To compare the efficacy and toxicity profiles of 3 intravesical regimens, including doxorubicin alone, bacillus Calmette-Guerin (BCG), and a cocktail regimen, in the prevention of bladder cancer recurrence.

Two hundred ninety patients with newly diagnosed non-muscle-invasive bladder cancer treated with transurethral resection (TUR) between March 1996 and December 2004 were analyzed retrospectively. Each cycle of the cocktail regimen contained 30 mg each of sequential weekly intravesical mitomycin-C (MMC), doxorubicin, and cisplatin (MDP). Two cycles of MDP were given within the first 6 weeks of TUR, followed by 1 cycle each at 3, 6, and 12 months, and every 6 months until 36 months after a negative cystoscopy. Doxorubicin and BCG alone was given at similar time points as the MDP and BCG protocols.

There were no demographic differences among the 3 groups. The median follow-up duration was 50 months. Dropout rates due to intolerance and/or poor compliance with the BCG, doxorubicin, and MDP protocols were 22.5%, 16.8%, and 11.0%, respectively. The MDP and BCG groups had similar bladder recurrence rates (37.9% vs. 33.9% at 5 years, respectively; P = 0.69). The doxorubicin group had significantly more recurrences than the BCG or MDP groups (HR = 1.9 (vs. BCG; P = 0.02) and 1.8 (vs. MDP; P = 0.01)). MDP was associated with less major adverse events than BCG (5.8% vs. 15.0%, respectively; P = 0.02).

Compared with maintenance BCG, the MDP group had a similar recurrence rate but less side effects. Large randomized study is warranted to further determine the benefit of MDP adjuvant intravesical therapy.

PMID: 20870427 [PubMed - as supplied by publisher] Source: National Library of Medicine.