Dexa-BEAM versus MIFAP as salvage regimen for recurrent lymphoma: a prospective randomized multicenter phase II trial with a median follow-up of 14.4 years.
J Cancer Res Clin Oncol
; 148(5): 1171-1181, 2022 May.
Article
em En
| MEDLINE
| ID: mdl-34176014
ABSTRACT
PURPOSE:
The aim of this study was to prospectively compare the MIFAP protocol, which had been shown to be effective in patients with relapsed and refractory Hodgkin's lymphoma (HL) or aggressive non-Hodgkin's lymphoma (NHL), to an established regimen like Dexa-BEAM.METHODS:
Seventy-three adult patients with HL (N = 25) or aggressive NHL (N = 48) suffering from relapse or refractory disease were randomly allocated to receive two cycles of Dexa-BEAM (dexamethasone, carmustine, etoposide, cytarabine, melphalan; N = 37) or MIFAP (mitoxantrone, fludarabine, cytarabine, cisplatin; N = 36) prior to a consolidating high-dose therapy and hematopoietic cell transplantation (HCT). Primary endpoint was the overall response rate (ORR) [complete response (CR) and partial response (PR)] after two courses of salvage chemotherapy.RESULTS:
The ORR was 51% (CR 38%) and 53% (CR 36%) in the Dexa-BEAM arm and in the MIFAP arm (both not significant), respectively. There was a significantly higher grade 3-4 toxicity after MIFAP compared to Dexa-BEAM. Thirty-five patients were consolidated by autologous (N = 29), allogeneic (N = 1) or sequential autologous/allogeneic (N = 5) HCT. No significant differences were found in progression-free survival (PFS) and overall survival (OS) between the Dexa-BEAM and the MIFAP arms.CONCLUSION:
Compared to Dexa-BEAM, MIFAP is associated with a higher toxicity and does not improve the outcome of patients with recurrent HL or aggressive NHL. For those patients, innovative treatment concepts like recently developed immunotherapies are necessary. TRIAL REGISTRATION NUMBER EudraCT number 2021-001937-38. DATE OF REGISTRATION 7 April 2021, retrospectively registered.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Linfoma não Hodgkin
/
Doença de Hodgkin
/
Linfoma
Idioma:
En
Ano de publicação:
2022
Tipo de documento:
Article