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      Survival outcomes with oral azacitidine maintenance in patients with acute myeloid leukemia in remission by receipt of initial chemotherapy: subgroup analyses from the phase III QUAZAR AML-001 trial

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          Most cited references7

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          Oral Azacitidine Maintenance Therapy for Acute Myeloid Leukemia in First Remission

          Although induction chemotherapy results in remission in many older patients with acute myeloid leukemia (AML), relapse is common and overall survival is poor.
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            Azacitidine maintenance after intensive chemotherapy improves DFS in older AML patients

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              Gemtuzumab ozogamicin as postremission treatment in AML at 60 years of age or more: results of a multicenter phase 3 study.

              In older patients with acute myeloid leukemia (AML), the prevention of relapse has remained one of the major therapeutic challenges, with more than 75% relapses after complete remission. The anti-CD33 immunotoxin conjugate gemtuzumab ozogamicin (GO) has shown antileukemic remission induction activity in patients with relapsed AML. Patients with AML or refractory anemia with excess blasts in first complete remission attained after intensive induction chemotherapy were randomized between 3 cycles of GO (6 mg/m(2) every 4 weeks) or no postremission therapy (control) to assess whether GO would improve outcome. The 2 treatment groups (113 patients receiving GO vs 119 control patients) were comparable with regard to age (60-78 years, median 67 years), performance status, and cytogenetics. A total of 110 of 113 received at least 1 cycle of GO, and 65 of 113 patients completed the 3 cycles. Premature discontinuation was mainly attributable to incomplete hematologic recovery or intercurrent relapse. Median time to recovery of platelets 50 x 10(9)/L and neutrophils 0.5 x 10(9)/L after GO was 14 days and 20 days. Nonhematologic toxicities were mild overall, but there was 1 toxic death caused by liver failure. There were no significant differences between both treatment groups with regard to relapse probabilities, nonrelapse mortality, overall survival, or disease-free survival (17% vs 16% at 5 years). Postremission treatment with GO in older AML patients does not provide benefits regarding any clinical end points. The HOVON-43 study is registered at The Netherlands Trial Registry (number NTR212) and at http://www.controlled-trials.com as ISRCTN77039377.
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                Author and article information

                Journal
                Haematologica
                Haematologica
                HAEMA
                Haematologica
                Fondazione Ferrata Storti
                0390-6078
                1592-8721
                23 March 2023
                01 October 2023
                : 108
                : 10
                : 2820-2825
                Affiliations
                [1 ]Department of Clinical Hematology, The Alfred Hospital, Melbourne, Victoria, Australia
                [2 ]Australian Center for Blood Diseases, Monash University , Melbourne, Victoria, Australia
                [3 ]Weill Cornell Medicine, New York, NY, USA
                [4 ]New York Presbyterian Hospital, New York, NY, USA
                [5 ]Hematology, Hôpital Saint-Louis, Assistance Publique – Hôpitaux de Paris (AP-HP), Paris, France
                [6 ]Institut de Recherche Saint-Louis, Université Paris Cité , Paris, France
                [7 ]Department of Internal Medicine III, Ulm University Hospital , Ulm, Germany
                [8 ]Princess Margaret Cancer Center, Toronto, Ontario, Canada
                [9 ]Hospital Universitario y Politécnico La Fe, Valencia, Spain
                [10 ]AZ Sint-Jan Brugge-Oostende AV, Bruges, Belgium
                [11 ]RM Gorbacheva Research Institute, Pavlov University , St. Petersburg, Russia
                [12 ]Bristol Myers Squibb, Summit, NJ, USA
                [13 ]University of Kansas Cancer Center , Kansas City, KS, USA
                [14 ]Department of Leukemia, The University of Texas MD Anderson Cancer Center , Houston, TX, USA
                Author notes
                °Current address Department of Clinical Hematology, Peter MacCallum Cancer Center and Royal Melbourne Hospital, Melbourne, Vicoria, Australia

