Page 112 - 2018_12-Haematologica-web

L. Adès et al.
other causes) and two (0.9%) had resistant leukemia. Seventeen patients were not randomized to consolidation treatment, including the nine patients who did not achieve a complete remission, three due to adverse events and five consequent to the patients’ decision.
One hundred and ninety-seven patients were random- ized to consolidation therapy, 99 in the chemotherapy group and 98 in the chemotherapy plus ATO groups. Pre- treatment characteristics were well balanced between the two groups (Table 2). With a median follow-up of 52 months, eight patients (4 in the chemotherapy group versus
Table 1. Baseline characteristics of the patients aged <70 years with standard-risk acute promyelocytic leukemia.
4 in the chemotherapy plus ATO group) had relapsed lead- ing to 5-year cumulative incidence rates of 4.6% [95% con- fidence interval (95% CI: 1.5; 10.6) and 3.5% (95% CI: 0.9; 9.2), P=0.99] and 13 patients had died in complete remis- sion including nine in the chemotherapy arm and four in the chemotherapy plus arm (P=0.98). One patient, random- ized to the chemotherapy plus ATO arm, developed AML/MDS. The 5-year overall survival rates were 90% and 93% in the chemotherapy and chemotherapy plus ATO groups, respectively (P=0.62), while the corresponding 5-
Table 2. Baseline characteristics of the patients aged less than 70 years with high-risk acute promyelocytic leukemia.
Median [Q1-Q3]
Age (years)
WBC (x109/L)
Platelets(x109/L) Fibrinogen (g/L) %M3v
Previous cancer
AraC Arm N=178
45.4 [32.45; 55.95]
1.3
[0.8; 2.3]
44.5 [25; 71]
1.8 [1.2; 2.7]
3%
12%
ATO Arm N=180
49.4 [38.85; 57.8]
1.4
[0.95; 2.615] 46 [20.75; 77] 1.7 [1.1; 2.65] 8%
12%
ATRA Arm N=180
50.5 [38.4; 60.8]
1.51
[0.8; 3.45]
42 [20; 68]
1.8 [1.2; 2.6]
5%
9%
Median [Q1-Q3]
Age (years)
WBC (x109/L)
Platelets (x109/L)
Fibrinogen (g/L)
%M3v
% Previous cancer
CT Arm n=99
39.2 [29.6 ; 54.1]
23.7
[14.7; 37.3]
26.5 [13.3; 47.8]
1.3
[1.1; 1.7] 34% 8%
CT + ATO Arm n=98
45.0 [33.85; 58.9]
19.7
[13; 34.2]
32 [18; 51]
1.3
[0.9; 1.8] 28% 11%
QI: first quartile; Q3: third quartile; AraC: cytarabine; ATO: arsenic trioxide; ATRA: all- trans retinoic acid; WBC: white blood cells; %M3v: microgranular variant (%).
QI:first quartile;Q3:third quartile;CT:chemotherapy;ATO:arsenic trioxide;WBC:white blood cells; %M3v: microgranular variant (%).
Figure 2. Event-free survival, cumulative incidence of relapse and overall survival in patients with standard- risk acute promyelocytic leukemia. ARAC: cytarabine; ATO: arsenic trioxide; ATRA: all-trans retinoic acid; CR: complete remission.
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