Treatment of carcinoma in situ of the urinary bladder with an alpha-emitter immunoconjugate targeting the epidermal growth factor receptor: a pilot study.

PURPOSE: Patients with carcinoma in situ (CIS) of the bladder refractory to bacillus Calmette-Guérin (BCG) treatment are usually treated with cystectomy. Therefore, new treatment options with preservation of the urinary bladder are needed. The objective of the study was to investigate the feasibility, safety and efficacy of a novel targeted alpha-emitter immunotherapy for CIS after BCG treatment failure. METHODS: A pilot study was conducted in 12 patients (age range 64-86 years, ten men, two women) with biopsy-proven CIS of the bladder refractory to BCG treatment. The patients were treated intravesically with a single instillation (one patient was treated twice) of the alpha-emitter 213Bi coupled to an anti-EGFR antibody (366-821 MBq). The primary aims of the study were to determine the feasibility of treatment with the 213Bi-immunoconjugate and evaluation of adverse effects. Therapeutic efficacy was monitored by histological mapping of the urinary bladder 8 weeks after treatment and at different time points thereafter. RESULTS: The study proved that intravesical instillation of the 213Bi-immunoconjugate targeting EGFR is feasible. No adverse effects were observed and all blood and urine parameters determined remained in their normal ranges. Therapeutic efficacy was considered satisfactory, in that three of the 12 patients showed no signs of CIS 44, 30 and 3 months after treatment. CONCLUSION: Intravesical instillation of 213Bi-anti-EGFR monoclonal antibody was well tolerated and showed therapeutic efficacy. Repeated instillation and/or instillation of higher activities of the 213Bi-immunoconjugate might lead to better therapeutic outcomes. A phase I clinical trial is planned.

[Virtual skills-training in urology : Teaching at the Technical University of Munich during the COVID-19-pandemic]. / Virtueller Praktikumstag Urologie : Studentenunterricht an der Technischen Universität München in Zeiten der COVID-19-Pandemie.

BACKGROUND AND INTRODUCTION: The COVID-19 pandemic presents the challenge for medical education to teach practical skills without practical training. To provide an alternative to hands-on training during the COVID-19 lockdown, we created a virtual curriculum to teach practical skills using videos combined with online exams on a virtual e­learning platform. The goal was to convey different theoretical and practical aspects of urology. MATERIALS AND METHODS: The videos were produced by department employees using a predefined concept. The students had access to the virtual curriculum via the university's Moodle e­learning platform. To assess the success of training, participating students had to pass an online exam about the curriculum's contents, followed by an evaluation of the course. RESULTS: A total of 164 participants took part in the virtual curriculum. The overall evaluation and feedback was very positive. The acceptance of the virtual alternative to hands-on teaching was high. DISCUSSION: The virtual curriculum offered a fast and contactless alternative to the regular hands-on teaching.