{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T06:13:23Z","timestamp":1790230403692,"version":"4.1.0"},"reference-count":39,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2018,3,2]],"date-time":"2018-03-02T00:00:00Z","timestamp":1519948800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100004336","name":"Novartis","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004336","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancer"],"published-print":{"date-parts":[[2018,5,15]]},"abstract":"<jats:sec><jats:title>BACKGROUND<\/jats:title><jats:p>Although a wealth of efficacy and safety data is available for many tyrosine kinase inhibitors used in chronic myeloid leukemia (CML), there is a dearth of information on their impact on patients' health\u2010related quality of life (HRQOL). The primary objective of this study was to evaluate HRQOL and fatigue outcomes in patients with CML receiving first\u2010line therapy with nilotinib.<\/jats:p><\/jats:sec><jats:sec><jats:title>METHODS<\/jats:title><jats:p>This was a multicenter, prospective study enrolling 130 patients with chronic\u2010phase CML. HRQOL and fatigue were evaluated with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire\u2010Core 30 (EORTC QLQ\u2010C30) and its validated Fatigue module at the baseline and then at 3, 6, 12, 18, and 24 months. The primary prespecified HRQOL endpoints defined in the study protocol for longitudinal analysis were the Physical Functioning, Social Functioning, Role Functioning, and Fatigue scales. The remaining scales were investigated on an exploratory basis.<\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p>The rate of baseline compliance with the HRQOL assessment was 95.4% (124 of 130), and the rate of overall compliance with HRQOL forms was 91%. Among the 4 prespecified primary HRQOL endpoints, statistically significant improvements over time were found for Physical Functioning (<jats:italic>P<\/jats:italic> = .013), Role Functioning (<jats:italic>P<\/jats:italic> = .004), and Fatigue (<jats:italic>P<\/jats:italic> &lt; .001). Clinically meaningful improvements were found already 3 months after the treatment start. The baseline patient self\u2010reported fatigue severity was an independent predictive factor for the achievement of a major molecular response with an odds ratio of 0.960 (95% confidence interval, 0.934\u20100.988; <jats:italic>P<\/jats:italic> = .005).<\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSIONS<\/jats:title><jats:p>For most patients, HRQOL improvements with nilotinib occur during the early phase of therapy and are maintained over time. Also, a more systematic HRQOL evaluation during the diagnostic workup of CML may help to predict clinical outcomes. <jats:bold><jats:italic>Cancer<\/jats:italic> 2018;124:2228\u201037<\/jats:bold>. \u00a9 <jats:italic>2018 American Cancer Society<\/jats:italic>.<\/jats:p><\/jats:sec>","DOI":"10.1002\/cncr.31323","type":"journal-article","created":{"date-parts":[[2018,3,2]],"date-time":"2018-03-02T13:26:43Z","timestamp":1519997203000},"page":"2228-2237","source":"Crossref","is-referenced-by-count":29,"title":["Health\u2010related quality of life in patients with chronic myeloid leukemia receiving first\u2010line therapy with nilotinib"],"prefix":"10.1002","volume":"124","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5065-5166","authenticated-orcid":false,"given":"Fabio","family":"Efficace","sequence":"first","affiliation":[{"name":"Data Center and Health Outcomes Research Unit Italian Group for Adult Hematologic Diseases Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fausto","family":"Castagnetti","sequence":"additional","affiliation":[{"name":"L. and A. Ser\u00e0gnoli Institute of Hematology, Department of Experimental, Diagnostic, and Specialty Medicine S. Orsola\u2010Malpighi University Hospital, University of Bologna Bologna Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruno","family":"Martino","sequence":"additional","affiliation":[{"name":"Hematology Unit Bianchi\u2010Melacrino\u2010Morelli Azienda Ospedaliera Reggio Calabria Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1163-6162","authenticated-orcid":false,"given":"Massimo","family":"Breccia","sequence":"additional","affiliation":[{"name":"Department of Cellular Biotechnologies and Hematology Sapienza University of Rome Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mariella","family":"D'Adda","sequence":"additional","affiliation":[{"name":"Hematology Unit Spedali Civili Azienda Ospedaliera Brescia Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emanuele","family":"Angelucci","sequence":"additional","affiliation":[{"name":"Ospedale Policlinico San Martino