Efficacy and safety of CAR-T cell therapy in penile and urethral carcinomas: A meta-analysis of preliminary clinical trials and case studies.

655 Background: Penile and urethral carcinomas are rare and aggressive cancers with limited treatment options, often leading to poor prognoses. Chimeric Antigen Receptor T-cell (CAR-T) therapy has shown promise in various malignancies, but its efficacy and safety in penile and urethral carcinomas remain under-explored. This meta-analysis aims to evaluate the preliminary clinical trials and case studies on CAR-T cell therapy in treating these rare carcinomas. Methods: The PubMed, Embase, Scopus and Cochrane databases were systematically searched from inception until June 2024 using relevant keywords. We performed proportional meta-analysis of untransformed proportions using Random Effects model in OpenMeta (version 5.3). The I 2 and X 2 statistics were used to evaluate inter-study heterogeneity. An I 2 value of >50% was considered significant heterogeneity. Subgroup analyses were performed to identify factors influencing treatment outcomes. Results: A total of 15 studies, including 10 clinical trials and 5 case reports, comprising 230 patients were included in the meta-analysis. The pooled overall response rate (ORR) was 42% (95% CI: 30%-55%), with a complete response rate (CRR) of 15% (95% CI: 8%-25%). Common adverse effects included cytokine release syndrome (CRS) (35%) and neurotoxicity (20%). Pre-existing comorbidities and prior treatments were significant factors affecting outcomes. No treatment-related mortality (TRM) was reported. Conclusions: CAR-T cell therapy demonstrates encouraging efficacy in penile and urethral carcinomas, with manageable safety profiles. While preliminary results are promising, larger and more comprehensive studies are needed to validate these findings and optimize treatment protocols.