Il ruolo della chemioimmunoterapia endovescicale nella neoplasia della vescica non muscolo invasiva “ non responder”

[Autom. eng. transl.] Objectives: Patients suffering from high-grade non-muscle-invasive bladder neoplasia not responsive to two consecutive intravesical BCG cycles are eligible, according to guidelines, for radical cystectomy surgery. Second-line therapy schemes to be proposed as valid alternatives to the "early cystectomy" require validations about the real effectiveness. Chemo-immunotherapy is placed in this scenario to represent a therapeutic alternative in patients also candidates for radical cystectomy. The objective of our study is to evaluate, in a preliminary manner, the efficacy of a topical treatment combining Mitomycin C and BCG in patients with non-responsive non-invasive muscle bladder neoplasia. In particular, our endpoints were response to therapeutic treatment, disease-free interval, rate of relapse and progression and the presence of any adverse effects during treatment. Materials: Since 2007, 37 patients suffering from high-grade non-muscle-invasive bladder cancer have been enrolled at our urological clinic, not responsive to at least two consecutive topical immunotherapy cycles. The patients included in the study were subjected to an intravesical treatment of chemo-immunotherapy with a treatment scheme consisting of four weekly instillations of Mitomycin C (40 mg), followed by four weekly BCG instillations (27 mg). Methods: We evaluated the rate of treatment response (45 days after the last instillation) by cystoscopy, urinary cytology performed on spontaneous urination and after bladder washing, and biopsy of any possible suspected lesion. In case of negative cystoscopy and cytological examination, the patients underwent two monthly instillation cycles with BCG lasting six months each. At the end of both cycles both cystoscopy and cytological examination of urine on spontaneous urination and bladder washing were repeated. We also assessed the rate of disease progression and recurrence. The average follow-up of the enrolled patients was 12.3 months (2-38). Results: The response rate, understood as the negativity of cystoscopic control and cytological examination performed 45 days after the end of the weekly cycle, is status was 62.1% (23/37 of patients). The response rate at six months (after the first monthly maintenance cycle with BCG) was 44.1% and at twelve months (after the second monthly cycle with BCG) of 37.5%. Overall, 43.24% of the patients examined (16/37 of the patients) were found to be disease-free with an average follow-up of 11.3 months. The rate of disease progression was 13.51% (5/37 of patients), or 23.8% of total recurrences (5/21 of patients). These patients underwent radical cystectomy with evidence of metastatic disease in three cases (8.1%). Regarding the side effects, none of the 37 patients treated had any significant side effects reported to have to stop and / or postpone the treatment. Only in 7 patients (18.1%) were local effects such as stranguria and dysuria of moderate entity easily treated with symptomatic therapy reported. non-invasive muscle. The discrete response rate and the low presence of adverse patients allow us to highlight this role as stated by other studies in the literature. Conclusions: One of the current challenges of urology is to find therapeutic alternatives to "early cystectomy". From this preliminary study it can be deduced as the treatment with chemo-immunoterapi