Safety of long-term exposure to abiraterone acetate in patients with castration-resistant prostate cancer and concomitant cardiovascular risk factors

Abstract

Background: We aimed to evaluate the long-term safety profile of abiraterone in patients with metastatic castration-resistant prostate cancer (mCRPC) with controlled cardiovascular comorbidities or risk factors. Methods: We retrospectively analysed the clinical charts of consecutive mCRPC patients with cardiac disorders/risk factors who had been treated with abiraterone 1000 mg once daily plus prednisone 5 mg twice daily for a median duration of 16 months at an oncology referral centre between April 2011 and July 2015. Patients underwent an electrocardiogram (ECG) and echocardiographic assessments, including measurement of left ventricular ejection fraction (LVEF) at baseline and at the end of treatment. Blood pressure (BP) was measured daily at home. During follow up (median 24 months), all adverse events were recorded. Cardiac events (CEs) were defined, according to Common Terminology Criteria for Adverse Events version 4.0, as the appearance of a symptomatic CE that required medical intervention. Results: A total of 51 patients (median age 71 years) were evaluated. Pre-existing cardiovascular conditions included hypertension (41%), cardiac ischaemia (12%), stroke (9%), dyslipidaemia (18%) and type 2 diabetes mellitus (12%). No CEs were recorded and no changes in LVEF were observed. The most frequently reported adverse events were Grade 1-2 fluid retention (18%), hypertension (16%) and asthenia (16%). No patients permanently discontinued abiraterone due to cardiac events. Conclusions: Long-term abiraterone treatment was well tolerated in mCRPC patients with controlled cardiovascular comorbidities/risk factors, with no apparent worsening of cardiovascular conditions from baseline over an extended observation period.

Hematologic toxicity of radium-223 in elderly patients with metastatic Castration Resistant Prostate Cancer: a real-life experience

“…The hematological toxicity related to the treatment with radium-223 is comparable to that registered with the new hormonal treatments, abiraterone and enzalutamide19, 20, 21 and significantly lower than that recorded with cytotoxic chemotherapies (docetaxel and cabazitaxel), in which myelosuppression represents the most frequent toxicity 22, 23. Moreover, radium-223 is distinguished from beta-emitting radiopharmaceuticals, which are associated with significant hematologic events (mainly leukopenia and thrombocytopenia) 24 …”

Cardiovascular Complications of Prostate Cancer Treatment

“…A population-based retrospective study from The Surveillance, Epidemiology, and End Results (SEER) database of patients using abiraterone or enzalutamide (n = 3,876) revealed that men with coexisting CV comorbidities have a higher mortality threat compared to individuals without a history of CV disorders ( Lu-Yao et al, 2020 ). However, there is also evidence that appropriate control of CV comorbidities before the treatment initiation may substantially reduce the CV risk of the prescribed therapy ( Verzoni et al, 2016 ). Currently, no real-world data studies on CV complications induced by apalutamide or darolutamide are available.…”

Abiraterone acetate and prednisone in the pre- and post-docetaxel setting for metastatic castration-resistant prostate cancer: a mono-institutional experience focused on cardiovascular events and their impact on clinical outcomes

“… 14 A data update of the same study, with longer follow-up time, confirmed the previously reported safety profile. 15 The results of an additional study, also including mCRPC patients previously treated with DX, were presented at the 2016 American Society of Clinical Oncology Annual Meeting. 16 This was a prospective study specifically aimed at monitoring cardiac functionality during treatment with AA and PDN.…”