A new study has revealed significant cardiac safety concerns for patients receiving Tagrisso (osimertinib) for EGFR-mutant non-small cell lung cancer (NSCLC), highlighting the need for enhanced cardiac monitoring during treatment.
The research, published in JAMA Network Open, found that Tagrisso was associated with a notably higher incidence of cancer therapy-related cardiac side effects (CTRCEs) compared to other EGFR tyrosine kinase inhibitors (TKIs). After a median follow-up of 23.2 months, 14.9% of Tagrisso-treated patients experienced cardiac events, compared to just 4.4% in the control group.
Significant Cardiac Risk Profile
The study analyzed 401 patients, with 195 receiving Tagrisso and 206 treated with other EGFR TKIs. Patients in the Tagrisso group showed a significantly higher risk of developing new arrhythmias and heart failure. Most concerning was the finding that these cardiac events were associated with a four-fold decrease in overall survival, independent of pre-existing cardiovascular conditions.
"Even patients with low cardiovascular risk while receiving Tagrisso had a higher hazard of CTRCEs," the researchers noted, challenging previous assumptions that cardiac complications primarily affected patients with pre-existing cardiovascular disease.
Patient Demographics and Study Design
The study population had a mean age of 69.2 years, with 63.1% being female and 82.5% nonsmokers. Common comorbidities included hypertension (42.4%) and diabetes or hyperlipidemia (20%). The research team carefully monitored for various cardiac events, including:
- Newly emerging arrhythmias
- Moderate or worse valvular heart disease
- Myocardial infarction
- Heart failure
Clinical Implications
These findings have particular significance for Asian populations, where EGFR mutations are present in approximately 50% of lung cancer cases. The researchers cautioned that while Tagrisso has shown superior survival benefits compared to older EGFR TKIs like gefitinib or erlotinib, these long-term outcomes could be compromised by cardiac complications.
Monitoring Recommendations
The study's results emphasize the critical importance of cardiac monitoring for all patients receiving Tagrisso, regardless of their baseline cardiovascular risk profile. This represents a shift from previous approaches that primarily focused on monitoring patients with pre-existing cardiac conditions.
Other factors independently associated with overall survival included:
- Patient age
- Disease stage
- Presence of brain metastases
- Performance status score
These findings suggest the need for a comprehensive approach to patient monitoring and risk assessment when using Tagrisso in EGFR-mutant NSCLC treatment.
