Efficacy and safety of switching to nilotinib in patients with CML-CP in major molecular response to imatinib: results of a ... View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2018-01-23

AUTHORS

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

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. More... »

PAGES

535-540

Journal

TITLE

International Journal of Hematology

ISSUE

5

VOLUME

107

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s12185-018-2401-y

DOI

http://dx.doi.org/10.1007/s12185-018-2401-y

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1100557131

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/29362980


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26 schema:description 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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33 BCR-ABL1 transcript levels
34 CML-CP
35 CML-CP patients
36 II trial
37 MMR
38 adverse events
39 age
40 atrial fibrillation
41 cardiovascular complications
42 chest tightness
43 complications
44 consent
45 cumulative incidence
46 deep molecular response
47 dyspnea
48 efficacy
49 events
50 failure
51 fibrillation
52 heart failure
53 imatinib
54 imatinib therapy
55 imatinib treatment
56 incidence
57 induction
58 infarction
59 initiation
60 initiation of imatinib
61 intolerance
62 levels
63 long-term imatinib therapy
64 long-term imatinib treatment
65 loss
66 loss of MMR
67 major molecular response
68 median age
69 molecular response
70 months
71 multicenter phase II trial
72 myocardial infarction
73 nilotinib
74 nilotinib 400
75 nilotinib treatment
76 patients
77 phase II trial
78 rapid induction
79 response
80 results
81 retraction
82 safety
83 study
84 therapy
85 tightness
86 time
87 transcript levels
88 treatment
89 trials
90 years
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