Cargando…

Azacitidine and lenalidomide combination: a novel relapse prophylaxis regimen after allogeneic hematopoietic stem-cell transplantation in patients with acute myeloid leukemia

INTRODUCTION: While allogeneic hematopoietic stem cell transplantation (allo-HSCT) can be a curative regimen for acute myeloid leukemia (AML), relapse of AML remains a serious risk post-transplantation. Once relapsed, salvage options are limited and management of AML is difficult. Here we designed a...

Descripción completa

Detalles Bibliográficos
Autores principales: Feng, Yimei, Chen, Ting, Zhang, Yun, Yao, Han, Wang, Ping, Wang, Lu, Cassady, Kaniel, Zou, Zhongmin, Liu, Yuqing, Zhao, Lu, Gao, Lei, Zhang, Xi, Kong, Peiyan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10332158/
https://www.ncbi.nlm.nih.gov/pubmed/37435080
http://dx.doi.org/10.3389/fimmu.2023.1182251
_version_ 1785070386269913088
author Feng, Yimei
Chen, Ting
Zhang, Yun
Yao, Han
Wang, Ping
Wang, Lu
Cassady, Kaniel
Zou, Zhongmin
Liu, Yuqing
Zhao, Lu
Gao, Lei
Zhang, Xi
Kong, Peiyan
author_facet Feng, Yimei
Chen, Ting
Zhang, Yun
Yao, Han
Wang, Ping
Wang, Lu
Cassady, Kaniel
Zou, Zhongmin
Liu, Yuqing
Zhao, Lu
Gao, Lei
Zhang, Xi
Kong, Peiyan
author_sort Feng, Yimei
collection PubMed
description INTRODUCTION: While allogeneic hematopoietic stem cell transplantation (allo-HSCT) can be a curative regimen for acute myeloid leukemia (AML), relapse of AML remains a serious risk post-transplantation. Once relapsed, salvage options are limited and management of AML is difficult. Here we designed a prospective study to examine the efficacy and tolerability of maintenance therapy with azacytidine (AZA) plus low-dose lenalidomide (LEN) to prevent relapse after allo-HSCT for AML patients (ChiCTR2200061803). METHODS: AML patients post-allo-HSCT were treated with AZA (75 mg/m(2) for 7 days), followed by LEN (5 mg/m(2), day 10-28), and a 4-week resting interval, which was defined as one treatment cycle. A total of 8 cycles was recommended. RESULTS: 37 patients were enrolled, 25 patients received at least 5 cycles, and 16 patients finished all 8 cycles. With a median follow-up time of 608 (43-1440) days, the estimated 1-year disease free survival (DFS) was 82%, cumulative incidence of relapse (CIR) was 18%, and overall survival (OS) was 100%. Three patients (8%) had grade 1-2 neutropenia without fever; one patient developed grade 3-4 thrombocytopenia and minor subdural hematoma; 4/37 patients (11%) developed chronic GVHD with a score of 1-2, without requiring systemic treatment; No patient developed acute GVHD. After AZA/LEN prophylaxis, increasing numbers of CD56(+)NK and CD8(+) T, and decreasing of CD19(+) B cells were observed. DISCUSSION: Azacitidine combined with low-dose lenalidomide was observed to be an effective relapse prophylaxis option after allo-HSCT in AML patients, and can be administered safely without significantly increasing the risk of GVHD, infection and other AEs. CLINICAL TRIAL REGISTRATION: www.chictr.org, identifier ChiCTR2200061803.
format Online
Article
Text
id pubmed-10332158
institution National Center for Biotechnology Information
language English
publishDate 2023
publisher Frontiers Media S.A.
record_format MEDLINE/PubMed
spelling pubmed-103321582023-07-11 Azacitidine and lenalidomide combination: a novel relapse prophylaxis regimen after allogeneic hematopoietic stem-cell transplantation in patients with acute myeloid leukemia Feng, Yimei Chen, Ting Zhang, Yun Yao, Han Wang, Ping Wang, Lu Cassady, Kaniel Zou, Zhongmin Liu, Yuqing Zhao, Lu Gao, Lei Zhang, Xi Kong, Peiyan Front Immunol Immunology INTRODUCTION: While allogeneic hematopoietic stem cell transplantation (allo-HSCT) can be a curative regimen for acute myeloid leukemia (AML), relapse of AML remains a serious risk post-transplantation. Once relapsed, salvage options are limited and management of AML is difficult. Here we designed a prospective study to examine the efficacy and tolerability of maintenance therapy with azacytidine (AZA) plus low-dose lenalidomide (LEN) to prevent relapse after allo-HSCT for AML patients (ChiCTR2200061803). METHODS: AML patients post-allo-HSCT were treated with AZA (75 mg/m(2) for 7 days), followed by LEN (5 mg/m(2), day 10-28), and a 4-week resting interval, which was defined as one treatment cycle. A total of 8 cycles was recommended. RESULTS: 37 patients were enrolled, 25 patients received at least 5 cycles, and 16 patients finished all 8 cycles. With a median follow-up time of 608 (43-1440) days, the estimated 1-year disease free survival (DFS) was 82%, cumulative incidence of relapse (CIR) was 18%, and overall survival (OS) was 100%. Three patients (8%) had grade 1-2 neutropenia without fever; one