Baseline characteristics of nonrandomized and randomized patients according to the up-front treatment response
| Parameter . | Values . | Nonrandomized patients . | CR Group, N = 105 . | Non-CR Group, N = 94 . | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Observation group . | ASCT group . | ASCT group . | FC group . | ||||||||
| N . | Statistics* . | N . | Statistics* . | N . | Statistics* . | N . | Statistics* . | N . | Statistics* . | ||
| Patients, no | 42 | 53 | 52 | 46 | 48 | ||||||
| Sex | Male | 35 | 83.3% | 36 | 67.9% | 33 | 63.5% | 37 | 80.4% | 40 | 83.3% |
| Female | 7 | 16.7% | 17 | 32.1% | 19 | 36.5% | 9 | 19.6% | 8 | 16.7% | |
| Age | Years | 42 | 57.2 (53.45;61.21] | 53 | 56.08 (49.5;59.38] | 52 | 56.74 (49.66;60.48) | 46 | l54.23 (51.21;57.66) | 48 | 57.07 (51.96;60.06) |
| Binet stage | B | 30 | 71.4% | 44 | 83% | 39 | 75% | 36 | 78.3% | 36 | 75% |
| C | 12 | 28.6% | 9 | 17% | 13 | 25% | 10 | 21.7% | 12 | 25% | |
| Beta2-m | ULN | 18 | 62.1% | 27 | 58.7% | 25 | 53.2% | 32 | 76.2% | 30 | 81.1% |
| nl | 11 | 37.9% | 19 | 41.3% | 22 | 46.8% | 10 | 23.8% | 7 | 18.9% | |
| na | 13 | 7 | 5 | 4 | 11 | ||||||
| LDH | ULN | 15 | 35.7% | 11 | 23.9% | 19 | 37.3% | 20 | 45.5% | 19 | 41.3% |
| nl | 27 | 64.3% | 42 | 76.1% | 33 | 64.7% | 26 | 54.5% | 27 | 58.7% | |
| Hemoglobin | g/dL | 41 | 12.8 (10;14.2) | 52 | 13.45 (12.7;14.42) | 52 | 13.3 (11.95;14.8) | 44 | 13.45 (11.77;14.3) | 48 | 13.05 (12;14.3) |
| Platelets | /mm3 | 42 | 164000 (114800;213500) | 53 | 187000 (135000;230000) | 52 | 177500 (129000;219200) | 45 | 168000 (114000;205000) | 48 | 145000 (110200;201200) |
| Lymphocytes | /mm3 | 42 | 78 870 (40 570;128200) | 53 | 26 650 (14 060;89280) | 52 | 23 720 (13 780;59760) | 45 | 58 620 (23 560;108900) | 48 | 95 820 (46 780;127900) |
| CD38 | Positive | 35 | 22 (1.5;58) | 45 | 13 (1;61) | 46 | 9 (1.25;49.75) | 36 | 32.5 (2;65.25) | 43 | 35 (4.5;60.5) |
| Abn karyotype | Yes | 18 | 54.5% | 27 | 64.3% | 23 | 50% | 28 | 71.8% | 21 | 55.3% |
| No | 15 | 44.5% | 15 | 35.7% | 23 | 50% | 11 | 28.2% | 17 | 44.7% | |
| na | 9 | 11 | 6 | 7 | 10 | ||||||
| Translocation | Yes | 16 | 48.5% | 8 | 19% | 10 | 21.7% | 16 | 41% | 9 | 23.7% |
| No | 17 | 51.5% | 34 | 81% | 36 | 78.3% | 23 | 59% | 29 | 76.3% | |
| na | 9 | 11 | 6 | 7 | 10 | ||||||
