Pivotal Role Remains With Bone-Targeting Agents in mCRPC

Excerpt:

“Prostate cancer researchers are continuing to explore strategies to optimally integrate bone-targeted agents into patient care.

“For example, an ongoing trial is assessing the combination of a radiopharmaceutical, radium-223 dichloride (Xofigo), with an androgen receptor-directed therapy, either abiraterone acetate (Zytiga) or enzalutamide (Xtandi). The open-label, phase IIa study is accruing patients with metastatic castration-resistant prostate cancer (mCRPC). The primary endpoint of the trial, which hopes to enroll 68 patients, is patient bone scan response rate (NCT02034552).”

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Higano Discusses the Potential for PARP Inhibitors in Prostate Cancer Treatment

Excerpt:

“The field of prostate cancer is rapidly progressing on several different fronts, says Celestia Higano, MD, who discussed several of the the latest advances at the 2017 Interdisciplinary Prostate Cancer Congress (IPCC).

” ‘I want the community to have a sense of the very rapid change of pace of prostate cancer therapy. I hope to spread the message of what is changing, why is it is changing, what has been shown in evidence-based therapies, and what is still experimental,’ said Higano, MD, professor of medicine and urology at the University of Washington, and a member of the Clinical Research Division at Fred Hutchinson Cancer Research Center.”

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Video: An Overview of the ALSYMPCA Study in Metastatic Prostate Cancer

Excerpt:

“Luke Nordquist, MD, FACP, a urologic medical oncologist and CEO of the Urology Cancer Center and GU Research Network, gives an overview of the Alpharadin in Symptomatic Prostate Cancer Patients (ALSYMPCA) study, and he discusses ongoing trials examining the use of radium-223 dichloride (Xofigo) in metastatic castration-resistant prostate cancer (mCRPC).”

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Safety, Survival Advantages of Radium-223 Continue to Offer Benefit in mCRPC

Excerpt:

“The manageable safety profile of radium-223 dichloride (Xofigo) compared with other radiopharmaceuticals is appealing to oncologists treating castration-resistant prostate cancer (CRPC) that is metastatic to the bone, says Richard G. Stock, MD.

“ ‘With previous radiopharmaceuticals, there has been a limitation with bone marrow toxicity,’ said Stock, senior faculty, Radiation Oncology, Mount Sinai Hospital. ‘Radium-223 really spares the bone marrow to a much greater degree than prior treatments, and that is why it has been embraced and much more widely utilized than any of the other radiopharmaceuticals.’ ”

“The FDA approved radium-223 in May 2013 based on findings from the phase III ALSYMPCA trial. In the study, radium-223 demonstrated a median overall survival of 14.9 months compared with 11.3 months with placebo for patients with bone-metastatic CRPC (HR, 0.70; P <.001).”

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Retreatment With Radium-223 Found Safe in mCRPC

Excerpt:

“To determine if a higher dose of radium-223 would be safe, an international, multicenter, prospective study examined 44 patients with mCRPC with bone metastases. Radium-223 was found to be well tolerated in this study, with incidence of adverse advents in retreated patients comparable or lower than those seen in the ALSYMPCA trial. No new safety concerns were observed with the higher dose.

“In an interview with OncLive, Nordquist, an investigator on the trial, provides more insight on the study and the ongoing potential of radium-223 in mCRPC.”

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Expert Says Xofigo Is "Game Changer" for Bone Metastatic CRPC

Excerpt:

“Radium-223 dichloride (Xofigo) opened an entirely new chapter in the treatment landscape of castration-resistant prostate cancer with bone metastases (mCRPC), says E. David Crawford, MD, professor of Radiation Oncology, Department of Surgery, at the University of Colorado Denver.

“ ‘Radium-223 is sort of a surprise drug, at least to me,’ says Crawford. “We have had radioisotopes around for a long period of time, including phosphorus-32, samarium-153 (Quadramet), strontium-89 (Metastron), and others. But, they all had a lot of baggage with them, in terms of side effects.

” ‘Now, we have a new one—radium-223—which is not associated with the side effects that we were seeing with the other ones, but it is associated with an improvement in survival rate. It’s a game changer.’ ”

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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.”


Radium-223 Benefits Survival, Not Just for Palliative Care

“Despite what many believe, not all radiopharmaceuticals are just for pain palliation, says Phillip J. Koo, MD, a radiologist of Memorial Hospital and University of Colorado Hospital.

“The ALSYMPCA trial, which was the basis for the 2013 FDA approval of radium-223 dichloride (Xofigo) showed a median overall survival (OS) of 14 months with radium-223 versus 11.2 months with placebo (HR, 0.70; P = .00185) in patients with metastatic castration-resistant prostate cancer (mCRPC).

“Despite the fact that it has been 3 years since the pivotal ALSYMPCA trial and the coinciding FDA approval, many oncologists still need to be educated regarding radium-223’s benefits, says Koo.”


Multiple Trials Explore Radium-223 Combinations for mCRPC

“Clinical trials are now assessing how to best use radium-223 (Xofigo) in combination with androgen inhibitors, following the rapid approval of several agents for men with castration-resistant prostate cancer (CRPC).

“In the first of these studies, a phase III being conducted by the European Organisation for Research and Treatment of Cancer (EORTC), single-agent enzalutamide (Xtandi) is being compared with radium-223 plus enzalutamide for men with asymptomatic or mildly symptomatic bone metastatic CRPC (NCT02194842). Additionally, this same approach is being examined in a phase II study conducted by the All Ireland Cooperative Oncology Research Group (NCT02225704).”