Efficacy, safety, and dose comparison of degarelix for the treatment of prostate cancer: A systematic review and meta-analysis

Table 1 Baseline characteristics of included studies

Ref.	Study arms (dose, Initial dose (mg)/monthly maintenance dosage (mg)	Regimen	Sample	Age (yr)	BMI (kg/m2)	T stage		Tumour stage				Gleason score			ECOG ( ≤ 2)	Duration (mo)
						T1/2	T3/4	Localized	Locally advanced	Metastatic	Not classifiable	2-6	7	8-10
Axcrona et al[14]	Degarelix (240/80)	Monthly	82	71.9 ± 7.7	26.8 ± 4.1	35	47	24	30	22	6	17	24	41	82	3
	Goserelin (3.6)	Goserelin 12 wk + 50 mg/d bicalutamide during the initial 28 d	97	73.0 ± 7.1	26.5 ± 3.7	42	55	32	23	31	11	16	31	50	96
Anderson et al[15]	Degarelix (240/80)	240 mg for 1 mo, 80 mg/mo	27	68 (53-87)	NR	5	21	NR				2	25		27	3
	Goserelin (3.6)	3.6 mg/mo goserelin + 50 mg/d bicalutamide	13	72 (57-85)	NR	2	11					0	13		13
Mason et al[16]	Degarelix (240/80)	240 mg day 0 + 80 mg day 28 and 56	180	70.6 ± 6.37	27.8 ± 3.99	116	64	111	63	NR	6	41	97	42	180	3
	Goserelin (3.6)	Goserelin 3.6 mg day 3, 31 and 59	64	70.8 ± 5.96	26.8 ± 3.69	42	21	41	20	NR	3	12	42	10	64
Klotz L et al[11]	Degarelix (240/80, 240/160)	240 mg for 1 mo + 80/160 mg monthly	207	72 (51-89)	26.7 ± 4.2	69	64	69	64	37	37	88	63	56	195	12
	Leuprolide (7.5)	Leuprolide 7.5 mg/mo	201	74 (50-88)	26.9 ± 3.9	63	52	63	52	47	39	87	62	51	190
Ozono et al[10]	Degarelix (240/80)	240 mg/dose + 80 mg/mo	136	74.7 ± 6.76	NR	61	42	61	42	33	0	19	117		NR	12
	Degarelix (240/160)	240 mg/dose + 160 mg/mo	137	74.2 ± 7.19	NR	64	41	64	41	31	1	23	114		NR
Van Poppel et al[12]	Degarelix (240/80)	240 mg/dose + 80 mg/mo	30	70 (57-88)	26 (18-41)	5	12	5	12	5	8	19	11		NR	12
	Degarelix (240/160)	240 mg/dose + 160 mg/mo	30	73 (52-82)	25 (20-30)	5	10	5	10	7	8	15	15		NR

BMI: Body mass index; ECOG: European Cooperative Oncology Group; NR: Not reported.

Table 2 Methodological quality of included studies

Ref.	Adequate sequence generation	Adequate allocation concealment	Blinding	Incomplete outcome data addressed	Free of selective reporting
Axcrona et al[14]	Unclear	Unclear	High risk	Low risk	Low risk
Anderson et al[15]	Unclear	Unclear	High risk	Low risk	Low risk
Mason et al[16]	Unclear	Unclear	High risk	Low risk	Low risk
Klotz et al[11]	Validated computer program	Low risk	High risk	Low risk	Low risk
Ozono et al[10]	Central allocation	Low risk	High risk	Low risk	Low risk
Van Poppel et al[12]	Unclear	Unclear	High risk	Low risk	Low risk

Table 3 Pooled adverse events for degarelix (240/80 mg) relative to goserelin (3.6 mg), leuprolide (7.5 mg), and degarelix (240/160 mg)

AEs	Degarelix (240/80 mg) vs goserelin (3.6 mg)				Degarelix (240/80 mg) vs leuprolide (7.5 mg)				Degarelix (240/80 mg) vs degarelix (240/160 mg)
	Stusies (n)	Heterogeneity	OR (95%CI)	P-value	Studies (n)	Heterogeneity	OR (95%CI)	P-value	Studies (n)	Heterogeneity	OR (95%CI)	P-value
Treatment-emergent AEs	3	I² = 0%, P = 0.64	0.62 (0.40, 0.95)	0.03	1	Not applicable	1.07 (0.67, 1.71)	0.78	3	I² = 0%, P = 0.97	0.80 (0.53, 1.2)	0.29
Injection site reactions	3	I² = 0%, P = 0.79	33.08 (15.01, 72.93)	< 0.00001	1	Not applicable	108.96 (14.96, 793.44)	< 0.00001	3	I² = 44%, P = 0.17	0.81 (0.60, 1.09)	0.16
Hot flush	3	I² = 0%, P = 0.59	0.80 (0.50, 1.28)	0.35	1	Not applicable	1.26 (0.80, 2.00)	0.32	3	I² = 11%, P = 0.32	1.23 (0.89, 1.70)	0.22
Weight increase	-	-	-	-	1	Not applicable	0.70 (0.37, 1.34)	0.28	3	I² = 17%, P = 0.30	1.13 (0.72, 1.76)	0.6
Hypertension	-	-	-	-	1	Not applicable	1.48 (0.59, 3.71)	0.4	2	I² = 0%, P = 0.88	0.79 (0.44, 1.42)	0.44
Constipation	-	-	-	-	1	Not applicable	0.57 (0.20, 1.60)	0.29	2	I² = 0%, P = 0.45	0.40 (0.19, 0.84)	0.02
UTI	1	Not applicable	0.08 (0.00-1.88)	0.12	1	Not applicable	0.52 (0.23, 1.15)	0.1	2	I² = 0%, P = 0.45	3.05 (0.97, 9.61)	0.06
Incidence of PSA recurrence	-	-	-	-	1	Not applicable	0.56 (0.29, 1.09)	0.09	-	-	-	-
Incidence of death	-	-	-	-	1	Not applicable	0.53 (0.17, 1.60)	0.26	-	-	-	-

AEs: Adverse events; PSA: Prostate-specific antigen; OR: Odds ratios.