title: Rituximab combined with DexaBEAM followed by high dose therapy as salvage therapy in patients with relapsed or refractory B-cell lymphoma: mature results of a phase II multicentre study.
abstract: Salvage therapy followed by high-dose therapy (HDT) remains a mainstay for patients with relapsed lymphoma, however no optimal regimen has been defined. Here we report on the results of R-DexaBEAM (rituximab, dexamethasone, carmustine, etoposide, cytarabine, melphalan) followed by HDT. Patients aged 18-65 years, Eastern Cooperative Oncology Group performance score 0-2, with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL) were eligible. R-Dexa-BEAM was given for two cycles followed by stem cell mobilization and HDT. Primary endpoint of the trial was progression-free-survival (PFS). One hundred and three patients were included: aggressive NHL (aNHL): diffuse large B-cell lymphoma 55, mantle cell lymphoma 7, follicular lymphoma (FL) grade 3: 5, indolent Lymphoma (iNHL): FL grade 1-2: 29, marginal zone lymphoma 6, Immunocytoma 1. The overall response rate after salvage therapy was 62% for aNHL and 78% for iNHL patients. 66% of patients with aNHL and 86% with iNHL underwent HDT. Treatment-related mortality for HDT was 1·3%. For aNHL patients, the median PFS was 0·83 years with 44% alive at the median follow-up of 7·3 years. Corresponding figures for iNHL were: median PFS 3·7 years and 72% alive after 8 years. The combination of rituximab with DexaBEAM followed by HDT resulted in high response rates and sustained remissions in responders. R-DexaBEAM followed by HDT can be considered a valid salvage option for NHL.
authors.affiliation: Department of Haematology, Oncology and Pneumology, University Medical School of the Johannes Gutenberg University Mainz, Mainz, Germany.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Kirschey
authors.forename: Thomas
authors.initials: T
authors.lastname: Flohr
authors.forename: Hans H
authors.initials: HH
authors.lastname: Wolf
authors.forename: Norbert
authors.initials: N
authors.lastname: Frickhofen
authors.forename: Martin
authors.initials: M
authors.lastname: Gramatzki
authors.forename: Hartmut
authors.initials: H
authors.lastname: Link
authors.forename: Nadezda
authors.initials: N
authors.lastname: Basara
authors.forename: Norma
authors.initials: N
authors.lastname: Peter
authors.forename: Ralf G
authors.initials: RG
authors.lastname: Meyer
authors.forename: Norbert
authors.initials: N
authors.lastname: Schmitz
authors.forename: Eckhart
authors.initials: E
authors.lastname: Weidmann
authors.forename: Andre
authors.initials: A
authors.lastname: Banat
authors.forename: Andrea
authors.initials: A
authors.lastname: Schulz
authors.forename: Karin
authors.initials: K
authors.lastname: Kolbe
authors.forename: Guenter
authors.initials: G
authors.lastname: Derigs
authors.forename: Matthias
authors.initials: M
authors.lastname: Theobald
authors.forename: Georg
authors.initials: G
authors.lastname: Hess
mesh_terms: D000328:Adult; D000368:Aged; D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002330:Carmustine / Q000008:administration & dosage / Q000009:adverse effects; D003561:Cytarabine / Q000008:administration & dosage / Q000009:adverse effects; D003907:Dexamethasone / Q000008:administration & dosage / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005047:Etoposide / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D019650:Hematopoietic Stem Cell Mobilization / Q000379:methods; D006801:Humans; D053208:Kaplan-Meier Estimate; D016393:Lymphoma, B-Cell / Q000188:drug therapy*; D008297:Male; D008558:Melphalan / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D018579:Patient Selection; D011446:Prospective Studies; D012008:Recurrence; D012074:Remission Induction; D000069283:Rituximab; D016879:Salvage Therapy / Q000379:methods*; D055815:Young Adult
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D003561:Cytarabine; D000069283:Rituximab; D005047:Etoposide; D003907:Dexamethasone; D008558:Melphalan; D002330:Carmustine
keywords: autologous transplantation; high dose therapy; non-Hodgkin lymphoma; rituximab