Pilot study of the tolerability and toxicity of intravesical valrubicin immediately after transurethral resection of superficial bladder cancer.
OBJECTIVE
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.
Patterson
A L
AL
Veterans Affairs Medical Center, Memphis, Tennessee, USA.
Greenberg
R E
RE
Weems
L
L
Bahnson
R
R
Wajsman
Z
Z
Israel
M
M
Sweatman
T
T
Webber
D
D
Gulfo
J
J
D000283:Administration, Intravesical; D000368:Aged; D002278:Carcinoma in Situ / Q000188:drug therapy* / Q000517:prevention & control / Q000601:surgery*; D003131:Combined Modality Therapy; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004334:Drug Administration Schedule; D006801:Humans; D008297:Male; D010865:Pilot Projects; D011183:Postoperative Complications / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology; D016879:Salvage Therapy; D016896:Treatment Outcome; D001743:Urinary Bladder / Q000601:surgery; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000517:prevention & control / Q000601:surgery*; D014555:Urination Disorders / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology
C016163:valrubicin; D004317:Doxorubicin