Efficacy and Safety of Androgen-Deprivation Therapy Combined with Docetaxel Plus Prednisone in High-Burden Metastatic Hormone-Sensitive Prostate Cancer

Figures & data

Table 1 Baseline Characteristics of the Patients

Characteristics	ADT + DocP (n=85)	ADT (n=66)	P
Age–yr median (IQR)	63.0 (41, 81)	68.5 (45, 83)	0.004
ECOG no. (%)			0.005
0–1	73 (85.9)	44 (66.7)
2–3	12 (14.1)	22 (33.3)
Gleason Score no. (%)			0.015
≤7	15 (17.6)	15 (22.7)
8–10	68 (80.0)	42 (63.6)
Unknown	2 (2.4)	9 (13.6)
Lymph node metastasis no. (%)	62 (72.9)	54 (81.8)	0.09
Bone metastasis no. (%)	68 (80.0)	55 (83.3)	0.80
Visceral metastases no. (%)	22 (26)	12 (18)	0.26

Note: Data are median (IQR) or n (%), unless otherwise stated.

Abbreviations: DocP, docetaxel plus prednisone; IQR, interquartile range; ECOG, Eastern Cooperative Oncology Group.

Table 2 Hazard Ratios for Death in Subgroups

Group	No. of Patients	Hazard Ratio (95% CI)	P*	P for Interaction^#
Overall	151	0.41 (0.21 to 0.80)	0.009	–
Age (yr)				0.01
<70	103	0.44 (0.20 to 0.94)	0.033
≥70	48	0.24 (0.03 to 1.85)	0.172
ECOG Score				0.048
0–1	117	0.31 (0.12 to 0.76)	0.011
2–3	34	1.18 (0.42 to 3.31)	0.756
Gleason Score				0.009
≤7	30	2.63 (0.68 to 10.13)	0.161
8–10	110	0.22 (0.09 to 0.53)	0.001
Visceral Metastasis				0.008
Yes	34	0.39 (0.07 to 2.01)	0.257
No	117	0.40 (0.19 to 0.85)	0.017
Bone Metastasis				0.011
Yes	123	0.25 (0.11 to 0.61)	0.002
No	28	1.85 (0.48 to 7.22)	0.375

Notes: Data are median (IQR) or n (%), unless otherwise stated. *P denotes heterogeneity within each subgroup, ^#P for interaction denotes heterogeneity between subgroups.

Abbreviations: IQR, interquartile range; ECOG, Eastern Cooperative Oncology Group.

Figure 1 Kaplan–Meier estimates of OS. Shown are data for OS. The dashed lines indicate the median. The median rate of OS was not reached in the ADT + docetaxel group and was 31.6 months in the ADT group; CI, confidence interval; NR, not reached. No. at Risk denotes the number at risk is the number of individuals at risk, defined as all those under study who died or were censored at a time later than the current time.

Figure 2 Kaplan–Meier estimates of PSA PFS. Data are shown for PSA PFS. The dashed lines indicate the median. The median rate of PSA PFS was 17.9 months in the ADT + docetaxel group and was 9.2 months in the ADT group; CI, confidence interval. No. at Risk denotes the number at risk is the number of individuals at risk, defined as all those under study who died or were censored at a time later than the current time.

Figure 3 Kaplan–Meier estimates of radiographic PFS. Data are shown for radiographic PFS. The dashed lines indicate the median. The median rate of radiographic PFS was 43 months in the ADT + docetaxel group and was 19.8 months in the ADT group; CI, confidence interval. No. at Risk denotes the number at risk is the number of individuals at risk, defined as all those under study who died or were censored at a time later than the current time.

Table 3 Characteristics of Clinical Trials Related to Docetaxel

Clinical Trials	Period	Number of Patients	Age, Yr, Median (IQR)	Control	Treatment	Median Follow-Up (months)	Median Overall Survival (months)	Median Time to Progression (months)
CHAARTED	7, 2006–11,2012	790	64 (36–91)	ADT (LHRH agonist or LHRH antagonist) or surgical castration	ADT + Doc (75 mg/m2 every 3 weeks for 6 cycles)	28.9	(ADT 57.6; ADT + Doc 44; P<0.001)	(ADT 11.7; ADT + Doc 20.2; P<0.001)
STAMPEDE^a	9, 2005–3, 2013	1776	65 (40–82)	ADT (LHRH analogs or LHRH antagonists or bilateral orchiectomy)	ADT + Doc (75 mg/m2 every 3 weeks for 6 cycles+predisone)	43	(ADT 71; ADT + Doc 81; P=0.006)	__
STAMPEDE^b	9, 2005–3, 2013	1186	66 (42–84)	ADT + ZA (4 mg every 3–4 weeks for 2 years)	ADT + ZA (4 mg every 3–4 weeks for 2 years) + Doc(75 mg/m2 every 3 weeks for 6 cycles + predisone)	43	(ADT + ZA) not reached; ADT + Doc 76	__
GETUG-15	10, 2004–12, 2008	385	63.5 (57–70)	ADT (LHRH agonist or surgical castration or combined androgen blockade)	ADT+Doc (75 mg/m2 every 3 weeks for up to 9 cycles)	83.9	(ADT 62.1; ADT + Doc 48.6; P=0.3)	(ADT 12.9; ADT + Doc 22.9; P<0.001)

Notes: ^aADT with or without docetaxel, ^bADT plus zoledronic acid with or without docetaxel.

Abbreviations: IQR, interquartile range; ADT, androgen deprivation therapy; Doc, docetaxel; ZA, zoledronic acid; LHRH, luteinizing hormone releasing hormone.