Treatment outcomes of BCG vaccine in patients with T1G3 urothelial cancer - a retrospective analysis
Abstract
The aim of the study was to determine the natural history, recurrence and progression risk after intravesical adjuvant bacillus Calmette-Guérin (BCG) immunotherapy in patients with T1G3 urothelial bladder tumors. Methods: Ninety-two patients diagnosed with a T1G3/ high grade tumor between 1990 and 2008 were evaluated.
All patients received a full induction course (i.e. 6 instillations) of BCG. A subgroup received maintenance BCG treatment following the full initial induction course.
The outcomes for each group were compared. Results: The median follow-up time was 4.8 (0.3-18.7) years.
Recurrence was confirmed in 29 patients, and the recurrence free survival rate at 1, 3 and 5 years was 82, 72 and 66% respectively. There was a significantly higher risk of 3.3% recurrence in patients treated with the induction course of BCG only compared to those receiving maintenance BCG treatment.
In the BCG induction plus maintenance group recurrence was detected in 16 patients. The progression free survival at 1, 3 and 5 year follow-ups was 95, 85 and 80%.
There was no significant correlation between the risk of progression and concomitant tumor in situ (TIS). On the other hand, BCG maintenance treatment significantly increased the progression-free survival (p = 0.007).
Patients without maintenance had 3-times higher risk of progression and 8-times higher risk of subsequent cys-tectomy BCG maintenance treatment was the most significant and favorable independent factor for cystectomy-free survival rate, both disease specific and overall survival. Conclusion: High-grade Tl (formerly T1G3) bladder cancer has a high propensity for recurrence and progression.
Treatment with maintenance BCG was shown to be a significant, favorable, independent factor of recurrence-free, progression-free, cystectomy-free, disease-free and overall survival rate.