Table 4.
Patient baseline characteristics according to the number of cabazitaxel treatment cycles received (1–2 vs. 3–10 vs. ≥11 cycles) across the CUP/EAP and CAPRISTANA studies.
| Patient Baseline Characteristics | CUP/EAP/CAPRISTANA N = 1621 |
|||
|---|---|---|---|---|
| Cabazitaxel Cycles Received | ||||
| 1–2 n = 237 |
3–10 n = 1173 |
≥11 n = 211 |
p Value | |
| Median age, years (range) | 70.0 (42–89) | 68.0 (42–89) | 68.0 (49–87) | 0.0114 |
| Age, n (%) <65 years 65–75 years ≥75 years |
64 (27.0) 103 (43.5) 70 (29.5) |
377 (32.1) 562 (47.9) 234 (19.9) |
60 (28.4) 107 (50.7) 44 (20.9) |
0.0177 |
| ECOG PS, n (%) 0–1 2 a |
n = 237 197 (83.1) 40 (16.9) |
n = 1172 1082 (92.3) 90 (7.7) |
n = 211 202 (95.7) 9 (4.3) |
0.0001 |
| Frailty, n (%) ECOG PS <2 and ≤75 years ECOG PS <2 and >75 years ECOG PS ≥2 and ≤75 years ECOG PS ≥2 and >75 years |
n = 237 149 (62.9) 48 (20.3) 26 (11.0) 14 (5.9) |
n = 1172 906 (77.3) 176 (15.0) 70 (6.0) 20 (1.7) |
n = 211 171 (81.0) 31 (14.7) 7 (3.3) 2 (0.9) |
<0.0001 |
| Median time from prostate cancer diagnosis, years (range) | 4.9 (1–22) | 4.4 (0–20) | 5.5 (1–18) | 0.0002 |
| Median time from mCRPC diagnosis, years (range) | 1.8 (0–10) | 1.7 (0–14) | 1.8 (0–10) | 0.2483 |
| Median docetaxel cycles at last administration, n (range) | 8 (1–34) | 8 (1–69) | 10 (2–49) | <0.0001 |
| Median cumulative dose of last docetaxel administration, mg/m2 (range) | 600 (50–2850) |
610.6 (50–8700) |
750 (120–2830) |
<0.0123 |
| Metastatic sites, n (%) Bone Regional lymph nodes Lungs Liver Visceral, other soft tissue |
n = 236 211 (89.0) 75 (31.6) 42 (17.7) 39 (16.5) 9 (3.8) |
n = 1173 1062 (90.5) 361 (30.8) 119 (10.1) 101 (8.6) 54 (4.6) |
n = 210 186 (88.2) 60 (28.4) 18 (8.5) 11 (5.2) 7 (3.3) |
- |
| Number of metastatic sites, n (%) 0 1 ≥2 |
n = 237 1 (0.4) 71 (30.0) 165 (69.6) |
n = 1173 0 415 (35.4) 758 (64.6) |
n = 211 1 (0.5) 84 (39.8) 126 (59.7) |
0.0203 |
| Pain at baseline (CAPRISTANA study only), n (%) None Moderate Severe |
n = 8 3 (37.5) 4 (50.0) 1 (12.5) |
n = 127 24 (18.9) 93 (73.2) 10 (7.9) |
n = 19 6 (31.6) 13 (68.4) 0 |
0.2260 |
a Includes one patient with ECOG PS 3 receiving 1–2 cabazitaxel cycles. CUP: compassionate use program; EAP: expanded access program; ECOG PS: Eastern Cooperative Oncology Group performance status; mCRPC: metastatic castration-resistant prostate cancer.