Table 1.
Demographic and Baseline Clinical Characteristics of the Patients.*
| Characteristic | Blinatumomab Group (N=271) |
Chemotherapy Group (N = 134) |
|---|---|---|
| Age — yr | ||
| Mean | 40.8 ± 17.1 | 41.1 ± 17.3 |
| Range | 18–80 | 18–78 |
| Male sex — no. (%) | 162 (59.8) | 77 (57.5) |
| Race — no. (%)† | ||
| White | 228 (84.1) | 112 (83.6) |
| Asian | 19 (7.0) | 9 (6.7) |
| Black | 5 (1.8) | 3 (2.2) |
| Other | 19 (7.0) | 10 (7.5) |
| Hispanic ethnic group — no. (%) | 26 (9.6) | 11 (8.2) |
| Geographic region — no. (%) | ||
| Europe | 180 (66.4) | 85 (63.4) |
| United States or Canada | 41 (15.1) | 23 (17.2) |
| Rest of world | 50 (18.5) | 26 (19.4) |
| ECOG performance status — no. (%)‡ | ||
| 0 | 96 (35.4) | 52 (38.8) |
| 1 | 134 (49.4) | 61 (45.5) |
| 2 | 41 (15.1) | 20 (14.9) |
| Missing data | 0 | 1 (07) |
| Key trial inclusion criteria — no. (%) | ||
| Disease refractory to primary therapy or salvage therapy | 115 (42.4) | 54 (40.3) |
| First relapse, with duration of first remission <12 mo | 76 (28.0) | 37 (27.6) |
| Untreated second or greater relapse§ | 32 (11.8) | 16 (11.9) |
| Relapse after allogeneic stem-cell transplantation§ | 46 (17.0) | 27 (20.1) |
| Not specified | 2 (0.7) | 0 |
| Previous allogeneic stem-cell transplantation — no. (%) | ||
| Yes | 94 (34.7) | 46 (34.3) |
| No | 176 (64.9) | 87 (64.9) |
| Unknown | 1 (0.4) | 1 (07) |
| Salvage-treatment phase — no. (%) | ||
| First | 114 (42.1) | 65 (48.5) |
| Second | 91 (33.6) | 43 (32.1) |
| Third | 45 (16.6) | 16 (11.9) |
| Fourth | 14 (5.2) | 5 (3.7) |
| Fifth or later | 7 (2.6) | 5 (3.7) |
| Maximum central or local bone marrow blasts — no. (%) | ||
| >5 to <10% | 9 (3.3) | 7 (5.2) |
| 10 to <50% | 60 (22.1) | 23 (17.2) |
| ≥50% | 201 (74.2) | 104 (77.6) |
| Unknown | 1 (0.4) | 0 |
| Peripheral blast count in blood (x 10−9/liter) | 4.4 ± 15.5 | 5.0 ± 15.7 |
*
Plus–minus values are means ±SD. There were no significant between-group differences in the characteristics evaluated at baseline. A complete summary of disease characteristics at baseline is provided in Table S3 in the Supplementary Appendix. Data are summarized for all patients who underwent randomization (intention-to-treat population). Percentages may not total 100 because of rounding.
†
Race was determined by the investigator.
‡
The Eastern Cooperative Oncology Group (ECOG) performance status scale ranges from 0 to 5, with higher numbers indicating greater disability.
§
Patients who met this inclusion criterion met none of the above inclusion criteria.