Review Article
Predictive and Prognostic Role of PD-L1 in Urothelial Carcinoma Patients with Anti-PD-1/PD-L1 Therapy: A Systematic Review and Meta-Analysis
Table 4
Characteristics of the included studies on predictive and prognostic value of tumour PD-L1 status in UC patients treated with anti-PD-1/PD-L1 therapy.
| | Study | Plimack et al. (2017) [23] | Powles et al. (2014) [24] | Sharma et al. (2016) [25] | Sharma et al. (2017) [26] | Patel et al. (2018) [22] |
| | Trial name | KEYNOTE-012 | PCD4989g | CheckMate 032 | CheckMate 275 | NCT01772004 | | Study design | MRCT | MRCT | MRCT | Nonrandomised | MRCT | | Trial phase | Phase 1b | Phase 1 | Phase 1/2 | Phase 2 | Phase 1 | | Study interval | May 2013-Dec 2013 | 2011-2013 | 2014-2015 | Mar 2015-Oct 2015 | Sept 2014-Mar 2016 | | UC patients | Locally advanced or metastatic UC | Metastatic UC | Recurrent metastatic UC | Metastatic UC | Locally advanced or metastatic UC | | Age (years) | 70 (44-85) | 65 (36-86) | 65.5 (31-85) | 66 (38-90) | 68 (63-76) | | Male/female | 23/10 | 46/19 | 54/24 | 211/59 | 178/71 | | Immunotherapy | Pembrolizumab | Atezolizumab | Nivolumab | Nivolumab | Avelumab | | Target | Anti-PD-1 | Anti-PD-L1 | Anti-PD-1 | Anti-PD-1 | Anti-PD-L1 | | Treatment | 10 mg/kg, iv every 2 weeks | 15 mg/kg, iv every 3 weeks | 3 mg/kg, iv every 2 weeks | 3 mg/kg, iv every 2 weeks | 10 mg/kg, iv every 2 weeks | | PD-L1 expression | Tumour cells | Tumour cells/TIICs | Tumour cells | Tumour cells | Tumour cells | | Detection method | IHC | IHC | IHC | IHC | IHC | | Cut-off value | 1% | 1%, 5% | 1%, 5% | 1% | 5% | | PD-L1+ (5%/1%) | 84.0% | 43.1%/10.8% | 46.0%/30.6% | 37.3% | 33.0% | | vs. | | | | | | No. of PD-L1+/- | | 7/58 | 81/184 | na | 63/76 | | ORR (PD-L1+/-) | na | 28.6%/25.9% | 28.4%/15.8% | na | 24%/13% | | CR (PD-L1+/-) | na | na | 4.9%/1.1% | na | 10%/3% | | PR (PD-L1+/-) | na | na | 23.5%/14.7% | na | 14%/11% | | SD (PD-L1+/-) | na | 14.3%/34.5% | 28.4%/20.1% | na | 29%/20% | | PD (PD-L1+/-) | na | 57.1%/29.3% | 25.9%/45.1% | na | 29%/50% | | vs. | | | | | | No. of PD-L1+/- | 21/4 | 28/37 | 122/143 | 25/42 | na | | ORR (PD-L1+/-) | 23.8%/0% | 28.6%/24.3% | 23.8%/16.1% | 24.0%/26.2% | na | | CR (PD-L1+/-) | na | na | 1.6%/0.7% | 16.0%/2.4% | na | | PR (PD-L1+/-) | na | na | 19.7%/15.4% | 8.0%/23.8% | na | | SD (PD-L1+/-) | na | 28.6%/35.1% | 28.7%/17.5% | 32.0%/26.2% | na | | PD (PD-L1+/-) | na | 35.7%/29.7% | 30.3%/46.9% | 32.0%/42.9% | na | | PFS(PD-L1+/-) (mon.) | na | na | na | na | 11.9(6.1-18)/6.1(5.9-8) | | OS rate (PD-L1+/-) | na | na | na | na | 59%/51% | | Follow-up (mons.) | 13 (5-23) | 4.2 (1.1-8.5) | 15.2 (12.9-16.8) | 7.0 (3.0-8.8) | 9.9 (4.3-12.1) |
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TCs: tumour cells; TIICs: tumour-inflating immune cells; UC: urothelial carcinoma; PD-L1: programmed death-ligand 1; +/-: positive/negative; MRCT: multicenter randomized controlled trial; IHC: immunohistochemistry; ORR: objective response rate; CR: completed response; PR: partial response; SD: stable disease; PD: progressive disease; PFS: progression-free survival; OS: overall survival; na: data not available.
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