{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T18:59:17Z","timestamp":1792609157390,"version":"4.5.0"},"reference-count":27,"publisher":"American Society of Hematology","issue":"8","content-domain":{"domain":["ashpublications.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2020,2,20]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>In chronic myeloid leukemia (CML) patients, tyrosine kinase inhibitors (TKIs) may select for drug-resistant BCR-ABL1 kinase domain (KD) mutants. Although Sanger sequencing (SS) is considered the gold standard for BCR-ABL1 KD mutation screening, next-generation sequencing (NGS) has recently been assessed in retrospective studies. We conducted a prospective, multicenter study (NEXT-in-CML) to assess the frequency and clinical relevance of low-level mutations and the feasibility, cost, and turnaround times of NGS-based BCR-ABL1 mutation screening in a routine setting. A series of 236 consecutive CML patients with failure (n = 124) or warning (n = 112) response to TKI therapy were analyzed in parallel by SS and NGS in 1 of 4 reference laboratories. Fifty-one patients (22 failure, 29 warning) who were negative for mutations by SS had low-level mutations detectable by NGS. Moreover, 29 (27 failure, 2 warning) of 60 patients who were positive for mutations by SS showed additional low-level mutations. Thus, mutations undetectable by SS were identified in 80 out of 236 patients (34%), of whom 42 (18% of the total) had low-level mutations somehow relevant for clinical decision making. Prospective monitoring of mutation kinetics demonstrated that TKI-resistant low-level mutations are invariably selected if the patients are not switched to another TKI or if they are switched to a inappropriate TKI or TKI dose. The NEXT-in-CML study provides for the first time robust demonstration of the clinical relevance of low-level mutations, supporting the incorporation of NGS-based BCR-ABL1 KD mutation screening results in the clinical decision algorithms.<\/jats:p>","DOI":"10.1182\/blood.2019002969","type":"journal-article","created":{"date-parts":[[2019,12,26]],"date-time":"2019-12-26T12:53:03Z","timestamp":1577364783000},"page":"534-541","update-policy":"https:\/\/doi.org\/10.1182\/blood.2019cm0000","source":"Crossref","is-referenced-by-count":87,"title":["Prospective assessment of NGS-detectable mutations in CML patients with nonoptimal response: the NEXT-in-CML study"],"prefix":"10.1182","volume":"135","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4508-0353","authenticated-orcid":false,"given":"Simona","family":"Soverini","sequence":"first","affiliation":[{"name":"Department of Experimental, Diagnostic and Specialty Medicine, Institute of Hematology \u201cL. e A. Ser\u00e0gnoli,\u201d University of Bologna, Bologna, Italy;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0543-7899","authenticated-orcid":false,"given":"Luana","family":"Bavaro","sequence":"first","affiliation":[{"name":"Department of Experimental, Diagnostic and Specialty Medicine, Institute of Hematology \u201cL. e A. Ser\u00e0gnoli,\u201d University of Bologna, Bologna, Italy;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4315-5996","authenticated-orcid":false,"given":"Caterina","family":"De Benedittis","sequence":"first","affiliation":[{"name":"Department of Experimental, Diagnostic and Specialty Medicine, Institute of Hematology \u201cL. e A. Ser\u00e0gnoli,\u201d University of Bologna, Bologna, Italy;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Margherita","family":"Martelli","sequence":"first","affiliation":[{"name":"Department of Experimental, Diagnostic and Specialty Medicine, Institute of Hematology \u201cL. e A. Ser\u00e0gnoli,\u201d University of Bologna, Bologna, Italy;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4401-0812","authenticated-orcid":false,"given":"Alessandra","family":"Iurlo","sequence":"first","affiliation":[{"name":"Hematology Division, Foundation Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Ca\u2019 Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicola","family":"Orofino","sequence":"first","affiliation":[{"name":"Hematology Division, Foundation Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Ca\u2019 Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simona","family":"Sica","sequence":"first","affiliation":[{"name":"Fondazione Policlinico Universitario A Gemelli-IRCCS, Istituto di Ematologia Universit\u00e0 Cattolica Sacro Cuore, Rome, Italy;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Federica","family":"Sor\u00e0","sequence":"first","affiliation":[{"name":"Fondazione Policlinico Universitario A Gemelli-IRCCS, Istituto di Ematologia Universit\u00e0 Cattolica Sacro Cuore, Rome, Italy;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesca","family":"Lunghi","sequence":"first","affiliation":[{"name":"Hematology and BMT Unit, University Vita-Salute San Raffaele, San Raffaele Scientific Institute, Milan, Italy;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabio","family":"Ciceri","sequence":"first","affiliation":[{"name":"Hematology and BMT Unit, University Vita-Salute San Raffaele, San Raffaele Scientific Institute, Milan, Italy;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7899-5966","authenticated-orcid":false,"given":"Sara","family":"Galimberti","sequence":"first","affiliation":[{"name":"Section of Hematology, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudia","family":"Barat\u00e8","sequence":"first","affiliation":[{"name":"Section of Hematology, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Massimiliano","family":"Bonifacio","sequence":"first","affiliation":[{"name":"Section of Hematology, Department of Medicine, University of Verona, Verona, Italy;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luigi","family":"Scaffidi","sequence":"first","affiliation":[{"name":"Section of Hematology, Department of Medicine, University of Verona, Verona, Italy;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fausto","family":"Castagnetti","sequence":"first","affiliation":[{"name":"Department of Experimental, Diagnostic and Specialty Medicine, Institute of Hematology \u201cL. e A. 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