Characteristics of the MCL0208 patient cohort analyzed for M-CH mutations
| Characteristic . | Sample for M-CH analysis available at diagnosis . | Paired samples for M-CH analysis available at diagnosis and after ASCT . | ||||
|---|---|---|---|---|---|---|
| Available, n = 254∗ . | Not available, n = 46∗ . | P value† . | Available, n = 191∗ . | Not available, n = 109∗ . | P value† . | |
| Sex | >.9 | .6 | ||||
| Female | 55 (22%) | 10 (22%) | 43 (23%) | 22 (20%) | ||
| Male | 199 (78%) | 36 (78%) | 148 (77%) | 87 (80%) | ||
| Age, y | .7 | .10 | ||||
| Median (range) | 57 (32, 66) | 58 (28-66) | 56 (32-66) | 58 (28-66) | ||
| Histology | .3 | .13 | ||||
| Blastoid | 20 (7.9%) | 6 (13%) | 13 (6.8%) | 13 (12%) | ||
| Classic | 234 (92%) | 40 (87%) | 178 (93%) | 96 (88%) | ||
| Ki67 index | .12 | .047 | ||||
| <30 | 163 (71%) | 24 (59%) | 128 (73%) | 59 (61%) | ||
| ≥30 | 67 (29%) | 17 (41%) | 47 (27%) | 37 (39%) | ||
| NA | 24 | 5 | 16 | 13 | ||
| LDH above ULN | .020 | .021 | ||||
| ≤ULN | 177 (70%) | 24 (52%) | 137 (72%) | 64 (59%) | ||
| >ULN | 77 (30%) | 22 (48%) | 54 (28%) | 45 (41%) | ||
| MIPI | .3 | .2 | ||||
| High risk | 38 (15%) | 9 (20%) | 28 (15%) | 19 (17%) | ||
| Intermediate risk | 59 (23%) | 14 (30%) | 41 (21%) | 32 (29%) | ||
| Low risk | 157 (62%) | 23 (50%) | 122 (64%) | 58 (53%) | ||
| MIPIc | .2 | .085 | ||||
| High risk | 17 (7.4%) | 7 (17%) | 13 (7.4%) | 11 (11%) | ||
| Intermediate-high risk | 29 (13%) | 6 (15%) | 23 (13%) | 12 (12%) | ||
| Intermediate-low risk | 67 (29%) | 12 (29%) | 44 (25%) | 35 (36%) | ||
| Low risk | 117 (51%) | 16 (39%) | 95 (54%) | 38 (40%) | ||
| NA | 24 | 5 | 16 | 13 | ||
| ECOG PS | .9 | .4 | ||||
| 1-2 | 58 (23%) | 11 (24%) | 41 (21%) | 28 (26%) | ||
| 0 | 196 (77%) | 35 (76%) | 150 (79%) | 81 (74%) | ||
| Stage | .5 | .5 | ||||
| Stage II-III | 14 (5.5%) | 4 (8.7%) | 10 (5.2%) | 8 (7.3%) | ||
| Stage IV | 240 (94%) | 42 (91%) | 181 (95%) | 101 (93%) | ||
| Bulky | .5 | .5 | ||||
| Bulky | 81 (32%) | 17 (37%) | 60 (31%) | 38 (35%) | ||
| Not bulky | 173 (68%) | 29 (63%) | 131 (69%) | 71 (65%) | ||
| TP53 status in tumor cells | >.9 | .3 | ||||
| Mutation or deletion | 28 (17%) | 3 (15%) | 19 (15%) | 12 (21%) | ||
| WT | 138 (83%) | 17 (85%) | 111 (85%) | 44 (79%) | ||
| NA | 88 | 26 | 61 | 53 | ||
| Type of sample at baseline | >.9 | .2 | ||||
| BM | 27 (11%) | — | 23 (12%) | — | ||
| PB | 227 (89%) | — | 168 (88%) | — | ||
| Type of sample within 12 mo from ASCT | >.9 | >.9 | ||||
| BM | 11 (5.8%) | — | 11 (5.8%) | — | ||
| PB | 180 (94%) | — | 180 (94%) | — | ||
| NA | 63 | 0 | ||||
| ASCT | <.001 | <.001 | ||||
| ASCT not received | 32 (13%) | 19 (41%) | 0 (0%) | 51 (47%) | ||
| ASCT received | 222 (87%) | 27 (59%) | 191 (100%) | 58 (53%) | ||
| Clinical response after ASCT | .5 | .4 | ||||
| CR | 201 (91%) | 25 (89%) | 170 (89%) | 56 (95%) | ||
| PR | 12 (5.4%) | 3 (11%) | 12 (6.3%) | 3 (5.1%) | ||
| SD or PD | 8 (3.6%) | 0 (0%) | 8 (4.2%) | 0 (0%) | ||
| NA | 33 | 18 | 1 | 50 | ||
| Randomized after ASCT | 182 (72%) | 23 (50%) | .004 | 160 (84%) | 45 (41%) | <.001 |
| Randomized to Lenalidomide | 94 (52%) | 10 (43%) | .5 | 79 (49%) | 25 (56%) | .5 |
| NA | 72 | 23 | 31 | 64 | ||
| Characteristic . | Sample for M-CH analysis available at diagnosis . | Paired samples for M-CH analysis available at diagnosis and after ASCT . | ||||
