دورية أكاديمية
أعرض في EDS

MR 4log and low levels of NK cells are associated with higher molecular relapse after imatinib discontinuation: Results of a prospective trial.

التفاصيل البيبلوغرافية
العنوان: MR 4log and low levels of NK cells are associated with higher molecular relapse after imatinib discontinuation: Results of a prospective trial.
المؤلفون: Seguro FS; Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil; Instituto do Câncer do Estado de São Paulo, Sao Paulo, SP, Brazil. Electronic address: fernanda.seguro@hc.fm.usp.br., Maciel FVR; Instituto do Câncer do Estado de São Paulo, Sao Paulo, SP, Brazil., Santos FM; Instituto do Câncer do Estado de São Paulo, Sao Paulo, SP, Brazil., Abdo ANR; Instituto do Câncer do Estado de São Paulo, Sao Paulo, SP, Brazil., Pereira TDM; Instituto do Câncer do Estado de São Paulo, Sao Paulo, SP, Brazil., Nardinelli L; Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil., Rocha V; Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil., Bendit I; Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.
المصدر: Leukemia research [Leuk Res] 2021 Feb; Vol. 101, pp. 106516. Date of Electronic Publication: 2021 Jan 21.
نوع المنشور: Clinical Trial; Journal Article
اللغة: English
بيانات الدورية: Publisher: Pergamon Press Country of Publication: England NLM ID: 7706787 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-5835 (Electronic) Linking ISSN: 01452126 NLM ISO Abbreviation: Leuk Res Subsets: MEDLINE
أسماء مطبوعة: Original Publication: Oxford ; New York : Pergamon Press
مواضيع طبية MeSH: Leukemia, Myelogenous, Chronic, BCR-ABL Positive*/blood , Leukemia, Myelogenous, Chronic, BCR-ABL Positive*/drug therapy, Imatinib Mesylate/*administration & dosage , Killer Cells, Natural/*metabolism, Adolescent ; Adult ; Aged ; Aged, 80 and over ; Female ; Humans ; Imatinib Mesylate/adverse effects ; Lymphocyte Count ; Male ; Middle Aged ; Pilot Projects ; Prospective Studies ; Recurrence ; Time Factors
مستخلص: Background: Treatment-free survival (TFS) in chronic myeloid leukemia (CML) is a new goal. This prospective study aims to evaluate imatinib discontinuation's feasibility and safety in patients with deep molecular response MR4 (BCR-ABL1 < 0.01 % IS).
Methods: Study was approved by the ethical committee and registered at Clinicaltrials.gov (NCT03239886). Incluision criteria were: age ≥ 18y, chronic phase, first-line imatinib for 36 months, MR4 for 12 months, no previous transplant or resistance. Imatinib was resumed when two samples confirmed the loss of MMR. The primary endpoint was molecular recurrence-free survival (MRFS) at 24 months. Lymphocyte subpopulations were counted in peripheral blood before discontinuation.
Results: 31 patients were included from Dec/2016 until Oct/2017. Median age was 54years, 58 % male, 58 % low Sokal, 65 % b3a2 transcripts, and 61 % were in MR4.5. Imatinib therapy's median time was 9.7y (3-14.9 y), median time of MR4 was 6.9y (1.6-10.3y). MRFS at 24 months was 55 % (95 % CI 39-75). Thirteen patients relapsed, 46 % after six months of discontinuation, and all patients recovered MMR. Median time to recover MMR was one month. MR4.5 was the only factor associated with MRFS. NK cells proportion at baseline was lower in patients with only MR4 who relapsed after discontinuation.
Conclusion: With a median duration of sustained MR4 above five years, as recommended by most TKI discontinuation guidelines, the TFS was similar to previous studies. Only MR4.5 was associated with lower risk of relapse. Further studies are needed to evaluate whether patients with only MR4 and low NK cell levels are suitable for discontinuation.
(Copyright © 2021 Elsevier Ltd. All rights reserved.)
فهرسة مساهمة: Keywords: Chronic myeloid leukemia; Deep molecular response; Discontinuation; Imatinib
سلسلة جزيئية: ClinicalTrials.gov NCT03239886
المشرفين على المادة: 8A1O1M485B (Imatinib Mesylate)
تواريخ الأحداث: Date Created: 20210131 Date Completed: 20210401 Latest Revision: 20210401
رمز التحديث: 20231215
DOI: 10.1016/j.leukres.2021.106516
PMID: 33517185
قاعدة البيانات: MEDLINE
الوصف
تدمد:1873-5835
DOI:10.1016/j.leukres.2021.106516