Table 2.

Summary of multiple regression analyses for response

VariableOR (95% CI] for failure to respondOR (95% CI] for failure to achieve CR
All patients (n = 428)400 mg monotherapy (n = 339)All patients (n = 428)400 mg monotherapy (n = 339)
Max node size, cm     
 ≥5 to <10 NI NI 3.1 (1.8-5.4) 3.5(1.6-7.5) 
 ≥10 NI NI 13.5 (3.1-58.5) 7.6 (1.7-34.5) 
Prior therapies     
 2 to 3 1.5 (0.7-3.3) 1.5 (0.6-3.5) 2.2 (1.1-4.0) 2.8 (1.3-6.0) 
 >3 2.5 (1.2-5.3) 2.7 (1.2-6.1) 2.6 (1.3-5.1) 3.5 (1.5-8.1) 
Fludarabine refractory NI NI NI NI 
Prior BCRi exposure 2.2(1.4-3.5) 2.4(1.4-4.0) 5.1(2.6-10.1) 3.0(1.4-6.4) 
TP53 mutation and/or 17p deletion NI 1.8 (1.0-3.1) NI NI 
13q deletion NI NI NI 0.4 (0.2-0.9) 
NOTCH1 mutation NI NI NI NI 
IGHV wild type NI NI NI NI 
Monotherapy vs combination* 0.8 (0.3-1.8) — 0.4(0.2-0.7) — 
VariableOR (95% CI] for failure to respondOR (95% CI] for failure to achieve CR
All patients (n = 428)400 mg monotherapy (n = 339)All patients (n = 428)400 mg monotherapy (n = 339)
Max node size, cm     
 ≥5 to <10 NI NI 3.1 (1.8-5.4) 3.5(1.6-7.5) 
 ≥10 NI NI 13.5 (3.1-58.5) 7.6 (1.7-34.5) 
Prior therapies     
 2 to 3 1.5 (0.7-3.3) 1.5 (0.6-3.5) 2.2 (1.1-4.0) 2.8 (1.3-6.0) 
 >3 2.5 (1.2-5.3) 2.7 (1.2-6.1) 2.6 (1.3-5.1) 3.5 (1.5-8.1) 
Fludarabine refractory NI NI NI NI 
Prior BCRi exposure 2.2(1.4-3.5) 2.4(1.4-4.0) 5.1(2.6-10.1) 3.0(1.4-6.4) 
TP53 mutation and/or 17p deletion NI 1.8 (1.0-3.1) NI NI 
13q deletion NI NI NI 0.4 (0.2-0.9) 
NOTCH1 mutation NI NI NI NI 
IGHV wild type NI NI NI NI 
Monotherapy vs combination* 0.8 (0.3-1.8) — 0.4(0.2-0.7) — 

All variables included in univariate analyses were tested in the multiple regressions. Covariates selected by stepwise regression are reported, and the effects of monotherapy vs combination were added as a variable of interest after model selection. Those bolded are significant, and are italicized if they are also confirmed as significant in a lesser powered sensitivity analysis that only included patients in whom all data for all genetic variables were informative (supplemental Table 4).

NI, not included in final model; —, not applicable

*

After pretreatment variables of significance in multiple regression analyses were identified, the treatment variable of venetoclax monotherapy (reference) or combination with rituximab was added into the multiple logistical regression model. Significant pretreatment variables remained significant.

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