Abstract | PURPOSE: 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.
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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)
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Chemical References |
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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)
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