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However, long-term TFR durability in real-world settings remains understudied. The J-SKI study, a large observational study, was conducted to evaluate long-term TFR outcomes in Japanese patients with CML. This interim analysis included 795 eligible patients from the prospective (n\u2009=\u2009283) and retrospective (n\u2009=\u2009512) cohorts. With a median follow-up of 32\u00a0months (range 0.8\u2013168) after TKI discontinuation, the 5-year TFR rate was 65.2% (95% confidence interval [CI]: 59.6\u201370.6%). Among patients who experienced molecular relapse, 99% (95% CI: 97\u2013100%) regained a major molecular response after resuming TKI therapy, with no observed disease progression. Multivariate analysis identified the duration of deep molecular response (DMR) as the sole independent predictor of successful TFR, with each additional year of DMR reducing the relapse risk by 12.5% (HR: 0.875,\n                    <jats:italic>p<\/jats:italic>\n                    \u2009&lt;\u20090.0001). A second TFR attempt was successful in 41% (95% CI: 22\u201359%) of the 32 patients. This study demonstrated that TKI discontinuation is a safe and feasible strategy in a real-world clinical setting. A sustained DMR is critical for TFR success, supporting its importance as a key therapeutic objective.\n                  <\/jats:p>","DOI":"10.1007\/s12185-026-04184-4","type":"journal-article","created":{"date-parts":[[2026,3,1]],"date-time":"2026-03-01T09:00:58Z","timestamp":1772355658000},"page":"96-103","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Five-year interim analysis of J-SKI: an observational study of TKI discontinuation in patients with CML in Japan"],"prefix":"10.1007","volume":"124","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6758-3787","authenticated-orcid":false,"given":"Naoto","family":"Takahashi","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shinya","family":"Kimura","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eri","family":"Matsuki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takaaki","family":"Ono","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Noriko","family":"Doki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masaki","family":"Iino","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masashi","family":"Sawa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshio","family":"Saburi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazunori","family":"Murai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katsumichi","family":"Fujimaki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shingo","family":"Kurahashi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Noriyoshi","family":"Iriyama","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takashi","family":"Onaka","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emiko","family":"Sakaida","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chikashi","family":"Yoshida","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keijiro","family":"Sato","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshihiro","family":"Miyamoto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomoiku","family":"Takaku","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Motoaki","family":"Shiratsuchi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fumihiko","family":"Kimura","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seiichiro","family":"Katagiri","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matsuo","family":"Yamamoto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akiko M.","family":"Saito","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hitoshi","family":"Kiyoi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Itaru","family":"Matsumura","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,3,1]]},"reference":[{"key":"4184_CR1","doi-asserted-by":"publisher","first-page":"1029","DOI":"10.1016\/S1470-2045(10)70233-3","volume":"11","author":"FX Mahon","year":"2010","unstructured":"Mahon FX, R\u00e9a D, Guilhot J, Guilhot F, Huguet F, Nicolini F, et al. 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Shinya Kimura received research funding and honoraria from Bristol-Myers Squibb; Otsuka Pharmaceutical Co., Ltd.; Novartis Pharma KK; and Pfizer Japan, Inc. Eri Matsuki received honoraria from Pfizer Japan Inc., Otsuka Pharmaceutical Co., Ltd., Bristol-Myers Squibb, and Novartis Pharma KK. Takaaki Ono received honoraria from Pfizer Japan Inc. and Novartis Pharma KK. Katsumichi Fujimaki received honoraria from Otsuka Pharmaceutical Co., Ltd. Noriyoshi Iriyama received honoraria from Otsuka Pharmaceutical Co., Ltd., Novartis Pharma KK, Pfizer Japan Inc., and Bristol-Myers Squibb. Chikashi Yoshida received honoraria from Otsuka Pharmaceutical Co., Ltd., Novartis Pharma KK, and Pfizer Japan Inc.; consultancy fees (including expert testimony) from Novartis Pharma KK; and research funding from Bristol-Myers Squibb. Tomoiku Takaku received honoraria from Novartis Pharma KK and Otsuka Pharmaceutical Co., Ltd., and he is the editor of the International Journal of Hematology. Itaru Matsumura received research funding and honoraria from Otsuka Pharmaceutical Co., Ltd., and honoraria from Bristol-Myers Squibb, Novartis Pharma KK, and Pfizer Japan Inc. The other authors declare no conflicts of interest.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}