Intravesical mycobacterial cell wall-DNA complex in the treatment of carcinoma in situ of the bladder after standard intravesical therapy has failed.

Abstract

PURPOSE:

We assessed the clinical efficacy and safety of mycobacterial cell wall-DNA complex after intravesical administration in patients with carcinoma in situ in whom prior therapy with bacillus Calmette-Guerin failed or in those who were treatment naïve.

MATERIALS AND METHODS:

Patients received 6 weekly instillations of 4 or 8 mg mycobacterial cell wall-DNA complex (formulated as an emulsion) followed by 3 weekly instillations at weeks 12 and 24. Efficacy and safety were evaluated throughout the treatment phase and at months 12 and 18.

RESULTS:

A total of 55 patients (mean age 74 years, 74.6% male) received 4 mg (25) or 8 mg (30) mycobacterial cell wall-DNA complex emulsion. All patients were previously treated with bacillus Calmette-Guerin except for 8 who were treatment naïve and 2 who received chemotherapy. In the intent to treat population the complete response rate was 27.3% at weeks 12 and 26 in the 4 mg group while 46.4% of patients receiving 8 mg had a complete response at both points. Mycobacterial cell wall-DNA complex was well tolerated by both dose groups. Overall 90% of all adverse events were mild to moderate in severity.

CONCLUSIONS:

Mycobacterial cell wall-DNA complex has shown antineoplastic activity in patients with bladder cancer with less toxicity than that associated with bacillus Calmette-Guerin administration. The tolerance and efficacy of mycobacterial cell wall-DNA complex might hold promise for the treatment of carcinoma in situ of the bladder.

• Authors: Alvaro Morales, Kiran Phadke, Gary Steinhoff
• Journal: The Journal of urology (J Urol) Vol. 181 Issue 3 Pg. 1040-5 (Mar 2009) ISSN: 1527-3792 [Electronic] United States
• PMID: 19150551 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• DNA, Bacterial

Topics

• Administration, Intravesical
• Aged
• Aged, 80 and over
• Carcinoma in Situ (therapy)
• Cell Wall
• DNA, Bacterial (administration & dosage)
• Female
• Humans
• Male
• Middle Aged
• Mycobacterium (genetics)
• Treatment Failure
• Urinary Bladder Neoplasms (therapy)