Characteristics and univariate analysis of factors associated with response and survival of the 44 MDS patients who received venetoclax and hypomethylating agent therapy
| . | Baseline characteristics . | Overall response, % . | . | Overall survival . | |||
|---|---|---|---|---|---|---|---|
| Variable . | Total evaluable, n . | Frequency, n (%) . | Yes . | No . | P . | HR (95% CI) . | Log rank . |
| Age, y | 44 | .13 | 0.10 | ||||
| ≤60 | 8 (18) | 62 | 38 | 1 | |||
| 60-67 | 11 (25) | 82 | 18 | 1.76 (0.16-19.51) | |||
| 67-74 | 13 (30) | 62 | 38 | 4.47 (0.54-37.28) | |||
| >74 | 12 (27) | 33 | 67 | 6.64 (0.83-53.36) | |||
| Sex | 44 | .36 | 0.16 | ||||
| Male | 24 (55) | 67 | 33 | 1 | |||
| Female | 20 (45) | 50 | 50 | 2.00 (0.75-5.33) | |||
| Therapy related | 44 | .11 | <0.01 | ||||
| No | 29 (66) | 69 | 31 | 1 | |||
| Yes | 15 (34) | 40 | 60 | 3.82 (1.4-10.46) | |||
| HMA exposure | 44 | .26 | 0.82 | ||||
| Naive | 12 (28) | 75 | 25 | 1 | |||
| ≤4 cycles | 16 (36) | 62 | 38 | 1.12 (0.30-4.2) | |||
| HMA failure | 16 (36) | 44 | 56 | 1.43 (0.42-4.84) | |||
| Bone marrow blast, T0, % | 44 | .54 | 0.30 | ||||
| >10 | 25 (57) | 64 | 36 | 1 | |||
| ≤10 | 19 (43) | 53 | 47 | 1.64 (0.63-4.26) | |||
| R-IPSS cytogenetic risk | 43 | .03 | <0.01* | ||||
| Other | 33 (77) | 70 | 30 | 1 | |||
| Very poor risk | 10 (23) | 30 | 70 | 9.21 (3.04-27.89) | |||
| TP53 mutated | 40 | .15 | <0.01* | ||||
| No | 29 (72) | 66 | 34 | 1 | |||
| Yes | 11 (28) | 36 | 64 | 8.32 (2.48-27.96) | |||
| R-IPSS risk | 42 | .12 | <0.01* | ||||
| Other | 24 (57) | 71 | 29 | 1 | |||
| Very high risk | 18 (43) | 44 | 56 | 7.94 (2.2-28.68) | |||
| Type of HMA with venetoclax | 44 | .22 | 0.03 | ||||
| Azacitidine | 27 (61) | 67 | 33 | 1 | |||
| Decitabine | 17 (39) | 47 | 53 | 2.78 (1.05-7.35) | |||
| Venetoclax dose, T0, mg | 43 | 1 | 0.45 | ||||
| 400 | 18 (42) | 61 | 39 | 1 | |||
| 200 | 16 (37) | 62 | 38 | 0.81 (0.23-2.81) | |||
| ≤100 | 9 (21) | 56 | 44 | 1.78 (0.56-5.65) | |||
| Azole antifungals | 44 | .36 | 0.39 | ||||
| No | 25 (57) | 52 | 48 | 1 | |||
| Yes | 19 (43) | 68 | 32 | 1.53 (0.58-4.01) | |||
| Cycle 2 or 3 delay ≥7 d | 24 | .41 | 0.92 | ||||
| No | 8 (33) | 50 | 50 | 1.09 (0.21-5.56) | |||
| Yes | 16 (67) | 69 | 31 | 1 | |||
| Venetoclax dosing first cycle, d | 44 | .42 | 0.56 | ||||
| ≤14 | 4 (9) | 50 | 50 | 1 | |||
| 15-21 | 6 (14) | 83 | 17 | 0.51 (0.13-1.69) | |||
| 22-28 | 34 (77) | 56 | 44 | 0.47 (0.10-2.71) | |||
