Baseline demographic and clinical characteristics of the patients
. | ven/aza (N = 439) . | CPX-351 (N = 217) . | P . |
---|---|---|---|
Age, y | 75 (36-88) | 67 (21-82) | <.001 |
Sex | .056 | ||
Female | 191 (44%) | 112 (52%) | |
Male | 248 (56%) | 105 (48%) | |
Practice type | <.001 | ||
Academic | 149 (34%) | 103 (47%) | |
Community | 290 (66%) | 114 (53%) | |
Insurance | .047 | ||
Commercial | 137 (31%) | 76 (35%) | |
Medicare | 126 (29%) | 43 (20%) | |
Other | 176 (40%) | 98 (45%) | |
Performance Status | .23 | ||
0-1 | 62 (14%) | 31 (14%) | |
2-4 | 197 (45%) | 72 (33%) | |
Missing | 181 (41%) | 116 (53%) | |
NPM1 mutation | .19 | ||
Negative | 277 (63%) | 131 (60%) | |
Positive | 36 (8%) | 25 (12%) | |
Missing | 126 (29%) | 61 (28%) | |
IDH1 or IDH2 mutation | .36 | ||
Negative | 244 (56%) | 113 (52%) | |
IDH1 or IDH2 | 72 (16%) | 41 (19%) | |
Missing | 124 (28%) | 63 (29%) | |
FLT3 | .17 | ||
Negative | 291 (66%) | 139 (64%) | |
FLT3 mutation | 30 (7%) | 13 (6%) | |
Missing | 118 (27%) | 65 (30%) | |
High-risk mutations | .17 | ||
Negative | 201 (46%) | 90 (41%) | |
RUNX1 | 29 (7%) | 22 (10%) | |
ASXL1 | 42 (10%) | 14 (6%) | |
TP53 | 57 (13%) | 33 (15%) | |
Missing | 110 (25%) | 58 (27%) | |
Type | <.001 | ||
De novo | 226 (51%) | 63 (29%) | |
History of MDS/MPN | 150 (34%) | 104 (47%) | |
Therapy-related | 63 (14%) | 50 (23%) | |
European LeukemiaNet 2017 risk group | .80 | ||
Favorable | 34 (8%) | 15 (7%) | |
Intermediate | 117 (27%) | 64 (30%) | |
Adverse | 172 (39%) | 92 (42%) | |
Missing | 116 (26%) | 46 (21%) | |
MRC | .63 | ||
Negative | 176 (40%) | 88 (40%) | |
Positive | 160 (36%) | 72 (33%) | |
Missing | 103 (23%) | 57 (26%) | |
HCT comorbidity index | .28 | ||
0 | 116 (26%) | 69 (32%) | |
1-2 | 156 (36%) | 70 (32%) | |
≥3 | 83 (19%) | 35 (16%) | |
Missing | 85 (19%) | 44 (20%) | |
Baseline marrow blasts | .14 | ||
Missing | 23 (5%) | 11 (5%) | |
<30% | 152 (35%) | 70 (32%) | |
31-50% | 136 (31%) | 86 (40%) | |
>50% | 128 (29%) | 50 (23%) | |
Baseline white blood cell count | .41 | ||
<20 | 228 (52%) | 105 (48%) | |
>20 | 211 (48%) | 112 (52%) | |
Grade 3 neutropenia | .37 | ||
Negative | 168 (38%) | 90 (41%) | |
Positive | 136 (31%) | 60 (28%) | |
Missing | 135 (31%) | 67 (31%) | |
Grade 3 anemia | 1.00 | ||
Negative | 224 (51%) | 111 (51%) | |
Positive | 80 (18%) | 39 (18%) | |
Missing | 135 (31%) | 67 (31%) | |
Grade 3 thrombocytopenia | .76 | ||
Negative | 173 (39%) | 83 (38%) | |
Positive | 131 (30%) | 67 (31%) | |
Missing | 135 (31%) | 67 (31%) | |
Albumin | .41 | ||
>3.5 | 81 (18%) | 47 (22%) | |
<3.5 | 157 (36%) | 74 (34%) | |
Missing | 201 (46%) | 96 (44%) | |
LDH | .93 | ||
<200 | 37 (8%) | 21 (10%) | |
200-1000 | 146 (33%) | 74 (34%) | |
>1000 | 11 (3%) | 6 (3%) | |
Missing | 245 (56%) | 116 (54%) |
. | ven/aza (N = 439) . | CPX-351 (N = 217) . | P . |
---|---|---|---|
Age, y | 75 (36-88) | 67 (21-82) | <.001 |
Sex | .056 | ||
Female | 191 (44%) | 112 (52%) | |
Male | 248 (56%) | 105 (48%) | |
Practice type | <.001 | ||
Academic | 149 (34%) | 103 (47%) | |
