Table 1.
Patients’ characteristics and results of the univariate analyses of OS after five years
| Training data set | No. of patients, N (%) | 5-y survival (%) | Log rank, P | Univariable comparison | HR* (95% CI†) |
|---|---|---|---|---|---|
| All patients | 1948 | 80.3% | |||
| Sex | 1948 | <.001 | |||
| Female | 615 (31.6) | 84.0 | |||
| Male | 1333 (68.4) | 78.6 | vs female | 1.5 (1.2-1.9) | |
| Time from diagnosis to study entry (y) | 1877 | .004 | |||
| ≤1 | 1187 (63.3) | 84.1 | |||
| >1 | 690 (36.7) | 78.1 | vs ≤1 | 1.3 (1.1-1.6) | |
| Age (y) | 1948 | .003 | |||
| Median (range) | 60.0 (30.0 - 81.0) | ||||
| ≤60 | 1019 (52.3) | 83.5 | |||
| >60 and ≤65 | 511 (26.2) | 76.7 | vs ≤60 | 1.5 (1.2-1.8) | |
| >65 and ≤70 | 275 (14.1) | 78.9 | vs ≤60 | 1.3 (1.0-1.7) | |
| >70 | 143 (7.3) | 73.2 | vs ≤60 | 1.4 (1.0-1.9) | |
| B symptoms | 1856 | <.001 | |||
| No | 1313 (70.7) | 83.5 | |||
| Yes | 543 (29.3) | 72.3 | vs no | 1.8 (1.5-2.2) | |
| Binet stage | 1863 | <.001 | |||
| A | 793 (42.6) | 89.5 | |||
| B | 702 (37.7) | 74.6 | |||
| C | 368 (19.8) | 70.1 | B/C vs A | 3.0 (2.4-3.6) | |
| Rai stage | 1863 | <.001 | |||
| 0 | 387 (20.8) | 91.4 | |||
| I | 342 (18.4) | 82.5 | |||
| II | 707 (37.9) | 80.0 | |||
| III | 161 (8.6) | 64.4 | |||
| IV | 266 (14.3) | 72.0 | 0-I vs II-IV | 2.1 (1.7-2.6) | |
| ECOG performance status | 1826 | <.001 | |||
| 0 | 1277 (69.9) | 84.6 | |||
| 1 | 533 (29.2) | 70.3 | 0 vs >0 | 2.1 (1.7-2.5) | |
| 2 | 16 (0.9) | 62.5 | |||
| IGHV MS | 1430 | <.001 | |||
| Mutated | 661 (46.2) | 89.1 | |||
| Unmutated | 769 (53.8) | 70.9 | vs mutated | 3.4 (2.7-4.3) | |
| Deletion 6q | 779 | .318 | |||
| No | 746 (95.8) | 84.0 | |||
| Yes | 33 (4.2) | 82.2 | vs no | 1.3 (0.7-2.4) | |
| Categories according to hierarchical model17 | 1557 | <.001 | |||
| Del(17p) | 89 (5.7) | 34.4 | vs del(13q)# | 5.9 (4.3-8.2) | |
| Del(11q)‡ | 250 (16.1) | 75.4 | vs del(13q)# | 2.1 (1.6-2.8) | |
| Trisomy 12§ | 163 (10.5) | 83.0 | vs del(13q)# | 1.1 (0.8-1.6) | |
| Normal¶ | 555 (35.6) | 86.9 | vs del(13q)# | 0.8 (0.6-1.0) | |
| Del(13q)# | 500 (32.1) | 85.3 | |||
| Hemoglobin (g/dL) | 1863 | <.001 | |||
| ≤10.0 | 182 (9.8) | 65.0 | vs >10.0 | 2.1 (1.6-2.7) | |
| >10.0 | 1681 (90.2) | 82.1 | |||
| Platelet count (× 103/µL) | 1859 | <.001 | |||
| <100.0 | 262 (14.1) | 70.0 | vs ≥100.0 | 1.9 (1.5-2.4) | |
| ≥100.0 | 1597 (85.9) | 82.3 | |||
| Leukocyte count (× 103/µL) | 1866 | <.001 | |||
| ≤50.0 | 1069 (57.3) | 86.0 | |||
| >50.0 | 797 (42.7) | 75.6 | vs <50.0 | 2.4 (2.0-2.9) | |
| Lymphocyte count (× 103/µL) | 1832 | <.001 | |||
| ≤50.0 | 1149 (62.7) | 85.3 | |||
| >50.0 | 683 (37.3) | 72.7 | vs ≤50.0 | 2.3 (1.9-2.8) | |
| Absolute neutrophil count (× 103/µL) | 1698 | <.001 | |||