| Trisomy 12 | Yes | 3 | 8.1% | 10 | 20.4% | 8 | 16.7% | 3 | 7.1% | 4 | 9.1% |
| no | 34 | 91.9% | 39 | 79.6% | 40 | 83.3% | 39 | 92.8 | 40 | 90.9 | |
| na | 5 | 4 | 4 | 4 | 4 | ||||||
| Del (13q) | Yes | 17 | 47.2% | 23 | 47.9% | 22 | 50% | 29 | 72.5% | 22 | 51.2% |
| No | 19 | 52.8% | 25 | 52.1% | 22 | 50% | 11 | 27.5% | 21 | 48.8% | |
| na | 6 | 5 | 8 | 6 | 5 | ||||||
| Del (11q23) | Yes | 15 | 42.9% | 9 | 19.1% | 2 | 4.5% | 13 | 31.7% | 12 | 27.9% |
| No | 20 | 57.1% | 38 | 80.9% | 42 | 95.5% | 28 | 68.3% | 31 | 72.1% | |
| na | 7 | 6 | 8 | 5 | 5 | ||||||
| Del (17p13) | Pos | 6 | 16.2% | 0 | 0% | 1 | 2.3% | 6 | 14.6% | 3 | 7% |
| No | 31 | 83.8% | 47 | 100% | 43 | 97.7% | 35 | 85.4% | 40 | 93% | |
| na | 5 | 6 | 8 | 5 | 5 | ||||||
| IGVH mutation | Yes | 8 | 26.7% | 19 | 42.2% | 21 | 50% | 9 | 22% | 14 | 30.4% |
| No | 22 | 73.3% | 26 | 57.8% | 21 | 50% | 32 | 78% | 32 | 69.6% | |
| na | 12 | 8 | 10 | 5 | 2 | ||||||
| ZAP70 | Positive | 16 | 69.6% | 17 | 51.5% | 27 | 77.1% | 24 | 80% | 24 | 72.7% |
| Negative | 7 | 30.4% | 16 | 48.5% | 8 | 22.9% | 6 | 20% | 9 | 27.3% | |
| na | 19 | 20 | 17 | 16 | 15 | ||||||
| Parameter . | Values . | Nonrandomized patients . | CR Group, N = 105 . | Non-CR Group, N = 94 . | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Observation group . | ASCT group . | ASCT group . | FC group . | ||||||||
| N . | Statistics* . | N . | Statistics* . | N . | Statistics* . | N . | Statistics* . | N . | Statistics* . | ||
| Patients, no | 42 | 53 | 52 | 46 | 48 | ||||||
| Sex | Male | 35 | 83.3% | 36 | 67.9% | 33 | 63.5% | 37 | 80.4% | 40 | 83.3% |
| Female | 7 | 16.7% | 17 | 32.1% | 19 | 36.5% | 9 | 19.6% | 8 | 16.7% | |
| Age | Years | 42 | 57.2 (53.45;61.21] | 53 | 56.08 (49.5;59.38] | 52 | 56.74 (49.66;60.48) | 46 | l54.23 (51.21;57.66) | 48 | 57.07 (51.96;60.06) |
| Binet stage | B | 30 | 71.4% | 44 | 83% | 39 | 75% | 36 | 78.3% | 36 | 75% |
| C | 12 | 28.6% | 9 | 17% | 13 | 25% | 10 | 21.7% | 12 | 25% | |
| Beta2-m | ULN | 18 | 62.1% | 27 | 58.7% | 25 | 53.2% | 32 | 76.2% | 30 | 81.1% |
| nl | 11 | 37.9% | 19 | 41.3% | 22 | 46.8% | 10 | 23.8% | 7 | 18.9% | |
| na | 13 | 7 | 5 | 4 | 11 | ||||||
| LDH | ULN | 15 | 35.7% | 11 | 23.9% | 19 | 37.3% | 20 | 45.5% | 19 | 41.3% |
| nl | 27 | 64.3% | 42 | 76.1% | 33 | 64.7% | 26 | 54.5% | 27 | 58.7% | |
