Recommendations for the management of cardiovascular risk in patients with chronic myeloid leukemia on tyrosine kinase inhibitors: risk assessment, stratification, treatment and monitoring

Seguro, Fernanda Salles; Silva, Carolina Maria Pinto Domingues Carvalho; Moura, Carla Maria Boquimpani de; Conchon, Mônika; Fogliatto, Laura; Funke, Vaneuza Araújo Moreira; Abdo, André; Macedo, Ariane Vieira Scarlatelli; Santos, Marcel Koenigkam; Saraiva, José Francisco Kerr

doi:10.1016/j.htct.2020.04.009

Cited by 8 publications

(8 citation statements)

References 32 publications

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“…Cardiovascular health is evolving as an important consideration in patients with CML, not only because of the improved prognosis being enjoyed by patients treated with TKI-based therapies, but also because some later-generation BCR :: ABL1 TKIs have been associated with cardiovascular complications [ 27 ]. These issues have heightened the need for cardiovascular risk assessment in patients with CML being initiated on TKI therapy, and a recently published consensus document has provided important governance on risk assessment, stratification, treatment, and monitoring [ 28 ].…”

Section: Discussionmentioning

confidence: 99%

Bosutinib in Japanese patients with newly diagnosed chronic-phase chronic myeloid leukemia: final 3-year follow-up results of a phase 2 study

et al. 2022

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Bosutinib has been evaluated for treatment of chronic-phase chronic myeloid leukemia (CP-CML) in several clinical studies, including in Japan. This open-label, single-arm, phase 2 study evaluated the efficacy and safety of bosutinib at a starting dose of 400 mg once daily in Japanese patients (n = 60) with newly diagnosed CP-CML. The minimum follow-up period was 3 years and median duration of treatment was 35.9 months. At study completion, 60% of patients were still on treatment. Cumulative rates of major molecular response (MMR), molecular response4 (MR4), and MR4.5 at any time were 70.0%, 53.3%, and 48.3%, respectively. No patient who achieved MMR or MR4 had a confirmed loss of response. No patient experienced on-treatment transformation to accelerated/blast phase or died within 28 days of the last bosutinib dose. Any-grade treatment-emergent adverse events (TEAEs) occurred in 100% (grade ≥ 3: 81.7%) of patients. The most common TEAEs were diarrhea (86.7%), increased alanine aminotransferase (55.0%), and increased aspartate aminotransferase (46.7%). No new safety signals emerged during the follow-up period. Bosutinib continues to demonstrate a favorable benefit/risk profile and is an important treatment option for Japanese patients with newly diagnosed CP-CML. Optimal management of TEAEs during initial treatment with bosutinib should be prioritized.Trial Registration: ClinicalTrials.gov ID: NCT03128411.

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Section: Discussionmentioning

confidence: 99%

Bosutinib in Japanese patients with newly diagnosed chronic-phase chronic myeloid leukemia: final 3-year follow-up results of a phase 2 study

et al. 2022

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“…No cases of ventricular arrhythmia were reported with QT prolongation with these drugs [6,7]. For this reason, QT assessment using an electrocardiogram is recommended when prescribing nilotinib [2][3][4]. In the case of dasatinib, dyspnea observed in some patients prompted the Food and Drug Administration (FDA) to issue warnings and recommend that patients be screened for signs and symptoms of cardiopulmonary disease before and during treatment.…”

Section: Review Cardiovascular Risk In Patients With CMLmentioning

confidence: 99%

“…Clinicians should focus all efforts on the treatment of CML patients to achieve large molecular response, deep molecular response, and treatment-free remission (TFR) [3,4,11].…”

Section: Reduction Of Cardiovascular Risk In Patients With CML Treate...mentioning

confidence: 99%

“…Given that the leading cause of death in the general population is cardiovascular disease (CVD), the issue of reducing cardiovascular risk is becoming relevant for patients with CML based on increased life expectancy in CML patients and the cardiovascular toxicity of TKIs. This problem is now attracting increasing attention from onco-hematologists and cardiologists around the world to improve the prognosis and life expectancy in this group of patients [2][3][4].…”

