QTc Interval-Prolonging Medications Among Patients With Lung Cancer: Implications for Clinical Trial Eligibility and Clinical Care

Le, Thanh; Yang, Hui; Rashdan, Sawsan; Link, Mark S.; Zaha, Vlad G.; Gerber, David E.

doi:10.1016/j.cllc.2019.07.008

Cited by 4 publications

(5 citation statements)

References 48 publications

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“…The variability in these results likely stems from the type of cancer populations that were studied and the duration of follow-up. The prevalence of prescriptions for ≥ 1 QT-prolonging drug in our cohort (99.6%) is higher than those found in past investigations, and this is likely due to the fact that we studied patients since their date of first cancer diagnosis (median duration of follow-up: 3.0 years), which was longer than study periods from past investigations that ranged from 1 week to 1 year ( 12 , 14 , 15 ).…”

Section: Discussioncontrasting

confidence: 64%

“…Past studies have consistently found that prescriptions for QT-prolonging drugs are common in cancer patients and that numerous cancer therapeutics prolong QTc. With regard to the prevalence of prescriptions for QT-prolonging drugs, retrospective studies have found that 17.1% ( 15 ), 28.4% ( 14 ), and 92.6% ( 12 ) of cancer patients were prescribed ≥ 1 QT-prolonging drug as determined by CredibleMeds ® . The variability in these results likely stems from the type of cancer populations that were studied and the duration of follow-up.…”

Section: Discussionmentioning

confidence: 99%

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Association of QT interval-prolonging drugs with clinical trial eligibility in patients with advanced cancer

Rowe

Shugg

et al. 2022

Front. Cardiovasc. Med.

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IntroductionDrug-induced prolongation of the heart rate-corrected QT interval (QTc) is associated with increased risk for the potentially fatal arrhythmia torsades de pointes. Due to arrhythmia risk, clinical trials with cancer therapeutics often exclude patients based on thresholds for QTc prolongation. Our objective was to assess associations between prescriptions for QT-prolonging drugs and the odds of meeting cancer trial exclusionary QTc thresholds in a cohort of adults with advanced cancer.MethodsElectronic health records were retrospectively reviewed for 271 patients seen at our institutional molecular solid tumor clinic. Collected data included demographics, QTc measurements, ventricular arrhythmia-related diagnoses, and all inpatient and outpatient prescriptions. Potential associations were assessed between demographic and clinical variables, including prescriptions for QT-prolonging drugs, and QTc measurements.ResultsWomen had longer median QTc measurements than men (p = 0.030) and were prescribed more QT-prolonging drugs during the study (p = 0.010). In all patients, prescriptions for QT-prolonging drugs were associated with longer median and maximum QTc measurements at multiple assessed time points (i.e., for QT-prolonging drugs prescribed within 10, 30, 60, and 90 days of QTc measurements). Similarly, the number of QT-prolonging drugs prescribed was correlated with longer median and maximum QTc measurements at multiple time points. Common QTc-related exclusionary criteria were collected from a review of ClinicalTrials.gov for recent cancer clinical trials. Based on common exclusion criteria, prescriptions for QT-prolonging drugs increased the odds of trial exclusion.ConclusionThis study demonstrates that prescriptions for QT-prolonging drugs were associated with longer QTc measurements and increased odds of being excluded from cancer clinical trials.

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Section: Discussioncontrasting

confidence: 64%

Section: Discussionmentioning

confidence: 99%

Association of QT interval-prolonging drugs with clinical trial eligibility in patients with advanced cancer

Rowe

Shugg

et al. 2022

Front. Cardiovasc. Med.

