A phase II study of DaunoXome ® in advanced urothelial transitional cell carcinoma

Liposomal encapsulation of anthracyclines is claimed to reduce toxicity and to improve pharmacokinetics. Therefore, 15 patients with locally advanced or metastatic transitional cell cancer (TCC) of the urinary tract were entered into a phase II study assessing the response rate (WHO criteria) and to...

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Bibliographic Details
Published in:European journal of cancer (1990) 1998-06, Vol.34 (7), p.1131-1132
Main Authors: Fosså, S.D., Aass, N., Parö, G.
Format: Article
Language:English
Subjects:
Aged
Antibiotics, Antineoplastic - administration & dosage
Antibiotics, Antineoplastic - adverse effects
Antineoplastic agents
Biological and medical sciences
Carcinoma, Transitional Cell - drug therapy
Carcinoma, Transitional Cell - secondary
Chemotherapy
Chest Pain - chemically induced
Daunorubicin - administration & dosage
Daunorubicin - adverse effects
DaunoXome
Female
Hematologic Diseases - chemically induced
Humans
hypotensive reaction
Liposomes
Male
Medical sciences
Pharmacology. Drug treatments
Treatment Failure
Urologic Neoplasms - drug therapy
urothelial TCC
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Summary:Liposomal encapsulation of anthracyclines is claimed to reduce toxicity and to improve pharmacokinetics. Therefore, 15 patients with locally advanced or metastatic transitional cell cancer (TCC) of the urinary tract were entered into a phase II study assessing the response rate (WHO criteria) and toxicity of DaunoXome ® 100 mg/m 2 given as a 1 h infusion every third week. During treatment, 6 patients remained stable and 8 had progressive disease. 1 patient died of pulmonary embolism after the first cycle and was not evaluable for response. No patient developed grade 4 myelotoxicity. Grade 3 leucopenia was seen in 5 patients and grade 1 thrombocytopenia in 1 patient, with no treatment-related changes of biochemical liver and kidney function tests. 4 patients complained of angina pectoris-like chest pain during the initial phase of the first or second infusion. The event was associated with a decrease in systolic blood pressure by 20–30 mm in 1 patient leading to permanent treatment discontinuation. In the other 3 and all subsequent patients, intramuscular application of 100 mg hydrocortisone 1 h prior to DaunoXome ® infusion prevented similar hypotensive reactions. In this study, intravenous (i.v.) DaunoXome ® 100 mg/m 2 every third week showed no anticancer activity in advanced TCC.
ISSN:0959-8049
1879-0852
DOI:10.1016/S0959-8049(97)10156-3