Table 1. Baseline patient and disease characteristics.
| Characteristic | Carfilzomib n=157 | Control n=158 | Total N=315 |
|---|---|---|---|
| Median age, years (range) | 63 (32–85) | 66 (43–81) | 65 (32–85) |
| ⩾65 years, n (%) | 75 (48) | 89 (56) | 164 (52) |
| ⩾75 years, n (%) | 25 (16) | 24 (15) | 49 (16) |
| Median time since diagnosis, years (range) | 6 (2–20) | 5 (2–24) | 6 (2–24) |
| Males, n (%) | 82 (52) | 96 (61) | 178 (57) |
| Region (%) | |||
| Europe | 140 (89) | 138 (87) | 278 (88) |
| Race, n (%) | |||
| White | 151 (96) | 148 (94) | 299 (95) |
| Black | 1 (1) | 1 (1) | 2 (1) |
| Other | 5 (3) | 9 (6) | 14 (4) |
| Ethnicity, n (%) | |||
| Not Hispanic or Latino | 131 (83) | 129 (82) | 260 (83) |
| Not reported | 4 (3) | 5 (3) | 9 (3) |
| ISS stage at initial diagnosis, n (%) | |||
| I | 26 (17) | 20 (13) | 46 (15) |
| II | 32 (20) | 41 (26) | 73 (23) |
| III | 66 (42) | 56 (35) | 122 (39) |
| Unknown | 33 (21) | 41 (26) | 74 (23) |
| Cytogenetics by FISH, n (%) | |||
| High riska | 22 (14) | 29 (18) | 51 (16) |
| Standard riskb | 68 (43) | 76 (48) | 144 (46) |
| Unknown risk | 67 (43) | 53 (34) | 120 (38) |
| ECOG performance status, n (%) | |||
| 0 | 49 (31) | 31 (20) | 80 (25) |
| 1 | 78 (50) | 93 (59) | 171 (54) |
| ⩾2 | 30 (19) | 34 (22) | 64 (20) |
| Serum β2-microglobulin ⩾5.5 mg/l, n (%) | 76 (48) | 82 (52) | 158 (50) |
| Presence of bone lesions, n (%) | 105 (67) | 111 (70) | 216 (69) |
| Light-chain immunoglobulin, n (%) | |||
| Kappa | 93 (59) | 95 (60) | 188 (60) |
| Lambda | 64 (41) | 62 (39) | 126 (40) |
| Missing | 0 (0) | 1 (1) | 1 (<1) |
| Measurable disease category, n (%) | |||
| SPEP and UPEP | 57 (36) | 51 (32) | 108 (34) |
| SPEP only | 72 (46) | 91 (58) | 163 (52) |
| UPEP only | 27 (17) | 14 (9) | 41 (13) |
| Light chain disease only | 29 (18) | 16 (10) | 45 (14) |
| Median CrCl (range), ml/min | 65 (16−190) | 63 (14−207) | 64 (14−207) |
| CrCl <30 ml/min, n (%) | 17 (11) | 14 (9) | 31 (10) |
| Baseline neuropathy grade, n (%) | |||
| 0 | 76 (48) | 81 (51) | 157 (50) |
| 1 | 66 (42) | 56 (35) | 122 (39) |
| ⩾2 | 15 (10) | 21 (13) | 36 (11) |
Abbreviations: CrCl, creatinine clearance; ECOG, Eastern Cooperative Oncology Group; FISH, fluorescence in situ hybridization; ISS, International staging system; SPEP, serum protein electrophoresis; UPEP, urine protein electrophoresis.
a
Includes patients with genetic subtype t(4;14) or t(14;16) or with deletion 17p in 60% or more of plasma cells, according to central review of bone marrow samples obtained at study entry.
b
Includes patients without t(4;14) or t(14;16) and with deletion 17p in fewer than 60% of plasma cells.