| Hemoglobin | g/dL | 41 | 12.8 (10;14.2) | 52 | 13.45 (12.7;14.42) | 52 | 13.3 (11.95;14.8) | 44 | 13.45 (11.77;14.3) | 48 | 13.05 (12;14.3) |
| Platelets | /mm3 | 42 | 164000 (114800;213500) | 53 | 187000 (135000;230000) | 52 | 177500 (129000;219200) | 45 | 168000 (114000;205000) | 48 | 145000 (110200;201200) |
| Lymphocytes | /mm3 | 42 | 78 870 (40 570;128200) | 53 | 26 650 (14 060;89280) | 52 | 23 720 (13 780;59760) | 45 | 58 620 (23 560;108900) | 48 | 95 820 (46 780;127900) |
| CD38 | Positive | 35 | 22 (1.5;58) | 45 | 13 (1;61) | 46 | 9 (1.25;49.75) | 36 | 32.5 (2;65.25) | 43 | 35 (4.5;60.5) |
| Abn karyotype | Yes | 18 | 54.5% | 27 | 64.3% | 23 | 50% | 28 | 71.8% | 21 | 55.3% |
| No | 15 | 44.5% | 15 | 35.7% | 23 | 50% | 11 | 28.2% | 17 | 44.7% | |
| na | 9 | 11 | 6 | 7 | 10 | ||||||
| Translocation | Yes | 16 | 48.5% | 8 | 19% | 10 | 21.7% | 16 | 41% | 9 | 23.7% |
| No | 17 | 51.5% | 34 | 81% | 36 | 78.3% | 23 | 59% | 29 | 76.3% | |
| na | 9 | 11 | 6 | 7 | 10 | ||||||
| Trisomy 12 | Yes | 3 | 8.1% | 10 | 20.4% | 8 | 16.7% | 3 | 7.1% | 4 | 9.1% |
| no | 34 | 91.9% | 39 | 79.6% | 40 | 83.3% | 39 | 92.8 | 40 | 90.9 | |
| na | 5 | 4 | 4 | 4 | 4 | ||||||
| Del (13q) | Yes | 17 | 47.2% | 23 | 47.9% | 22 | 50% | 29 | 72.5% | 22 | 51.2% |
| No | 19 | 52.8% | 25 | 52.1% | 22 | 50% | 11 | 27.5% | 21 | 48.8% | |
| na | 6 | 5 | 8 | 6 | 5 | ||||||
| Del (11q23) | Yes | 15 | 42.9% | 9 | 19.1% | 2 | 4.5% | 13 | 31.7% | 12 | 27.9% |
| No | 20 | 57.1% | 38 | 80.9% | 42 | 95.5% | 28 | 68.3% | 31 | 72.1% | |
| na | 7 | 6 | 8 | 5 | 5 | ||||||
| Del (17p13) | Pos | 6 | 16.2% | 0 | 0% | 1 | 2.3% | 6 | 14.6% | 3 | 7% |
| No | 31 | 83.8% | 47 | 100% | 43 | 97.7% | 35 | 85.4% | 40 | 93% | |
| na | 5 | 6 | 8 | 5 | 5 | ||||||
| IGVH mutation | Yes | 8 | 26.7% | 19 | 42.2% | 21 | 50% | 9 | 22% | 14 | 30.4% |
| No | 22 | 73.3% | 26 | 57.8% | 21 | 50% | 32 | 78% | 32 | 69.6% | |
| na | 12 | 8 | 10 | 5 | 2 | ||||||
| ZAP70 | Positive | 16 | 69.6% | 17 | 51.5% | 27 | 77.1% | 24 | 80% | 24 | 72.7% |
| Negative | 7 | 30.4% | 16 | 48.5% | 8 | 22.9% | 6 | 20% | 9 | 27.3% | |
| na | 19 | 20 | 17 | 16 | 15 | ||||||
LDH indicates lactate dehydrogenase; na, not available; nl, normal; ULN, upper limit of normal; Abn, abnormal; and Del, deletion.
Median (Q1-Q3), %.