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 Printable version |
Randomized study of recombinant interleukin-2 after autologous bone marrow transplantation for acute leukemia in first complete remission. |
European Cytokine Network. Volume 11, Number 1, 91-8, March 2000, Articles originaux
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 Free Article
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Author(s) : D. Blaise, M. Attal, J. Reiffers, M. Michallet, C. Bellanger, J.-L. Pico, A.-M. Stoppa, C. Payen, G. Marit, R. Bouabdallah, J.J. Sotto, J.-F. Rossi, M. Brandely, T. Hercend, D. Maraninchi |
Summary : Immunological control of acute leukemia may be achieved after allogeneic transplant. Despite promising preliminary results, the impact of immunotherapy with interleukin-2 (r-IL-2) on patients with acute leukemia (AL), in first complete remission (CR1) remains unclear. We conducted a prospective multicenter randomized trial to compare outcome in patients with AL in CR1, treated with autologous bone marrow transplantation (BMT) with or without postgraft r-IL-2. One hundred and thirty patients with AL in CR1 (myeloblastic (AML): N = 78; lymphoblastic (ALL): N = 52) were randomized at time of BMT to receive (N = 65) or not (N = 65) r-IL-2. r-IL-2 (RU 49637 from Roussel Uclaf) was started after hematological recovery, as a five cycle regimen (12 M IU/m2/day continuous infusion on day 1-5, 15-17, 29-31,43-45 and 57-59). The two groups were balanced for patient and transplant characteristics. Analysis was based on an intent to treat. Thirty-eight (59%) of the 65 patients randomized into the study group started r-IL-2 at a median of sixty-eight days (23-140) after transplant and received 77% (16-100) of the scheduled dosage. They received a median of 120 x 106 IU/m2 (25-156) over 10 (3-13) days during a total median period of 56 (3-78) days. With a median follow-up of 7 years (5.4-8.1 years), 79 patients relapsed (study group: 43 (66%); control group: 36 (55%): p = NS). Survival and leukemia-free survival estimates were 33% (23-45) versus 43% (22-52) and 29% (19-41) versus 36% (24-51) respectively for study and control groups (all p = NS). These results show that leukemic control after autologous BMT is not increased by r-IL-2 therapy. Further studies should investigate more appropriate
r-IL-2 schedules and the possibilities offered by better antigen recognition and activated effector cells. |
Keywords : acute leukemia, autologous bone marrow transplantation, immunotherapy, interleukin-2, prospective studies. |
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