Table 1.
Patient demographics and baseline disease characteristics
| Characteristic | All patients, N = 49 | t(11;14), n = 13 | Non-t(11;14), n = 36 |
|---|---|---|---|
| Median age (range), y | 66 (37-79) | 63 (47-75) | 68 (37-79) |
| Race, n (%) | |||
| White | 39 (80) | 10 (77) | 29 (81) |
| Black or African American | 10 (20) | 3 (23) | 7 (19) |
| ECOG performance status, n (%) | |||
| 0 | 15 (31) | 4 (31) | 11 (31) |
| 1-2 | 29 (59) | 7 (54) | 22 (61) |
| Missing | 5 (10) | 2 (15) | 3 (8) |
| ISS stage, n (%) | |||
| I | 18 (37) | 8 (62) | 10 (28) |
| II | 15 (31) | 1 (8) | 14 (39) |
| III | 15 (31) | 4 (31) | 11 (31) |
| Unknown | 1 (2) | 0 | 1 (3) |
| Cytogenetic status, n (%) | |||
| High-risk* | 13 (27) | 4 (31) | 9 (25) |
| Standard risk† | 29 (59) | 9 (69) | 20 (56) |
| Unknown | 7 (14) | 0 (0) | 7 (19) |
| Cytogenetic abnormalities, n (%) | |||
| t(11;14) | 13 (27) | 13 (100) | 0 |
| t(4;14) | 2 (4) | 0 | 2 (6) |
| t(14;16) | 2 (4) | 0 | 2 (6) |
| del(17p) | 10 (20) | 4 (31) | 6 (17) |
| 1q21 gain (≥3 copies) | 21 (43) | 5 (39) | 16 (44) |
| Hyperdiploid | 11 (22) | 2 (15) | 9 (25) |
| Median time from diagnosis to treatment (range), months | 37.4 (2.4-195.6) | 37.7 (4.9-126.7) | 34.7 (2.4-195.6) |
| Median no. of prior lines of therapy (range) | 1 (1-3) | 1 (1-2) | 1 (1-3) |
| Refractory to last prior therapy, n (%) | 42 (86) | 9 (69) | 33 (92) |
| Prior stem cell transplantation, n (%) | 25 (51) | 3 (23) | 22 (61) |
| Prior exposure to PI, n (%) | 47 (96) | 12 (92) | 35 (97) |
| Refractory to PI | 28 (57) | 9 (69) | 19 (53) |
| Prior exposure to IMiD, n (%) | 44 (90) | 10 (77) | 34 (94) |
| Refractory to IMiD | 35 (71) | 9 (69) | 26 (72) |
| Prior exposure to PI+IMiD, n (%) | 42 (86) | 9 (69) | 33 (92) |
| Double refractory | 22 (45) | 6 (46) | 16 (44) |
| BCL-2 expression (IHC), n/n (%) ‡ | |||
| High | 26/28 (93) | 7/7 (100) | 19/21 (90) |
| Low | 2/28 (7) | 0 | 2/21 (10) |
| BCL2 expression (qPCR), n/n (%) § | |||
| High | 22/39 (56) | 8/9 (89) | 14/30 (47) |
| Low | 17/39 (44) | 1/9 (11) | 16/30 (53) |
IHC, immunohistochemistry; IMiD, immunomodulatory drug; qPCR, quantitative polymerase chain reaction.
*
t(4;14), t(14;16), or del(17p).
†
No high-risk cytogenetics present.
‡
Baseline BM core biopsy samples from 28 patients were evaluable for BCL-2 protein expression by IHC. High expression was defined as ≥50% of tumor cells with a cytoplasmic intensity score of ≥2+ on a 0 to 3+ intensity scale. Percentages exclude patients with missing data.
§
Baseline BM aspirate samples from 39 patients were evaluable for BCL2 gene expression by qPCR. High expression was defined as previously described.20 Percentages exclude patients with missing data.