Cardiovascular Toxicity of Tyrosine Kinase Inhibitors Used in Chronic Myeloid Leukemia: An Analysis of the FDA Adverse Event Reporting System Database (FAERS)

Cirmi, Santa; El, Asmae; Létinier, Louis; Navarra, Michele; Salvo, Francesco

doi:10.3390/cancers12040826

Cited by 85 publications

(88 citation statements)

References 35 publications

(38 reference statements)

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“…Largely reversible pulmonary arterial hypertension has been reported as a rare but serious side effect of dasatinib. [80][81][82] In the DASISION study, pulmonary hypertension was reported in 5% of patients treated with dasatinib compared with ,1% of patients treated with imatinib. 70 Evaluation for signs and symptoms of underlying cardiopulmonary disease before initiating and during treatment with dasatinib is recommended.…”

Section: Dasatinibmentioning

confidence: 99%

“…Nilotinib labeling contains a black box warning regarding the risk of QT interval prolongation, and sudden cardiac death has been reported in patients receiving nilotinib. 82 QT interval prolongation could be managed with dose reduction. Electrolyte abnormalities should be corrected before the start of treatment with nilotinib and electrolytes should be monitored periodically.…”

Section: Nilotinibmentioning

confidence: 99%

See 1 more Smart Citation

Chronic Myeloid Leukemia, Version 2.2021, NCCN Clinical Practice Guidelines in Oncology

Deininger

Shah

Altman³

et al. 2020

Journal of the National Comprehensive Cancer Network

165

210

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Chronic myeloid leukemia (CML) is defined by the presence of Philadelphia chromosome (Ph) which results from a reciprocal translocation between chromosomes 9 and 22 [t(9;22] that gives rise to a BCR-ABL1 fusion gene. CML occurs in 3 different phases (chronic, accelerated, and blast phase) and is usually diagnosed in the chronic phase. Tyrosine kinase inhibitor therapy is a highly effective first-line treatment option for all patients with newly diagnosed chronic phase CML. This manuscript discusses the recommendations outlined in the NCCN Guidelines for the diagnosis and management of patients with chronic phase CML.

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Section: Dasatinibmentioning

confidence: 99%

Section: Nilotinibmentioning

confidence: 99%

Chronic Myeloid Leukemia, Version 2.2021, NCCN Clinical Practice Guidelines in Oncology

Deininger

Shah

Altman³

et al. 2020

Journal of the National Comprehensive Cancer Network

165

210

View full text Add to dashboard Cite

show abstract

“…Recently, an FDA analysis of the adverse event reporting system database showed that among 64,232 reported cardiovascular events of cancer patients, 2678 of them are CML patients managed with TKIs. The cardiovascular effects of the TKI used to treat CML were analyzed and are summarized in Table 3 [94]. Determined by the odds ratio, nilotinib treatment is associated with cardiac arrhythmias.…”

Section: The Use Of Tkis In CML and Their Association With Cardiovascmentioning

confidence: 99%

“…A "red" background means that the drug use was associated with an adverse cardiovascular effect. These data were extracted and tabulated presently from information in Supplementary Tables S1-S8 presented in Reference [94].…”

Section: The Use Of Tkis In CML and Their Association With Cardiovascmentioning

confidence: 99%

Ponatinib and other CML Tyrosine Kinase Inhibitors in Thrombosis

Zeng

2020

IJMS

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Abl1 kinase has important biological roles. The Bcr-Abl1 fusion protein creates undesired kinase activity and is pathogenic in 95% of chronic myeloid leukemia (CML) and 30% of acute lymphoblastic leukemia (ALL) patients. Targeted therapies to these diseases are tyrosine kinase inhibitors. The extent of a tyrosine kinase inhibitor’s targets determines the degree of biologic effects of the agent that may influence the well-being of the patient. This fact is especially true with tyrosine kinase inhibitor effects on the cardiovascular system. Thirty-one percent of ponatinib-treated patients, the tyrosine kinase inhibitor with the broadest inhibitory spectrum, have thrombosis associated with its use. Recent experimental investigations have indicated the mechanisms of ponatinib-associated thrombosis. Further, an antidote to ponatinib is in development by re-purposing an FDA-approved medication.

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“…Atherothrombotic events included acute coronary syndromes, and cerebrovascular and lower extremity artery disease (LEAD) events. [ 17 , 18 ].…”

Section: Methodsmentioning

confidence: 99%

Cardiovascular Events throughout the Disease Course in Chronic Myeloid Leukaemia Patients Treated with Tyrosine Kinase Inhibitors—A Single-Centre Retrospective Study

Varga

Ţilea

Petra

et al. 2020

JCM

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Introduction. Cardiovascular risk factors, pre-existing comorbidities, molecular factors, and the direct effects of second- and third-generation BCR-ABL1 tyrosine kinase inhibitors on the vascular endothelium contribute to the progression of cardiovascular (CV) events, especially atherothrombotic conditions. The study objective was to evaluate comorbidities, the cardiovascular risk profile, and events throughout the chronic myeloid leukaemia disease course. Methods. Retrospective data from adults who experienced haematology treatment at a single centre were continuously updated and followed throughout the disease course. A total of 43 subjects conforming with the inclusion and exclusion criteria of the study protocol were finally recruited. The median disease course was 77.0 ± 17.5 months. Statistical analyses were performed. Results. More than three CV risk factors were identified in 41.9% of cases. Almost half of the cases had relevant comorbidities (Charlson Comorbidity Index (CCI) ≥ 4), and no statistically significant comorbidities were found when comparing the tyrosine kinase inhibitor (TKI) treatment subgroups (p = 0.53). The patients at high and very high CV risk, according to Systematic Coronary Risk Evaluation (SCORE) risk classification, had 75.0% CV events (12/22 patients), p = 0.45. Throughout the disease course, 19 cardiovascular events were reported in 37.2% patients (13 males/3 females, p < 0.03). Conclusion. To the best of our knowledge, this is the first study exploring cardiovascular risk factors in Romanian chronic myeloid leukaemia patients. This study reinforces the need for close long-term follow-up that should be performed by a multidisciplinary team. The target should be not only the disease and specific drug-related toxicities but, also, the identification of cardiovascular and metabolic risk factors before the commencement of and throughout TKI therapy.

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Cardiovascular Toxicity of Tyrosine Kinase Inhibitors Used in Chronic Myeloid Leukemia: An Analysis of the FDA Adverse Event Reporting System Database (FAERS)

Cited by 85 publications

References 35 publications

Chronic Myeloid Leukemia, Version 2.2021, NCCN Clinical Practice Guidelines in Oncology

Chronic Myeloid Leukemia, Version 2.2021, NCCN Clinical Practice Guidelines in Oncology

Ponatinib and other CML Tyrosine Kinase Inhibitors in Thrombosis

Cardiovascular Events throughout the Disease Course in Chronic Myeloid Leukaemia Patients Treated with Tyrosine Kinase Inhibitors—A Single-Centre Retrospective Study

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