Selected outcomes of monotherapy azacitidine or decitabine (n > 75 patients)
Trial . | CALGB 9221 . | NCT01522976 . | NCT00071799 . | NCT00102687 . | NCT02158936 . | NCT01751867 . | NCT00260065 . | NCT00043381 . | NCT00067808 . | NCT00043134 . | NCT01041846 . |
---|---|---|---|---|---|---|---|---|---|---|---|
Drug | Azacitidine | Azacitidine | Azacitidine | Azacitidine | Azacitidine | Decitabine | Decitabine | Decitabine | Decitabine | Decitabine | Decitabine |
N | 99 | 92 | 179 | 151 | 177 | 132 | 99 | 89 | 95 | 119 | 103 |
IPSS | |||||||||||
Low | 2 | 3 | 0 | 1 | |||||||
INT-1 | 21 | 25 | 5 | 61 | 57 | 52 | 28 | 19 | 8 | 52 | |
INT-2 | 9 | 40 | 76 | 83 | 58 | 23 | 38 | 26 | 64 | 35 | |
High | 7 | 20 | 82 | 33 | 20 | 23 | 23 | 11 | 46 | 13 | |
Cytogenetic risk | |||||||||||
Good | 29 | 83 | 81 | 49 | 38 | 65 | |||||
Intermediate | 16 | 37 | 22 | 15 | 9 | 15 | |||||
Poor | 33 | 50 | 32 | 29 | 57 | 19 | |||||
MDS subtype | |||||||||||
MDS SLD | 17 | 0 | 65 | 27 | 20 | 12 | 5 | 4 | |||
MDS RS | 5 | 0 | 21 | 4 | 17 | 7 | 3 | ||||
MDS MLD | 0 | 27 | |||||||||
LB MDS | 22 | 0 | 86 | 31 | 37 | 19 | 8 | 31 | |||
MDS EB1 | 29 | 14 | 10 | 23 | 30 | 26 | |||||
MDS EB2 | 35 | 98 | 31 | 30 | 31 | 32 | |||||
MDS-EB | 32 | 64 | 112 | 45 | 85 | 41 | 47 | 53 | 61 | 58 | |
Unspecified MDS | 1 | 10 | 19 | ||||||||
AML | 37 | 55 | 4 | 11 | 10 | 17 | 5 | 41 | |||
CMML | 7 | 18 | 11 | 16 | 8 | 11 | 6 | 18 | 11 | ||
Reported responses | |||||||||||
CR | 7 | 22 | 30 | 6 | 26 | 13 | 17 | 8 | 32 | 16 | 13 |
PR | 16 | 0 | 21 | 5 | 0 | 7 | 1 | 7 | 1 | ||
mCR | 11 | 36 | 22 | 15 | 10 | 23 | |||||
HI | 37 | 13 | 87/177 | 73/151 | 59/177 | 50 | 18 | 12 | 13 | 18 | 19 |
HI-E | 13 | 62/157 | 58/130 | 7 | 35/97 | ||||||
HI-P | 20 | 46/141 | 23/54 | 7 | 30/69 | ||||||
HI-N | 16 | 25/131 | 17/70 | 3 | 20/53 | ||||||
RBC TI | 29/65 | 50/111 | 40/71 | 38/88 | 22/66 | ||||||
OS | 20 mo | 15 mo | 24.5 mo | 23.8 mo | 19.4 mo | 23.5 mo | 19 mo | 10.1mo | 17.7mo |
Trial . | CALGB 9221 . | NCT01522976 . | NCT00071799 . | NCT00102687 . | NCT02158936 . | NCT01751867 . | NCT00260065 . | NCT00043381 . | NCT00067808 . | NCT00043134 . | NCT01041846 . |
---|---|---|---|---|---|---|---|---|---|---|---|
Drug | Azacitidine | Azacitidine | Azacitidine | Azacitidine | Azacitidine | Decitabine | Decitabine | Decitabine | Decitabine | Decitabine | Decitabine |
N | 99 | 92 | 179 | 151 | 177 | 132 | 99 | 89 | 95 | 119 | 103 |
IPSS | |||||||||||
Low | 2 | 3 | 0 | 1 | |||||||
INT-1 | 21 | 25 | 5 | 61 | 57 | 52 | 28 | 19 | 8 | 52 | |
INT-2 | 9 | 40 | 76 | 83 | 58 | 23 | 38 | 26 | 64 | 35 | |
High | 7 | 20 | 82 | 33 | 20 | 23 | 23 | 11 | 46 | 13 | |
Cytogenetic risk | |||||||||||
Good | 29 | 83 | 81 | 49 | 38 | 65 | |||||
Intermediate | 16 | 37 | 22 | 15 | 9 | 15 | |||||
Poor | 33 | 50 | 32 | 29 | 57 | 19 | |||||
MDS subtype | |||||||||||
MDS SLD | 17 | 0 | 65 | 27 | 20 | 12 | 5 | 4 | |||
MDS RS | 5 | 0 | 21 | 4 | 17 | 7 | 3 | ||||
MDS MLD | 0 | 27 | |||||||||
LB MDS | 22 | 0 | 86 | 31 | 37 | 19 | 8 | 31 | |||
MDS EB1 | 29 | 14 | 10 | 23 | 30 | 26 | |||||
MDS EB2 | 35 | 98 | 31 | 30 | 31 | 32 | |||||
MDS-EB | 32 | 64 | 112 | 45 | 85 | 41 | 47 | 53 | 61 | 58 | |
Unspecified MDS | 1 | 10 | 19 | ||||||||
AML | 37 | 55 | 4 | 11 | 10 | 17 | 5 | 41 | |||
CMML | 7 | 18 | 11 | 16 | 8 | 11 | 6 | 18 | 11 | ||
Reported responses | |||||||||||
CR | 7 | 22 | 30 | 6 | 26 | 13 | 17 | 8 | 32 | 16 | 13 |
PR | 16 | 0 | 21 | 5 | 0 | 7 | 1 | 7 | 1 | ||
mCR | 11 | 36 | 22 | 15 | 10 | 23 | |||||
HI | 37 | 13 | 87/177 | 73/151 | 59/177 | 50 | 18 | 12 | 13 | 18 | 19 |
HI-E | 13 | 62/157 | 58/130 | 7 | 35/97 | ||||||
HI-P | 20 | 46/141 | 23/54 | 7 | 30/69 | ||||||
HI-N | 16 | 25/131 | 17/70 | 3 | 20/53 | ||||||
RBC TI | 29/65 | 50/111 | 40/71 | 38/88 | 22/66 | ||||||
OS | 20 mo | 15 mo | 24.5 mo | 23.8 mo | 19.4 mo | 23.5 mo | 19 mo | 10.1mo | 17.7mo |
HI-E, Hematologic improvement - erythroid; HI-N, hematologic improvement - neutrophils; HI-P, hematologic improvement - platelets; MLD, multilineage dysplasia; RBC TI, red blood cell transfusion independence; RS, ring sideroblasts; SLD, single lineage dysplasia.