| . | Baseline characteristics . | Overall response, % . | . | Overall survival . | |||
|---|---|---|---|---|---|---|---|
| Variable . | Total evaluable, n . | Frequency, n (%) . | Yes . | No . | P . | HR (95% CI) . | Log rank . |
| Age, y | 44 | .13 | 0.10 | ||||
| ≤60 | 8 (18) | 62 | 38 | 1 | |||
| 60-67 | 11 (25) | 82 | 18 | 1.76 (0.16-19.51) | |||
| 67-74 | 13 (30) | 62 | 38 | 4.47 (0.54-37.28) | |||
| >74 | 12 (27) | 33 | 67 | 6.64 (0.83-53.36) | |||
| Sex | 44 | .36 | 0.16 | ||||
| Male | 24 (55) | 67 | 33 | 1 | |||
| Female | 20 (45) | 50 | 50 | 2.00 (0.75-5.33) | |||
| Therapy related | 44 | .11 | <0.01 | ||||
| No | 29 (66) | 69 | 31 | 1 | |||
| Yes | 15 (34) | 40 | 60 | 3.82 (1.4-10.46) | |||
| HMA exposure | 44 | .26 | 0.82 | ||||
| Naive | 12 (28) | 75 | 25 | 1 | |||
| ≤4 cycles | 16 (36) | 62 | 38 | 1.12 (0.30-4.2) | |||
| HMA failure | 16 (36) | 44 | 56 | 1.43 (0.42-4.84) | |||
| Bone marrow blast, T0, % | 44 | .54 | 0.30 | ||||
| >10 | 25 (57) | 64 | 36 | 1 | |||
| ≤10 | 19 (43) | 53 | 47 | 1.64 (0.63-4.26) | |||
| R-IPSS cytogenetic risk | 43 | .03 | <0.01* | ||||
| Other | 33 (77) | 70 | 30 | 1 | |||
| Very poor risk | 10 (23) | 30 | 70 | 9.21 (3.04-27.89) | |||
| TP53 mutated | 40 | .15 | <0.01* | ||||
| No | 29 (72) | 66 | 34 | 1 | |||
| Yes | 11 (28) | 36 | 64 | 8.32 (2.48-27.96) | |||
| R-IPSS risk | 42 | .12 | <0.01* | ||||
| Other | 24 (57) | 71 | 29 | 1 | |||
| Very high risk | 18 (43) | 44 | 56 | 7.94 (2.2-28.68) | |||
| Type of HMA with venetoclax | 44 | .22 | 0.03 | ||||
| Azacitidine | 27 (61) | 67 | 33 | 1 | |||
| Decitabine | 17 (39) | 47 | 53 | 2.78 (1.05-7.35) | |||
| Venetoclax dose, T0, mg | 43 | 1 | 0.45 | ||||
| 400 | 18 (42) | 61 | 39 | 1 | |||
| 200 | 16 (37) | 62 | 38 | 0.81 (0.23-2.81) | |||
| ≤100 | 9 (21) | 56 | 44 | 1.78 (0.56-5.65) | |||
| Azole antifungals | 44 | .36 | 0.39 | ||||
| No | 25 (57) | 52 | 48 | 1 | |||
| Yes | 19 (43) | 68 | 32 | 1.53 (0.58-4.01) | |||
| Cycle 2 or 3 delay ≥7 d | 24 | .41 | 0.92 | ||||
| No | 8 (33) | 50 | 50 | 1.09 (0.21-5.56) | |||
| Yes | 16 (67) | 69 | 31 | 1 | |||
| Venetoclax dosing first cycle, d | 44 | .42 | 0.56 | ||||
| ≤14 | 4 (9) | 50 | 50 | 1 | |||
| 15-21 | 6 (14) | 83 | 17 | 0.51 (0.13-1.69) | |||
| 22-28 | 34 (77) | 56 | 44 | 0.47 (0.10-2.71) | |||
Boldface numbers indicate variables with P < .05.
CI, confidence interval; T0, time at start of combination treatment.
P values below Bonferroni-adjusted level considering all comparisons, 0.0017 (0.05/30).