論文

査読有り
2019年4月

Feasibility of the imatinib stop study in the Japanese clinical setting: delightedly overcome CML expert stop TKI trial (DOMEST Trial).

International journal of clinical oncology
  • Shin Fujisawa
  • ,
  • Yasunori Ueda
  • ,
  • Kensuke Usuki
  • ,
  • Hajime Kobayashi
  • ,
  • Eisei Kondo
  • ,
  • Noriko Doki
  • ,
  • Takafumi Nakao
  • ,
  • Yoshinobu Kanda
  • ,
  • Nobuharu Kosugi
  • ,
  • Hiroshi Kosugi
  • ,
  • Takashi Kumagai
  • ,
  • Hiroshi Harada
  • ,
  • Masato Shikami
  • ,
  • Yasuhiro Maeda
  • ,
  • Toru Sakura
  • ,
  • Koiti Inokuchi
  • ,
  • Akio Saito
  • ,
  • Yuichiro Nawa
  • ,
  • Masahiro Ogasawara
  • ,
  • Junji Nishida
  • ,
  • Takeshi Kondo
  • ,
  • Chikashi Yoshida
  • ,
  • Hiroyuki Kuroda
  • ,
  • Yoko Tabe
  • ,
  • Yoshinobu Maeda
  • ,
  • Kenji Imajo
  • ,
  • Kensuke Kojima
  • ,
  • Satoshi Morita
  • ,
  • Sho Komukai
  • ,
  • Atsushi Kawaguchi
  • ,
  • Junichi Sakamoto
  • ,
  • Shinya Kimura

24
4
開始ページ
445
終了ページ
453
記述言語
英語
掲載種別
研究論文(学術雑誌)
DOI
10.1007/s10147-018-1368-2

BACKGROUND: Treatment-free remission (TFR), the ability to maintain a molecular response (MR), occurs in approximately 50% of patients with chronic myelogenous leukemia (CML) treated with tyrosine kinase inhibitors (TKIs). METHODS: A multicenter phase 2 trial (Delightedly Overcome CML Expert Stop TKI Trial: DOMEST Trial) was conducted to test the safety and efficacy of discontinuing imatinib. Patients with CML with a sustained MR of 4.0 or MR4.0-equivalent for at least 2 years and confirmed MR4.0 at the beginning of the study were enrolled. In the TFR phase, the international scale (IS) was regularly monitored by IS-PCR testing. Molecular recurrence was defined as the loss of MR4.0. Recurrent patients were immediately treated with dasatinib or other TKIs including imatinib. RESULTS: Of 110 enrolled patients, 99 were evaluable. The median time from diagnosis to discontinuation of imatinib was 103 months, and the median duration of imatinib therapy was 100 months. Molecular recurrence-free survival rates were 69.6%, 68.6% and 64.3% at 6, 12, and 24 months, respectively. After discontinuation of imatinib therapy, 26 patients showed molecular recurrence, and 25 re-achieved deep MR after dasatinib treatment. Molecular response MR4.0 was achieved in 23 patients within 6 months and 25 patients within 12 months. Multivariate analysis revealed that a longer time from diagnosis to discontinuation of imatinib therapy (p = 0.0002) and long duration of imatinib therapy (p = 0.0029) predicted a favorable prognosis. CONCLUSIONS: This DOMEST Trial showed the feasibility of TKI discontinuation in a Japanese clinical setting.

リンク情報
DOI
https://doi.org/10.1007/s10147-018-1368-2
PubMed
https://www.ncbi.nlm.nih.gov/pubmed/30421023
PubMed Central
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6438937
URL
http://orcid.org/0000-0003-0995-9405

エクスポート
BibTeX RIS