Front-line imatinib treatment in children and adolescents with chronic myeloid leukemia: results from a phase III trial

Suttorp M, Schulze P, Glauche I, Goehring G, Von Neuhoff N, Metzler M, Sedlacek P, De Bont ESJM, Balduzzi A, Lausen B, Aleinikova O, Sufliarska S, Henze G, Strauss G, Eggert A, Kremens B, Groll AH, Berthold F, Klein C, Gross-Wieltsch U, Sykora KW, Borkhardt A, Kulozik AE, Schrappe M, Nowasz C, Krumbholz M, Tauer JT, Claviez A, Harbott J, Kreipe HH, Schlegelberger B, Thiede C (2018)

Publication Type: Journal article

Publication year: 2018

Journal

Book Volume: 32

Pages Range: 1657-1669

Journal Issue: 7

DOI: 10.1038/s41375-018-0179-9

Abstract

A total of 156 patients (age range 1.3-18.0 years, median 13.2 years; 91 (58.3%) male) with newly diagnosed CML (N = 146 chronic phase (CML-CP), N = 3 accelerated phase (CML-AP), N = 7 blastic phase (CML-BP)) received imatinib up-front (300, 400, 500 mg/m2, respectively) within a prospective phase III trial. Therapy response, progression-free survival, causes of treatment failure, and side effects were analyzed in 148 children and adolescents with complete data. Event-free survival rate by 18 months for patients in CML-CP (median follow-up time 25 months, range: 1-120) was 97% (95% CI, 94.2-99.9%). According to the 2006 ELN-criteria complete hematologic response by month 3, complete cytogenetic response (CCyR) by month 12, and major molecular response (MMR) by month 18 were achieved in 98, 63, and 59% of the patients, respectively. By month 36, 86% of the patients achieved CCyR and 74% achieved MMR. Thirty-eight patients (27%) experienced imatinib failure because of unsatisfactory response or intolerance (N = 9). In all, 28/148 patients (19%) underwent stem cell transplantation (SCT). In the SCT sub-cohort 2/23 patients diagnosed in CML-CP, 0/1 in CML-AP, and 2/4 in CML-BP, respectively, died of relapse (N = 3) or SCT-related complications (N = 2). This large pediatric trial extends and confirms data from smaller series that first-line imatinib in children is highly effective.

Authors with CRIS profile

Involved external institutions

Technische Universität Dresden Germany (DE) Medizinische Hochschule Hannover (MHH) / Hannover Medical School Germany (DE) Univerzita Karlova v Praze / Charles University in Prague Czech Republic (CZ) University Medical Center Groningen (UMCG) / Universitair Medisch Centrum Groningen Netherlands (NL) University of Milano-Bicocca / Università degli Studi di Milano-Bicocca, UNIMIB Italy (IT) Rigshospitalet Denmark (DK) Belarusian Research Center for Pediatric Oncology, Hematology and Immunology Belarus (BY) Comenius University Bratislava Slovakia (SK) Charité - Universitätsmedizin Berlin Germany (DE) Universitätsklinikum Essen Germany (DE) Universitätsklinikum Münster Germany (DE) Ludwig-Maximilians-Universität (LMU) Germany (DE) Heinrich-Heine-Universität Düsseldorf Germany (DE) Universitätsklinikum Heidelberg Germany (DE) Universitätsklinikum Schleswig-Holstein (UKSH) Germany (DE) Universitätsklinikum Gießen und Marburg (UKGM) Germany (DE) Universitätsklinikum Köln Germany (DE) Klinikum Stuttgart Germany (DE)

How to cite

APA:

Suttorp, M., Schulze, P., Glauche, I., Goehring, G., Von Neuhoff, N., Metzler, M.,... Thiede, C. (2018). Front-line imatinib treatment in children and adolescents with chronic myeloid leukemia: results from a phase III trial. Leukemia, 32(7), 1657-1669. https://doi.org/10.1038/s41375-018-0179-9

MLA:

Suttorp, Meinolf, et al. "Front-line imatinib treatment in children and adolescents with chronic myeloid leukemia: results from a phase III trial." Leukemia 32.7 (2018): 1657-1669.

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