Table 2.
Baseline patient characteristics by MRD status for patients randomly assigned to FCR and tested successfully for MRD
| Variable/category | MRD− | MRD+ | Total | P |
|---|---|---|---|---|
| Patients, n | 83 | 39 | 122 | – |
| Age | ||||
| Mean (SD) | 56.4 (7.3) | 56.6 (6.7) | 56.4 (7.1) | .895 |
| Median (Q1, Q3) | 57.0 (51.0, 62.0) | 57.0 (53.0, 60.0) | 57.0 (52.0, 61.8) | |
| [Min, max] | [32.0, 69.0] | [28.0, 68.0] | [28.0, 69.0] | |
| Freq. of missing | 0 | 0 | 0 | |
| Age, category | ||||
| <60 | 51 (61.4) | 24 (61.5) | 75 (61.5) | 1.000 |
| ≥60 | 32 (38.6) | 15 (38.5) | 47 (38.5) | |
| Unknown/missing | 0 | 0 | 0 | |
| Sex | ||||
| Female | 30 (36.1) | 10 (25.6) | 40 (32.8) | .304 |
| Male | 53 (63.9) | 29 (74.4) | 82 (67.2) | |
| Unknown/missing | 0 | 0 | 0 | |
| RAI stage | ||||
| Low, 0 | 8 (9.6) | 1 (2.6) | 9 (7.4) | .170 |
| Intermediate, I-II | 47 (56.6) | 19 (48.7) | 66 (54.1) | |
| High, III-IV | 28 (33.7) | 19 (48.7) | 47 (38.5) | |
| Unknown/missing | 0 | 0 | 0 | |
| ECOG performance status | ||||
| 0 | 50 (60.2) | 20 (51.3) | 70 (57.4) | .593 |
| 1 | 32 (38.6) | 18 (46.2) | 50 (41.0) | |
| 2 | 1 (1.2) | 1 (2.6) | 2 (1.6) | |
| Unknown/missing | 0 | 0 | 0 | |
| Hemoglobin, g/dL | ||||
| Mean (SD) | 12.6 (2.0) | 11.6 (1.8) | 12.2 (2.0) | .004 |
| Median (Q1, Q3) | 12.8 (11.5, 14.1) | 11.9 (10.6, 12.6) | 12.5 (11.2, 13.8) | |
| [Min, max] | [5.5, 17.6] | [6.9, 15.9] | [5.5, 17.6] | |
| Freq. of missing | 1 | 1 | 2 | |
| Platelets, 103/μL | ||||
| Mean (SD) | 163.9 (79.7) | 151.6 (84.1) | 159.9 (81.0) | .339 |
| Median (Q1, Q3) | 151.0 (105.0, 204.0) | 130.0 (98.5, 183.0) | 144.5 (103.5, 191.5) | |
| [Min, max] | [43.0, 485.0] | [13.0, 433.0] | [13.0, 485.0] | |
| Freq. of missing | 0 | 0 | 0 | |
| WBC, 103/μL | ||||
| Mean (SD) | 92.9 (95.8) | 129.9 (117.4) | 104.7 (104.1) | .017 |
| Median (Q1, Q3) | 53.5 (18.8, 151.5) | 95.4 (43.6, 165.6) | 72.4 (26.4, 160.8) | |
| [Min, max] | [3.1, 434.1] | [11.8, 638.9] | [3.1, 638.9] | |
| Freq. of missing | 0 | 0 | 0 | |
| β2-Microglobulin, mg/L | ||||
| Mean (SD) | 3.8 (1.8) | 4.4 (2.1) | 4.0 (1.9) | .065 |
| Median (Q1, Q3) | 3.4 (2.5, 4.5) | 3.8 (3.1, 5.3) | 3.4 (2.7, 4.8) | |
| [Min, max] | [1.3, 12.2] | [2.0, 11.1] | [1.3, 12.2] | |
| Freq. of missing | 0 | 0 | 0 | |
| β2-Microglobulin, category * | ||||
| Elevated | 38 (45.8) | 21 (53.8) | 59 (48.4) | .442 |
| Normal | 45 (54.2) | 18 (46.2) | 63 (51.6) | |
| Unknown/missing | 0 | 0 | 0 | |
| Serum creatinine, mg/dL | ||||
| Mean (SD) | 96.0 (5.6) | 96.1 (6.1) | 96.0 (5.7) | .943 |
| Median (Q1, Q3) | 95.1 (91.9, 99.6) | 94.5 (92.5, 97.4) | 94.7 (92.5, 98.5) | |
| [Min, max] | [86.8, 117.1] | [87.5, 117.9] | [86.8, 117.9] | |
| Freq. of missing | 0 | 0 | 0 | |
| Coombs test † | ||||
| Negative | 75 (92.6) | 38 (97.4) | 113 (94.2) | .425 |
| Positive | 6 (7.4) | 1 (2.6) | 7 (5.8) | |
| Unknown/missing | 2 | 0 | 2 | |
| Splenomegaly | ||||
| No | 52 (62.7) | 18 (46.2) | 70 (57.4) | .116 |
| Yes | 31 (37.3) | 21 (53.8) | 52 (42.6) | |
| Unknown/missing | 0 | 0 | 0 | |
| Lymphadenopathy | ||||
| No | 31 (37.3) | 9 (23.1) | 40 (32.8) | .149 |
