TY - JOUR
T1 - Pilot study of the tolerability and toxicity of intravesical valrubicin immediately after transurethral resection of superficial bladder cancer
AU - Patterson, A. Lynn
AU - Greenberg, Richard E.
AU - Weems, Lamar
AU - Bahnson, Robert R.
AU - Wajsman, Zev
AU - Israel, Mervyn
AU - Sweatman, Trevor
AU - Webber, Denise
AU - Gulfo, Joseph
PY - 2000/8
Y1 - 2000/8
N2 - Objectives. To assess in a pilot study the safety, tolerability, and technical feasibility of administering intravesical valrubicin immediately after transurethral resection of bladder tumors (TURBT) in patients with superficial bladder cancer and to evaluate the optimal dose of valrubicin and its systemic absorption.Methods. Twenty-two patients with recurrent or newly diagnosed Stage Ta or T1 transitional cell tumors received a single dose of 400 mg, 600 mg, or 800 mg of intravesical valrubicin immediately after TURBT. Four patients thought to be at high risk of recurrence were followed up with five additional doses of 800 mg valrubicin, given weekly.Results. The use of valrubicin after TURBT was generally well tolerated. Little evidence was found to suggest a direct relationship among the dose of valrubicin, the time between the end of TURBT and drug instillation, and the occurrence of most bladder symptoms. The most commonly reported adverse events included dysuria (77%), hematuria (59%), and urgency/frequency (23%). Pharmacokinetic analyses revealed that the mean systemic exposure to valrubicin and its metabolites depended on the extent of the TURBT and the damage to the bladder wall.Conclusions. The results of this study indicated that administration of valrubicin immediately after TURBT is feasible. Copyright (C) 2000 Elsevier Science Inc.
AB - Objectives. To assess in a pilot study the safety, tolerability, and technical feasibility of administering intravesical valrubicin immediately after transurethral resection of bladder tumors (TURBT) in patients with superficial bladder cancer and to evaluate the optimal dose of valrubicin and its systemic absorption.Methods. Twenty-two patients with recurrent or newly diagnosed Stage Ta or T1 transitional cell tumors received a single dose of 400 mg, 600 mg, or 800 mg of intravesical valrubicin immediately after TURBT. Four patients thought to be at high risk of recurrence were followed up with five additional doses of 800 mg valrubicin, given weekly.Results. The use of valrubicin after TURBT was generally well tolerated. Little evidence was found to suggest a direct relationship among the dose of valrubicin, the time between the end of TURBT and drug instillation, and the occurrence of most bladder symptoms. The most commonly reported adverse events included dysuria (77%), hematuria (59%), and urgency/frequency (23%). Pharmacokinetic analyses revealed that the mean systemic exposure to valrubicin and its metabolites depended on the extent of the TURBT and the damage to the bladder wall.Conclusions. The results of this study indicated that administration of valrubicin immediately after TURBT is feasible. Copyright (C) 2000 Elsevier Science Inc.
KW - Administration, Intravesical
KW - Aged
KW - Carcinoma in Situ/drug therapy
KW - Combined Modality Therapy
KW - Doxorubicin/administration & dosage
KW - Drug Administration Schedule
KW - Humans
KW - Male
KW - Pilot Projects
KW - Postoperative Complications/diagnosis
KW - Salvage Therapy
KW - Treatment Outcome
KW - Urinary Bladder Neoplasms/drug therapy
KW - Urinary Bladder/surgery
KW - Urination Disorders/diagnosis
UR - http://www.scopus.com/inward/record.url?scp=0033943168&partnerID=8YFLogxK
U2 - 10.1016/S0090-4295(00)00654-3
DO - 10.1016/S0090-4295(00)00654-3
M3 - Article
C2 - 10925084
SN - 0090-4295
VL - 56
SP - 232
EP - 235
JO - Urology
JF - Urology
IS - 2
ER -