Table 4.
Comparison of our study with available literature
| Study | DiNardo CD et al. (2019) [14] | Wei et al. (2018) [20] | Aldoss et al. (2018) [21] | DiNardo et al. (2018) [22] | Winters AC et al. (2019) [23] | DiNardo et al. (2020) [27] | Wei et al. [28] | Our study |
|---|---|---|---|---|---|---|---|---|
| Patient population | ND% (n=145) | ND% (n=82) | R/R^ (n=33) | R/R^ (n=39) | ND% (n=33)/(n=36) | ND% (n=433) | ND% (n=211) | ND%+R/R^ (n=24) |
| Venetoclax (Ven) along with - | HMAs¶ (Aza@/Dac#), LDAC* | LDAC* | HMAs¶ (Aza@/Dac#) | HMAs¶ (Aza@/Dac#), LDAC* | HMAs¶ | HMA¶+Ven (n=286) vs HMA¶+placebo (n=145) | LDAC*+Ven (n=143) vs LDAC*+placebo (n=68) | HMAs¶ (Aza)@ |
| Venetoclax dose (mg)/duration (days) | 400 OD (28) | 600 OD (28) | 400 OD (28) | 400/600 OD (14-28) | 400 OD (28) | 400 OD (28) | 600 OD (28) | 400 OD (14-28) |
| CR/CRi¥ (%) | 67 | 54 | 51.5 | 12 | 63/84 | 66.4 vs 28.3 | 48 vs 13 | 58.3 |
| Median Time to CR (months) | 2.1 | 2.5 | 2 | 1 | 1 | 1.3 | n/a( | 2 |
| CR duration (months) | 11.3 | 8.1 | 8.9 | n/a | 11/not reached | 17.5 vs 13.3 | n/a( | 8.1 |
| Grade 3-4 leukopenia (%) | 31 | 34 | n/a | 100 | 40 (n=28) | 21 vs 12 | 46 vs 16 (neutropenia) | 70 |
| % mortality | 8 (60-day) | 6 (30-day) | n/a( | 12 (30-day) | 13 (30-day) | 7 vs 6 (30-day) | 13 vs 16 (30-day) | 8 (60-day) |
| FN$ | 43% | 42% | 42% | 72% | n=14 | 42 vs 19 | 32 vs 29 | 36 (33%) [All cycles] |
| 32 (64%) [First 2 cycles] | ||||||||
| TLS& | n=0 | n=2 | n/a( | n=0 | n/a( | n/a( | 6 vs 0 | n=2 (1.8%) |
| OS£ | 17.5 months | 10 months | 53% (1 year) | 3 months | 12 months/29 months | 14.6 months vs 9.1 months | 7.2 months vs 4.1 months | 8 months (55.8%, 1 year) |
| (whole cohort), | ||||||||
| 15 months (responders) |
FN: Febrile neutropenia;
CR/CRi: Complete Remission/Complete Remission with Incomplete Hematologic Recovery;
LDAC: Low dose Cytarabine;
TLS: Tumor Lysis syndrome;
OS: Overall survival;
HMA: Hypomethylating agents;
Aza: azacytidine;
- Dac: Decitabine;
- ND: newly diagnosed;
- R/R: Relapsed/refractory;
- n/a: not available.