Genoa Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabio","family":"Stagno","sequence":"additional","affiliation":[{"name":"Department of Hematology University of Catania Catania Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesco","family":"Cottone","sequence":"additional","affiliation":[{"name":"Data Center and Health Outcomes Research Unit Italian Group for Adult Hematologic Diseases Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandra","family":"Malato","sequence":"additional","affiliation":[{"name":"Department of Hematology Hospital Cervello Palermo Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elena","family":"Trabacchi","sequence":"additional","affiliation":[{"name":"Hematology and Bone Marrow Transplantation Unit, Department of Hematology and Oncology G. da Saliceto Hospital Piacenza Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Silvana Franca","family":"Capalbo","sequence":"additional","affiliation":[{"name":"Hematology Unit Azienda Ospedaliero\u2010Universitaria Ospedali Riuniti Foggia Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marco","family":"Gobbi","sequence":"additional","affiliation":[{"name":"Clinical Hematology, Ospedale Policlinico S. Martino Istituto di Ricovero e Cura a Carattere Scientifico Genoa Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giuseppe","family":"Visani","sequence":"additional","affiliation":[{"name":"Hematology and Stem Cell Transplantation Unit Azienda Ospedaliera Ospedali Riuniti Marche Nord Pesaro Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marzia","family":"Salvucci","sequence":"additional","affiliation":[{"name":"Hematology Unit Santa Maria delle Croci Hospital Ravenna Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isabella","family":"Capodanno","sequence":"additional","affiliation":[{"name":"Hematology Unit, Arcispedale Santa Maria Nuova Istituto di Ricovero e Cura a Carattere Scientifico Reggio Emilia Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrizia","family":"Tosi","sequence":"additional","affiliation":[{"name":"Hematology Unit Infermi Hospital Rimini Rimini Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mario","family":"Tiribelli","sequence":"additional","affiliation":[{"name":"Division of Hematology and Bone Marrow Transplantation, Department of Experimental and Clinical Medical Sciences Azienda Ospedaliero\u2010Universitaria di Udine Udine Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna Rita","family":"Scortechini","sequence":"additional","affiliation":[{"name":"Clinical Hematology Laboratory, Department of Molecular and Clinical Sciences Polytechnic University of Marche Ancona Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luciano","family":"Levato","sequence":"additional","affiliation":[{"name":"Hematology Unit Pugliese\u2010Ciaccio Hospital Catanzaro Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elena","family":"Maino","sequence":"additional","affiliation":[{"name":"Hematology Unit Dell'Angelo Hospital Venezia\u2010Mestre Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gianni","family":"Binotto","sequence":"additional","affiliation":[{"name":"Hematology and Clinical Immunology, Department of Medicine Padua School of Medicine Padua Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabriele","family":"Gugliotta","sequence":"additional","affiliation":[{"name":"L. and A. Ser\u00e0gnoli Institute of Hematology, Department of Experimental, Diagnostic, and Specialty Medicine S. Orsola\u2010Malpighi University Hospital, University of Bologna Bologna Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marco","family":"Vignetti","sequence":"additional","affiliation":[{"name":"Data Center and Health Outcomes Research Unit Italian Group for Adult Hematologic Diseases Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michele","family":"Baccarani","sequence":"additional","affiliation":[{"name":"L. and A. Ser\u00e0gnoli Institute of Hematology, Department of Experimental, Diagnostic, and Specialty Medicine S. Orsola\u2010Malpighi University Hospital, University of Bologna Bologna Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gianantonio","family":"Rosti","sequence":"additional","affiliation":[{"name":"L. and A. Ser\u00e0gnoli Institute of Hematology, Department of Experimental, Diagnostic, and Specialty Medicine S. Orsola\u2010Malpighi University Hospital, University of Bologna