Routine use of denosumab for prevention of skeletal-related events in patients with bone metastases from prostate carcinoma in Bulgaria: a prospective observational study

Figures & data

Figure 1. Patient disposition.

Table 1. Tumor diagnosis and tumor characteristics at baseline.

Variable	Overall N = 100	CRPC N = 26	HSCP N = 74
Time since initial tumor diagnosis, months	N = 99	N = 26	N = 73
Median (Q1, Q3)	21.6 (8.1, 52.4)	40.3 (19.9, 63.3)	18.0 (5.7, 46.6)
Gleason score^a	N = 96	N = 25	N = 71
Median (Q1, Q3)	8.0 (7.0, 9.0)	9.0 (7.0, 9.0)	8.0 (7.0, 8.0)
Gleason grade group	N = 89	N = 19	N = 70
Median (Q1, Q3)	4.0 (2.0, 5.0)	5.0 (2.0, 5.0)	3.0 (2.0, 4.0)
TNM stage – T category, n(%)
T1	26 (26.0)	6 (23.1)	20 (27.0)
T2	32 (32.0)	8 (30.8)	24 (32.4)
T3	24 (24.0)	7 (26.9)	17 (23.0)
T4	15 (15.0)	5 (19.2)	10 (13.5)
Tx	3 (3.0)	0	3 (4.1)
TNM stage – N category, n(%)
N0	49 (49.0)	13 (50.0)	36 (48.6)
N1	27 (27.0)	7 (26.9)	20 (27.0)
N2	3 (3.0)	1 (3.8)	2 (2.7)
N3	1 (1.0)	0	1 (1.4)
Nx	20 (20.0)	5 (19.2)	15 (20.3)
TNM stage – M category, n(%)
M1	100 (100)	26 (100)	74 (100)
Risk assessment, n(%)
Very low	3 (3.0)	0	3 (4.1)
Low	4 (4.0)	0	4 (5.4)
Favorable intermediate	7 (7.0)	2 (7.7)	5 (6.8)
Unfavorable intermediate	3 (3.0)	2 (7.7)	1 (1.4)
High	35 (35.0)	16 (61.5)	19 (25.7)
Very high	22 (22.0)	6 (23.1)	16 (21.6)
Unknown	26 (26.0)	0	26 (35.1)

CRPC, castration-resistant prostate cancer; HSPC, hormone sensitive prostate cancer; TNM stage, tumour stage with T = the extent of the main (primary) tumour (T category), N = cancer spread to nearby lymph nodes (N category), M = cancer spread (metastasized) to other parts of the body (M category).

^a The Gleason score is defined as having a value between 1 and 10.

Table 2. Skeletal-related events and symptomatic skeletal-related events over time.

	Baseline	Month								End of observation
		1	2	3	4	5	6	8	9
SRE, events
Pathological fracture	2	0	0	1	0	0	0	0	0	0
Radiation to bone	7	1	1	0	1	1	1	1	1	2
Spinal cord compression	1	0	0	0	0	0	0	0	0	0
Total	10	1	1	1	1	1	1	1	1	2
SRE, patients
Pathological fracture	2	0	0	1	0	0	0	0	0	0
Radiation to bone	5	1	1	0	1	1	1	1	1	1
Spinal cord compression	1	0	0	0	0	0	0	0	0	0
Total	7	1	1	1	1	1	1	1	1	1
Average number of SREs	1.4	1.0	1.0	1.0	1.0	1.0	1.0	1.0	1.0	2.0
SSEs
Total	0	0	0	0	0	0	0	0	0	0

SRE, skeletal-related event; SSE, symptomatic skeletal-related event.

Figure 2. Time from first denosumab dose to non-persistence with denosumab. LFUP, loss to follow-up; LOCP, last observation carried forward. Calculated from the first dose within the 6-month retrospective period. Persistence was assessed for the 60-day gap. LOCF approach: the loss of persistence was at the last dose before the loss to follow-up + the 60-day gap). LFUP censored approach: patients were considered persistent by the date of loss to follow-up and then they were censored.

Table 3. Summary of denosumab-related adverse drug reactions (by MedDRA classification).

System organ class	Preferred term	Related	Serious	N
Gastrointestinal disorders	Loose tooth	Yes	No	1
General disorders and administration site conditions	Oedema	Yes	No	1
Infections and infestations	Osteomyelitis	Yes	Yes	1
Investigations	Radioisotope uptake increased	Yes	No	1
Metabolism and nutrition disorders	Hypocalcaemia	Yes	No	15
Musculoskeletal and connective tissue disorders	Osteitis	Yes	Yes	1
Musculoskeletal and connective tissue disorders	Osteonecrosis	Yes	No	1
Musculoskeletal and connective tissue disorders	Pain in jaw	Yes	No	2
Musculoskeletal and connective tissue disorders	Osteonecrosis of jaw	Yes	No	1

Bold font highlights denosumab-related serious adverse drug reactions.

Data availability statement

Qualified researchers may request data from Amgen clinical studies. Complete data are available at the following: https://wwwext.amgen.com/about/how-we-operate/policies-practices-and-disclosures/ethical-research/clinical-data-transparency-practices/clinical-trial-data-sharing-request.