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“…Some working group participants urged caution regarding concomitant medication-related eligibility (eg, drug-drug interactions, QTc prolongation risk) given the frequency and unclear clinical significance of these issues in clinical practice. 24,25…”

Section: Othermentioning

confidence: 99%

“…Examples considered by the group included reproductive status, autoimmune disease for immunotherapy, bleeding/clotting for antiangiogenic therapies, active infection for cytotoxic/immunosuppressive therapies, and drug-drug interactions. Some working group participants urged caution regarding concomitant medication-related eligibility (eg, drug-drug interactions, QTc prolongation risk) given the frequency and unclear clinical significance of these issues in clinical practice …”

Section: Recommendationsmentioning

confidence: 99%

A New Approach to Simplifying and Harmonizing Cancer Clinical Trials—Standardizing Eligibility Criteria

et al. 2022

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ancer clinical trial accrual remains a persistent challenge. Difficulties recruiting and retaining representative participants result in prolonged study duration, premature trial closure, heightened costs of clinical research, and delayed advances in the field. Many oncology trials close prematurely, and those that do finish are generally extremely costly. Multiple factors contribute to these problems, including complexity of trial protocols, lack of access to trial sites, and stringent eligibility criteria. 1 Clinical trial sponsors rely on eligibility criteria to control the characteristics of study participants to generate interpretable and reproducible results. Over the past several decades, however, the number and specificity of eligibility criteria have increased substantially, further slowing accrual and limiting generalizability of study findings to real-world populations. 2 In response to these trends, several multistakeholder efforts have sought to modernize eligibility criteria to ensure that more patients can access therapies in development. [3][4][5][6][7][8][9] These activities focused primarily on reforming approaches to developing clinical trial eligibility criteria. LUNGevity Foundation (hereafter, LUNGevity), a nonprofit patient advocacy or-ganization committed to increasing quality of life and survivorship of people with lung cancer, formed a scientific and clinical research roundtable initiative to streamline lung cancer clinical trials. To date, this group has issued 2 sets of recommendations regarding eligibility criteria. 10,11 To address the need for consistency in how clinical trial eligibility criteria are defined and listed in protocols, LUNGevity collaborated with the US Food and Drug Administration (FDA) and the National Cancer Institute (NCI) to address 3 challenges arising from confusing and inconsistent eligibility criteria in clinical trials for advanced-stage non-small cell lung cancer (NSCLC): (1) patients, caregivers, and clinicians often face difficulties navigating trial protocols to determine eligibility because publicly available trial search engines do not standardize the listing of inclusion and exclusion criteria; (2) increasingly numerous and stringent eligibility criteria exclude a growing proportion of patients; and (3) heterogeneous study populations render cross-trial comparisons difficult.Herein, we present the result of this effort: a prioritized list of recommended terms for inclusion and exclusion criteria in first-IMPORTANCE Clinical trial sponsors rely on eligibility criteria to control the characteristics of patients in their studies, promote the safety of participants, and optimize the interpretation of results. However, in recent years, complex and often overly restrictive inclusion and exclusion criteria have created substantial barriers to patient access to novel therapies, hindered trial recruitment and completion, and limited generalizability of trial results. A LUNGevity Foundation working group developed a framework for lung cancer clinical trial elig...

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“…Em 28,4% dos casos, houve prescrição de um medicamento prolongador do intervalo QT. Em 7,3% foram prescritos dois medicamentos simultâneos (105) . 0,7-40,7 milissegundos; p=0,047) (107) .…”

Section: Epidemiologia Das Interações Medicamentosas Prolongadoras Dounclassified

Interações Medicamentosas Prolongadoras do Intervalo QT em Unidade de Terapia Intensiva: Coorte de idosos

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QTc Interval-Prolonging Medications Among Patients With Lung Cancer: Implications for Clinical Trial Eligibility and Clinical Care

Cited by 4 publications

References 48 publications

Association of QT interval-prolonging drugs with clinical trial eligibility in patients with advanced cancer

Association of QT interval-prolonging drugs with clinical trial eligibility in patients with advanced cancer

A New Approach to Simplifying and Harmonizing Cancer Clinical Trials—Standardizing Eligibility Criteria

Interações Medicamentosas Prolongadoras do Intervalo QT em Unidade de Terapia Intensiva: Coorte de idosos

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