Treatment of acute myelogenous leukemia: An EBMT-EORTC retrospective analysis of chemotherapy versus allogeneic or autologous bone marrow transplantation

doi:10.1016/0277-5379(89)90268-X

European Journal of Cancer and Clinical Oncology

Volume 25, Issue 3, March 1989, Pages 545-550

European Journal of ...

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Abstract

In a retrospective analysis, patients with acute myelogenous leukemia (AML), treated in first complete remission (CR) with chemotherapy or with allogeneic or autologous bone marrow transplantation were compared with respect to their leukemia-free survival from CR. Two hundred and thirty-six patients treated with chemotherapy according to the EORTC AML-5 and AML-6 trials were included. The data of the transplanted patients were taken from two EBMT registries; 453 with an allogeneic and 182 with an autologous BMT.

The very different sources of the data (trials and registries) forced us to be cautious in our conclusions. However, for the patient cohorts analyzed in the present study, BMT patients tended to have a better leukemia-free survival than chemotherapy patients. This was especially the case for the allogeneic BMT after 6 months of transplant.

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Cited by (39)

Allogeneic compared with autologous stem cell transplantation in the treatment of patients younger than 46 years with acute myeloid leukemia (AML) in first complete remission (CR1): An intention-to-treat analysis of the EORTC/GIMEMA AML-10 trial
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Citation Excerpt :
The comparison of the effects of allo- and auto-SCT has also been performed on the basis of registration data of the International and European Blood and Bone Marrow Transplantation Registries.13-15 Because these registries contain only data of patients in whom a transplantation has been performed, this type of analysis is biased because of selection of patients with good performance, variability of the interval between the moment of remission and the transplantation, and exclusion of early relapses.16 In the previous AML-8A trial of the European Organization for Research and Treatment of Cancer (EORTC) Leukemia Group and the Italian Gruppo Italiano Malattie Ematologiche dell’ Adulto (GIMEMA) group, it has been shown that auto-SCT leads to a significantly longer DFS than a second IC course, but significant differences between auto-SCT and allo-SCT could not be detected.6
In the European Organization for Research and Treatment of Cancer Leukemia Group and Gruppo Italiano Malattie Ematologiche dell’ Adulto (EORTC-LG/GIMEMA) acute myeloid leukemia (AML)–10 trial, patients in first complete remission (CR1) received a single intensive consolidation (IC) course. Subsequently, those patients younger than 46 years with an HLA-identical sibling donor were assigned to undergo allogeneic (allo) stem cell transplantation (SCT), and patients without such a donor were planned for autologous (auto) SCT. Between November 1993 and December 1999, of 1198 patients aged younger than 46 years, 822 achieved CR. The study group constituted 734 patients who received IC: 293 had a sibling donor and 441 did not. Allo-SCT and auto-SCT were performed in 68.9% and 55.8%, respectively. Cytogenetic determination was successfully performed in 446 patients. Risk groups were good (t(8;21), inv16), intermediate (NN or –Y only), and bad/very bad (all others). Median follow-up was 4 years; 289 patients relapsed, 66 died in CR1, and 293 died. Intention-to-treat analysis revealed that the 4-year disease-free survival (DFS) rate of patients with a donor versus those without a donor was 52.2% versus 42.2%,P= .044; hazard ratio = 0.80, 95% confidence interval (0.64, 0.995), the relapse incidence was 30.4% versus 52.5%, death in CR1 was 17.4% versus 5.3%, and the survival rate was 58.3% versus 50.8% (P= .18). The DFS rates in patients with and without a sibling donor were similar in patients with good/intermediate risk but were 43.4% and 18.4%, respectively, in patients with bad/very bad risk cytogenetics. In younger patients (15-35 years), the difference was more pronounced. The strategy to perform early allo-SCT led to better overall results than auto-SCT, especially for younger patients or those with bad/very bad risk cytogenetics.
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Comparing the outcome of chemotherapy and bone marrow transplants in the absence of a randomized trial is difficult but necessary for diseases where small numbers of patients make such trials difficult if not impossible. To address this issue for adults with acute lymphoblastic leukemia in first remission, we created an empirical database using two separate datasets, one from the International Bone Marrow Transplant Registry and the other from two multicenter chemotherapy studies. Prior to combining the datasets, a study protocol was developed to define inclusion criteria, outcomes to be compared and statistical methods. The main problems of a nonrandomized comparison are biases potentially introduced by differences in baseline composition of the two cohorts and differences in time-to-treatment. The source of the latter bias is different distributions of waiting times between achieving complete remission and receiving post-remission therapy. Several techniques to control these biases were evaluated; each gave qualitatively similar results. These methods can easily be applied to other clinical situations where randomized trials are not available.
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²: for EBMT Leukemia Working Party

¹: for EORTC

³: for EBMT Autologous BMT Working Party.

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European Journal of Cancer and Clinical Oncology

Treatment of acute myelogenous leukemia: An EBMT-EORTC retrospective analysis of chemotherapy versus allogeneic or autologous bone marrow transplantation

Abstract

Bone marrow transplantation or chemotherapy after remission induction for adults with acute nonlymphoblastic leukemia

Ann Intern Med

Treatment of acute myelogenous leukemia

Ann Intern Med

A critical comparison of allogeneic bone marrow transplantation and conventional chemotherapy as treatment for acute nonlymphocytic leukemia

J Clin Oncol

Bone marrow transplantation for acute leukemia: recent advances and comparison with alternative therapies

Sem Hematol

A randomized comparison of maintenance treatment with androgens, immunotherapy and chemotherapy in adult acute myelogenous leukemia

Allogeneic compared with autologous stem cell transplantation in the treatment of patients younger than 46 years with acute myeloid leukemia (AML) in first complete remission (CR1): An intention-to-treat analysis of the EORTC/GIMEMA AML-10 trial

Autologous stem cell transplantation in acute myelocytic leukemia

Comparison of chemotherapy and bone marrow transplants using two independent clinical databases

Multiple myeloma

The European LeukemiaNet AML Working Party consensus statement on allogeneic HSCT for patients with AML in remission: An integrated-risk adapted approach

Comparative analysis of the value of allogeneic hematopoietic stem-cell transplantation in acute myeloid leukemia with monosomal karyotype versus other cytogenetic risk categories