Patient-reported outcomes for patients with metastatic castration-resistant prostate cancer receiving docetaxel and Atrasentan versus docetaxel and placebo in a randomized phase III clinical trial (SWOG S0421)

Table 1 Baseline Patient Characteristics and Baseline Health Related Quality-of-Life^a

		Docetaxel + Placebo (n = 489)			Docetaxel + Astrasentan (n = 489)
Patient Characteristic	Categories	N (%)			N (%)
Age: median (range)		69.6 (43.2–89.1)			69.4 (40.8–92.0)
Hispanic ethnicity	Yes	20 (4.1%)			20 (4.1%)
Race	White	397 (83.6%)			399 (83.3%)
	Black	64 (13.5%)			72 (15.0%)
	Asian	12 (2.5%)			6 (1.3%)
	Pacific Islander	2 (0.4%)			3 (0.6%)
	Native	1 (0.2%)			1 (0.2%)
	Unknown	14			10
Performance status 2 or 3	Yes	39 (8.0%)			35 (7.2%)
Baseline progression type	Measurable or evaluable	390 (79.8%)			402 (82.2%)
Extraskeletal metastases	Yes	272 (55.6%)			281 (57.5%)
Prior Prostatectomy	Yes	142 (29.0%)			165 (33.7%)
Gleason score	5–6	48 (10.3%)			52 (11.1%)
	7	133 (28.7%)			138 (29.5%)
	8–10	272 (58.6%)			271 (57.9%)
	Missing	25			21
Pain Medication (worst)	0 – None	14 (4.4%)			18 (5.6%)
	1 – Non-narcotic	116 (36.7%)			118 (36.5%)
	2 – Weak opioid	97 (30.7%)			90 (27.9%)
	3 – Strong opioid	89 (28.2%)			97 (30.0%)
	Missing	173			166
Health Related QOL	Categories	N	Mean	SD	N	Mean	SD
Brief Pain Inventory	Worst pain	488	3.4	2.8	489	3.5	3.0
	Worst pain, baseline + 4 week average	434	2.8	2.3	440	2.7	2.4
	Pain interference	486	2.4	2.5	487	2.5	2.6
	Pain interference, baseline + 4 week average	428	2.1	2.2	437	1.9	2.0
SF-36^b	Energy/vitality	487	48.2	23.3	487	48.3	24.1
SF-36^b	Energy/vitality, baseline + 4 week average	435	49.5	20.7	437	51.7	21.0
FACT-P^c	Trial outcome index	487	67.5	17.4	484	67.5	17.9
	FACT-G total score	487	77.2	15.7	486	77.7	16.5
	FACT-P total score	487	106.5	22.0	483	107.0	23.0
EORTC QLQ-C30^d	Global quality of life score	483	63.7	22.7	480	63.6	22.6

^aPercentages shown among those with known date only
^bMedical Outcomes Study 36 Item Short Form Health Survey
^cFunction Assessment of Cancer Therapy – Prostate Cancer
^dEuropean Organisation for Research and Treatment of Cancer – Quality of Life Questionnaire