|---|---|---|---|---|---|---|
| Available, n = 254∗ . | Not available, n = 46∗ . | P value† . | Available, n = 191∗ . | Not available, n = 109∗ . | P value† . | |
| Sex | >.9 | .6 | ||||
| Female | 55 (22%) | 10 (22%) | 43 (23%) | 22 (20%) | ||
| Male | 199 (78%) | 36 (78%) | 148 (77%) | 87 (80%) | ||
| Age, y | .7 | .10 | ||||
| Median (range) | 57 (32, 66) | 58 (28-66) | 56 (32-66) | 58 (28-66) | ||
| Histology | .3 | .13 | ||||
| Blastoid | 20 (7.9%) | 6 (13%) | 13 (6.8%) | 13 (12%) | ||
| Classic | 234 (92%) | 40 (87%) | 178 (93%) | 96 (88%) | ||
| Ki67 index | .12 | .047 | ||||
| <30 | 163 (71%) | 24 (59%) | 128 (73%) | 59 (61%) | ||
| ≥30 | 67 (29%) | 17 (41%) | 47 (27%) | 37 (39%) | ||
| NA | 24 | 5 | 16 | 13 | ||
| LDH above ULN | .020 | .021 | ||||
| ≤ULN | 177 (70%) | 24 (52%) | 137 (72%) | 64 (59%) | ||
| >ULN | 77 (30%) | 22 (48%) | 54 (28%) | 45 (41%) | ||
| MIPI | .3 | .2 | ||||
| High risk | 38 (15%) | 9 (20%) | 28 (15%) | 19 (17%) | ||
| Intermediate risk | 59 (23%) | 14 (30%) | 41 (21%) | 32 (29%) | ||
| Low risk | 157 (62%) | 23 (50%) | 122 (64%) | 58 (53%) | ||
| MIPIc | .2 | .085 | ||||
| High risk | 17 (7.4%) | 7 (17%) | 13 (7.4%) | 11 (11%) | ||
| Intermediate-high risk | 29 (13%) | 6 (15%) | 23 (13%) | 12 (12%) | ||
| Intermediate-low risk | 67 (29%) | 12 (29%) | 44 (25%) | 35 (36%) | ||
| Low risk | 117 (51%) | 16 (39%) | 95 (54%) | 38 (40%) | ||
| NA | 24 | 5 | 16 | 13 | ||
| ECOG PS | .9 | .4 | ||||
| 1-2 | 58 (23%) | 11 (24%) | 41 (21%) | 28 (26%) | ||
| 0 | 196 (77%) | 35 (76%) | 150 (79%) | 81 (74%) | ||
| Stage | .5 | .5 | ||||
| Stage II-III | 14 (5.5%) | 4 (8.7%) | 10 (5.2%) | 8 (7.3%) | ||
| Stage IV | 240 (94%) | 42 (91%) | 181 (95%) | 101 (93%) | ||
| Bulky | .5 | .5 | ||||
| Bulky | 81 (32%) | 17 (37%) | 60 (31%) | 38 (35%) | ||
| Not bulky | 173 (68%) | 29 (63%) | 131 (69%) | 71 (65%) | ||
| TP53 status in tumor cells | >.9 | .3 | ||||
| Mutation or deletion | 28 (17%) | 3 (15%) | 19 (15%) | 12 (21%) | ||
| WT | 138 (83%) | 17 (85%) | 111 (85%) | 44 (79%) | ||
| NA | 88 | 26 | 61 | 53 | ||
| Type of sample at baseline | >.9 | .2 | ||||
| BM | 27 (11%) | — | 23 (12%) | — | ||
| PB | 227 (89%) | — | 168 (88%) | — | ||
| Type of sample within 12 mo from ASCT | >.9 | >.9 | ||||
| BM | 11 (5.8%) | — | 11 (5.8%) | — | ||
| PB | 180 (94%) | — | 180 (94%) | — | ||
| NA | 63 | 0 | ||||
| ASCT | <.001 | <.001 | ||||
| ASCT not received | 32 (13%) | 19 (41%) | 0 (0%) | 51 (47%) | ||
| ASCT received | 222 (87%) | 27 (59%) | 191 (100%) | 58 (53%) | ||
| Clinical response after ASCT | .5 | .4 | ||||
| CR | 201 (91%) | 25 (89%) | 170 (89%) | 56 (95%) | ||
| PR | 12 (5.4%) | 3 (11%) | 12 (6.3%) | 3 (5.1%) | ||
| SD or PD | 8 (3.6%) | 0 (0%) | 8 (4.2%) | 0 (0%) | ||
| NA | 33 | 18 | 1 | 50 | ||
| Randomized after ASCT | 182 (72%) | 23 (50%) | .004 | 160 (84%) | 45 (41%) | <.001 |
| Randomized to Lenalidomide | 94 (52%) | 10 (43%) | .5 | 79 (49%) | 25 (56%) | .5 |
| NA | 72 | 23 | 31 | 64 | ||
Boldface values indicate statistically significant P values (P < .05). CR, complete remission; ECOG PS; Eastern Cooperative Oncology Group performance status; LDH, lactate dehydrogenase; MIPIc, MIPI combined; NA, data not available; PD, progressive disease; PR, partial remission; SD, stable disease; ULN, upper limit of normal; WT, wild-type.
n (%).
Pearson χ2 test; Wilcoxon rank-sum test; Fisher exact test.