A better strategy is to decrease the dose of BCG when toxicity occurs so that patients can stay on treatment. Figure 1 Recurrence-free survival is better in patients receiving an intensive maintenance schedule than in those who received an induction course alone or less intensive maintenance. BCG, bacillus Calmette-Guérin; SWOG, Southwest Oncology Group. This … Table 3 Characteristics of Therapy With BCG Several meta-analyses have explored the efficacy of intravesical BCG

and mitomycin Inhibitors,research,lifescience,medical C. The reliability of such analyses is limited because the included studies had different eligibility criteria, follow-up, and maintenance strategies. The addition of a maintenance strategy significantly improves outcome with BCG.3 A critical issue is defining treatment failure. The SWOG trial of BCG maintenance versus no maintenance included 116 patients with carcinoma in situ (CIS) randomized to induction only and 117 randomized to maintenance.2 Not unexpectedly, after 6 weeks of BCG, the 2 groups had essentially identical complete response Inhibitors,research,lifescience,medical (CR)

rates. At the 6-month evaluation, investigators found an additional 11% of patients in the induction-only arm disease free, increasing the overall response rate from 57% to 68%. The maintenance group received another 3 weeks of BCG, and their response rate increased from 55% to 84% at 6 months, a rate that was significantly better than that seen in the induction Inhibitors,research,lifescience,medical only arm (P = .004). These data suggest that with CIS, BCG can result in a delayed response, but maintenance therapy substantially increases the rate of CR at 6 months. BCG and Interferon Prior to the advent of intravesical BCG, CIS progressed at a rate of about 7% per year.4 Maintenance BCG therapy can decrease the risk of progression.3 Intravesical chemotherapy for CIS Inhibitors,research,lifescience,medical provides CR rates up to 52%, but has lower response rates than BCG and has not been demonstrated to reduce progression risk. Interest in interferon as an intravesical agent against bladder cancer developed

in the 1980s. Results of early prospective series Inhibitors,research,lifescience,medical with interferon were disappointing, but patients tolerated regimens well, and interferon appeared to have some activity against CIS. Over the subsequent decade, sufficient experience with both agents had accumulated to suggest using them together as salvage therapy in patients with recurrence following most intravesical BCG. In 2001, a preliminary trial of this selleck chemical approach reported that 63% of patients were disease free at 12 months and 53% were disease free at 24 months.5 A large multicenter phase II trial to assess the combination of BCG and interferon enrolled about 1000 patients, 231 with CIS (Figure 2).6 Focusing on the CIS subgroup, approximately 95% of patients enrolled were older than 50 and 84% were male. Sixty-three percent had CIS alone; the remainder had CIS with papillary disease. Slightly less than half of the patients enrolled had never been treated with BCG.