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).
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.
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).
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.
Journal of geriatric oncology. 2018 Apr 16 [Epub ahead of print]
Marco Racioppi, Luca Di Gianfrancesco, Mauro Ragonese, Giuseppe Palermo, Emilio Sacco, PierFrancesco Bassi
Department of Urology, "Agostino Gemelli" Academic Hospital Foundation, IRCCS, Catholic University School of Medicine, Rome, Italy., Department of Urology, "Agostino Gemelli" Academic Hospital Foundation, IRCCS, Catholic University School of Medicine, Rome, Italy. Electronic address: .