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Blood, 1 August 2006, Vol. 108, No. 3, pp. 1092-1099.
Prepublished online as a Blood First Edition Paper on March 21, 2006; DOI 10.1182/blood-2005-10-4165.
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TRANSPLANTATION
Long-term survival in refractory acute myeloid leukemia after sequential treatment with chemotherapy and reduced-intensity conditioning for allogeneic stem cell transplantation
Christoph Schmid,
Michael Schleuning,
Rainer Schwerdtfeger,
Bernd Hertenstein,
Eva Mischak-Weissinger,
Donald Bunjes,
Stephanie v. Harsdorf,
Christoph Scheid,
Udo Holtick,
Hildegard Greinix,
Felix Keil,
Barbara Schneider,
Michael Sandherr,
Gesine Bug,
Johanna Tischer,
Georg Ledderose,
Michael Hallek,
Wolfgang Hiddemann, and
Hans-Jochem Kolb
From the Department of Internal Medicine III, Ludwig-Maximilians-University of Munich, Munich, Germany; the Clinical Cooperative Group "Stem Cell Transplantation," Gesellschaft für Strahlenforschung (GSF) Research Center for Environment and Health, Munich, Germany; the Clinical Cooperative Group "Acute Leukemia," GSF Research Center for Environment and Health, Munich, Germany; the Bone Marrow Transplantation (BMT) Unit, Deutsche Klinik für Diagnostik, Wiesbaden, Germany; the Department of Hematology/Oncology, Medizinische Hochschule Hannover, Hannover, Germany; the Department of Medicine III, University of Ulm, Ulm, Germany; the Department of Medicine I, University of Cologne, Cologne, France; the Department of Medicine I, Medical University of Vienna, Vienna, Austria; the Core Unit for Medical Statistics and Informatics, Section of Medical Statistics, University of Vienna, Austria; the Department of Medicine II, Klinikum Augsburg, Augsburg, Germany; and the Department of Medicine II, University of Frankfurt, Frankfurt, Germany.
A sequential regimen of chemotherapy, reduced-intensity conditioning (RIC) for allogeneic stem cell transplantation (SCT), and prophylactic donor lymphocyte transfusion (pDLT) was studied in 103 patients with refractory acute myeloid leukemia (AML). According to published criteria, refractoriness was defined by primary induction failure (PIF; n = 37), early (n = 53), refractory (n = 8), or second (n = 5) relapse. Chemotherapy consisted of fludarabine (4 x 30 mg/m2), cytarabine (4 x 2 g/m2), and amsacrine (4 x 100 mg/m2), followed 4 days later by RIC, comprising 4 Gy total body irradiation (TBI), cyclophosphamide, and antithymocyte globulin. Patients without graft-versus-host disease (GvHD) at day +120 received pDLT in escalating doses. Patients' median age was 51.8 years. Before conditioning, 99 patients had active disease, 3 were aplastic, 1 was in second complete remission (CR2). Forty-one patients had family donors, 62 had unrelated donors. With a 25-month median follow-up, overall survival (OS) at 1, 2, and 4 years was 54%, 40%, and 32%; the respective leukemia-free survival (LFS) was 47%, 37%, and 30%. Patients with PIF showed a 2-year OS of 62.5%. OS was 87% in 17 patients receiving pDLT. One-year cumulative incidence of leukemic death and non–relapse-mortality was 28.7% and 17.2%. In a multivariate analysis, more than 2 courses of prior chemotherapy were the strongest predictor for poor outcome (P = .007; HR = 3.01 [OS]; P = .002; HR = 3.25 [LFS]). These results indicate a high activity of the regimen in refractory AML.
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