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Afatinib (Gilotrif) Treatment Should Be Stopped On Symptomatic LV (Left Ventricular) Dysfunction
#84307
08/04/18 01:30 PM
08/04/18 01:30 PM
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OP
Master Elite Member
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Joined: Dec 1999
Posts: 30,797
Maine, USA
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"Afatinib is approved for first-line treatment of metastatic nonsmall-cell lung cancer, and treatment should be stopped if patients develop symptomatic LV (left ventricular) dysfunction; however, there are no recommended LVEF (LV ejection fraction) monitoring guidelines in the package insert. (Source: "Cardiotoxicity: An Unexpected Consequence of HER2-Targeted Therapies"; American College of Cardiology, 2016. - http://www.acc.org/latest-in-cardiology/articles/2016/06/06/09/32/cardiotoxicity) --- "Cardiotoxicity induced by anticancer treatment is increasing in importance as metastatic cancer patients today survive longer." "...many studies have been performed and have revealed that HER2 (human epi-dermal growth factor receptor 2) signaling is essential for maintaining the heart function...we now have potentially cardiotoxic agents including osimeritinib and afatinib...which inhibit HER2. (Source: "Congestive Heart Failure During Osimertinib Treatment for Epidermal Growth Factor Receptor (EGFR)-mutant Non-small Cell Lung Cancer (NSCLC)"; Internal Medicine, 2017 - https://tinyurl.com/ydxj8tl9) --- "7.5.2.5. Cardiac Failure - Afatinib is an inibitor of HER2. Other HER2 inhibitors (lapatinib and trastuzumab) have been associated with the development of impaired left ventricular function and cardiac failure. LVEF was monitored in both of the RCTs, by echocardiography or MUGA scan. Potentially clinically significant changes in LVEF were definted as a ≥ 20% reduction from baseline and a decrease to below the institutional lower limit of normal (or to below 50% if the institutional lower limit of normal was not known). The incidence in the 2 RCTs of adverse events suggestive of cardiac failure is shown in Table 43. The incidence of such events was only slightly higher in the afatinib arms. It should be noted that subjects at risk of cardiac failure were generally excluded from clinical trials. (Source: "Extract from the Clinical Evaluation Report for afatinib"; Australian Government Depart of Health - Therapeutic Goods Administration, 2013 - https://tinyurl.com/y8wzaly9)
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