Table 2 Summary of statistical analyses of OS in the subset of PSA-matched African American and Caucasian patients with mCRPC who were treated with sipuleucel-T in PROCEED.

Comparison	Median OS, months for sipuleucel-T-treated, PSA-matched patients HR (95% CI)^a		Difference in OS, months	HR (95% CI)^b,c	P value^c
Comparison	African American	Caucasian	Difference in OS, months	HR (95% CI)^b,c	P value^c
All patients	35.3 (28.7–42.7) n = 219^d	25.8 (22.6–29.0) n = 438	9.5	0.70 (0.57–0.86)	<0.001
By median baseline PSA
≤29.48 ng/mL	54.3 (43.0–NE) n = 107	33.4 (29.8–36.6) n = 222	20.9	0.52 (0.37–0.72)	<0.001
>29.48 ng/mL	22.7 (19.2–27.6) n = 112	17.6 (14.3–22.1) n = 216	5.1	0.86 (0.66–1.11)	0.249
By baseline PSA quartile^d
≤8 ng/mL	54.3 (43.0–NE) n = 53	37.4 (31.6–47.7) n = 112	16.9	0.49 (0.29–0.81)	0.005
>8 to ≤29.48 ng/mL	48.8 (31.2–NE) n = 54	30.9 (25.0–33.4) n = 110	17.9	0.54 (0.35–0.85)	0.008
>29.48 to ≤82.4 ng/mL	27.2 (22.4–33.0) n = 56	22.1 (17.5–25.4) n = 108	5.1	0.80 (0.55–1.16)	0.236
>82.4 ng/mL	16.4 (10.7–25.1) n = 56	13.0 (10.7–18.3) n = 108	3.4	0.92 (0.64–1.32)	0.638

Almost all patients who died or left the study did so before the estimated median time in months of 54.3 months. In the group with baseline PSA ≤8 ng/mL, 18 of the 19 patients (who experienced a death) died as of the estimated median survival time of 54.3 months. In the group with baseline PSA > 8 to ≤ 29.48 ng/mL, 24 of the 25 died as of the estimated median survival time of 48.8 months.
CI confidence interval, HR hazard ratio, NE not evaluable, OS overall survival, PSA prostate-specific antigen.
^aKaplan–Meier method.
^bHR < 1 indicates a better outcome in African American patients treated with sipuleucel-T versus sipuleucel-T-treated PSA-matched Caucasians.
^cA Cox regression model with Caucasians as the reference arm.
^dPROCEED enrolled 221 African Americans: two were excluded as one patient had no baseline PSA and the other had a baseline PSA of 1462 ng/mL with no matching Caucasian patients.

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