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R. Aplenc et al.
Minimal residual disease (MRD) assessment at the end of Induction I was available in 95% of patients, and was neg- ative in 75%. Thus, approximately 78% of all patients were classified as low-risk based on cytogenetic, molecu- lar, and disease response features, while 22% were classi- fied as high-risk.
Of the 1,097 patients enrolled on AAML1031, approxi- mately 84% survived and achieved a remission at the end
of two courses of induction. For the 1,024 patients who initiated the second course of induction therapy and were evaluable at the end of Induction II, the remission rate was 90% and there was no difference between study arms. No differences in EFS and OS were observed by study arm (Table 2 and Figure 2). Specifically, the 3-year EFS from study entry for the no bortezomib and bortezomib arms were 44.8%±4.5% versus 47.0%±4.5% (P=0.236) and the
Table 2. Event-free survival, overall survival, and treatment-related mortality by study arm.
3-year EFS from study entry
3-year OS from study entry
3-year CI of relapse from study entry 1-year TRM from study entry
3-year DFS from end of Induction I 3-year OS from end of Induction I 3-year DFS from end of Induction II 3-year OS from end of Induction II
1-year TRM from end of Induction II
Overall
N % ± 2 SE%
1097 45.9 ± 3.2
1097 65.4 ± 3.1
1097 47.2 ± 3.2
1097 11.8 ± 5.2
1015 47.8 ± 3.3
1015 66.6 ± 3.2
910 52.4 ± 3.5
910 70.5 ± 3.3
910 9.7 ± 5.2
Arm A
N % ± 2 SE%
542 44.8 ± 4.5
542 63.6 ± 4.5
542 48.0 ± 4.5
542 13.3 ± 8.2
506 46.9 ± 4.6
506 65.2 ± 4.6
453 51.8 ± 4.9
453 69.3 ± 4.8
453 10.4 ± 7.6
Arm B
N % ± 2 SE%
555 47.0 ± 4.5
555 67.2 ± 4.3
555 46.4 ± 4.4
555 10.5 ± 6.6
509 48.7 ± 4.6
509 68.0 ± 4.5
457 53.0 ± 4.9
457 71.7 ± 4.7
457 9.0 ± 7.2
P
0.236
0.356 0.378 0.577 0.261 0.451 0.444 0.453 0.331
EFS: event-free survival; OS: overall survival; CI: cumulative incidence; TRM: treatment-related mortality; DFS: disease-free survival; SE: standard error.
Figure 1. Consort diagram – AAML1031, as of December 31, 2017. High AR: W/D: Elective withdrawal. Reasons include terminating therapy to due to physician's choice or patient's refusal of further protocol therapy. SCT: stem cell transplantation; TX: therapy; n: number.
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haematologica | 2020; 105(7)