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

de Witte, Theo;Hagemeijer, Anne;Suciu, Stefan;Belhabri, Amin;Willemze, Roel;et.al.
(2010) Haematologica : the hematology journal — Vol. 95, n° 10, p. 1754-1761 (2010)

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  • de Witte, Theo
    Author
  • Hagemeijer, Anne
    Author
  • Suciu, Stefan
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  • Belhabri, Amin
    Author
  • Ferrant, AugustinUCLouvain
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  • Willemze, Roel
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Abstract
Background Allogeneic stem cell transplantation is usually considered the only curative treatment option for patients with advanced or transformed myelodysplastic syndromes in complete remission, but post-remission chemotherapy and autologous stem cell transplantation are potential alternatives, especially in patients over 45 years old. Design and Methods We evaluated, after intensive anti-leukemic remission-induction chemotherapy, the impact of the availability of an HLA-identical sibling donor on an intention-to treat basis. Additionally, all patients without a sibling donor in complete remission after the first consolidation course were randomized to either autologous peripheral blood stem cell transplantation or a second consolidation course consisting of high-dose cytarabine. Results The 4-year survival of the 341 evaluable patients was 28%. After achieving complete remission, the 4-year survival rates of patients under 55 years old with or without a donor were 54% and 41%, respectively, with an adjusted hazard ratio of 0.81 (95% confidence interval [95% CI], 0.49-1.35) for survival and of 0.67 (95% CI, 0.42-1.06) for disease-free survival. In patients with intermediate/high risk cytogenetic abnormalities the hazard ratio in multivariate analysis was 0.58 (99% CI, 0.22-1.50) (P=0.14) for survival and 0.46 (99% CI, 0.22-1.50) for disease-free survival (P=0.03). In contrast, in patients with low risk cytogenetic characteristics the hazard ratio for survival was 1.17 (99% CI, 0.40-3.42) and that for disease-free survival was 1.02 (99% CI, 0.40-2.56). The 4-year survival of the 65 patients randomized to autologous peripheral blood stem cell transplantation or a second consolidation course of high-dose cytarabine was 37% and 27%, respectively. The hazard ratio in multivariate analysis was 1.22 (95% CI, 0.65-2.27) for survival and 1.02 (95% CI, 0.56-1.85) for disease-free survival. Conclusions Patients with a donor and candidates for allogeneic stem cell transplantation in first complete remission may have a better disease-free survival than those without a donor in case of myelodysplastic syndromes with intermediate/high-risk cytogenetics. Autologous peripheral blood stem cell transplantation does not provide longer survival than intensive chemotherapy. © 2010 Ferrata Storti Foundation.
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de Witte, T., Hagemeijer, A., Suciu, S., Belhabri, A., Delforge, M., Kobbe, G., Selleslag, D., Schouten, H. C., Ferrant, A., Biersack, H., Amadori, S., Muus, P., Jansen, J. H., Hellström-Lindberg, E., Kovacsovics, T., Wijermans, P., Ossenkoppele, G., Gratwohl, A., Marie, J.-P., & Willemze, R. (2010). 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. Haematologica : the hematology journal, 95(10), 1754-1761. https://doi.org/10.3324/haematol.2009.019182 (Original work published 2010)