| Yes | 52 (62.7) | 30 (76.9) | 82 (67.2) | |
| Unknown/missing | 0 | 0 | 0 | |
| Del(11q22.3) | ||||
| Abnormal | 15 (18.1) | 11 (28.2) | 26 (21.3) | .238 |
| Normal | 68 (81.9) | 28 (71.8) | 96 (78.7) | |
| Unknown/missing | 0 | 0 | 0 | |
| Dohner classification ‡ | ||||
| Del(17p) | 0 (0.0) | 0 (0.0) | 0 (0.0) | .226 |
| Del(11q22) | 15 (18.1) | 11 (28.2) | 26 (21.3) | |
| Trisomy 12 | 15 (18.1) | 9 (23.1) | 24 (19.7) | |
| Normal | 19 (22.9) | 3 (7.7) | 22 (18.0) | |
| Del(13q) | 28 (33.7) | 12 (30.8) | 40 (32.8) | |
| Other | 6 (7.2) | 4 (10.3) | 10 (8.2) | |
| Unknown/missing | 0 | 0 | 0 | |
| IGHV | ||||
| Mutated | 34 (49.3) | 9 (25.7) | 43 (41.3) | .034 |
| Unmutated | 35 (50.7) | 26 (74.3) | 61 (58.7) | |
| Unknown/missing | 14 | 4 | 18 | |
| Time up and go, s § | ||||
| Mean (SD) | 8.5 (2.1) | 9.8 (3.3) | 8.9 (2.6) | .053 |
| Median (Q1, Q3) | 8.0 (7.0, 10.0) | 9.0 (8.0, 10.0) | 9.0 (7.2, 10.0) | |
| [Min, max] | [2.0, 16.0] | [5.0, 20.0] | [2.0, 20.0] | |
| Freq. of missing | 0 | 0 | 0 | |
| CIRS | ||||
| Mean (SD) | 2.2 (1.9) | 2.5 (2.0) | 2.3 (2.0) | .360 |
| Median (Q1, Q3) | 2.0 (0.0, 3.5) | 2.0 (1.0, 4.0) | 2.0 (1.0, 4.0) | |
| [Min, max] | [0.0, 7.0] | [0.0, 7.0] | [0.0, 7.0] | |
| Freq. of missing | 8 | 9 | 17 | |
| % CD19+CD5+cells | ||||
| Mean (SD) | 69.5 (28.8) | 83.1 (17.8) | 73.8 (26.5) | .012 |
| Median (Q1, Q3) | 79.3 (53.0, 93.6) | 90.3 (72.6, 96.3) | 85.1 (61.4, 94.5) | |
| [Min, max] | [3.8, 99.2] | [33.6, 99.1] | [3.8, 99.2] | |
| Freq. of missing | 2 | 1 | 3 | |
| % CD38+ cells | ||||
| Mean (SD) | 35.1 (36.8) | 31.3 (34.5) | 33.9 (36.0) | .372 |
| Median (Q1, Q3) | 15.6 (2.0, 70.9) | 19.8 (1.0, 55.7) | 17.9 (1.5, 65.9) | |
| [Min, max] | [0.1, 99.7] | [0.2, 95.3] | [0.1, 99.7] | |
| Freq. of missing | 2 | 1 | 3 | |
| %CD38+ cells, category | ||||
| High (>30%) | 36 (44.4) | 15 (39.5) | 51 (42.9) | .693 |
| Low (≤30%) | 45 (55.6) | 23 (60.5) | 68 (57.1) | |
| Unknown/missing | 2 | 1 | 3 | |
| % CD49d+ cells | ||||
| Mean (SD) | 46.1 (44.3) | 25.4 (36.9) | 39.5 (43.0) | .009 |
| Median (Q1, Q3) | 22.4 (1.5, 98.0) | 7.8 (0.4, 35.8) | 13.9 (1.0, 97.0) | |
| [Min, max] | [0.2, 100.0] | [0.1, 100.0] | [0.1, 100.0] | |
| Freq. of missing | 2 | 1 | 3 | |
| %CD49d+ cells, category | ||||
| High (>30%) | 40 (49.4) | 11 (28.9) | 51 (42.9) | .047 |
| Low (≤30%) | 41 (50.6) | 27 (71.1) | 68 (57.1) | |
| Unknown/missing | 2 | 1 | 3 | |
| % ZAP-70+ cells | ||||
| Mean (SD) | 19.2 (19.7) | 19.7 (24.0) | 19.3 (21.1) | .713 |
| Median (Q1, Q3) | 9.6 (3.9, 31.6) | 12.9 (2.6, 23.7) | 9.6 (3.5, 30.6) | |
| [Min, max] | [0.1, 67.1] | [0.2, 82.7] | [0.1, 82.7] | |
| Freq. of missing | 2 | 1 | 3 | |
| %ZAP-70+ cells, category | ||||
| High (>20%) | 30 (37.0) | 12 (31.6) | 42 (35.3) | .682 |
| Low (≤20%) | 51 (63.0) | 26 (68.4) | 77 (64.7) | |
| Unknown/missing | 2 | 1 | 3 | |
| TK (U/L) | ||||
| Mean (SD) | 24.5 (28.6) | 43.2 (87.3) | 30.5 (55.0) | .091 |
| Median (Q1, Q3) | 15.0 (7.1, 34.7) | 26.3 (11.1, 42.5) | 17.7 (8.4, 37.4) | |
| [Min, max] | [0.0, 199.0] | [0.0, 547.0] | [0.0, 547.0] | |
| Freq. of missing | 2 | 1 | 3 |