Lung Cancer Drug Tagrisso Linked to Heart Failure, Other Adverse Cardiac Events: Study

A new study reveals that non-small cell lung cancer (NSCLC) patients taking Tagrisso face a fourfold higher risk of adverse cardiac events compared to those using older, alternative treatment options.

Non-small cell lung cancer is the most prevalent form of lung cancer globally, accounting for approximately 85% of all diagnosed cases. It is a broad category of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma and large cell carcinoma, each with distinct characteristics and growth patterns.

Tagrisso (osimertinib) was developed by AstraZeneca and approved by the U.S. Food and Drug Administration (FDA) in November 2015, for the treatment of patients with metastatic non-small cell lung cancer who have epidermal growth factor receptor T790M mutations.

The drug works by targeting and blocking a specific protein called the epidermal growth factor receptor (EGFR), which helps cancer cells grow and spread. It is especially effective against tumors with the EGFR T790M mutation, a genetic change that makes the cancer resistant to older treatments, helping to slow or stop tumor growth in patients with advanced non-small cell lung cancer.

Since the drug’s introduction, Tagrisso has become one of the front-line treatment options for patients who are diagnosed with NSCLC, with more than 800,000 individuals having been treated with the drug globally.

However, in a study published in JAMA Network Open on December 5, researchers from Taiwan indicate that Tagrisso could be responsible for an increased risk of adverse cardiac events, including emerging arrhythmias, valvular heart disease, myocardial infarction and heart failure, which could lead to death.

A research team led by Chien-Yu Lin from National Cheng Kung University in Tainan, Taiwan, analyzed data from 401 NSCLC patients and found that those treated with Tagrisso experienced significantly higher rates of negative cardiac events compared to patients receiving other EGFR inhibitors.

The study included data from 253 female and 195 male patients who were treated with Tagrisso or its generic equivalent, osimertinib, at National Cheng Kung University Hospital between September 1, 2019, and July 31, 2022, with follow-ups concluding on January 31, 2024.

After accounting for various comorbidities, such as age, sex, smoking, and alcohol consumption, the researchers found that while Tagrisso extended the survival rate for NSCLC patients, it also significantly increased the risk of long-term complications, including arrhythmias, valvular heart disease, myocardial infarction and heart failure.

“Despite the extended survival observed in patients with EGFR variations treated with osimertinib compared with gefitinib or erlotinib, long-term outcomes may be compromised by significant cardiac risks,” Lin said.

Researchers noted that further research is required to determine the precise reason why Tagrisso may be associated with this greater risk of cardiovascular disease than other EGFR treatment options.

Tagrisso Skin Reaction Side Effects

This is not the first time adverse side effects have been linked to patients taking Tagrisso. In April 2022, a case report highlighted severe skin reactions associated with Tagrisso, including worsening psoriasis, Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis, all of which are potentially life-threatening conditions.

SJS is a known side effect of several medications, which produces blisters and severe rashes that may cause the skin to separate from the body.

When the skin lesions affect more than 30% of the body, the condition is typically referred to as toxic epidermal necrolysis (TEN), which is a more severe form of SJS that causes the skin to begin to burn from the inside out.