Page 132 - 2019_01-Haematologica-web

N. Niktoreh et al.
Results
Patients’ characteristics and treatment with GO
The majority of patients were initially diagnosed with AML with the French-American-British (FAB) classifica- tion of M4 (without atypical eosinophils) or M5 (n=29,
Table 1. Patients’ characteristics at initial diagnosis.
Feature n
Total number of patients 76
Age, years
Median (range) Categories
0-2 15 3-10 26 11-18 35
Sex
Female 33 Male 43
FAB Classification
M0 6 M1/M2 25 M3 1 M4Eo-/M5 29 M6 1 M7 7 AML-not classified 7
WBC count at diagnosis
Median x109/L(range)
Patients with WBC ≤100x109/L 62 Patients with WBC >100x109/L 13 Nodata 1
Previous treatments
Pre-treatment with FLA/G 12 Pre-treatment with FLA/G+DX (+/- FLA/G)a 43 Pre-treatment without FLA/G+DX or FLA/G 21
HSCT prior to GO treatment
Yes 14 No 62
Disease status prior to GO
Refractory de novo AMLb 10 De novo AML- refractory to 1st early relapsec 41 De novo AML-refractory to 1st late relapsec 10 De novo AML- refractory to 2nd relapsec 8 De novo AML-refractory to 3rd relapsec 2 Secondary AML- refractory to 1st/2nd relapsec 5
Risk groupd
Standard risk 9 High risk 67
39%) and 13 (17%) patients had white blood cell (WBC) counts higher than 100x109/L at the time of their diagno- sis. In total, 67 (88%) patients had high-risk AML as defined by morphology, cytogenetics and response to treatment, retrospectively (Table 1). Most of the patients (n=43, 56%) had been previously treated with liposomal
9.3 (1 months - 17 years)
%
100
20 34 46
43 57
8 33 1 39 1 9 9
82 17 1
16 56 28
18 82
13 54 13 11 3 6
12
88
14.8 (0.39 - 324)
n: number; FAB classification: French-American-British classification; M4Eo-: AML M4 subtype without the presence of atypical eosinophils; AML: acute myeloid leukemia; HSCT: hematopoietic stem cell transplantation; FLA/G: fludarabine, cytarabine with or without granulocyte colony stimulating factor; DX: liposomal daunorubicin; GO: gemtuzumab ozogamicin;WBC:white blood cell.aSome of the patients in this category received FLA/G in addition to FLA/G+DX.bGO was administered after failure of first-line treatment(s). cGO was administered after failure of treatment for the relapse episode. dStandard risk indicates FAB M1/2 with Auer rods, FAB M4 with atypical eosinophils (M4Eo), FAB M3 and/or favorable cytogenetics, such as t(8;21) and/or AML1-ETO, t(15;17), and/or PML-RARA and inv(16) or t(16;16) and/or CBFB/MYH1, if there was no persistence of BM blasts (≥5%) on day 15.FLT3-ITD positivity was not considered.All others were classified as high-risk patients.
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