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Figure 14.9 EFS by day 7 bone marrow response. The 6-year EFS ± SD was 85% ± 2% for M1 (<5% blasts, solid line); 79% ± 3% for M2 (5-25% blasts, dotted line) and 76% ± 3% for M3 (<25% blasts, dashed line) (p = 0.002). Reproduced with permission of the American Society of Hematology (full reference on p. 295).

Bone marrow response

There was no difference in either the day 7 or at the end of induction marrow status by randomized steroid. Poor marrow response on day 7 of treatment was an adverse prognostic factor (Figure 14.9).

Relapse site

Isolated CNS relapses were lower in the dexametha-sone arm compared to the prednisolone arm (6-year cumulative estimates being dexamethasone, 3.7 ± 0.8% versus prednisolone, 7.1 ± 1.1%; p = 0.01) (Figure 14.10). In addition, patients randomized to dexamethasone showed a trend toward fewer bone marrow relapses, with 6-year estimates of 7.9 ± 1.3% versus 11.1 ± 1.5% (p = 0.08). Table 14.15 shows the events by treatment regimen.

Prognostic factors

Patients randomized to dexamethasone had a better 6-year EFS compared to prednisolone for patients with day 7 M1 marrow status (89 ± 2% versus 82 ± 3%), M2 marrow status (83 ± 4% versus 77 ± 4%) and M3 marrow status (82 ± 4% versus 71 ± 4%).

EFS and OS

The 6-year EFS and OS for the entire cohort was 81 ± 2% and 92 ± 1%, respectively.

The 6-year EFS for patients randomized to dexamethasone was 85 ± 2% versus 77 ± 2% for prednisolone (p = 0.002, RR 0.65; Figure 14.11).

The 6-year OS was similar for both groups of patients (dexamethasone group, 93 ± 1% versus prednisolone group, 91 ± 1%, p = 0.17, RR 0.74).

Toxicity

Both groups of patients had identical incidences of bacteraemia during induction (13%) and also similar incidences of fever, neutropenia, duration of hospital stay and supportive care interventions; 6 patients died of infections during induction or shortly thereafter: 2 in the prednisolone arm and 4 in the dexametha-sone arm.

During intensification when all patients receive dexamethasone, 5 died due to infectious complications (4 prednisolone assigned patients and 1 dexam-ethasone assigned).

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