Real-world effectiveness and safety of goserelin 10.8-mg depot in Chinese patients with localized or locally advanced prostate cancer

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Figure 1
Flow diagram.
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Figure 2
Serum testosterone: (A) mean (SD) serum testosterone level in the FAS; (B) mean (SD) change from baseline in serum testosterone level in the FAS; (C) proportion of patients with chemical castration (serum testosterone < 50 ng/dL) for the FAS; and (D) mean (SD) serum testosterone level in the testosterone subset. The gray dotted line in (A) represents zero, and the gray solid line in (A) represents the serum testosterone level of 50 ng/dL. FAS, full analysis set; SD, standard deviation.
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Figure 3
Serum PSA: (A) mean (SD) change from baseline in serum PSA level for the FAS; (B) mean (SD) serum PSA level for the FAS; (C) mean (SD) serum PSA level in the PSA subset. The gray dotted lines in (A), (B) and (C) represent zero. FAS, full analysis set; PSA, prostate-specific antigen; SD, standard deviation.

Table 1

Baseline demographics and characteristics in the full analysis set, the testosterone subset, and the PSA subset

Characteristics	FAS (n = 294)	Testosterone subset^† (n = 80)	PSA subset^† (n = 107)
Mean age ± SD, years	70.2 ± 7.7	68.9 ± 6.9	68.9 ± 6.6
ECOG score, n (%)
0	152 (51.7)	47 (58.8)	58 (54.2)
1	131 (44.6)	32 (40.0)	46 (43.0)
2–3	11 (3.7)	1 (1.3)	3 (2.8)
Mean serum PSA ± SD, ng/mL	36.7 ± 88.8	–	39.5 ± 116.4
Mean serum testosterone ± SD, ng/dL	574.5 ± 2,053.5	392.2 ± 169.8	–
Disease status, n (%)
Localized	135 (45.9)	35 (43.8)	49 (45.8)
Locally advanced	159 (54.1)	45 (56.3)	58 (54.2)
RP status, n (%)
RP	182 (61.9)	57 (71.3)	80 (74.8)
No RP	112 (38.1)	23 (28.8)	27 (25.2)
T staging, n (%)
T1–2	108 (36.7)	31 (38.8)	39 (36.4)
T3–4	161 (54.8)	45 (56.3)	60 (56.1)
Missing	25 (8.5)	4 (5.0)	8 (7.5)
N staging, n (%)
N0	221 (75.2)	60 (75.0)	79 (73.8)
N1	35 (11.9)	12 (15.0)	15 (14.0)
Nx	18 (6.1)	7 (8.8)	7 (6.5)
Missing	20 (6.8)	1 (1.3)	6 (5.6)
Gleason score, n (%)
6	19 (6.5)	4 (5.0)	6 (5.6)
7	110 (37.4)	30 (37.5)	43 (40.2)
8	77 (26.2)	18 (22.5)	25 (23.4)
≥ 9	76 (25.9)	23 (28.8)	27 (25.2)
Missing	3 (1.0)	1 (1.3)	1 (0.9)

↵^†The testosterone and PSA subsets consisted of all patients who completed the three tests for serum testosterone and PSA, respectively, at baseline, week 12 ± 2, and week 24 ± 2. ECOG, Eastern Cooperative Oncology Group; PSA, prostate-specific antigen; RP, radical prostatectomy; SD, standard deviation.

Table 2

Summary of AEs in the FAS

AE, n (%)	FAS (n = 294)
Any AEs	117 (39.8)
Treatment-emergent AEs (TEAEs)	109 (37.1)
Adverse drug reactions (ADRs)	22 (7.5)
AEs with CTCAE grade ≥ 3	32 (10.9)
TEAEs with CTCAE grade ≥ 3	31 (10.5)
Serious AEs	30 (10.2)
Serious TEAEs	30 (10.2)
Treatment-related serious TEAEs	1 (0.3)
TEAEs leading to death	1 (0.3)
TEAEs leading to treatment discontinuation	1 (0.3)
ADRs leading to treatment discontinuation	0
AEs of interest (cardiovascular, sexual)	0

AE, adverse event; CTCAE, common terminology criteria for adverse events; TEAE, treatment-emergent adverse event.

Table 3

Summary of treatment-emergent adverse events (TEAEs) by preferred terms reported in > 1% of patients in the FAS

TEAE, n (%)	FAS (n = 294)
Urinary tract infection	21 (7.1)
Anemia	19 (6.5)
Pneumonia	8 (2.7)
Hypoproteinemia	8 (2.7)
Diarrhea	6 (2.0)
Hypokalemia	6 (2.0)
Hematuria	6 (2.0)
Hepatic function abnormal	6 (2.0)
Hot flush	6 (2.0)
Constipation	5 (1.7)
Insomnia	5 (1.7)
Upper respiratory tract infection	5 (1.7)
Liver injury	5 (1.7)
Chronic gastritis	4 (1.4)
Hyperlipidemia	4 (1.4)
Blood lactate dehydrogenase increased	4 (1.4)