Pertuzumab Aracılı Kardiyotoksisite: Tek Merkezli Bir Çalışma

Abstract

Amaç: Son klinik çalışmalar, trastuzumaba pertuzumab eklenmesinin tedaviye hücresel yanıtı iyileştirdiğini ve tek başına trastuzumab ile karşılaştırıldığında sağkalım avantajı sağladığını göstermiştir. Bununla birlikte, kardiyotoksisite riskini arttırabileceği konusunda endişe uyandırmıştır. Pertuzumabın neden olduğu kardiyotoksisiteye ilişkin gerçek yaşam verileri kısıtlıdır. Gereç ve Yöntemler: Ocak 2017-Haziran 2022 tarihleri arasında trastuzumab beraberinde pertuzumab tedavisi gören ve kontrol vizitleri kapsamında düzenli olarak transtorasik ekokardiyografi çekilen hastalar çalışmaya dahil edildi. Kardiyak advers olay riskini arttırabilecek hasta özelliklerini ve tedavilerini değerlendirmek için tanımlayıcı istatistiksel analizler kullanıldı. Başlangıçta ve pertuzumab tedavisi sırasında her 3 ayda bir 2 boyutlu ekokardiyografi ile yapılan ardışık sol ventrikül ejeksiyon fraksiyonu (SoVEF) ölçümleri değerlendirildi ve SoVEF’nin %10’dan fazla düşüşle %55’in altına inmesi kardiyotoksisite olarak tanımlandı. Bulgular: Dahil edilme kriterlerini karşılayan 118 hasta vardı. Populasyonun yaş ortancası 51 (41-60) yıldı. Pertuzumab tedavisinin ortanca süresi 15 (9-57) haftaydı. Pertuzumab tedavisi iki hastada alerjik reaksiyon, diğer iki hastada kardiyotoksisite nedeniyle kesildi. Azalan SoVEF her 2 hastada da başlangıç değerlerine geri dönmedi. Sonuç: Mevcut çalışmada kardiyotoksisite insidansı (%1,69) tek başına trastuzumab için beklenenden daha yüksek değildi. Önceki çalışmalardan elde edilen veriler ve bu çalışmanın sonuçları pertuzumabın kardiyotoksisitede artışa neden olmadığını desteklemektedir. Yine de, gerçek yaşam koşullarında pertuzumabın kardiyak güvenliliğini desteklemek için büyük çaplı klinik çalışmalara ihtiyaç vardır.

Keywords

• meme kanseri;
• kardiyotoksisite;
• pertuzumab

Pertuzumab-mediated Cardiotoxicity: A Single Center Study.

Abstract

Pertuzumab-mediated Cardiotoxicity: A Single Center Study. Objective: Recent clinical trials have shown that adding pertuzumab to trastuzumab improved the cellular response to therapy and provides a survival benefit compared with trastuzumab alone. However, it has raised concerns about additive risk of cardiotoxicity. Real life data on pertuzumab-induced cardiotoxicity are limited. Materials and Methods: Patients a diagnosis of breast cancer who had been treated trastuzumab plus pertuzumab between January 2017 and June 2022 and had undergone regularly transthoracic echocardiography, as a part of control visits, in our medical center were included. We performed descriptive statistical analysis to evaluate the patients’ characteristics and therapies, which could increase the risk of cardiac adverse events. Cardiotoxicity was evaluated by serial left ventricular ejection fraction (LVEF) measuring by 2D echocardiography at baseline and every three months during pertuzumab therapy and was defined as a decrease in LVEF > 10% to below 55%. Results: There were 118 patients fulfilling the inclusion criteria. The median age of the population was 51 (41-60) years. The median duration of pertuzumab therapy was 15 (9–57) weeks. Pertuzumab therapy was discontinued in two patients because of an allergic reaction and in other two patients due to cardiotoxicity. The reduced LVEF did not recover to baseline values in either patient. Conclusion: The incidence of cardiotoxicity (1.69%) in the current study was no higher than expected for trastuzumab alone. Data from previous studies and the results of this study support that pertuzumab causes no increase in cardiotoxicity. Still, large clinical trials are needed to verify the cardiac safety of pertuzumab in a real-world setting.

Keywords

• breast cancer; cardiotoxicity; pertuzumab.

References

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