Pembrolizumab with or without enzalutamide in selected populations of men with previously untreated metastatic castration-resistant prostate cancer harbouring programmed cell death ligand-1 staining: a retrospective study

Table 1 Characteristics of patients who underwent treatment

Variable	PE (n = 100)	PA (n = 106)	p-value
Age, years	64 (43–85)	65 (45–82)	0.227^a
Time since diagnosis, month(s)	7 (2–15)	7 (1–17)	0.361^a
PSA level^c, ng/mL	121 (2–2165)	126 (4–2110)	0.183^a
Alkaline phosphatase level^c, U/L	181 (72–1023)	173 (66–983)	0.219^a
Albumin g/dl	3.6 (2.2–3.9)	3.7 (2.1–4.2)	0.127^a
Clinical stage at diagnosis, n (%)			0.794^b
T1c	9 (9.0)	7 (6.6)
T2b	12 (12.0)	14 (13.2)
T2c	14 (14.0)	20 (18.8)
T3	20 (20.0)	21 (19.8)
M0	22 (22.0)	20 (18.8)
M1	23 (23.0)	24 (22.6)
Pathological stage at diagnosis, n (%)			0.297^b
T2	22 (22.0)	20 (18.9)
T3	28 (28.0)	26 (24.5)
N0	30 (30.0)	33 (31.1)
N1	20 (20.0)	27 (25.5)
Gleason sum at diagnosis, n (%)			0.941^b
≤ 6	23 (23.0)	24 (22.6)
7	35 (35.0)	37 (34.9)
≥ 8	42 (42.0)	45 (42.4)
PD-L1 expression (CPS cut-off values), n (%)			0.872^b
1–20	64 (64.0)	67 (63.2)
20–50	22 (22.0)	23 (21.7)
50–100	14 (14.0)	16 (15.1)
mCRPC-related brain metastasis, n (%)			0.134^b
Asymptomatic CNS metastasis	35 (35.0)	48 (45.3)
Without CNS metastasis	65 (65.0)	58 (54.7)
Duration of drug treatment (months)	16 (1–34)	17 (2–33)	0.103^a
ECOG status, n (%)			0.608^b
0^d	38 (38.0)	44 (41.5)
1^e	62 (62.0)	62 (58.5)
No. of metastatic sites, n (%)			0.597^b
3	23 (23.0)	31 (29.2)
> 3	62 (62.0)	57 (53.8)
Unclear	15 (15.0)	18 (17.0)

^aIndependent samples t-test; ^b Mann-Whitney U test; ^c Calculated one week prior to the start of PE or PA; 0^d, Fully active, able to carry on all pre-disease performance without restriction; 1^e, Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, i.e., light housework, office work
PE pembrolizumab plus enzalutamide, PA pembrolizumab alone, PSA prostate-specific antigen, CNS central nervous system, PD-L1 programmed cell death ligand-1, CPS combined positive score, mCRPC metastatic castration-resistant prostate cancer, ECOG Eastern Collaborative Oncology Group

ISSN: 1471-2407