Abstract
We conducted this meta-analysis and systematic literature review to study the ability of PD-L1 to predict objective response in patients with urothelial cancer treated with PD-1/PD-L1 inhibitors. Relevant studies of PD-1 or PD-L1 inhibitors in urothelial cancer that reported objective response rate (orr) based on PD-L1 expression status in PubMed, embase, and the Cochrane Library were retrieved. Efficacy of PD-L1 expression status in predicting orr and the efficacy, safety of PD-1 and PD-L1 drugs were analyzed. Studies were divided into ≥1%, ≥5%, and ≥25% based on PD-L1 positivity threshold, and the patients were grouped into PD-L1 positive and negative. In all 3 expression thresholds, patients with positive PD-L1 expression were more likely to experience an objective response [≥1% threshold odds ratio (or): 1.74; 95% confidence interval (ci): 1.20 to 2.53; ≥5% threshold or: 2.74; 95% ci: 2.01 to 3.724; ≥25% threshold or: 7.13; 95% ci: 2.38 to 21.40] in comparison with patients with negative PD-L1 expression. Of the 3 thresholds, the ≥25% threshold was better in predicting orr (1.74 vs. 2.93 vs. 7.13; p < 0.0001). The ≥1% PD-L1 threshold had a relatively high sensitivity in predicting orr; the ≥5% PD-L1 threshold was better for specificity. Sensitivity was higher at the ≥25% threshold than at the other two thresholds, but specificity was lower. Further, we found that there is no statistically significant difference in efficacy between PD-1 and PD-L1 drugs. Urothelial cancer patients with PD-L1 positive expression responded better than PD-L1 negative patients did, and a threshold of ≥5% or greater for PD-L1 expression might predict positive clinical response.
Highlights
IntroductionUrothelial carcinomas are paradoxical in their predilection for the developed world, where their incidence is higher than in the rest of the world[1]
Among all malignancies, urothelial carcinomas are paradoxical in their predilection for the developed world, where their incidence is higher than in the rest of the world[1]
There are 5 immunotherapy-based drugs belonging to the PD-1/PD-L1 class approved by the U.S Food and Drug Administration for urothelial cancer
Summary
Urothelial carcinomas are paradoxical in their predilection for the developed world, where their incidence is higher than in the rest of the world[1]. The therapeutic armamentarium against urothelial cancer is further reduced in cisplatin-ineligible patients, for whom the therapeutic options are limited[2]. The approvals were based on phase i/ii trials for cisplatin-ineligible patients and as second-line therapy[3,4,5,6,7]. These drugs are monoclonal antibodies targeting PD-1/PDL1, which play a role in conferring antitumour immunity. Cells in the tumour microenvironment—tumour cells and e656 We conducted this meta-analysis and systematic literature review to study the ability of PD-L1 to predict objective response in patients with urothelial cancer treated with PD-1/PD-L1 inhibitors
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