Table 2.

Baseline demographics and disease characteristics in patients with mCRPC with and without elevated eosinophil counts after sipuleucel-T in phase III trials (pooled data)

Elevated eosinophil count
ParameterYes (n = 105)No (n = 272)P valuea
Median age (range), years70 (49–91)72 (49–89)0.360
Median weight (range), lbs191 (131–384)194 (131–350)0.164
Race, n (%)
 Caucasian92 (87.6)242 (89.0)0.609
 Black or African American6 (5.7)19 (7.0)
 Asian1 (1.0)1 (0.4)
 Hispanic4 (3.8)8 (2.9)
 Other2 (1.9)2 (0.7)
ECOG PS = 0, n (%)89 (84.8)220 (80.9)0.456
Gleason sum, n (%)
 ≤615 (14.3)39 (14.3)1.000
 763 (60.0)165 (60.7)
 ≥826 (24.8)68 (25.0)
 Unknown1 (1.0)0 (0)
Localization of disease, n (%)
 Bone only53 (50.5)139 (51.1)0.773
 Soft tissue only10 (9.5)20 (7.4)
 Both bone and soft tissue42 (40.0)113 (41.5)
Bisphosphonate use, n (%)40 (38.1)119 (43.8)0.353
Number of bone metastases, n (%)
 0–550 (47.6)110 (40.4)0.271
 6–1011 (10.5)44 (16.2)
 >1043 (41.0)117 (43.0)
 Unknown1 (1.0)1 (0.4)
Time from diagnosis to randomization, median (range), years7.1 (0.8–22.7)6.8 (0.8–24.5)0.496
Prior hormone therapy, n (%)105 (100.0)272 (100.0)1.000
Orchiectomy19 (18.1)25 (9.2)0.020
Prior chemotherapy, n (%)
 Any11 (10.5)51 (18.8)0.062
 Docetaxel6 (5.7)41 (15.1)0.014
Radical prostatectomy38 (36.2)94 (34.6)0.810
Previous radiotherapy56 (53.3)142 (52.2)0.908
Median serum laboratory value
 PSA (range), ng/mL43.0 (5.2–649.9)56.1 (5.3–8005.6)0.123
 LDH (range), U/L189.0 (84.0–428.0)194.0 (101.0–1730.0)0.240
 Hemoglobin (range), g/dL13.0 (11.1–17.9)12.8 (8.4–16.2)0.002
 Alkphos (range), U/L93.0 (42.0–694.0)101.5 (18.0–3900.0)0.222
Median Halabi score (range), months21.6 (9.6–32.0)20.1 (4.8–32.0)0.010

Abbreviations: Alkphos, alkaline phosphatase; ECOG PS, Eastern Cooperative Oncology Group performance status; LDH, lactate dehydrogenase.

  • aThe Fisher exact test was used to evaluate categorical data, and the Wilcoxon test was used for continuous data.