| ≤6.5 | 1284 (75.6) | 83.2 | |||
| >6.5 | 414 (24.4) | 75.2 | vs ≤6.5 | 1.6 (1.3-1.9) | |
| LDH (U/L) | 1762 | <.001 | |||
| ≤210.0 | 1149 (65.2) | 84.7 | |||
| >210.0 | 613 (34.8) | 71.6 | vs ≤210.0 | 2.1 (1.7-2.5) | |
| s-TK (U/L) | 1670 | <.001 | |||
| ≤10.0 | 801 (48.0) | 91.7 | |||
| >10.0 and ≤24.0 | 450 (27.0) | 78.6 | vs ≤10.0 | 31 (2.4-4.1) | |
| >24.0 | 419 (25.0) | 66.4 | vs ≤10.0 | 54 (4.2-7.0) | |
| s-β2m (mg/L) | 1676 | <.001 | |||
| ≤1.7 | 403 (24.0) | 94.2 | |||
| >1.7 and ≤3.5 | 861 (51.4) | 82.7 | vs ≤1.7 | 2.8 (2.0-3.9) | |
| >3.5 | 412 (24.6) | 67.9 | vs ≤1.7 | 6.5 (4.6-9.3) | |
| ZAP-70 (%) | 502 | .2 | |||
| ≤20.0 | 310 (61.8) | 73.5 | |||
| >20.0 | 192 (38.2) | 68.6 | vs ≤20.0 | 1.2 (0.9-1.7) | |
| CD38 (%) | 914 | .8 | |||
| ≤30.0 | 619 (67.7) | 75.2 | |||
| >30.0 |
295 (32.3) |
70.9 |
vs ≤30.0 |
1.1 (0.9-1.4) |
|
|
Mayo validation data set | |||||
| All patients | 676 | ||||
| Sex | 676 | .2 | |||
| Female | 223 (33.0) | 92.9 | |||
| Male | 453 (67.0) | 87.1 | vs female | 1.4 (0.9-2.2) | |
| Age (y) | 676 | <.001 | |||
| Median (range) | 61.5 (32.0 - 89.0) | ||||
| ≤60 | 314 (46.4) | 94.3 | |||
| >60 and ≤65 | 116 (17.2) | 91.6 | |||
| >65 and ≤70 | 102 (15.1) | 88.3 | |||
| >70 | 144 (21.3) | 77.0 | >60 vs ≤60 | 2.3 (1.4-3.7) | |
| Rai stage | 676 | <.001 | |||
| 0 | 386 (57.1) | 91.8 | |||
| I | 230 (34.0) | 85.0 | |||
| II | 40 (5.9) | 88.9 | 0 vs I-II | 1.6 (1.01-2.4) | |
| III | 7 (1.0) | 51.4 | |||
| IV | 13 (1.9) | 92.3 | 0 vs III-IV | 4.5 (1.9-10.6) | |
| ECOG performance status | 676 | <.001 | |||
| 0 | 635 (93.9) | 89.8 | |||
| >0 | 41 (6.1) | 70.6 | 0 vs >0 | 1.8 (1.3-2.6) | |
| IGHV MS | 676 | <.001 | |||
| Mutated | 382 (56.5) | 91.4 | |||
| Unmutated | 294 (43.5) | 85.1 | vs mutated | 2.6 (1.7-4.0) | |
| Categories according to hierarchical model17 | 676 | <.001 | |||
| Del(17p) | 30 (4.4) | 39.7 | vs del(13q)# | 8.9 (4.5-17.5) | |
| Del(11q)‡ | 66 (9.8) | 81.0 | vs del(13q)# | 2.6 (1.3-5.1) | |
| Trisomy 12§ | 133 (19.7) | 88.6 | vs del(13q)# | 1.7 (1.0-3.2) | |
| Normal¶ | 160 (23.7) | 90.5 | vs del(13q)# | 1.2 (0.7-2.3) | |
| Del(13q)# | 287 (42.5) | 93.8 | |||
| s-TK (U/L) | 676 | .01 | |||
| ≤10.0 | 493 (72.9) | 91.0 | |||
| >10.0 | 183 (27.1) | 81.7 | vs ≤10.0 | 1.7 (1.1-2.8) | |
| s-β2m (mg/L) | 672 | <.001 | |||
| ≤1.7 | 88 (13.1) | 98.2 | |||
| >1.7 and ≤3.5 | 468 (69.6) | 92.5 | vs ≤1.7 | 2.7 (0.9-8.8) | |
| >3.5 | 116 (17.3) | 65.5 | vs ≤1.7 | 11.6 (3.6-37.6) | |
*
Hazard ratio.
†
Confidence interval.
‡
Not including deletion 17p.
§
Not including deletion 17p and deletion 11q.
¶
No abnormalities according to the hierarchical model including deletion 17p, deletion 11q, trisomy 12, and deletion13q.
#
Not including deletion 17p, deletion 11q, and trisomy 12.