                Disclosures

                BS and CLB were employed by Bristol Myers Squibb at the time the study was conducted. AHW has served on advisory boards for AbbVie, Agios, Amgen, Celgene/Bristol Myers Squibb, Gilead, Janssen, MacroGenics, Novartis, Pfizer, Roche, and Servier; has received research funding to his institution from AbbVie, Amgen, AstraZeneca, Celgene/Bristol Myers Squibb, Novartis, and Servier; has served on a speakers bureau for AbbVie, Celgene, and Novartis; and is eligible for royalty payments from the Walter and Eliza Hall Institute of Medical Research related to venetoclax. GJR reports receiving research support from Janssen and has served in an advisory position for AbbVie, Agios, Amgen, Astellas, AstraZeneca, Bluebird Bio, Blueprint Medicines, Bristol Myers Squibb, Catamaran, Celgene, Glaxo SmithKline, Helsinn, Janssen, Jasper Therapeutics, Jazz Pharmaceuticals, Mesoblast, Novartis, Pfizer, Roche, Syndax, and Takeda (IRC Chair). HDo reports receiving honoraria from Incyte and Servier. HDö has served in a consultancy position for AbbVie, Agios, Amgen, Astellas, Berlin-Chemie, Bristol Myers Squibb, Daiichi Sankyo, Gilead, Janssen, Jazz Pharmaceuticals, Novartis, Servier, and Syndax; reports receiving research funding from AbbVie, Agios, Amgen, Astellas, Bristol Myers Squibb, Jazz Pharmaceuticals, Kronos Bio, Novartis, and Pfizer; and reports receiving honoraria from AbbVie, Agios, Amgen, Astellas, AstraZeneca, Berlin-Chemie, Bristol Myers Squibb, Daiichi Sankyo, Gilead, Janssen, Jazz Pharmaceuticals, Novartis, Servier, and Syndax. ACS has served on an advisory committee for AbbVie, Agios, Amgen, Astellas, Bristol Myers Squibb, Jazz, Pfizer, Teva, and Servier; reports receiving research funding from AbbVie, Agios, Amgen, Astellas, Bristol Myers Squibb, GlycoMimetics, Kite/Gilead, Pfizer, and Servier; and reports receiving honoraria from AbbVie, Agios, Amgen, Astellas, Bristol Myers Squibb, Pfizer, Teva, and Servier. PM has served in a consultancy position for Menarini/Stemline, Gilead, Otsuka, Kura Oncology, AbbVie, Bristol Myers Squibb, Novartis, Jazz Pharmaceuticals, BeiGene, Astellas, Pfizer, Incyte, Takeda, Ryvu, and Nerviano; reports receiving research funding from AbbVie, Bristol Myers Squibb, Jazz Pharmaceuticals, Menarini/Stemline, Novartis, Pfizer, and Takeda; and has served on a speakers bureau for AbbVie, Astellas, Bristol Myers Squibb, Gilead, Jazz Pharmaceuticals, and Pfizer. DS reports receiving grants or contracts, honoraria, consulting fees, and travel support from AbbVie, Bristol Myers Squibb, Novartis, and Pfizer; and has served in a leadership role for the Belgian College for Reimbursement of Orphan Drugs. TP reports employment and stock ownership with Bristol Myers Squibb. YL reports employment with Bristol Myers Squibb and Eli Lilly stock ownership. BS reports prior employment with Celgene/Bristol Myers Squibb. CLB reports prior employment and stock ownership with Bristol Myers Squibb. FR reports receiving research funding from Amgen, Astellas, Astex/Taiho, Biomea Fusion, Celgene/Bristol Myers Squibb, Prelude, Syros, and Xencor; and honoraria from AbbVie, Astellas, AstraZeneca, Celgene/Bristol Myers Squibb, Novartis, and Syros. AstraZeneca, Celgene/Bristol Myers Squibb, Novartis, and Syros.

                Contributions

                The sponsors collected and analyzed data in conjunction with all authors. AHW wrote the first draft of the manuscript. All authors revised the manuscript and reviewed and approved the final version for submission.

                Data-sharing statement

                Bristol Myers Squibb policy on data sharing may be found at https://www.bms.com/researchers-and-partners/independent-research/data-sharing-request-process.html.

                Article
                10.3324/haematol.2022.282296
                10542842
                36951156
                afe66161-2957-4579-86cf-df3219f61969
                Copyright© 2023 Ferrata Storti Foundation

                This article is distributed under the terms of the Creative Commons Attribution Noncommercial License ( by-nc 4.0) which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and source are credited.

                History
                : 25 October 2022
                : 16 March 2023
                Page count
                Figures: 2, Tables: 1, Equations: 0, References: 10, Pages: 6
                Funding
                Funding: Writing and editorial support was provided by Korin Albert, PhD, of Excerpta Medica, funded by Bristol Myers Squibb. The study was sponsored by Bristol Myers Squibb.
                Categories
                Letter to the Editor

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