Patient characteristics at baseline according to random assignment for induction with or without lenalidomide
| . | No. of patients evaluated . | Control induction treatment . | Lenalidomide induction treatment . |
|---|---|---|---|
| Total | 392 (100) | 388 (100) | |
| Male sex | 210 (54) | 233 (60) | |
| Age, y | |||
| Median (range) | 53 (18-65) | 54 (18-65) | |
| ≤45 | 110 (28) | 99 (26) | |
| 46-60 | 194 (49) | 195 (50) | |
| >60 | 88 (22) | 94 (24) | |
| WHO/ECOG performance status | |||
| 0 | 239 (61) | 264 (66) | |
| 1 | 138 (35) | 113 (29) | |
| 2 | 15 (4) | 11 (3) | |
| Diagnostic subgroup | |||
| AML | 356 (91) | 351 (90) | |
| High-risk RAEB | 33 (8) | 35 (9) | |
| Leukemia with ambiguous lineage | 3 (1) | 2 (1) | |
| AML type | |||
| De novo | 358 (91) | 351 (90) | |
| sAML | 19 (5) | 24 (6) | |
| tAML | 15 (4) | 13 (3) | |
| WBC, × 109/L | |||
| Median (range) | 8.0 (0-265) | 6.7 (0.4-297) | |
| ≤20 | 259 (66) | 257 (66) | |
| 20-100 | 109 (28) | 103 (27) | |
| >100 | 23 (6) | 27 (7) | |
| Unknown | 1 (0) | 1 (0) | |
| Median blasts in bone marrow, % | 52 | 52 | |
| Cytogenetics* | |||
| t(8;21) | 11 (3) | 22 (6) | |
| inv(16) or t(16;16) | 23 (6) | 26 (7) | |
| CN-X-Y | 211 (54) | 199 (51) | |
| CA rest | 97 (25) | 95 (24) | |
| Monosomal karyotype | 39 (10) | 34 (9) | |
| Unknown | 11 (3) | 12 (3) | |
| Gene mutations† | |||
| NPM1-mut | 744 | 129 (33) | 115 (30) |
| FLT3-ITD-mut | 742 | 85 (22) | 69 (18) |
| FLT3-TKD835-mut | 742 | 34 (9) | 33 (9) |
| NPM1-mut FLT3-ITD-negative | 741 | 69 (18) | 77 (20) |
| NPM1-mut FLT3-ITD-mut | 59 (15) | 38 (10) | |
| NPM1-wt FLT3-ITD-negative | 217 (55) | 224 (58) | |
| NPM1-wt FLT3-ITD-mut | 26 (7) | 31 (8) | |
| DNMT3A-mut | 739 | 108 (28) | 105 (27) |
| IDH1-mut | 739 | 35 (9) | 34 (9) |
| IDH2-mut | 739 | 45 (11) | 45 (12) |
| TET2-mut | 739 | 54 (14) | 41 (11) |
| Biallelic CEBPA-mut | 739 | 16 (4) | 12 (3) |
| RUNX1-mut | 742 | 41 (10) | 49 (13) |
| ASXL1-mut | 742 | 39 (10) | 31 (8) |
| TP53-mut | 742 | 28 (7) | 29 (7) |
| SF3B1-mut or SRSF2-mut‡ | 739 | 46 (12) | 43 (11) |
| SRSF2-mut‡ | 739 | 30 (8) | 28 (7) |
| PTPN11-mut | 739 | 44 (11) | 33 (9) |
| KRAS-mut | 739 | 23 (6) | 18 (5) |
| NRAS-mut | 739 | 60 (15) | 69 (18) |
| JAK2-mut | 739 | 3 (1) | 4 (1) |
| BCOR-mut or BCOR1-mut | 739 | 29 (7) | 25 (6) |
| EVI1 overexpression | 594 | 21 (5) | 28 (7) |
| Prognostic risk according to 2017 ELN criteria§ | |||
| Favorable | 134 (34) | 150 (39) | |
| Intermediate | 127 (32) | 94 (24) | |
| Adverse | 119 (30) | 139 (36) | |
| Unknown | 12 (3) | 5 (1) |
| . | No. of patients evaluated . | Control induction treatment . | Lenalidomide induction treatment . |
|---|---|---|---|
| Total | 392 (100) | 388 (100) | |
| Male sex | 210 (54) | 233 (60) | |
| Age, y | |||
| Median (range) | 53 (18-65) | 54 (18-65) | |
| ≤45 | 110 (28) | 99 (26) | |
| 46-60 | 194 (49) | 195 (50) | |
| >60 | 88 (22) | 94 (24) | |
| WHO/ECOG performance status | |||
| 0 | 239 (61) | 264 (66) | |
| 1 | 138 (35) | 113 (29) | |
| 2 | 15 (4) | 11 (3) | |
| Diagnostic subgroup | |||
| AML | 356 (91) | 351 (90) | |
| High-risk RAEB | 33 (8) | 35 (9) | |
| Leukemia with ambiguous lineage | 3 (1) | 2 (1) | |
| AML type | |||
| De novo | 358 (91) | 351 (90) | |
