A clinical study of PMCJ-9 (Bacillus Calmette-Guérin Connaught strain) treatment of superficial bladder cancer and carcinoma in situ of the bladder.
BACKGROUND
Intravesical Bacillus Calmette-Guérin (BCG) is now a standard treatment for Ta, T1 carcinoma and carcinoma in situ (CIS) of the urinary bladder. In Japan, however, only BCG Tokyo 172 strain is commercially available. We therefore designed a clinical study of PMCJ-9 (BCG Connaught strain) for obtaining approval from Japanese Ministry of Health, Labor and Welfare.


METHODS
In the phase I-II study, PMCJ-9 40.5, 81 (standard dose overseas) or 121.5 mg in saline was instilled into the bladder of patients with Ta, T1 or CIS once weekly for 8 weeks. The recommended dose was decided and similarly administered in the late phase II study.


RESULTS
In the phase I-II study, 49 patients were evaluable for efficacy. The complete response (CR) rates were 60.0% (9/15), 68.2% (15/22) and 75.0% (9/12) in the 40.5, 81 and 121.5 mg groups. The incidence of adverse drug reactions (ADRs) was similar in all groups, but four 121.5 mg group patients developed severe ADRs. Thus, 81 mg was the recommended dose for the late phase II study. In that study, 39 patients were evaluable, showing CR rates of 71.8% (28/39) overall and 61.5% (16/26) and 92.3% (12/13) for the Ta, T1 and CIS cases. The safety was assessed in 42 patients and three (7.1%) were discontinued owing to ADRs.


CONCLUSIONS
The recommended dose for the BCG Connaught strain was decided as 81 mg. PMCJ-9 administration at this dose level weekly for 8 weeks showed a clear antitumor effect and good safety profile against Ta, T1 and CIS transitional cell carcinoma of the bladder.
Akaza
Hideyuki
H
Department of Urology, Institute of Clinical Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan. akazah@md.tsukuba.ac.jp
Koiso
Kenkichi
K
Ozono
Seiichiro
S
Kuroda
Masao
M
Kameyama
Shuji
S
Okajima
Eigoro
E
Kotake
Toshihiko
T
Kakizoe
Tadao
T
Kawabe
Kazuki
K
D000283:Administration, Intravesical; D000328:Adult; D000368:Aged; D001500:BCG Vaccine / Q000008:administration & dosage* / Q000009:adverse effects; D002278:Carcinoma in Situ / Q000473:pathology / Q000628:therapy*; D002295:Carcinoma, Transitional Cell / Q000473:pathology / Q000628:therapy*; D005260:Female; D006417:Hematuria / Q000209:etiology; D006801:Humans; D007167:Immunotherapy; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D001749:Urinary Bladder Neoplasms / Q000473:pathology / Q000628:therapy*; D014555:Urination Disorders / Q000209:etiology
C087507:BCG Connaught; D001500:BCG Vaccine