Patient characteristics
Of 745 patients included in CoALL08-09 89 patients (11.9 %) were
allocated to the HR-I treatment arm according to MRD levels at EOI
(figure 2). Twelve patients from the HR-I group did not receive AEP (six
patients underwent SCT without prior AEP bridging treatment, three
patients died before receiving AEP due to a treatment-related morbidity
and three patients received other therapy modifications upon physicians’
individual decision).
Fortytwo patients (5.6 %) were classified as failure of remission
induction by morphology and confirmed by MRD analysis. Twenty of those
did not receive AEP, because SCT was performed prior to AEP (nine
patients), treatment-related mortality before AEP (two patients),
allergic reaction to amsacrine (one patient) or other therapy
modifications according to physicians’ decision (eight patients). One
patient had to be excluded from the response analysis in the AEP cohort
because of lacking MRD data (figure 2).
The remaining 77 patients in the HR-I group and 22 patients prior to SCT
received AEP and were therefore eligible and evaluable for this
analysis.
There were 42 high-risk patients from the predecessor trial CoALL07-03
(4.9 % of all patients) with MRD EOI in a comparable range as the HR-I
patients, i.e. B-lineage ALL: MRD ≥ 10-3 at day 29 and
T-lineage-ALL: MRD ≥ 10-3 at day 29 and day 43. This
patient cohort did not receive AEP as part of their consolidation
treatment (figure 1) and was used for comparative analysis. The reason
for the small proportion of patients with an MRD result in CoALL07-03 is
the fact that MRD analysis was not used by default in the first three
years of this trial. Due to substantial heterogeneity in treatment
approaches we did not perform a comparative analysis of ALL patients
with IF including historical control cohorts.
There was an equal distribution of sex and age in the different patient
groups. With regard to the molecular genetic features we noted fewerETV6/RUNX1 + translocations among patients in
the CoALL08-09 cohort without reaching statistical significance (table
1).