![]() ![]() The most common adverse effect was grade 3 anemia (12%) and combined grade 3–4 cytopenia (anemia, thrombocytopenia, leucopenia and neutropenia) occurred in 20% of patients. Grade 1–2 adverse effects occurred in 32% of patients and 37% of patients experienced any grade 3–4 toxicity. Discontinuation of radium-223 due to adverse effects occurred in 21% patients. Combination treatment was reported to be well-tolerated. The same benefit did not extend to patients undergoing treatment with radium-223 and bisphosphonates. After a median follow-up of 7.5 months, the authors reported improved overall survival in patients who received concomitant radium-223 and either abiraterone, enzalutamide, abiraterone and enzalutamide or denosumab. The primary endpoints for the study were safety and overall survival. Patients could receive concomitant administration of abiraterone, enzalutamide, or denosumab. Although, men with nodal disease were permitted, patients with visceral metastases were excluded from the study. The trial involved a majority of Caucasian men aged 65 years and older with bone-predominant disease with at least two or more skeletal metastases. ( 9) conducted a single-arm, phase 3b, international multicenter clinical trial investigating the safety and efficacy of radium-223 and concomitant therapies in 696 patients with CRPC. In a recently published article, Saad et al. Ongoing debate has focused on the initiation of Radium-223 earlier in the disease course and the question of safety and efficacy of combining Radium-223 with other AR-directed therapies ( 8). As such, both the American Society of Clinical Oncologists and the American Urologic Association have recommended incorporation of Radium-223 into the treatment algorithm ( 6, 7). More recently, Radium-223 (Xofigo ®) became the first approved radiopharmaceutical which decreased SRE’s, palliated pain, and showed improved overall survival in symptomatic or minimally symptomatic patients with CRPC and bone metastasis only ( 5). Abiraterone (Zytiga ®) ( 3), and Enzalutamide (Xtandi ®) ( 4) were approved based on data supporting improved overall survival compared to placebo and in addition, both agents decreased time to SRE and increased rates of pain palliation in the case of Abiraterone. Over the last decade, significant strides have been made in the development of therapies for patients with castrate resistant metastatic prostate cancer (CRPC). Furthermore, skeletal related events (SRE) such as spinal cord compression, pathologic fractures and requirement for external beam radiation for pain palliation continue to represent a significant cause of morbidity for patients with bone metastasis ( 2). Skeletal metastasis is common in castrate resistant prostate cancer and is an independent poor prognostic factor ( 1). Most patients with relapsed prostate cancer develop metastatic disease and eventually become castration-resistant. Radium-223 and concomitant therapies in patients with metastatic castration-resistant prostate cancer: an international, early access, open-label, single-arm phase 3b trial. Lue, MD, ScD (Hon), FACS, Professor and Vice Chair, (Department of Urology, University of California San Francisco, San Francisco, USA).Ĭomment on: Saad F, Carles J, Gillessen S, et al. Email: This is a Guest Editorial commissioned by Editor-in-Chief Tom F. Genitourinary Oncology Service, Sidney Kimmel Center for Prostate and Urologic Cancers, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, New York 10065, USA. Interviews with Outstanding Guest EditorsĬorrespondence to: Susan F. ![]() Policy of Dealing with Allegations of Research Misconduct.Policy of Screening for Plagiarism Process. ![]()
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