title: Modified BEAM with triple autologous stem cell transplantation for patients with relapsed aggressive non-Hodgkin lymphoma.
abstract: Treatment of relapse and primary progression in aggressive lymphoma remains unsatisfactory; outcome is still poor. Better treatment strategies are much needed for this patient population. The R1 study is a prospective multi-center phase I/II study evaluating a dose finding approach with a triple transplant regimen in four BEAM dose levels in patients with relapsed aggressive non-Hodgkin lymphoma. The aim of the study was to determine feasibility, toxicity, and remission rate. In a total of 39 patients (pts.) enrolled in the study, 24 pts. were evaluated in the following analysis. Twenty pts. had aggressive B cell lymphoma, and two pts. had T cell lymphoma. All evaluated patients responded to DexaBEAM with a sufficient stem cell harvest. The phase I/II study was started with BEAM dose level II. Four patients were treated at dose level II, and 20 pts. were treated at dose level III. Due to the early termination of the study, dose levels I and IV were never administered. Sixteen pts. completed therapy according to protocol, and eight pts. (33.3 %) stopped treatment early. Infections (27 %) and stomatitis (13 %) were the most frequent grade III/IV non-hematologic toxicities. Thirteen percent of patients presented with severe grade III/IV lung toxicity during modified BEAM (m-BEAM). Fourteen pts. achieved a complete response (CR), one pt. achieved no change (NC), six pts. had progressive disease (PD), and two pts. died; for one pt., outcome is not known. One-year and 3-year event-free survival (EFS) was 38 and 33 %, respectively. Overall survival (OS) after 1 and 3 years was 50 and 38 %. In conclusion, dose escalation of standard BEAM is not feasible due to toxicity.
authors.affiliation: Kantonsspital Graubünden, Hematology and Oncology, Chur, Switzerland. karin.hohloch@med.uni-goettingen.de.|Department of Hematology and Medical Oncology, University Medicine, Georg August University, Robert Koch Str. 40, 37075, Göttingen, Germany. karin.hohloch@med.uni-goettingen.de.
authors.forename: Karin
authors.initials: K
authors.lastname: Hohloch
authors.affiliation: Institute for Medical Informatics, Statistics, and Epidemiology, Universität Leipzig, Leipzig, Germany.
authors.forename: Samira
authors.initials: S
authors.lastname: Zeynalova
authors.affiliation: Department of Hematology and Medical Oncology, University Medicine, Georg August University, Robert Koch Str. 40, 37075, Göttingen, Germany.|Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
authors.forename: Björn
authors.initials: B
authors.lastname: Chapuy
authors.affiliation: Department of Internal Medicine I, University Clinic of Saarland, Homburg, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Pfreundschuh
authors.affiliation: Institute for Medical Informatics, Statistics, and Epidemiology, Universität Leipzig, Leipzig, Germany.
authors.forename: Markus
authors.initials: M
authors.lastname: Loeffler
authors.affiliation: Institute for Medical Informatics, Statistics, and Epidemiology, Universität Leipzig, Leipzig, Germany.
authors.forename: Marita
authors.initials: M
authors.lastname: Ziepert
authors.affiliation: Department of Pathology, University of Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.
authors.forename: Alfred C
authors.initials: AC
authors.lastname: Feller
authors.affiliation: Department of Hematology and Medical Oncology, University Medicine, Georg August University, Robert Koch Str. 40, 37075, Göttingen, Germany.
authors.forename: Lorenz
authors.initials: L
authors.lastname: Trümper
authors.affiliation: Institute for Medical Informatics, Statistics, and Epidemiology, Universität Leipzig, Leipzig, Germany.
authors.forename: Dirk
authors.initials: D
authors.lastname: Hasenclever
authors.affiliation: Department of Hematology and Medical Oncology, University Medicine, Georg August University, Robert Koch Str. 40, 37075, Göttingen, Germany.
authors.forename: Gerald
authors.initials: G
authors.lastname: Wulf
authors.affiliation: Department of Hematology, Oncology and Stem Cell Transplantation, Asklepios Klinik St. Georg, Hamburg, Germany.
authors.forename: Norbert
authors.initials: N
authors.lastname: Schmitz
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D002330:Carmustine / Q000008:administration & dosage; D003131:Combined Modality Therapy / Q000379:methods; D003561:Cytarabine / Q000008:administration & dosage; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation / Q000379:methods*; D006801:Humans; D008228:Lymphoma, Non-Hodgkin / Q000175:diagnosis* / Q000628:therapy*; D008297:Male; D008558:Melphalan / Q000008:administration & dosage; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000175:diagnosis* / Q000628:therapy*; D011034:Podophyllotoxin / Q000008:administration & dosage; D011446:Prospective Studies; D016879:Salvage Therapy / Q000379:methods; D014182:Transplantation, Autologous / Q000379:methods; D055815:Young Adult
chemical_list: D003561:Cytarabine; D011034:Podophyllotoxin; D008558:Melphalan; D002330:Carmustine
keywords: Aggressive lymphoma; Relapse; Triple transplant approach