{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,20]],"date-time":"2026-07-20T23:53:35Z","timestamp":1784591615019,"version":"3.55.0"},"reference-count":27,"publisher":"SAGE Publications","issue":"3","license":[{"start":{"date-parts":[[2018,3,1]],"date-time":"2018-03-01T00:00:00Z","timestamp":1519862400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Therapeutic Advances in Hematology"],"published-print":{"date-parts":[[2018,3]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Nilotinib, a second-generation tyrosine kinase inhibitor (TKI), is approved for the treatment of patients with chronic myeloid leukemia (CML) in many countries, including Taiwan. Though a number of controlled clinical trials have demonstrated the safety and efficacy of nilotinib, studies assessing the safety and efficacy of nilotinib in routine clinical practice are limited.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>The current study was an open-label, single-arm study conducted across 12 centers in Taiwan in adult patients with CML in chronic or accelerated phase with confirmed Ph+ chromosome (or BCR-ABL) and resistant or intolerant to one or more previous TKIs. The primary objective was to collect the long-term safety data in patients treated with nilotinib 400 mg, twice daily for up to 2 years.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      The study enrolled 85 patients with CML, including 76 in the chronic phase (CML-CP) and 9 in the accelerated phase (CML-AP). Overall, 1166 adverse events (AEs) were reported in 80 patients (94.1%), of which 70 AEs (6%) in 28 patients (32.9%) were serious and 336 AEs (28.8%) reported in 60 patients (70.6%) were drug-related. Common drug-related AEs were thrombocytopenia (21.2%), increased alanine aminotransferase (21.2%) and pruritus (17.7%). Of the 85 patients, 19 switched from imatinib due to intolerance \u2013 AEs were resolved in 16 of these 19 patients (84.2%). By 24 months, the cumulative rates of complete cytogenetic response (CCyR), major molecular response (MMR), MR4.0 ( BCR-ABL1\n                      <jats:sup>IS<\/jats:sup>\n                      \u2a7d0.01%) and MR4.5 ( BCR-ABL1\n                      <jats:sup>IS<\/jats:sup>\n                      \u2a7d0.0032%) were 75.3, 56.8, 16.2 and 7.4%, respectively. Patients with CML-CP at baseline had higher overall survival (OS) and progression-free survival (PFS) than those with CML-AP.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>This is the first study that demonstrated that nilotinib is effective and well-tolerated in patients resistant or intolerant to imatinib in the real-world setting in Taiwan, reflecting effective management of CML by physicians under routine clinical practice in Taiwan.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/2040620718756603","type":"journal-article","created":{"date-parts":[[2018,3,5]],"date-time":"2018-03-05T00:55:55Z","timestamp":1520211355000},"page":"65-78","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":12,"title":["Safety and efficacy of nilotinib in routine clinical practice in patients with chronic myeloid leukemia in chronic or accelerated phase with resistance or intolerance to imatinib: results from the NOVEL study"],"prefix":"10.1177","volume":"9","author":[{"given":"Ching-Yuan","family":"Kuo","sequence":"first","affiliation":[{"name":"Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City, Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Po-Nan","family":"Wang","sequence":"additional","affiliation":[{"name":"Chang Gung Memorial Hospital\u2013Linko, Taoyuan, Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wen-Li","family":"Hwang","sequence":"additional","affiliation":[{"name":"Taichung Veterans General Hospital, Taichung City, Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cheng-Hwai","family":"Tzeng","sequence":"additional","affiliation":[{"name":"Taipei Veterans General Hospital, Taipei, Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Li-Yaun","family":"Bai","sequence":"additional","affiliation":[{"name":"China Medical University Hospital, Taichung, Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jih-Luh","family":"Tang","sequence":"additional","affiliation":[{"name":"National Taiwan University Hospital, Taipei, Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ming-Chih","family":"Chang","sequence":"additional","affiliation":[{"name":"Mackay Memorial Hospital, Taipei, Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sheng-Fung","family":"Lin","sequence":"additional","affiliation":[{"name":"Kaohsiung Medical University and Hospital, Kaohsiung, Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tsai-Yun","family":"Chen","sequence":"additional","affiliation":[{"name":"National Cheng Kung University Hospital, Tainan, Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yeu-Chin","family":"Chen","sequence":"additional","affiliation":[{"name":"Tri-Service General Hospital (TSGH), Taipei, Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tran-Der","family":"Tan","sequence":"additional","affiliation":[{"name":"Koo Foundation Sun Yet-Sen Cancer Center, Taipei, Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chih-Yi","family":"Hsieh","sequence":"additional","affiliation":[{"name":"Novartis (Taiwan) Co. 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