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Inotuzumab Ozogamicin and Low-Intensity Chemotherapy in Older Patients With Newly Diagnosed CD22+ Philadelphia Chromosome-Negative B-Cell Precursor Acute Lymphoblastic Leukemia
P. Chevallier, T. Leguay, M. Delord, C. Salek, R. Kim, F. Huguet, Y. Hicheri, U. Wartiovaara-Kautto, E. Raffoux, T. Cluzeau, M. Balsat, G. Roth-Guepin, E. Tavernier, S. Lepretre, K. Bilger, H. Bergugnat, A. Berceanu, M. Alexis, M. Doubek, E....
Language English Country United States
Document type Journal Article, Clinical Trial, Phase II, Multicenter Study
NLK
Free Medical Journals
from 2004 to 1 year ago
Open Access Digital Library
from 1999-01-01
PubMed
39418626
DOI
10.1200/jco.24.00490
Knihovny.cz E-resources
- MeSH
- Sialic Acid Binding Ig-like Lectin 2 * MeSH
- Cyclophosphamide administration & dosage therapeutic use MeSH
- Dexamethasone administration & dosage therapeutic use MeSH
- Philadelphia Chromosome MeSH
- Inotuzumab Ozogamicin * therapeutic use MeSH
- Middle Aged MeSH
- Humans MeSH
- Precursor B-Cell Lymphoblastic Leukemia-Lymphoma * drug therapy mortality genetics MeSH
- Prospective Studies MeSH
- Antineoplastic Combined Chemotherapy Protocols * therapeutic use MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Vincristine administration & dosage therapeutic use MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase II MeSH
- Multicenter Study MeSH
PURPOSE: The use of inotuzumab ozogamicin (InO), a conjugated anti-CD22 monoclonal antibody, is becoming a promising frontline treatment for older patients with ALL. PATIENTS AND METHODS: EWALL-INO is an open-label prospective multicenter phase II trial (ClinicalTrials.gov identifier: NCT03249870). Patients age 55 years and older with newly diagnosed CD22+ Philadelphia chromosome-negative (Ph-) B-cell precursor (BCP) ALL were eligible. After a prephase, a first induction consisting of vincristine, dexamethasone, and three injections of InO (0.8 mg/m2 day 1, 0.5 mg/m2 day 8/day 15) was followed by a second induction combining cyclophosphamide, dexamethasone, and two injections of InO (0.5 mg/m2 day 1/day 8). Responders received up to six cycles of chemotherapy consolidation and 18-month chemotherapy maintenance. Allotransplant was allowed after three consolidations. The primary end point was 1-year overall survival (OS). RESULTS: Between December 2017 and March 2022, 131 patients (median age 68 years) were included. Three patients died during induction 1 (n = 130), two from multiple organ failure and one from hemorrhage, and none during induction 2 (n = 120). After induction 2, 90% of the patients achieved complete remission (CR) or CR with incomplete platelet recovery (CRp) and 80% had measurable residual disease (MRD2) <10-4. Among responders (n = 119), 47 relapsed and 14 died in CR/CRp. One-year OS, relapse-free survival (RFS), and cumulative incidence of relapse (CIR) rates were 73.2%, 66%, and 25%, respectively. High-risk cytogenetics and lower CD22 expression (<70%) were associated with worse OS, while both high-risk cytogenetics and MRD2 ≥10-4 were associated with lower RFS and higher CIR. The 10 allotransplanted patients had very favorable outcomes (90% 2-year OS/RFS and no relapse). Only one nonfatal sinusoidal obstructive syndrome was documented during the study. CONCLUSION: Our results support InO's use in first-line regimens for older patients with CD22+ Ph- BCP-ALL.
CRCI2NA INSERM UMR 1307 and CNRS UMR 6075 IRS_UN University of Nantes Nantes France
Hematology Department Centre Henri Becquerel Rouen France
Hematology Department Centre Lyon Bérard Lyon France
Hematology Department CHR d'Orleans Orleans France
Hematology Department CHR de la Côte Basque Bayonne France
Hematology Department CHR Métropole Savoie Chambéry France
Hematology Department CHU Amiens Sud Amiens France
Hematology Department CHU d'Angers Angers France
Hematology Department CHU de Caen Caen France
Hematology Department CHU de Clermont Ferrand Clermont Ferrand France
Hematology Department CHU de Dijon Dijon France
Hematology Department CHU de Limoges Limoges France
Hematology Department CHU de Nancy Nancy France
Hematology Department CHU de Nîmes Nîmes France
Hematology Department CHU de Reims Reims France
Hematology Department CHU de St Etienne Saint Priest en Jarez France
Hematology Department CHU Hôpital Haut Lévèque Pessac France
Hematology Department CHU Jean Minjoz Besançon France
Hematology Department Fakulni Nemocnice Brno Brno Czech Republic
Hematology Department Helsinki University Hospital Helsinki Finland
Hematology Department Hôpital Archet CHU Nice Nice France
Hematology Department Hôpital Avicenne APHP Paris France
Hematology Department Hôpital Pontchaillou CHU Rennes France
Hematology Department Hôpital St Eloi CHU Montpellier France
Hematology Department Hôpital St Louis APHP Paris France
Hematology Department Hôpital Victor Provo Roubaix France
Hematology Department Hospices Civils de Lyon Hôpital Lyon Sud Pierre Bénite France
Hematology Department Institut de Cancérologie Strasbourg Europe Strasbourg France
Hematology Department Institut Paoli Calmettes Marseille France
Hematology Department Nantes University Hospital Nantes France
Sorbonne University Hematology Department Saint Antoine Hospital INSERM UMR 938 Paris France
References provided by Crossref.org
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