Efficacy and safety of switching to nilotinib in patients with CML-CP in major molecular response to imatinib: results of a multicenter phase II trial (NILSw trial)

Jun Ishikawa, Itaru Matsumura, Tatsuya Kawaguchi, Junya Kuroda, Hirohisa Nakamae, Toshihiro Miyamoto, Ken ichi Matsuoka, Hirohiko Shibayama, Masayuki Hino, Chikara Hirase, Tomohiko Kamimura, Takayuki Shimose, Koichi Akashi, Yuzuru Kanakura

研究成果: ジャーナルへの寄稿記事

1 引用 (Scopus)

抄録

We evaluated the efficacy and safety of switching to nilotinib in CML-CP patients who had achieved MMR with continuous detectable BCR-ABL1 transcript levels after long-term imatinib treatment. Patients who had achieved MMR, but not deep molecular response (DMR), after > 18 months from the initiation of imatinib received nilotinib 400 mg twice daily for up to 24 months. BCR-ABL1 transcript levels were assessed every 3 months. Thirty-eight patients with a median age of 57.5 years (range 22–76 years) were evaluated. Twenty-seven patients completed 24 months of nilotinib treatment; 11 discontinued nilotinib due to retraction of consent (three patients), loss of MMR (1), intolerance (3) or AEs (5). Twenty patients [52.6%, (90% CI 38.2–66.7%)] achieved DMR. The cumulative incidence of achieving DMR by the time of 3, 6, 9, 12, 15, 18, and 21 months was 22.9, 37.7, 47.0, 53.7, 53.7, 53.7, and 53.7%, respectively. Adverse events were consistent with those reported in other nilotinib studies. Patients experienced each of the following cardiovascular complications: atrial fibrillation (G2), chest tightness and dyspnea (G1), myocardial infarction (G2) and heart failure (G3) (n = 1 for each complication). This study indicates nilotinib achieves strong, rapid induction of DMR for patients who achieved MMR after long-term imatinib therapy.

元の言語英語
ページ(範囲)535-540
ページ数6
ジャーナルInternational journal of hematology
107
発行部数5
DOI
出版物ステータス出版済み - 5 1 2018

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Safety
4-methyl-N-(3-(4-methylimidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-pyridin-3-ylpyrimidin-2-yl)amino)benzamide
Imatinib Mesylate
Dyspnea
Atrial Fibrillation
Reaction Time
Thorax
Therapeutics
Heart Failure
Myocardial Infarction
Incidence

All Science Journal Classification (ASJC) codes

  • Hematology

これを引用

Efficacy and safety of switching to nilotinib in patients with CML-CP in major molecular response to imatinib : results of a multicenter phase II trial (NILSw trial). / Ishikawa, Jun; Matsumura, Itaru; Kawaguchi, Tatsuya; Kuroda, Junya; Nakamae, Hirohisa; Miyamoto, Toshihiro; Matsuoka, Ken ichi; Shibayama, Hirohiko; Hino, Masayuki; Hirase, Chikara; Kamimura, Tomohiko; Shimose, Takayuki; Akashi, Koichi; Kanakura, Yuzuru.

:: International journal of hematology, 巻 107, 番号 5, 01.05.2018, p. 535-540.