| sAML | 19 (5) | 24 (6) | |
| tAML | 15 (4) | 13 (3) | |
| WBC, × 109/L | |||
| Median (range) | 8.0 (0-265) | 6.7 (0.4-297) | |
| ≤20 | 259 (66) | 257 (66) | |
| 20-100 | 109 (28) | 103 (27) | |
| >100 | 23 (6) | 27 (7) | |
| Unknown | 1 (0) | 1 (0) | |
| Median blasts in bone marrow, % | 52 | 52 | |
| Cytogenetics* | |||
| t(8;21) | 11 (3) | 22 (6) | |
| inv(16) or t(16;16) | 23 (6) | 26 (7) | |
| CN-X-Y | 211 (54) | 199 (51) | |
| CA rest | 97 (25) | 95 (24) | |
| Monosomal karyotype | 39 (10) | 34 (9) | |
| Unknown | 11 (3) | 12 (3) | |
| Gene mutations† | |||
| NPM1-mut | 744 | 129 (33) | 115 (30) |
| FLT3-ITD-mut | 742 | 85 (22) | 69 (18) |
| FLT3-TKD835-mut | 742 | 34 (9) | 33 (9) |
| NPM1-mut FLT3-ITD-negative | 741 | 69 (18) | 77 (20) |
| NPM1-mut FLT3-ITD-mut | 59 (15) | 38 (10) | |
| NPM1-wt FLT3-ITD-negative | 217 (55) | 224 (58) | |
| NPM1-wt FLT3-ITD-mut | 26 (7) | 31 (8) | |
| DNMT3A-mut | 739 | 108 (28) | 105 (27) |
| IDH1-mut | 739 | 35 (9) | 34 (9) |
| IDH2-mut | 739 | 45 (11) | 45 (12) |
| TET2-mut | 739 | 54 (14) | 41 (11) |
| Biallelic CEBPA-mut | 739 | 16 (4) | 12 (3) |
| RUNX1-mut | 742 | 41 (10) | 49 (13) |
| ASXL1-mut | 742 | 39 (10) | 31 (8) |
| TP53-mut | 742 | 28 (7) | 29 (7) |
| SF3B1-mut or SRSF2-mut‡ | 739 | 46 (12) | 43 (11) |
| SRSF2-mut‡ | 739 | 30 (8) | 28 (7) |
| PTPN11-mut | 739 | 44 (11) | 33 (9) |
| KRAS-mut | 739 | 23 (6) | 18 (5) |
| NRAS-mut | 739 | 60 (15) | 69 (18) |
| JAK2-mut | 739 | 3 (1) | 4 (1) |
| BCOR-mut or BCOR1-mut | 739 | 29 (7) | 25 (6) |
| EVI1 overexpression | 594 | 21 (5) | 28 (7) |
| Prognostic risk according to 2017 ELN criteria§ | |||
| Favorable | 134 (34) | 150 (39) | |
| Intermediate | 127 (32) | 94 (24) | |
| Adverse | 119 (30) | 139 (36) | |
| Unknown | 12 (3) | 5 (1) |
All data are n (%) unless otherwise indicated. RAEB is defined as having a Revised International Prognostic Scoring System score >4.5.16
CA, abnormal cytogenetics; CN, normal cytogenetics; ECOG, Eastern Cooperative Oncology Group; mut, mutation; sAML, secondary AML (after myelodysplastic syndrome and antecedent hematologic disease); tAML, therapy-related AML (in case of previous chemotherapy or radiotherapy) (for details see “Patients and methods”); WHO, World Health Organization; wt, wild-type.
AML with core binding factor abnormalities: t(8;21)(q22;q22), inv(16)(p13.1;q22), or t(16;16)(p13.1;q22); monosomal karyotype defined as described in Breems et al.20
Gene mutations include ASXL1, additional sex combs–like 1; CEPBA, CCAAT/enhancer-binding protein α; DNMT3A, DNA methyltransferase 3 α; EVI1, ecotropic virus integration 1; FLT3, fms-like tyrosine kinase-3; FLT3-ITD-negative, FLT3 without internal tandem duplications (ITDs); FLT3-TKD835, FLT3-tyrosine kinase domain 835, FLT3 gene with point mutation at position D835; IDH1/IDH2, isocitrate dehydrogenase 1 and 2; NPM1, nuclephosmin-1; PTPN11, protein tyrosine phosphatase nonreceptor type 11; RUNX1, runt-related transcription factor 1; SF3B1, splicing factor 3B subunit; SRSF2, serine/arginine-rich splicing factor 2; TET2, Tet methylcytosine dioxygenase 2.
We considered the frequencies of SRSF2 alone and SRSF2 and SF3B1 in combination.
The ELN prognostic risk categories as described in Döhner et al.1