ArticleBiomarker research2014
Multicenter phase II clinical trial of nilotinib for patients with imatinib-resistant or -intolerant chronic myeloid leukemia from the East Japan CML study group evaluation of molecular response and the efficacy and safety of nilotinib.
Article in Biomarker research, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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Who cites it
8 citing papers in PubMed, 25 citations in OpenAlex.
- Cardiovascular toxicity from tyrosine kinase inhibitors in chronic myeloid leukemia with severe dilated cardiomyopathy.International journal of hematology · 2025Article
- Concomitant T315I and E459K mutations in chronic myeloid leukemia: A case report.Oncology letters · 2025Article
- Tyrosine Kinase Inhibitors-Induced Arrhythmias: From Molecular Mechanisms, Pharmacokinetics to Therapeutic Strategies.Frontiers in cardiovascular medicine · 2021Review
- Novel analytical methods to interpret large sequencing data from small sample sizes.Human genomics · 2019Article
- Persistent detection of alternatively spliced BCR-ABL variant results in a failure to achieve deep molecular response.Cancer science · 2017Article
- Presence of novel compound BCR-ABL mutations in late chronic and advanced phase imatinib sensitive CML patients indicates their possible role in CML progression.Cancer biology & therapy · 2017Article
- Nilotinib, a tyrosine kinase inhibitor exhibits protection against acute pancreatitis-induced lung and liver damage in rats.Naunyn-Schmiedeberg's archives of pharmacology · 2017Article
- How 'Optimal' are Optimal Sampling Times for Tyrosine Kinase Inhibitors in Cancer? Practical Considerations.Clinical pharmacokinetics · 2016Review
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Authors and funding
30 authors at 20 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundNilotinib is a second-generation tyrosine kinase inhibitor that exhibits significant efficacy as first- or second-line treatment in patients with chronic myeloid leukemia (CML). We conducted a multicenter Phase II Clinical Trial to evaluate the safety and efficacy of nilotinib among Japanese patients with imatinib-resistant or -intolerant CML-chronic phase (CP) or accelerated phase (AP).
resultsWe analyzed 49 patients (33 imatinib-resistant and 16 imatinib-intolerant) treated with nilotinib 400 mg twice daily. The major molecular response (MMR) rate was 47.8% at 12 months among 35 patients who did not demonstrate an MMR at study entry. Somatic BCR-ABL1 mutations (Y253H, I418V, and exon 8/9 35-bp insertion [35INS]) were detected in 3 patients at 12 months or upon discontinuation of nilotinib. Although 75.5% of patients were still being treated at 12 months, nilotinib treatment was discontinued because of progressing disease in 1 patient, insufficient effect in 2, and adverse events in 9. There was no statistically significant correlation between MMR and trough concentrations of nilotinib. Similarly, no correlation was observed between trough concentrations and adverse events, except for pruritus and hypokalemia. Hyperbilirubinemia was frequently observed (all grades, 51.0%; grades 2-4, 29%; grades 3-4, 4.1%). Hyperbilirubinemia higher than grade 2 was significantly associated with the uridine diphosphate glucuronosyltransferase (UGT)1A9 I399C/C genotype (P = 0.0086; Odds Ratio, 21.2; 95% Confidence Interval 2.2-208.0).
conclusionsNilotinib was efficacious and well tolerated by patients with imatinib-resistant or -intolerant CML-CP/AP. Hyperbilirubinemia may be predicted before nilotinib treatment, and may be controlled by reducing the daily dose of nilotinib in patients with UGT1A9 polymorphisms.
trial registrationclinicaltrials.gov: UMIN000002201.
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