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performance status, features of leukostasis syndrome, and higher WBC count. Hydroxyurea treatment was given to 49 patients in the dexamethasone group and to 59 patients in the no dexamethasone group. Allogeneic stem cell transplantation was given to 19 patients in the dexam- ethasone group and to 25 patients in the no dexametha- sone group. Of note, overall survival of patients (aged 18– 75 years) with a WBC count <50 x 109/L who were treated with intensive chemotherapy between 2004 and 2009 (336 patients with 232 deaths; median overall survival, 21.5 months; IQR: 7.6–158.8) did not differ significantly from that of patients treated between 2010 and 2015 (295 patients with 164 deaths, median overall survival, 25.8 months; IQR: 9.1–not achieved) (hazard ratio for 2010– 2015 vs. 2004–2009=0.95; 95% CI: 0.77–1.16; P=0.595).
Impact of dexamethasone during the induction phase
Fifty patients (83.3%) from the dexamethasone group and 74 (74%) from the no dexamethasone group achieved a complete response (P=0.171) (Table 2). At day 60 of induction chemotherapy, 7 patients (11.7%) in the dexam- ethasone group had died compared to 20 patients (20%) in the no dexamethasone group (P=0.173). There were no significant differences between the two groups in terms of
fungal (P=0.710) or bacterial (P=0.192) infections. However, grade 3-4 bleeding events were more frequent in the dexamethasone group compared to the no dexam- ethasone group [13 (21.7%) vs. 6 (6.2%); P=0.038] as were admissions to the intensive-care unit by day 90 [29 (48.3%) vs. 17 (17.0%); P<0.0001].
Impact of dexamethasone on relapse and survival
In the univariate analyses, the use of dexamethasone was associated with an improved outcome, with the improvement reaching statistical significance for relapse incidence (sub-HR: 0.43; 95% CI: 0.25-0.74; P=0.003), dis- ease-free survival (HR: 0.48; 95% CI: 0.29-0.80; P=0.005), event-free survival (HR: 0.52; 95% CI: 0.34-0.79; P=0.002), and overall survival (HR: 0.55; 95% CI: 0.35-0.85; P=0.005) (Figure 2). In a Fine and Gray competing risks model, the use of dexamethasone was associated with a significantly lower risk of relapse (adjusted sub-HR: 0.30; 95% CI: 0.14-0.62; P=0.001) (Online Supplementary Table S1). In multivariate analyses, the use of dexamethasone was associated with significantly better outcomes when considering disease-free survival (adjusted HR: 0.50; 95% CI: 0.29-0.84; P=0.010) (Online Supplementary Table S2), event-free survival (adjusted HR: 0.35; 95% CI: 0.21-0.58;
Figure 1. Study flowchart. y: years; WBC: white blood cell; OS: overall survival; CR: complete response.
haematologica | 2018; 103(6)