Bologna Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,3,2]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM200104053441401"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2015.66.2866"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrclinonc.2016.139"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0912614"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1002315"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1182\/asheducation-2016.1.164"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1182\/asheducation-2016.1.170"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.3109\/10428194.2011.560310"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2003.12.154"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2011-04-347575"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.3324\/haematol.2016.144949"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2009.25.0779"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2006-01-0092"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood.V63.4.789.789"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/90.11.850"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2010-12-319038"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/85.5.365"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.1995.13.5.1249"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1002\/pon.3092"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/djw273"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1093\/pubmed\/fdi031"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/0197-2456(89)90005-6"},{"key":"e_1_2_8_24_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejca.2012.02.059"},{"key":"e_1_2_8_25_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.MLR.0000062554.74615.4C"},{"key":"e_1_2_8_26_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejca.2010.07.023"},{"key":"e_1_2_8_27_1","doi-asserted-by":"publisher","DOI":"10.1634\/theoncologist.2011-0085"},{"key":"e_1_2_8_28_1","unstructured":"CottoneF AnotaA BonnetainF EfficaceF.Time to quality of life improvement as a method for longitudinal analysis of treatment efficacy [abstract 295]. Abstract presented at: 24th Annual Conference of the International Society for Quality of Life Research; October 18\u201021 2017; Philadelphia PA."},{"key":"e_1_2_8_29_1","doi-asserted-by":"publisher","DOI":"10.1038\/leu.2013.51"},{"key":"e_1_2_8_30_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00520-012-1630-5"},{"key":"e_1_2_8_31_1","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.31082"},{"key":"e_1_2_8_32_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clml.2017.01.001"},{"key":"e_1_2_8_33_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clml.2016.02.002"},{"key":"e_1_2_8_34_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2007.13.3439"},{"key":"e_1_2_8_35_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(15)00206-5"},{"key":"e_1_2_8_36_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2005.04.0824"},{"key":"e_1_2_8_37_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2015-08-662874"},{"key":"e_1_2_8_38_1","doi-asserted-by":"crossref","first-page":"1025","DOI":"10.1182\/blood.V118.21.1025.1025","article-title":"Does baseline health\u2010related quality of life or symptom burden predict clinical outcomes in patients with newly diagnosed CML\u2010CP treated with nilotinib or imatinib?","volume":"118","author":"Beaumont JL","year":"2011","journal-title":"Blood."},{"key":"e_1_2_8_39_1","doi-asserted-by":"crossref","first-page":"1321","DOI":"10.1182\/blood.V124.21.1321.1321","article-title":"Prospective analysis of the quality of life of chronic phase CML patients on second generation tyrosine kinase inhibitors after imatinib failure. An observational study","volume":"124","author":"Nicolini FE","year":"2014","journal-title":"Blood."},{"issue":"1","key":"e_1_2_8_40_1","first-page":"2181","article-title":"Is quality of life (QOL) predictive for clinical response in chronic phase\u2010chronic myeloid leukemia (CP\u2010CML) patients treated with dasatinib?","volume":"130","author":"Ionova T","year":"2017","journal-title":"Blood."}],"container-title":["Cancer"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fcncr.31323","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/acsjournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cncr.31323","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,12]],"date-time":"2025-10-12T08:27:53Z","timestamp":1760257673000},"score":1,"resource":{"primary":{"URL":"https:\/\/acsjournals.onlinelibrary.wiley.com\/doi\/10.1002\/cncr.31323"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,3,2]]},"references-count":39,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2018,5,15]]}},"alternative-id":["10.1002\/cncr.31323"],"URL":"https:\/\/doi.org\/10.1002\/cncr.31323","archive":["Portico"],"relation":{},"ISSN":["0008-543X","1097-0142"],"issn-type":[{"value":"0008-543X","type":"print"},{"value":"1097-0142","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,3,2]]}}}