TY - JOUR
T1 - Initial report on intravesical administration of N- trifluoroacetyladriamycin-14-valerate (AD 32) to patients with refractory superficial transitional cell carcinoma of the urinary bladder
AU - Greenberg, Richard E.
AU - Bahnson, Robert R.
AU - Wood, David
AU - Childs, Stacy J.
AU - Bellingham, Charles
AU - Edson, Mitchell
AU - Bamberger, Mitchell H.
AU - Steinberg, Gary D.
AU - Israel, Mervyn
AU - Sweatman, Trevor
AU - Giantonio, Bruce
AU - O'Dwyer, Peter J.
PY - 1997/5
Y1 - 1997/5
N2 - Objectives. 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.
AB - Objectives. 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.
KW - Administration, Intravesical
KW - Aged
KW - Aged, 80 and over
KW - Anthracyclines/administration & dosage
KW - Carcinoma, Transitional Cell/drug therapy
KW - Doxorubicin/administration & dosage
KW - Female
KW - Humans
KW - Male
KW - Middle Aged
KW - Urinary Bladder Neoplasms/drug therapy
UR - http://www.scopus.com/inward/record.url?scp=0030968305&partnerID=8YFLogxK
UR - https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=purepublist2023&SrcAuth=WosAPI&KeyUT=WOS:A1997WN96000035&DestLinkType=FullRecord&DestApp=WOS
U2 - 10.1016/S0090-4295(96)00621-8
DO - 10.1016/S0090-4295(96)00621-8
M3 - Article
C2 - 9123721
SN - 0090-4295
VL - 49
SP - 471
EP - 475
JO - Urology
JF - Urology
IS - 3
ER -