Phase II marker lesion study with intravesical instillation of apaziquone for superficial bladder cancer: toxicity and marker response.
OBJECTIVE
We studied the ablative activity of intravesical apaziquone (EOquin) on a papillary marker tumor and determined the incidence of side effects.


METHODS
A total of 46 patients with multiple pTa or pT1 bladder tumors underwent visible lesion resection except for 1 marker tumor. Patients were then treated with 6 instillations of apaziquone at weekly intervals. The response was determined 2 to 4 weeks after the last instillation.


RESULTS
One patient withdrew informed consent and refused the last treatment due to side effects. A histologically proven complete response was seen in 30 patients. Progression to invasive stage was not observed. Local side effects in this study were comparable to those due to other chemotherapy instillations, such as mitomycin C and epirubicin, but less severe and less frequent compared to those of bacillus Calmette-Guerin instillations.


CONCLUSIONS
The histological complete response rate after 6 consecutive instillations of apaziquone in patients with superficial bladder cancer was 67% (95% CI 51 to 80). Local side effects were comparable to side effects due to other chemotherapy instillations.
van der Heijden
Antoine G
AG
University Medical Centre Nijmegen, Nijmegen, The Netherlands.
Moonen
Paula M J
PM
Cornel
Erik B
EB
Vergunst
Henk
H
de Reijke
Theo M
TM
van Boven
Erika
E
Barten
Evert J
EJ
Puri
Rajiv
R
van Kalken
Coenraad K
CK
Witjes
J Alfred
JA
D000283:Administration, Intravesical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001388:Aziridines / Q000008:administration & dosage* / Q000009:adverse effects; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy* / Q000473:pathology*; D015331:Cohort Studies; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D045563:Indolequinones / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000473:pathology*
D000970:Antineoplastic Agents; D001388:Aziridines; D045563:Indolequinones; C060817:apaziquone