Trial reportHaematologica2015
Long-term outcome of a phase 2 trial with nilotinib 400 mg twice daily in first-line treatment of chronic myeloid leukemia.
Trial report in Haematologica, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
20 citing papers in PubMed.
- Treatment-free remission in chronic myeloid leukemia patients treated front-line with nilotinib: 10-year followup of the GIMEMA CML 0307 study.Haematologica · 2022Trial
- Trial
- Nilotinib dose-optimization in newly diagnosed chronic myeloid leukaemia in chronic phase: final results from ENESTxtnd.British journal of haematology · 2017Trial
- Nilotinib 300 mg twice daily: an academic single-arm study of newly diagnosed chronic phase chronic myeloid leukemia patients.Haematologica · 2016Trial
- Long-term evaluation of cardiac and vascular toxicity in patients with Philadelphia chromosome-positive leukemias treated with bosutinib.American journal of hematology · 2016Trial
- Atrial fibrillation associated with tyrosine kinase inhibitors: A case-control study of real-world pharmacovigilance data.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Mitochondrial Dysfunction in Cardiotoxicity Induced by BCR-ABL1 Tyrosine Kinase Inhibitors -Underlying Mechanisms, Detection, Potential Therapies.Cardiovascular toxicology · 2023Review
- Pro-Inflammatory and Pro-Oxidative Changes During Nilotinib Treatment in CML Patients: Results of a Prospective Multicenter Front-Line TKIs Study (KIARO Study).Frontiers in oncology · 2022Article
- A Review of Cancer Immunotherapy Toxicity II: Adoptive Cellular Therapies, Kinase Inhibitors, Monoclonal Antibodies, and Oncolytic Viruses.Journal of medical toxicology : official journal of the American College of Medical Toxicology · 2022Review
- Predictive value of early molecular response for deep molecular response in chronic phase of chronic myeloid leukemia.Medicine · 2019Article
- Tyrosine Kinase Inhibitors Available for Chronic Myeloid Leukemia: Efficacy and Safety.Frontiers in oncology · 2019Review
- Tyrosine kinase inhibitor-induced carotid stenosis: A case report.Leukemia research reports · 2019Article
- Risk factors and mechanisms contributing to TKI-induced vascular events in patients with CML.Leukemia research · 2017Review
- Cardiovascular Complications of Targeted Therapies for Chronic Myeloid Leukemia.Current treatment options in cardiovascular medicine · 2017Review
- Tyrosine kinase inhibitors in chronic myeloid leukaemia: which, when, for whom?Nature reviews. Clinical oncology · 2017Review
- Article
- Best Practices in Chronic Myeloid Leukemia Monitoring and Management.The oncologist · 2016Review
- Long-Term Side Effects of Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia.Current hematologic malignancy reports · 2016Review
- The Cancer Stem Cell Fraction in Hierarchically Organized Tumors Can Be Estimated Using Mathematical Modeling and Patient-Specific Treatment Trajectories.Cancer research · 2016Article
- Oncogene Overdose: Too Much of a Bad Thing for Oncogene-Addicted Cancer Cells.Biomarkers in cancer · 2015Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
26 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Nilotinib is a second-generation tyrosine kinase inhibitor that has been approved for the first-line treatment of chronic-phase chronic myeloid leukemia, based on the results of a prospective randomized study of nilotinib versus imatinib (ENESTnd). Apart from this registration study, very few data are currently available on first-line nilotinib treatment. We report here the long-term, 6-year results of the first investigator-sponsored, GIMEMA multicenter phase 2, single-arm trial with nilotinib 400 mg twice daily as first-line treatment in 73 patients with chronic-phase chronic myeloid leukemia. Six-year overall survival and progression-free survival rates were 96%, with one death after progression to blast phase. At 6 years, 75% of the patients were still on nilotinib. The cumulative incidence of major molecular response was 98%; only one patient had a confirmed loss of major molecular response. The cumulative incidence of deep molecular response (MR 4.0) was 76%. Deep molecular response was stable (≥ 2 years) in 34% of these patients. Cardiovascular adverse events, mainly due to arterial thrombosis, occurred in 11/73 patients (15%), after 24 to 76 months of therapy. They were more frequent in elderly patients, and in those with baseline cardiovascular risk factors. None was fatal, although there was a relevant morbidity. This is the study with the longest follow-up of a high dose of nilotinib (400 mg twice daily): it highlights the high efficacy and the cardiovascular toxicity of the drug (CTG.NCT.00481052).
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.