{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,7,30]],"date-time":"2025-07-30T09:44:18Z","timestamp":1753868658817,"version":"3.41.2"},"reference-count":23,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2024,4,25]],"date-time":"2024-04-25T00:00:00Z","timestamp":1714003200000},"content-version":"vor","delay-in-days":24,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Reports"],"published-print":{"date-parts":[[2024,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Gemtuzumab\u2010ozogamycin (GO) is approved in combination with high\u2010dose chemotherapy for treatment\u2010na\u00efve low\u2010 and intermediate\u2010risk acute myeloid leukemia (AML).<\/jats:p><\/jats:sec><jats:sec><jats:title>Aims<\/jats:title><jats:p>In this retrospective real\u2010life multicenter study, we reported efficacy and safety of GO plus high\u2010dose chemotherapy in newly diagnosed AML patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods and Results<\/jats:title><jats:p>A total of 31 fit low\u2010 and intermediate\u2010risk AML patients treated with GO\u2010based regimens were retrospectively included in this real\u2010life multicenter study, and results were compared with a control cohort treated with 3\u2009+\u20097 alone. Complete remission (CR) rate after induction was 77%, and most responders (45%) underwent two GO\u2010based consolidation, and minimal residual disease (MRD) negativity was observed in 17 cases (55%) after the end of consolidation. Low genetic risk was associated with increased CR rate compared with intermediate\u2010risk AML (88% vs. 33%; <jats:italic>p<\/jats:italic>\u2009&lt;\u2009.001), as well as prolonged overall survival (OS; hazard ratio, 0.16; 95% confidential interval, 0.02\u20130.89; <jats:italic>p<\/jats:italic>\u2009&lt;\u2009.001). GO addition resulted in a survival benefit for low\u2010risk AML (median OS not reached vs. 25\u2009months; <jats:italic>p<\/jats:italic>\u2009=\u2009.19) while not for intermediate\u2010risk subjects (10 vs. 13\u2009months; <jats:italic>p<\/jats:italic>\u2009=\u2009.92), compared with the control group. Moreover, GO\u2010treated patients experienced fever of unknown origin or sepsis in 42% or 36% of cases, respectively, with one death during induction due to septic shock, with similar rates compared with the control group (<jats:italic>p<\/jats:italic>\u2009=\u2009.3480 and <jats:italic>p<\/jats:italic>\u2009=\u2009.5297, respectively). No cases of veno\u2010occlusive disease after allogeneic transplantation were observed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Our real\u2010life multicenter study confirmed GO\u2010based treatment efficacy with high MRD negativity rates in fit newly diagnosed AML patients, especially in those with low genetic risk and core binding factor, while limited benefits were observed in intermediate\u2010risk AML. However, further validation on larger prospective cohorts is required.<\/jats:p><\/jats:sec>","DOI":"10.1002\/cnr2.2044","type":"journal-article","created":{"date-parts":[[2024,4,25]],"date-time":"2024-04-25T15:28:36Z","timestamp":1714058916000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Limited efficacy of 3\u2009+\u20097 plus gemtuzumab ozogamycin in newly diagnosed fit intermediate genetic risk acute myeloid leukemia patients"],"prefix":"10.1002","volume":"7","author":[{"given":"Bianca","family":"Serio","sequence":"first","affiliation":[{"name":"Hematology Unit University Hospital \u201cSan Giovanni di Dio e Ruggi d'Aragona\u201d  Salerno Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francesco","family":"Grimaldi","sequence":"additional","affiliation":[{"name":"Hematology Unit, Department of Medicine and Surgery University of Naples \u201cFederico II\u201d  Naples Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lucia","family":"Ammirati","sequence":"additional","affiliation":[{"name":"Hematology Unit, Hospital \u201cA. Tortora\u201d  Pagani Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mario","family":"Annunziata","sequence":"additional","affiliation":[{"name":"Hematology Unit, Hospital \u201cS. G. Moscati\u201d  Aversa Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Giovanna","family":"De Santis","sequence":"additional","affiliation":[{"name":"Hematology Unit, Hospital \u201cS. Giuseppe Moscati\u201d  Avellino Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alessandra","family":"Perrotta","sequence":"additional","affiliation":[{"name":"Hematology Unit, Department of Medicine and Surgery University of Naples \u201cFederico II\u201d  Naples Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Danilo","family":"De Novellis","sequence":"additional","affiliation":[{"name":"Hematology Unit University Hospital \u201cSan Giovanni di Dio e Ruggi d'Aragona\u201d  Salerno Italy"},{"name":"Department of Medicine, Surgery, and Dentistry University of Salerno  Baronissi Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7492-6848","authenticated-orcid":false,"given":"Valentina","family":"Giudice","sequence":"additional","affiliation":[{"name":"Hematology Unit University Hospital \u201cSan Giovanni di Dio e Ruggi d'Aragona\u201d  Salerno Italy"},{"name":"Department of Medicine, Surgery, and Dentistry University of Salerno  Baronissi Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Denise","family":"Morini","sequence":"additional","affiliation":[{"name":"Hematology Unit University Hospital \u201cSan Giovanni di Dio e Ruggi d'Aragona\u201d  Salerno Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gabriella","family":"Storti","sequence":"additional","affiliation":[{"name":"Hematology Unit, Hospital \u201cS. 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