patient developed grade 3-4 thrombocytopenia and minor subdural hematoma; 4/37 patients (11%) developed chronic GVHD with a score of 1-2, without requiring systemic treatment; No patient developed acute GVHD. After AZA/LEN prophylaxis, increasing numbers of CD56(+)NK and CD8(+) T, and decreasing of CD19(+) B cells were observed. DISCUSSION: Azacitidine combined with low-dose lenalidomide was observed to be an effective relapse prophylaxis option after allo-HSCT in AML patients, and can be administered safely without significantly increasing the risk of GVHD, infection and other AEs. CLINICAL TRIAL REGISTRATION: www.chictr.org, identifier ChiCTR2200061803. Frontiers Media S.A. 2023-06-22 /pmc/articles/PMC10332158/ /pubmed/37435080 http://dx.doi.org/10.3389/fimmu.2023.1182251 Text en Copyright © 2023 Feng, Chen, Zhang, Yao, Wang, Wang, Cassady, Zou, Liu, Zhao, Gao, Zhang and Kong https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Immunology
Feng, Yimei
Chen, Ting
Zhang, Yun
Yao, Han
Wang, Ping
Wang, Lu
Cassady, Kaniel
Zou, Zhongmin
Liu, Yuqing
Zhao, Lu
Gao, Lei
Zhang, Xi
Kong, Peiyan
Azacitidine and lenalidomide combination: a novel relapse prophylaxis regimen after allogeneic hematopoietic stem-cell transplantation in patients with acute myeloid leukemia
title Azacitidine and lenalidomide combination: a novel relapse prophylaxis regimen after allogeneic hematopoietic stem-cell transplantation in patients with acute myeloid leukemia
title_full Azacitidine and lenalidomide combination: a novel relapse prophylaxis regimen after allogeneic hematopoietic stem-cell transplantation in patients with acute myeloid leukemia
title_fullStr Azacitidine and lenalidomide combination: a novel relapse prophylaxis regimen after allogeneic hematopoietic stem-cell transplantation in patients with acute myeloid leukemia
title_full_unstemmed Azacitidine and lenalidomide combination: a novel relapse prophylaxis regimen after allogeneic hematopoietic stem-cell transplantation in patients with acute myeloid leukemia
title_short Azacitidine and lenalidomide combination: a novel relapse prophylaxis regimen after allogeneic hematopoietic stem-cell transplantation in patients with acute myeloid leukemia
title_sort azacitidine and lenalidomide combination: a novel relapse prophylaxis regimen after allogeneic hematopoietic stem-cell transplantation in patients with acute myeloid leukemia
topic Immunology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10332158/
https://www.ncbi.nlm.nih.gov/pubmed/37435080
http://dx.doi.org/10.3389/fimmu.2023.1182251
work_keys_str_mv AT fengyimei azacitidineandlenalidomidecombinationanovelrelapseprophylaxisregimenafterallogeneichematopoieticstemcelltransplantationinpatientswithacutemyeloidleukemia
AT chenting azacitidineandlenalidomidecombinationanovelrelapseprophylaxisregimenafterallogeneichematopoieticstemcelltransplantationinpatientswithacutemyeloidleukemia
AT zhangyun azacitidineandlenalidomidecombinationanovelrelapseprophylaxisregimenafterallogeneichematopoieticstemcelltransplantationinpatientswithacutemyeloidleukemia
AT yaohan azacitidineandlenalidomidecombinationanovelrelapseprophylaxisregimenafterallogeneichematopoieticstemcelltransplantationinpatientswithacutemyeloidleukemia
AT wangping azacitidineandlenalidomidecombinationanovelrelapseprophylaxisregimenafterallogeneichematopoieticstemcelltransplantationinpatientswithacutemyeloidleukemia
AT wanglu azacitidineandlenalidomidecombinationanovelrelapseprophylaxisregimenafterallogeneichematopoieticstemcelltransplantationinpatientswithacutemyeloidleukemia
AT cassadykaniel azacitidineandlenalidomidecombinationanovelrelapseprophylaxisregimenafterallogeneichematopoieticstemcelltransplantationinpatientswithacutemyeloidleukemia
AT zouzhongmin azacitidineandlenalidomidecombinationanovelrelapseprophylaxisregimenafterallogeneichematopoieticstemcelltransplantationinpatientswithacutemyeloidleukemia
AT liuyuqing azacitidineandlenalidomidecombinationanovelrelapseprophylaxisregimenafterallogeneichematopoieticstemcelltransplantationinpatientswithacutemyeloidleukemia
AT zhaolu azacitidineandlenalidomidecombinationanovelrelapseprophylaxisregimenafterallogeneichematopoieticstemcelltransplantationinpatientswithacutemyeloidleukemia
AT gaolei azacitidineandlenalidomidecombinationanovelrelapseprophylaxisregimenafterallogeneichematopoieticstemcelltransplantationinpatientswithacutemyeloidleukemia
AT zhangxi azacitidineandlenalidomidecombinationanovelrelapseprophylaxisregimenafterallogeneichematopoieticstemcelltransplantationinpatientswithacutemyeloidleukemia
AT kongpeiyan azacitidineandlenalidomidecombinationanovelrelapseprophylaxisregimenafterallogeneichematopoieticstemcelltransplantationinpatientswithacutemyeloidleukemia