Expert Report: Caelyx.TM. (Stealth.RTM. Liposomal Doxorubicin HCI). Hum. Exp. Toxicol., 15: 752-785, 1996. |
Physicians Desk Reference, Doxil.RTM.(Doxorubicin HCI Liposome Injection, Sequus Pharmaceuticals). 2984-2988, 1999. |