{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,30]],"date-time":"2026-10-30T18:20:18Z","timestamp":1793384418262,"version":"4.5.0"},"reference-count":27,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"1","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["J Clin Oncol"],"published-print":{"date-parts":[[2026,1]]},"abstract":"<jats:sec>\n                    <jats:title>PURPOSE<\/jats:title>\n                    <jats:p>\n                      Quizartinib, an oral, selective, second-generation, type-II FMS-like tyrosine kinase 3 (FLT3) inhibitor with high binding affinity to internal tandem duplication (ITD) and wild-type (WT) FLT3, has shown early clinical activity as monotherapy in patients with relapsed\/refractory\n                      <jats:italic toggle=\"yes\">FLT3<\/jats:italic>\n                      -ITD\u2013negative AML. The phase III QuANTUM-First trial showed that quizartinib significantly prolonged survival versus placebo when added to standard chemotherapy, followed by single-agent maintenance, in patients with newly diagnosed (ND)\n                      <jats:italic toggle=\"yes\">FLT3-<\/jats:italic>\n                      ITD\u2013positive AML. We investigated the safety and efficacy of quizartinib in patients with ND\n                      <jats:italic toggle=\"yes\">FLT3<\/jats:italic>\n                      -ITD\u2013negative AML.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS<\/jats:title>\n                    <jats:p>\n                      The phase II, randomized, double-blind, placebo-controlled QUIWI trial enrolled patients age 18-70 years with ND\n                      <jats:italic toggle=\"yes\">FLT3<\/jats:italic>\n                      -ITD\u2013negative (mutant-to-WT allelic ratio &lt;0.03) AML. Patients were randomly assigned 2:1 to receive standard induction and consolidation chemotherapy combined with either quizartinib 60 mg once daily or placebo, followed by single-agent maintenance with quizartinib or placebo. The primary end point was event-free survival (EFS). Secondary end points included overall survival (OS) and safety.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>\n                      Overall, 273 patients were randomly assigned to quizartinib (n = 180) or placebo (n = 93). At data cutoff, median EFS was 20.4 months and 9.9 months in the quizartinib and placebo arms, respectively (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = .046). Median OS was not reached and 29.3 months in the quizartinib and placebo arms, respectively (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = .012); 3-year OS rates were 60.8% and 45.7%. The most frequently reported adverse events (any grade) were fever, rash, diarrhea, and mucositis.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSION<\/jats:title>\n                    <jats:p>\n                      The addition of quizartinib to standard chemotherapy was associated with significantly longer EFS and OS than placebo in patients with ND\n                      <jats:italic toggle=\"yes\">FLT3<\/jats:italic>\n                      -ITD\u2013negative AML.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1200\/jco-25-01841","type":"journal-article","created":{"date-parts":[[2025,10,13]],"date-time":"2025-10-13T20:00:21Z","timestamp":1760385621000},"page":"42-53","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":17,"title":["Quizartinib for Newly Diagnosed\n                    <i>FLT3<\/i>\n                    -Internal Tandem Duplication\u2013Negative AML: The Randomized, Double-Blind, Placebo-Controlled, Phase II QUIWI Study"],"prefix":"10.1200","volume":"44","clinical-trial-number":[{"clinical-trial-number":"nct04107727","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3275-5593","authenticated-orcid":true,"given":"Pau","family":"Montesinos","sequence":"first","affiliation":[{"name":"Hospital Universitari I Polit\u00e9cnic La Fe, Valencia, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rebeca","family":"Rodr\u00edguez-Veiga","sequence":"additional","affiliation":[{"name":"Hospital Universitari I Polit\u00e9cnic La Fe, Valencia, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8229-1208","authenticated-orcid":true,"given":"Juan Miguel","family":"Bergua","sequence":"additional","affiliation":[{"name":"Hospital San Pedro de Alc\u00e1ntara, C\u00e1ceres, 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