OBJECTIVES: To evaluate the efficacy and safety of a tailored endovesical 
immunotherapy protocol with biweekly BCG for elderly Patients with high risk non 
muscle invasive bladder cancer (HG-NMIBC).
MATERIALS AND METHODS: We retrospectively evaluated data from 200 patients older 
than 80 years newly diagnosed with HG-NMIBC: 100 (group 1) with multiple 
comorbidities (WHO PS 2-3, ASA score ≥3, Charlson Comorbidity index ≥3, 
GFR<60 mL/min) were treated with BCG induction course administered biweekly; 100 
(group 2) with statistically significant better conditions were treated with 
standard weekly BCG therapy. After the induction treatment disease-free patients 
underwent to at least one year of BCG maintenance therapy. Endpoints were: 
initial response to BCG, cancer-free survival and rate of progression at 
2 years, rate of complications.
RESULTS: No statistically significant differences were found in terms of initial 
response to BCG (69% in Group 1 vs 71% in Group 2, P = 0.75), cancer free 
survival (57% vs 55% respectively, P = 0.77) and rate of progression (20% vs 14% 
respectively, P = 0.26) at 2 years. The difference in the rate of overall 
complications was statistically significant (15% in Group 1 vs 27% in Group 2, 
P = 0.03), in the rate of severe complications was not statistically significant 
(5% in Group 1 vs 7% in Group 2, P = 0.61).
CONCLUSION: A tailored regimen of BCG administration is possible and safe in 
frail elderly patients, limiting side effects and risk of undertreatment but 
maintaining oncological outcomes. Preliminary results in a small patients group 
are promising but larger randomized studies are needed to confirm our data.