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Initial report on intravesical administration of N-trifluoroacetyladriamycin-14-valerate (AD 32) to patients with refractory superficial transitional cell carcinoma of the urinary bladder. 1997

R E Greenberg, and R R Bahnson, and D Wood, and S J Childs, and C Bellingham, and M Edson, and M H Bamberger, and G D Steinberg, and M Israel, and T Sweatman, and B Giantonio, and P J O'Dwyer
Department of Surgery, Fox Chase Cancer Center, Philadelphia, Pennsylvania 19111, USA.

OBJECTIVE This study was designed to assess the pharmacokinetics, safety, and antitumor activity of intravesically administered AD 32, a novel anthracycline, in patients with transitional cell carcinoma (TCC) of the bladder. METHODS Six weekly doses of AD 32 (200 to 900 mg) were administered to 32 patients with superficial TCC who were candidates for intravesical treatment. Serum drug levels were measured during the 6-hour period after administration of the first, third, and sixth doses. Patients underwent bladder evaluations at 3-month intervals to determine responses to treatment. RESULTS Very low levels of unmetabolized AD 32 and its two primary metabolites were measured in serum. The lack of systemic exposure was confirmed by the finding of only a few minor systemic adverse events. Local bladder irritation, the main toxicity associated with intravesical administration of AD 32, persisted for several days after each instillation. The maximum tolerated dose was 800 mg. Thirteen patients had complete responses to treatment, including 8 who remained disease free for 12.1 to 38.5 months. CONCLUSIONS AD 32 is an active drug for the treatment of superficial bladder cancer. Further studies of intravesical administration of AD 32 are warranted.

UI MeSH Term Description Entries
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D001749 Urinary Bladder Neoplasms Tumors or cancer of the URINARY BLADDER. Bladder Cancer,Bladder Neoplasms,Cancer of Bladder,Bladder Tumors,Cancer of the Bladder,Malignant Tumor of Urinary Bladder,Neoplasms, Bladder,Urinary Bladder Cancer,Bladder Cancers,Bladder Neoplasm,Bladder Tumor,Cancer, Bladder,Cancer, Urinary Bladder,Neoplasm, Bladder,Neoplasm, Urinary Bladder,Tumor, Bladder,Tumors, Bladder,Urinary Bladder Neoplasm
D002295 Carcinoma, Transitional Cell A malignant neoplasm derived from TRANSITIONAL EPITHELIAL CELLS, occurring chiefly in the URINARY BLADDER; URETERS; or RENAL PELVIS. Carcinomas, Transitional Cell,Cell Carcinoma, Transitional,Cell Carcinomas, Transitional,Transitional Cell Carcinoma,Transitional Cell Carcinomas
D004317 Doxorubicin Antineoplastic antibiotic obtained from Streptomyces peucetius. It is a hydroxy derivative of DAUNORUBICIN. Adriamycin,Adriablastin,Adriablastine,Adriblastin,Adriblastina,Adriblastine,Adrimedac,DOXO-cell,Doxolem,Doxorubicin Hexal,Doxorubicin Hydrochloride,Doxorubicin NC,Doxorubicina Ferrer Farm,Doxorubicina Funk,Doxorubicina Tedec,Doxorubicine Baxter,Doxotec,Farmiblastina,Myocet,Onkodox,Ribodoxo,Rubex,Urokit Doxo-cell,DOXO cell,Hydrochloride, Doxorubicin,Urokit Doxo cell
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000283 Administration, Intravesical The instillation or other administration of drugs into the bladder, usually to treat local disease, including neoplasms. Bladder Drug Administration,Drug Administration, Bladder,Instillation, Bladder,Intravesical Drug Administration,Administration, Intravesical Drug,Injections, Intravesical,Intravesical Administration,Intravesical Injection,Intravesical Instillation,Administration, Bladder Drug,Administrations, Bladder Drug,Administrations, Intravesical,Administrations, Intravesical Drug,Bladder Drug Administrations,Bladder Instillation,Bladder Instillations,Drug Administration, Intravesical,Drug Administrations, Bladder,Drug Administrations, Intravesical,Injection, Intravesical,Instillation, Intravesical,Instillations, Bladder,Instillations, Intravesical,Intravesical Administrations,Intravesical Drug Administrations,Intravesical Injections,Intravesical Instillations
D000368 Aged A person 65 years of age or older. For a person older than 79 years, AGED, 80 AND OVER is available. Elderly
D000369 Aged, 80 and over Persons 80 years of age and older. Oldest Old

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