Marco Racioppi1, Luca Di Gianfrancesco2, Mauro Ragonese1, Giuseppe Palermo1, Emilio Sacco1, PierFrancesco Bassi1. 1. Department of Urology, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore di Roma, Rome, Italy. 2. Department of Urology, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore di Roma, Rome, Italy. Electronic address: luca.digian@libero.it.
Abstract
BACKGROUND: Mitomycin C (MMC) is widely used, but the optimal dose and schedule have not been established. OBJECTIVE: To evaluate the ablative power and patient safety of a short-term intensive schedule of intravesical MMC in patients with recurrent non-muscle-invasive bladder cancer (NMIBC). DESIGN, SETTING, AND PARTICIPANTS: This was a prospective, single-center, nonrandomized study that compared 47 patients (group 1) with a history of low- to intermediate-risk NMIBC with long free-recurrence intervals, recurrence of ≤1cm in maximum diameter, and negative cytology to 47 consecutive patients with the same baseline characteristics (group 2). INTERVENTION: Intravesical MMC three times per week for 2 wk for group 1. Transurethral resection of bladder tumor (TUR-BT) and early instillation and a weekly schedule of intravesical MMC for group 2. All cancer-free patients underwent monthly MMC maintenance. Follow-up included bladder mapping, voiding and washing urinary cytology, TUR of suspected area, TUR of previous tumor location, and ultrasound or computed tomography/magnetic resonance imaging. OUTCOME MEASUREMENT AND STATISTICAL ANALYSIS: We used χ2 and Student's t test for comparison of categorical and continuous variables, respectively. Kaplan-Meier curves were plotted to estimate cancer-free survival. The significance level was set to p<0.05. RESULTS AND LIMITATIONS: The complete response rate at 39 mo was 61.7% in group 1 and 70.2% in group 2 (p=0.38). Kaplan-Mayer analysis revealed no difference in cancer-free survival rates overall (log-rank <3.84), according to tumor size in each group (log-rank <3.84), or between the groups (log-rank <7.82). No cases of systemic toxicity were observed. Local toxicities did not differ between the groups (p=0.32) and resolved on treatment of symptoms, and no patient discontinued their treatment. Limitations include the small number of patients, selection bias because of the single tertiary center, and short follow-up. CONCLUSIONS: The proposed MMC schedule had good ablative power that can be explained by better concordance between the scheduled timing and the tumor cell duplication rate. The short-term intensive schedule could be considered as a therapeutic strategy to replace TUR-BT in selected NMIBC patients. PATIENT SUMMARY: We report our experience of a tailored intravesical therapy schedule for bladder cancer. This schedule could be considered a therapeutic strategy to replace surgery for selected patients.
BACKGROUND:Mitomycin C (MMC) is widely used, but the optimal dose and schedule have not been established. OBJECTIVE: To evaluate the ablative power and patient safety of a short-term intensive schedule of intravesical MMC in patients with recurrent non-muscle-invasive bladder cancer (NMIBC). DESIGN, SETTING, AND PARTICIPANTS: This was a prospective, single-center, nonrandomized study that compared 47 patients (group 1) with a history of low- to intermediate-risk NMIBC with long free-recurrence intervals, recurrence of ≤1cm in maximum diameter, and negative cytology to 47 consecutive patients with the same baseline characteristics (group 2). INTERVENTION: Intravesical MMC three times per week for 2 wk for group 1. Transurethral resection of bladder tumor (TUR-BT) and early instillation and a weekly schedule of intravesical MMC for group 2. All cancer-free patients underwent monthly MMC maintenance. Follow-up included bladder mapping, voiding and washing urinary cytology, TUR of suspected area, TUR of previous tumor location, and ultrasound or computed tomography/magnetic resonance imaging. OUTCOME MEASUREMENT AND STATISTICAL ANALYSIS: We used χ2 and Student's t test for comparison of categorical and continuous variables, respectively. Kaplan-Meier curves were plotted to estimate cancer-free survival. The significance level was set to p<0.05. RESULTS AND LIMITATIONS: The complete response rate at 39 mo was 61.7% in group 1 and 70.2% in group 2 (p=0.38). Kaplan-Mayer analysis revealed no difference in cancer-free survival rates overall (log-rank <3.84), according to tumor size in each group (log-rank <3.84), or between the groups (log-rank <7.82). No cases of systemic toxicity were observed. Local toxicities did not differ between the groups (p=0.32) and resolved on treatment of symptoms, and no patient discontinued their treatment. Limitations include the small number of patients, selection bias because of the single tertiary center, and short follow-up. CONCLUSIONS: The proposed MMC schedule had good ablative power that can be explained by better concordance between the scheduled timing and the tumor cell duplication rate. The short-term intensive schedule could be considered as a therapeutic strategy to replace TUR-BT in selected NMIBC patients. PATIENT SUMMARY: We report our experience of a tailored intravesical therapy schedule for bladder cancer. This schedule could be considered a therapeutic strategy to replace surgery for selected patients.