Marker tumour responses to the sequential combination of intravesical therapy with mitomycin-C and BCG-RIVM in multiple superficial bladder tumours. Report from the European Organisation for Research and Treatment on Cancer-Genitourinary Group (EORTC 30897).
OBJECTIVE
To study the ablative activity of intravesical mitomycin C followed by intravesical bacillus Calmette-Guérin (BCG) on a papillary marker tumour and to determine the incidence of side effects.


METHODS
Thirty-five patients with multiple pTa or pT1 bladder tumours were treated with 4 instillations of mitomycin C at weekly intervals followed by 6 instillations at weekly intervals of BCG-RIVM. All visible tumours were resected before starting intravesical instillations except one marker tumour. Response was determined 2 weeks after the last instillation.


RESULTS
The incidence of adverse effects was similar to previously reported toxicity of either mitomycin C or BCG alone. Complete response, histologically proven, was observed in 16 of 35 patients and in 3 patients without histological confirmation. One patient showed progression.


CONCLUSIONS
The sequential combination of mitomycin C and BCG is an efficacious treatment. The measurement of response to a marker tumour is a safe and efficient method to test new drugs or combinations of drugs.
Van der Meijden
A P
AP
Department of Urology Bosch Medicentrum, 's-Hertogenbosch, The Netherlands.
Hall
R R
RR
Macaluso
M P
MP
Pawinsky
A
A
Sylvester
R
R
Van Glabbeke
M
M
D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D000283:Administration, Intravesical; D000368:Aged; D000369:Aged, 80 and over; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage / Q000627:therapeutic use*; D001500:BCG Vaccine / Q000276:immunology / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000378:metabolism; D002295:Carcinoma, Transitional Cell / Q000473:pathology / Q000628:therapy*; D003114:Colony-Forming Units Assay; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D007167:Immunotherapy; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage / Q000627:therapeutic use*; D009364:Neoplasm Recurrence, Local / Q000473:pathology / Q000628:therapy; D009378:Neoplasms, Multiple Primary / Q000473:pathology / Q000628:therapy*; D001749:Urinary Bladder Neoplasms / Q000473:pathology / Q000628:therapy*
D000276:Adjuvants, Immunologic; D000903:Antibiotics, Antineoplastic; D001500:BCG Vaccine; D014408:Biomarkers, Tumor; D016685:Mitomycin