Community | 290 (66%) | 114 (53%) | |
Insurance | .047 | ||
Commercial | 137 (31%) | 76 (35%) | |
Medicare | 126 (29%) | 43 (20%) | |
Other | 176 (40%) | 98 (45%) | |
Performance Status | .23 | ||
0-1 | 62 (14%) | 31 (14%) | |
2-4 | 197 (45%) | 72 (33%) | |
Missing | 181 (41%) | 116 (53%) | |
NPM1 mutation | .19 | ||
Negative | 277 (63%) | 131 (60%) | |
Positive | 36 (8%) | 25 (12%) | |
Missing | 126 (29%) | 61 (28%) | |
IDH1 or IDH2 mutation | .36 | ||
Negative | 244 (56%) | 113 (52%) | |
IDH1 or IDH2 | 72 (16%) | 41 (19%) | |
Missing | 124 (28%) | 63 (29%) | |
FLT3 | .17 | ||
Negative | 291 (66%) | 139 (64%) | |
FLT3 mutation | 30 (7%) | 13 (6%) | |
Missing | 118 (27%) | 65 (30%) | |
High-risk mutations | .17 | ||
Negative | 201 (46%) | 90 (41%) | |
RUNX1 | 29 (7%) | 22 (10%) | |
ASXL1 | 42 (10%) | 14 (6%) | |
TP53 | 57 (13%) | 33 (15%) | |
Missing | 110 (25%) | 58 (27%) | |
Type | <.001 | ||
De novo | 226 (51%) | 63 (29%) | |
History of MDS/MPN | 150 (34%) | 104 (47%) | |
Therapy-related | 63 (14%) | 50 (23%) | |
European LeukemiaNet 2017 risk group | .80 | ||
Favorable | 34 (8%) | 15 (7%) | |
Intermediate | 117 (27%) | 64 (30%) | |
Adverse | 172 (39%) | 92 (42%) | |
Missing | 116 (26%) | 46 (21%) | |
MRC | .63 | ||
Negative | 176 (40%) | 88 (40%) | |
Positive | 160 (36%) | 72 (33%) | |
Missing | 103 (23%) | 57 (26%) | |
HCT comorbidity index | .28 | ||
0 | 116 (26%) | 69 (32%) | |
1-2 | 156 (36%) | 70 (32%) | |
≥3 | 83 (19%) | 35 (16%) | |
Missing | 85 (19%) | 44 (20%) | |
Baseline marrow blasts | .14 | ||
Missing | 23 (5%) | 11 (5%) | |
<30% | 152 (35%) | 70 (32%) | |
31-50% | 136 (31%) | 86 (40%) | |
>50% | 128 (29%) | 50 (23%) | |
Baseline white blood cell count | .41 | ||
<20 | 228 (52%) | 105 (48%) | |
>20 | 211 (48%) | 112 (52%) | |
Grade 3 neutropenia | .37 | ||
Negative | 168 (38%) | 90 (41%) | |
Positive | 136 (31%) | 60 (28%) | |
Missing | 135 (31%) | 67 (31%) | |
Grade 3 anemia | 1.00 | ||
Negative | 224 (51%) | 111 (51%) | |
Positive | 80 (18%) | 39 (18%) | |
Missing | 135 (31%) | 67 (31%) | |
Grade 3 thrombocytopenia | .76 | ||
Negative | 173 (39%) | 83 (38%) | |
Positive | 131 (30%) | 67 (31%) | |
Missing | 135 (31%) | 67 (31%) | |
Albumin | .41 | ||
>3.5 | 81 (18%) | 47 (22%) | |
<3.5 | 157 (36%) | 74 (34%) | |
Missing | 201 (46%) | 96 (44%) | |
LDH | .93 | ||
<200 | 37 (8%) | 21 (10%) | |
200-1000 | 146 (33%) | 74 (34%) | |
>1000 | 11 (3%) | 6 (3%) | |
Missing | 245 (56%) | 116 (54%) |
Data are presented as median (range) for continuous measures and n (%) for categorical measures. Performance Status refers to Eastern Cooperative Oncology Group definitions. MRC is “myelodysplasia related changes” referring to the following cytogenetic changes (del5q, del7q, del11, del12, del17, or 3 or more cytogenetic changes without recurrent genetic abnormalities; supplemental Table 7b); additional cytogenetic defining changes are not captured in Flatiron Health. Grade 3 neutropenia, anemia, and thrombocytopenia according to the Common Terminology criteria for Adverse Events.