Abstract 1933
Background
Very few therapeutic options are available in patients with advanced or metastatic urothelial carcinoma progressed or unfit to platinum based therapy. After decades of failures, a new classes of agents: the immune-checkpoint inhibitors seem to be a new promising hope for these patients. However, to date of the two randomized studies comparing these compounds to standard chemotherapy only one trial showed a clear survival advantage in this setting.
Methods
We performed a systematic review and meta-analysis to assess the efficacy, in terms of overall survival, of single agent immune-checkpoint inhibitors vs. single agent chemotherapy as second-line treatment. Moreover, we evaluated the assessed ORR of single-agent immune-checkpoint inhibitors in patients with advanced urothelial cancer exploring the predictive value of patients’ selection according to PD-L1 expression. To do this, we reviewed clinical trials published on Pubmed/Medline, Cochrane library and clinical abstracts presented on main International meeting between 2014 and 2018.
Results
Systematic review included randomized (n = 2) and non-randomized (n = 9) clinical trials. We restricted meta-analysis to trials exploring immune-checkpoint inhibitors in previously platinum treated patients.In randomized trials, immune checkpoint inhibitors were associated with a significant improvement of overall survival compared to chemotherapy in unselected patients, with pooled Hazard Ratio 0.80 (95% confidence interval 0.69 – 0.93, p = 0.003), while the difference was not statistically significant in the subgroup of patients selected for the highest PD-L1 expression (Hazard Ratio 0.72, 95% confidence interval 0.48 – 1.09, p = 0.12). Polled probability of objective response was 0.18 (95% confidence interval 0.16 – 0.20) in unselected patients and 0.27% (95% confidence interval 0.25 – 0.32) in patients selected for the highest expression of PD-L1.
Conclusions
Immunotherapy showed a significant survival advantage in patients not selected for PD-L1 expression while both OS and ORR analysis suggested that the predictive value of PD-L1 expression is far from being optimal.
Clinical trial identification
Legal entity responsible for the study
Francesco Massari.
Funding
Has not received any funding.
Editorial Acknowledgement
Disclosure
All authors have declared no conflicts of interest.
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