研究成果: ジャーナルへの寄稿記事

Ishikawa, J, Matsumura, I, Kawaguchi, T, Kuroda, J, Nakamae, H, Miyamoto, T, Matsuoka, KI, Shibayama, H, Hino, M, Hirase, C, Kamimura, T, Shimose, T, Akashi, K & Kanakura, Y 2018, 'Efficacy and safety of switching to nilotinib in patients with CML-CP in major molecular response to imatinib: results of a multicenter phase II trial (NILSw trial)', International journal of hematology, 巻. 107, 番号 5, pp. 535-540. https://doi.org/10.1007/s12185-018-2401-y
Ishikawa, Jun ; Matsumura, Itaru ; Kawaguchi, Tatsuya ; Kuroda, Junya ; Nakamae, Hirohisa ; Miyamoto, Toshihiro ; Matsuoka, Ken ichi ; Shibayama, Hirohiko ; Hino, Masayuki ; Hirase, Chikara ; Kamimura, Tomohiko ; Shimose, Takayuki ; Akashi, Koichi ; Kanakura, Yuzuru. / Efficacy and safety of switching to nilotinib in patients with CML-CP in major molecular response to imatinib : results of a multicenter phase II trial (NILSw trial). :: International journal of hematology. 2018 ; 巻 107, 番号 5. pp. 535-540.
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abstract = "We evaluated the efficacy and safety of switching to nilotinib in CML-CP patients who had achieved MMR with continuous detectable BCR-ABL1 transcript levels after long-term imatinib treatment. Patients who had achieved MMR, but not deep molecular response (DMR), after > 18 months from the initiation of imatinib received nilotinib 400 mg twice daily for up to 24 months. BCR-ABL1 transcript levels were assessed every 3 months. Thirty-eight patients with a median age of 57.5 years (range 22–76 years) were evaluated. Twenty-seven patients completed 24 months of nilotinib treatment; 11 discontinued nilotinib due to retraction of consent (three patients), loss of MMR (1), intolerance (3) or AEs (5). Twenty patients [52.6{\%}, (90{\%} CI 38.2–66.7{\%})] achieved DMR. The cumulative incidence of achieving DMR by the time of 3, 6, 9, 12, 15, 18, and 21 months was 22.9, 37.7, 47.0, 53.7, 53.7, 53.7, and 53.7{\%}, respectively. Adverse events were consistent with those reported in other nilotinib studies. Patients experienced each of the following cardiovascular complications: atrial fibrillation (G2), chest tightness and dyspnea (G1), myocardial infarction (G2) and heart failure (G3) (n = 1 for each complication). This study indicates nilotinib achieves strong, rapid induction of DMR for patients who achieved MMR after long-term imatinib therapy.",
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AU - Ishikawa, Jun

AU - Matsumura, Itaru

AU - Kawaguchi, Tatsuya

AU - Kuroda, Junya

AU - Nakamae, Hirohisa

AU - Miyamoto, Toshihiro

AU - Matsuoka, Ken ichi

AU - Shibayama, Hirohiko

AU - Hino, Masayuki

AU - Hirase, Chikara

AU - Kamimura, Tomohiko

AU - Shimose, Takayuki

AU - Akashi, Koichi

AU - Kanakura, Yuzuru

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N2 - We evaluated the efficacy and safety of switching to nilotinib in CML-CP patients who had achieved MMR with continuous detectable BCR-ABL1 transcript levels after long-term imatinib treatment. Patients who had achieved MMR, but not deep molecular response (DMR), after > 18 months from the initiation of imatinib received nilotinib 400 mg twice daily for up to 24 months. BCR-ABL1 transcript levels were assessed every 3 months. Thirty-eight patients with a median age of 57.5 years (range 22–76 years) were evaluated. Twenty-seven patients completed 24 months of nilotinib treatment; 11 discontinued nilotinib due to retraction of consent (three patients), loss of MMR (1), intolerance (3) or AEs (5). Twenty patients [52.6%, (90% CI 38.2–66.7%)] achieved DMR. The cumulative incidence of achieving DMR by the time of 3, 6, 9, 12, 15, 18, and 21 months was 22.9, 37.7, 47.0, 53.7, 53.7, 53.7, and 53.7%, respectively. Adverse events were consistent with those reported in other nilotinib studies. Patients experienced each of the following cardiovascular complications: atrial fibrillation (G2), chest tightness and dyspnea (G1), myocardial infarction (G2) and heart failure (G3) (n = 1 for each complication). This study indicates nilotinib achieves strong, rapid induction of DMR for patients who achieved MMR after long-term imatinib therapy.

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