Bacille-Calmette-Guerin Non-Responders: How to Manage
Bacille-Calmette-Guerin Non-Responders: How to Manage
Several Phase I and Phase II studies indicate both the safety and potential efficacy of intravesical Gemcitabine. Dalbagni et al. found that the majority of high-risk patients who initially responded at 3 months had recurred by 12 months with a 1-year RFS of 21%. This suggests a potential role for maintenance gemcitabine therapy. The cost of this regimen is very high at about $1,000 per dose though gemcitabine is now off patent and the cost is likely to decrease. A prospective randomized phase II trial compared gemcitabine versus BCG in 80 patients with persistent disease after one BCG induction course. 2-year RFS were 19% and 3% respectively. The SWOG S0353 phase II trial investigated the role of gemcitabine in patients with NMIBC (intermediate and high-risk) after two prior courses of BCG. The treatment schedule included a 6 weeks induction treatment and monthly maintenance treatments up to 12 months. Forty-seven percent of patients responded at 3 months and 28% were free of recurrence at 1 year and 21% after 2 years. The response rates are similar to Valrubicin suggesting that this is an additional treatment option for patients unfit for major surgery.
Gemcitabine
Several Phase I and Phase II studies indicate both the safety and potential efficacy of intravesical Gemcitabine. Dalbagni et al. found that the majority of high-risk patients who initially responded at 3 months had recurred by 12 months with a 1-year RFS of 21%. This suggests a potential role for maintenance gemcitabine therapy. The cost of this regimen is very high at about $1,000 per dose though gemcitabine is now off patent and the cost is likely to decrease. A prospective randomized phase II trial compared gemcitabine versus BCG in 80 patients with persistent disease after one BCG induction course. 2-year RFS were 19% and 3% respectively. The SWOG S0353 phase II trial investigated the role of gemcitabine in patients with NMIBC (intermediate and high-risk) after two prior courses of BCG. The treatment schedule included a 6 weeks induction treatment and monthly maintenance treatments up to 12 months. Forty-seven percent of patients responded at 3 months and 28% were free of recurrence at 1 year and 21% after 2 years. The response rates are similar to Valrubicin suggesting that this is an additional treatment option for patients unfit for major surgery.
