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 3

Characteristics of the included studies on predictive and prognostic value of tumour-infiltrating immune cell PD-L1 status in UC patients treated with anti-PD-1/PD-L1 therapy.

Study	Balar et al. (2017) [13]	Powles et al. (2014) [24]	Rosenberg et al. (2016) [28]	Petrylak et al. (2018) [27]
Trial name	IMvigor210	PCD4989g	NCT02108652	NCT01375842
Study design	MRCT	MRCT	MRCT	MRCT
Trial phase	Phase 2	Phase 1	Phase 2	Phase 1
Study interval	2014-2015	2011-2013	May 2014-Nov 2014	Mar 2013-Aug 2015
UC patients	Locally advanced and metastatic UC	Metastatic UC	Locally advanced and metastatic UC	Metastatic UC
Age (years)	73 (51-92)	65 (36-86)	66 (32-91)	66 (36-89)
Male/female	96/23	46/19	241/69	72/23
Immunotherapy	Atezolizumab	Atezolizumab	Atezolizumab	Atezolizumab
Target	Anti-PD-L1	Anti-PD-L1	Anti-PD-L1	Anti-PD-L1
Treatment	1200 mg, iv every 3 weeks	15 mg/kg, iv every 3 weeks	1200 mg, iv every 3 weeks	15 mg/kg, iv every 3 weeks
PD-L1 expression	TIICs	Tumour cells/TIICs	TIICs	TIICs
Detection method	IHC	IHC	IHC	IHC
Cut-off value	1%, 5%	1%, 5%	1%, 5%	5%
PD-L1+ (5%/1%)	67.2%/26.9%	81.5%/46.2%	66.8%/32.3%	52.6%
vs.
No. of PD-L1+/-	32/87	30/35	100/210	50/44
ORR (PD-L1+/-)	28.1%/20.7%	43.3%/11.4%	26.0%/9.0%	40.0%/11.0%
CR (PD-L1+/-)	12.5%/8.0%	na	11.0%/1.9%	16.0%/2.0%
PR (PD-L1+/-)	15.6%/12.6%	na	15.0%/7.1%	24.0%/9.0%
SD (PD-L1+/-)	na	26.7%/37.1%	16.0%/20.5%	18.0%/21.0%
PD (PD-L1+/-)	na	26.7%/37.1%	44.0%/54.8%	34.0%/55.0%
vs.
No. of PD-L1+/-	80/39	53/12	207/103	na
ORR (PD-L1+/-)	23.8%/20.5%	30.2%/8.3%	17.9%/7.8%	na
CR (PD-L1+/-)	10.0%/7.7%	na	6.3%/1.9%	na
PR (PD-L1+/-)	13.8%/12.8%	na	11.6%/5.8%	na
SD (PD-L1+/-)	na	30.2%/41.7%	1.9%/24.3%	na
PD (PD-L1+/-)	na	30.2%/41.7%	51.7%/50.5%	na
PFS(PD-L1+/-) (mon.)	/	na	/	5.5(2.7-10.8)/1.4(1.3-2.7)
OS rate (PD-L1+/-)	52%/59%	na	48%/30%	42%/10%
Follow-up (mons.)	17.2 (0.2-23.5)	4.2 (1.1-8.5)	11.7 (11.4-12.2)	37.8 (0.7-44.4)

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.