Patients with newly diagnosed acute myelogenous leukemia treated with autologous or allogeneic bone marrow transplantation are more likely to be cured than patients treated with conventional-dose consolidation chemotherapy.

Patients with newly diagnosed acute myelogenous leukemia who achieve a complete remission following remission induction therapy have historically been advised to receive consolidation treatment with either an HLA matched identical sibling bone marrow transplant, high-dose chemotherapy and autologous bone marrow transplant, or conventional-dose chemotherapy delivered without bone marrow support. Patients have received one of these consolidation treatment strategies based on their perceptions of the outcomes associated with each treatment, the availability of an HLA matched sibling bone marrow donor, their physician’s bias concerning the appropriateness of each treatment option, and the geographic availability of each treatment. In 1986 a consortium of research centers designed a clinical trial that would compare these 3 treatment options in order to determine whether one was superior to the other and what risks might be associated with each treatment strategy.

This large, randomized, Phase III clinical trial evaluated 576 patients with acute myelogenous leukemia, subtypes M1-M7 and age less than 60 years, who had achieved a complete remission from induction therapy and received a single cycle of consolidation chemotherapy. Of these 576 patients, 168 had an HLA matched sibling bone marrow donor and therefore received allogeneic bone marrow transplantation. The remaining 254 patients were randomly allocated to be treated with a second course of intensive consolidation chemotherapy or unpurged autologous bone marrow transplantation. A direct comparison between allogeneic bone marrow transplantation, autologous bone marrow transplantation and non-bone marrow supported intensive chemotherapy consolidation was performed.

The patients treated with allogeneic or autologous bone marrow transplantation were more likely to be cured of their disease than patients receiving conventional-dose consolidation chemotherapy. Evaluation at 4 years from initial treatment revealed that allogeneic bone marrow transplantation patients had a 55% chance and autologous bone marrow transplantation patients had a 48% chance of being alive without evidence of disease recurrence compared to only 30% of patients treated with conventional-dose consolidation chemotherapy. Patients receiving allogeneic bone marrow transplantation were more likely to die as a complication of therapy than patients receiving autologous bone marrow transplantation or conventional-dose consolidation chemotherapy. The treatment related mortality of allogeneic bone marrow transplantation was 17.3% compared to 9.4% and 7.1%, respectively, for autologous bone marrow transplantation and conventional-dose consolidation chemotherapy.

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In summary, allogeneic and autologous bone marrow transplantation produce superior cure rates compared to a single cycle of conventional consolidation chemotherapy for patients with newly diagnosed acute myelogenous leukemia in complete remission under 60 years old. ( New England Journal of Medicine, Vol 332, pp 217-223, 1995)

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