The presence of an HLA-identical sibling donor has no impact on outcome of patients with high-risk MDS or secondary AML (sAML) treated with intensive chemotherapy followed by transplantation: results of a prospective study of the EORTC, EBMT, SAKK and GIMEMA Leukemia Groups (EORTC study 06921)

Abstract

This report used the framework of a large European study to investigate the outcome of patients with and without an HLAidentical sibling donor on an intention-to-treat basis. After a common remission-induction and consolidation course, patients with an HLA-identical sibling donor were scheduled for allogeneic transplantation and patients lacking a donor for autologous transplantation. In all, 159 patients alive at 8 weeks from the start of treatment were included in the present analysis. In total, 52 patients had a donor, 65 patients did not have a donor and in 42 patients the availability of a donor was not assessed. Out of 52 patients, 36 (69%) with a donor underwent allogeneic transplantation (28 in CR1). Out of 65 patients, 33 (49%) received an autograft (27 in CR1). The actuarial survival rates at 4 years were 33.3% (s.e. = 6.7%) for patients with a donor and 39.0% (s.e. = 6.5%) for patients without a donor (P = 0.18). Event-free survival rates were 23.1% (s.e. = 6.2%) and 21.5% (s.e. = 5.3%), respectively (P = 0.66). Correction for alternative donor transplants did not substantially alter the survival of the group without a donor. Also, the survival in the various cytogenetic risk groups was not significantly different when comparing the donor vs the no-donor group. This analysis shows that patients with high-risk myelodysplastic syndrome and secondary acute myeloid leukemia may benefit from both allogeneic and autologous transplantation. We were unable to demonstrate a survival advantage for patients with a donor compared to patients without a donor.

Value of allogeneic versus autologous stem cell transplantation and chemotherapy in patients with myelodysplastic syndromes and secondary acute myeloid leukemia. Final results of a prospective randomized European Intergroup Trial

“…[20][21][22] In a previous study by our group, we analyzed 100 patients in first complete remission who were candidates for SCT. 9,23 The 4-year disease-free survival rates in the donor versus no-donor groups were similar: 31% and 27%, respectively. This outcome suggests that patients with advanced stages of MDS may benefit both from allogeneic and from autologous SCT.…”

“…6 In the present study the non-relapse mortality was only 14% in the donor-group compared to 27% in the previous study. 9,23 Subgroup analysis of this study showed that the advantage of the presence of a donor was only apparent in the group of patients with intermediate and high risk cytogenetics (table 3). This observation is in line with the previous study 9 which showed only long-term survivors after autologous SCT in patients with good-risk characteristics.…”

“…9,23 Subgroup analysis of this study showed that the advantage of the presence of a donor was only apparent in the group of patients with intermediate and high risk cytogenetics (table 3). This observation is in line with the previous study 9 which showed only long-term survivors after autologous SCT in patients with good-risk characteristics. 24 The overall survival in the donor group was not significantly superior to that in the no-donor group, although in patients with intermediate and high-risk cytogenetic characteristics a trend to a superior survival in the donor group was observed (HR, 0.58; 99% CI, 0.22-1.50; P=0.14).…”

“…[6][7][8] However, the outcome of autologous peripheral blood SCT for patients lacking a suitable donor, appeared, in some studies, comparable to that of allogeneic SCT. 6,9,10 Moreover, a retrospective study comparing intensive chemotherapy alone against chemotherapy followed by transplantation did not show a clear benefit for chemotherapy followed by SCT. 11 This study addressed the issue of whether the existence of an HLA-identical sibling donor and the intention to perform an allogeneic SCT after the first consolidation course of chemotherapy results in a favorable outcome.…”

Allogeneic and autologous transplantation for haematological diseases, solid tumours and immune disorders: current practice in Europe 2009

“…The results of a large European study show that autologous HSCT can be recommended in patients with good-risk cytogenetic characteristics. 23 …”