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. 2021 Jun 15;11(3):290–302.

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.