Drug May Be an Alternative to Cystectomy for BCG Failures

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VIENNA—Mycobacterial cell wall DNA complex (MCC) may provide an alternative to cystectomy for patients with non-muscle invasive bladder cancer refractory to bacillus Calmette-Guérin (BCG) treatment, according to preliminary study findings.

Alvaro Morales, MD, of Queen's University in Kingston, Ontario, Canada, and colleagues tested MCC in 129 Caucasian patients with non-muscle invasive bladder cancer who failed to respond to one or more courses of BCG. The treatment consisted of six weekly intravesical instillations of 8 mg MCC (induction), followed by three once-weekly instillations at three, six, 12, 18, and 24 months (maintenance). MCC has two modes of action: immune stimulation and direct anticancer activity.

Of the 129 patients, 95 (73.6%) were male. At study entry, 91 (70.5%) had carcinoma in situ and 38 (29.5%) had papillary tumors.

The overall one-year disease-free survival (DFS) rate was 25%, the researchers reported at the 26th Annual Congress of the European Association of Urology. The one-year DFS rate was 21.0% for patients with CIS tumors and 35.1% for those with papillary tumors. The treatment was well tolerated, and most adverse events were mild to moderate in intensity and few led to treatment discontinuation.

Dr. Morales' group explained that patients with tumors refractory to BCG generally have a poor response to second-line therapies. Radical cystectomy, they noted, is the standard of care following BCG failure, but some patients refuse surgery or are not good surgical candidates.

The drug, which has the trademark name Urocidin, is being developed by Endo Pharmaceuticals, of Chadds Ford, Pa., and Bioniche Life Sciences, of Belleville, Ontario.

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