Rodolfo Hurle1, Roberto Contieri1, Paolo Casale1, Emanuela Morenghi2, Alberto Saita1, Nicolòmaria Buffi3, Giovanni Lughezzani4, Piergiuseppe Colombo5, Nicola Frego1, Vittorio Fasulo1, Marco Paciotti1, Giorgio Guazzoni4, Massimo Lazzeri6. 1. Department of Urology, Humanitas Clinical and Research Center - IRCCS, Milan, Italy. 2. Department of Medical Statistic, Humanitas Clinical and Research Center - IRCCS, Milan, Italy. 3. Department of Urology, Humanitas Clinical and Research Center - IRCCS, Milan, Italy; Department of Medical Statistic, Humanitas Clinical and Research Center - IRCCS, Milan, Italy; Department of Urology, Department of Biomedical Sciences, Pieve Emanuele - Milano, Italy. 4. Department of Urology, Humanitas Clinical and Research Center - IRCCS, Milan, Italy; Department of Urology, Department of Biomedical Sciences, Pieve Emanuele - Milano, Italy. 5. Department of Pathology, Humanitas Clinical and Research Center - IRCCS, (Milan), Italy. 6. Department of Urology, Humanitas Clinical and Research Center - IRCCS, Milan, Italy. Electronic address: massimo.lazzeri@humanitas.it.
Abstract
BACKGROUND: There is a high demand for bladder sparing therapies in patients who do not respond to bacillus Calmette-Guérin (BCG). OBJECTIVE: To report the mid-term results of intravesical gemcitabine in non-muscle-invasive bladder cancer (NMIBC) patients, who failed BCG and who were unwilling to undergo radical cystectomy (RC). MATERIAL & METHODS: This is an extended confirmatory open-label, single-arm study, which enrolled consecutive patients who failed BCG or were BCG intolerant and unwilling to undergo the RC (histologically confirmed Tis (CIS), T1 high grade or multifocal Ta high grade of the urinary bladder). Intravesical gemcitabine was administered once a week for 6 consecutive weeks and once a month for 12 months. The primary outcome was disease-free survival (DFS) defined as the lack of tumor on cystoscopy and negative urine cytology. The secondary endpoint was safety, defined according a grading of side effects. overall survival, progression-free survival and DFS were described with Kaplan-Meier method at 12, 24, and 36 months. RESULTS AND LIMITATIONS: Overall 46 patients were enrolled. The mean follow-up was 40 months. The DFS was 69.05% at the end of induction phase and 32.69% at 36 months. The progression-free survival at 36 months was 65.38%. The overall survival and cancer specific survival were 66.97% (95% confidence interval 47.25%-80.70%) and 78.71% (95% confidence interval 59.16%-89.66%), respectively. There was no life-threatening event or treatment related death (grade 4 or 5). The most common mild and moderate adverse events reported were urinary symptoms (lower urinary tract symptoms) and fatigue (G1-G2). CONCLUSION: Intravesical gemcitabine seemed to represent a valid and safe alternative at 3 years follow-up for patients who failed BCG and were unwilling to undergo RC.
BACKGROUND: There is a high demand for bladder sparing therapies in patients who do not respond to bacillus Calmette-Guérin (BCG). OBJECTIVE: To report the mid-term results of intravesical gemcitabine in non-muscle-invasive bladder cancer (NMIBC) patients, who failed BCG and who were unwilling to undergo radical cystectomy (RC). MATERIAL & METHODS: This is an extended confirmatory open-label, single-arm study, which enrolled consecutive patients who failed BCG or were BCG intolerant and unwilling to undergo the RC (histologically confirmed Tis (CIS), T1 high grade or multifocal Ta high grade of the urinary bladder). Intravesical gemcitabine was administered once a week for 6 consecutive weeks and once a month for 12 months. The primary outcome was disease-free survival (DFS) defined as the lack of tumor on cystoscopy and negative urine cytology. The secondary endpoint was safety, defined according a grading of side effects. overall survival, progression-free survival and DFS were described with Kaplan-Meier method at 12, 24, and 36 months. RESULTS AND LIMITATIONS: Overall 46 patients were enrolled. The mean follow-up was 40 months. The DFS was 69.05% at the end of induction phase and 32.69% at 36 months. The progression-free survival at 36 months was 65.38%. The overall survival and cancer specific survival were 66.97% (95% confidence interval 47.25%-80.70%) and 78.71% (95% confidence interval 59.16%-89.66%), respectively. There was no life-threatening event or treatment related death (grade 4 or 5). The most common mild and moderate adverse events reported were urinary symptoms (lower urinary tract symptoms) and fatigue (G1-G2). CONCLUSION: Intravesical gemcitabine seemed to represent a valid and safe alternative at 3 years follow-up for patients who failed BCG and were unwilling to undergo RC.
Authors: Hye Won Lee; Mi Ju Kang; Young-Ju Kwon; Sama Abdi Nansa; Eui Hyun Jung; Sung Han Kim; Sang-Jin Lee; Kyung-Chae Jeong; Youngwook Kim; Heesun Cheong; Ho Kyung Seo Journal: Biomedicines Date: 2022-05-18
Authors: Edward I Broughton; Kyna M Gooden; Katie L Mycock; Ivana Rajkovic; Gavin Taylor-Stokes Journal: BMC Urol Date: 2022-02-26 Impact factor: 2.264