Section: Introductionmentioning

confidence: 99%

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A New Paradigm of Cardio-Hematological Monitoring in Chronic Myeloid Leukemia Patients Treated With Tyrosine Kinase Inhibitors

Лопина¹,

Dmytrenko²,

Hamov³

et al. 2022

Cureus

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Significant progress has been achieved in treating patients with onco-hematological diseases, including chronic myeloid leukemia (CML). This is primarily associated with the development of targeted therapy involving tyrosine kinase inhibitors (TKIs), such as imatinib, nilotinib, bosutinib, dasatinib, and ponatinib. Along with the increased survival of patients with CML, special attention has recently been paid to cardiovascular complications in CML patients due to the prevalence of cardiovascular diseases in the general population and the toxicity profile of targeted drugs. This article presents the strategy for reducing cardiovascular risk in CML patients treated with TKIs. We discuss the components of cardiovascular risk in CML patients and the findings of current studies. Current data confirm the increased cardiovascular risk in the CML population compared to the general population, which necessitates the widespread introduction of cardiovascular prevention strategies in CML patients. The pharmacokinetics and pharmacodynamics of TKIs on the cardiovascular system are discussed. We propose two main approaches in the strategy of cardiovascular risk prevention in patients with CML, namely, before the start of TKI administration and during TKI treatment. This article presents the diagnostic assessment before prescribing TKIs, as well as while monitoring TKI therapy, and discusses the features of the choice of TKIs depending on patients' general and cardiovascular comorbidity. Emphasis is placed on the risk stratification in patients with CML following general population algorithms, lifestyle modifications, and statin therapy for achieving the target levels of cardiovascular indicators. We also discuss unsolved questions in the current clinical guidelines and ways to further develop a cardiovascular risk-reducing strategy for CML patients.

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“…Having car di ol ogy pres ent as part of the CML edu ca tion ses sion at the 2017 Amer i can Society of Hematology meet ing dem on strated the need for closer alli ance, col lab o ra tion, and coman age ment. 64 Provisional guide lines have been published in reviews over the last sev eral years focused on man ag ing car dio vas cu lar adverse events in CML, [65][66][67] focused spe cif cally on ponatinib and nilotinib, [68][69][70] as well as posi tion papers suggesting CML clin i cal trial adverse event reporting should align with car dio vas cu lar med i cine def ni tions. 71 So, who?…”

Section: Assessing Comorbidity In the CML Patient Pop U La Tionmentioning

confidence: 99%

Lifelong TKI therapy: how to manage cardiovascular and other risks

Mauro

2021

Hematology

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Beginning with imatinib and now spanning 6 oral, highly active, and mostly safe agents, the development of specific targeted therapy for patients with chronic myeloid leukemia (CML) has created a new world featuring chronic maintenance chemotherapy for all treated as such, treatment-free remission, and functional cure after prolonged deep remission in a subset. As a result comes a necessary shift in focus from acute to chronic toxicity, increasing attention to patient comorbidities, and critical thinking around specific adverse events such as metabolic, cardiovascular, and cardiopulmonary effects, which vary from agent to agent. This review aims to pull together the state of the art of managing the “C” in CML—a chronic myeloproliferative neoplasm treated at present over many years with oral BCR-ABL-targeted agents in a population whose overall health can be complex and potentially affected by disease and therapy—and determine how we can better manage a highly treatable and increasingly curable cancer.

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Recommendations for the management of cardiovascular risk in patients with chronic myeloid leukemia on tyrosine kinase inhibitors: risk assessment, stratification, treatment and monitoring

Cited by 8 publications

References 32 publications

Bosutinib in Japanese patients with newly diagnosed chronic-phase chronic myeloid leukemia: final 3-year follow-up results of a phase 2 study

Bosutinib in Japanese patients with newly diagnosed chronic-phase chronic myeloid leukemia: final 3-year follow-up results of a phase 2 study

A New Paradigm of Cardio-Hematological Monitoring in Chronic Myeloid Leukemia Patients Treated With Tyrosine Kinase Inhibitors

Lifelong TKI therapy: how to manage cardiovascular and other risks

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