Adding Bone Drugs to Radium-223 May Enhance Benefit in mCRPC

Excerpt:

“Men with bone-metastatic castration-resistant prostate cancer (mCRPC) appeared to derive additional benefits from treatment with radium-223 with concomitant bone-targeted therapies, according to data from an extended-access program.

“After a median follow-up of 7.5 months from initial injection of radium-223, patients on concomitant denosumab had yet to reach a median overall survival (OS), whereas patients treated with radium-223 alone had a median survival of 13.4 months.”

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Radium-223 Improves QoL Over Placebo in CRPC

“Analyses from the phase III ALSYMPCA trial showed that treatment with the alpha-emitting radiopharmaceutical radium-223 resulted in quality-of-life (QoL) improvements over placebo in patients with castration-resistant prostate cancer (CRPC) and symptomatic bone metastases.

“ ‘Patients with CRPC and bone metastases often present with symptoms such as pain fatigue, anorexia, and, rarely, spinal cord compression, contributing to rapid and significant deterioration in health-related QoL and mortality,’ wrote study authors led by Sten Nilsson, MD, PhD, of Karolinska University Hospital in Stockholm.

“The ALSYMPCA trial found that radium-223 prolonged overall survival (OS) as well as time to first symptomatic skeletal event by significant periods. The trial included prospective QoL measurements using the EuroQoL EQ-5D and the Functional Assessment of Cancer Therapy–Prostate (FACT-P). The results from these tests were published online ahead of print in Annals of Oncology.”


Certain Prostate Cancer Patients in England and Wales May Soon Get Access to Xofigo Treatment

“It is looking likely that patients with prostate cancer will, in certain circumstances, get ‘routine’ access to treatment with Bayer’s Xofigo (radium 223) on the National Health Service in England and Wales.

“The National Institute for Health and Care Excellence has published draft guideline’s endorsing the drug as an option to treat adults with hormone-relapsed prostate cancer, symptomatic bone metastases and no known visceral metastases.

“But this only extends to patients who have already been treated with docetaxel, and the recommendation is contingent upon on Bayer providing the drug with a confidential discount agreed in a patient access scheme.

“Xofigo is a radio-pharmaceutical agent designed to directly deliver alpha radiation to bone metastases without affecting normal bone marrow. Bayer estimates the average cost for a six-month course with the drug (administered intravenously every four weeks) to be around £24,240.”


Radium-223 Dichloride Effective in CRPC, Regardless of Prior Docetaxel

The gist: The drug Xofigo (aka radium-223 dichloride) is often used to treat bone metastases in patients with castration-resistant prostate cancer. New research results show that it is safe and effective for these patients whether or not they have previously been treated with the chemotherapy drug docetaxel.

“Radium Ra 223 dichloride appeared safe and effective in patients with castration-resistant prostate cancer and symptomatic bone metastases regardless of whether they received prior docetaxel, according to a subgroup analysis from a randomized phase 3 trial.

“Results of the ALSYMPCA showed radium Ra 223 dichloride [radium-223 (Xofigo, Bayer)], a targeted alpha-emitter, extended OS compared with placebo in patients with castration-resistant prostate cancer and symptomatic bone metastases. The agent also appeared well tolerated.

“Researchers established prior docetaxel treatment as a trial stratification factor.

“In the prespecified subgroup analysis, researchers sought to assess the effect of prior docetaxel treatment on efficacy and safety outcomes.”


Radium Ra 223 Dichloride Safe, Effective for Prostate Cancer Bone Metastases

“Radium Ra 223 dichloride reduced the time to a first symptomatic skeletal event compared with placebo in patients with castration-resistant prostate cancer and symptomatic bone metastases, according to results of a randomized, double blind, phase 3 study.

“Researchers also determined radium Ra 223 dichloride (Xofigo, Bayer HealthCare) decreased use of external beam radiation therapy for bone pain and also decreased the need for spinal cord compression.

“The trial included 921 patients with castration-resistant prostate cancer and bone metastases.

Editor’s note: Last year, the U.S. Food and Drug Administration (FDA) approved the drug Xofigo for treating men with late-stage prostate cancer with bone metastases. (Read about the FDA-approval in a previous news story.) In this study, researchers found further benefit for the drug in patients with castration-resistant prostate cancer and symptomatic bone metastases.