Between 1996 and 2004, a total of 708 patients were enrolled in the AML ´96 and 2002 studies of the East German Study Group. Of those, 138 patients (19.5%) had unfavourable cytogenetics defined as complex karyotype, del (5q)/-5, del (7q)/-7,
abn (3q26) and abn (11q23). Seventy-seven (56%) patients achieved CR1 after induction chemotherapy and were eligible for HCT.
HCT was performed after a median of two cycles of consolidation chemotherapies in the AML ´96 and one cycle in the AML 2002 (p=0.03). After a median follow up of 21 months, OS amounted 73±14%, 50±14% and 14±8% at 3 years for patients
after related HCT, unrelated HCT and chemotherapy, respectively (p=.008). Differences in outcomes were mainly due to a lower relapse incidence (26±13% for related and 48±15% for unrelated HCT) in patients after HCT compared to a higher relapse incidence in patients undergoing consolidation chemotherapy (89±8%; p=.003). Treatment-related mortality was low and not statistically significantly different between the three treatment groups (10±9%, 14±10% and 6± 6% for related, unrelated and chemotherapy; p=0.98).
We conclude that early HCT from related or unrelated donors led to significantly better OS and LFS compared to chemotherapy in patients with unfavourable karyo type.
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