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Superiority of Allogeneic Hematopoietic Stem-Cell Transplantation Compared With Chemotherapy Alone in High-Risk Childhood T-Cell Acute Lymphoblastic Leukemia: Results From ALL-BFM 90 and 95

André Schrauder, Alfred Reiter, Helmut Gadner, Dietrich Niethammer, Thomas Klingebiel, Bernhard Kremens, Christina Peters, Wolfram Ebell, Martin Zimmermann, Felix Niggli, Wolf-Dieter Ludwig, Hansjörg Riehm, Karl Welte, Martin Schrappe

From the Department of Pediatrics, University Medical Center Schleswig-Holstein, Campus Kiel, Kiel; Department of Pediatric Hematology and Oncology, Justus-Liebig University, Gießen; Department of Pediatric Hematology and Oncology, University Hospital, Tübingen; Department of Pediatric Hematology and Oncology, Johann Wolfgang Goethe University, Frankfurt; Department of Pediatric Hematology and Oncology, University Hospital, Essen; Department of General Pediatrics and Bone Marrow Transplantation, Charité, University Medicine Berlin, Berlin; Department of Pediatric Hematology and Oncology, Hannover Medical School, Hannover; Department of Hematology, Oncology and Tumor Immunology, Robert-Rössle-Clinic at the HELIOS Clinic Berlin-Buch, Charité, Germany; Children's Hospital St Anna, Wien, Austria; and the Department of Pediatric Hematology and Oncology, University Hospital, Zürich, Switzerland

Address reprint requests to Martin Schrappe, MD, PhD, Department of Pediatrics, University Medical Center Schleswig-Holstein, Campus Kiel, Schwanenweg 20, 24105 Kiel, Germany; e-mail: m.schrappe{at}pediatrics.uni-kiel.de

PURPOSE: The role of hematopoietic stem-cell transplantation (SCT) in first complete remission (CR1) for children with very high–risk (VHR) acute lymphoblastic leukemia (ALL) is still under critical discussion.

PATIENTS AND METHODS: In the ALL–Berlin-Frankfurt-Münster (BFM) 90 and ALL-BFM 95 trials, 387 patients were eligible for SCT if there was a matched sibling donor (MSD). T-cell ALL (T-ALL) patients with poor in vivo response to initial treatment represented the largest homogeneous subgroup within VHR patients.

RESULTS: Of 191 high-risk (HR) T-ALL patients, 179 patients (94%) achieved CR1. Twenty-three patients received an MSD-SCT. Furthermore, in trial ALL-BFM 95, eight matched unrelated donors (MUDs) and five mismatched family donors (MMFDs) were used. The median time to SCT was 5 months (range, 2.4 to 10.8 months) from diagnosis. The 5-year disease-free survival (DFS) was 67% ± 8% for 36 patients who received an SCT in CR1 and 42% ± 5% for the 120 patients treated with chemotherapy alone having an event-free survival time of at least the median time to transplantation (Mantel-Byar, P = .01). Overall survival (OS) rate for the SCT group was 67% ± 8% at 5 years, whereas patients treated with chemotherapy alone had an OS rate of 47% ± 5% at 5 years (Mantel-Byar, P = .01). Outcome of patients who received MSD-SCT versus MUD-/MMFD-SCT was comparable (DFS, 65% ± 10% v 69% ± 13%, respectively). However, relapses only occurred after MSD-SCT (eight of 23 patients), whereas treatment-related mortality only occurred after MUD-/MMFD-SCT (four of 13 patients).

CONCLUSION: SCT in CR1 is superior to treatment with chemotherapy alone for childhood HR-T-ALL.

Supported by the Madeleine-Schickedanz-Kinderkrebsstiftung (Fürth, Germany) and the Deutsche Krebshilfe (Bonn, Germany; Project 50-2614-Ri 6).

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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