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) |
| 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.