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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Shore Shares Insight on Challenges of Bone Metastases in mCRPC

Excerpt:

“Bone metastases in castration-resistant prostate cancer (mCRPC) create a significant problem, Neal Shore, MD, medical director of the Carolina Urologic Research Institute, said in a recent presentation at the 2016 American Urological Association Annual Meeting.

” ‘A bone-metastatic event is really a seminal event,’ said Shore, who discussed the prevalence of bone metastases and possible preventative solutions. ‘It is quite an outstanding biologic and prognostic factor in mortality and, often times, in morbidity.’ ”

“Prostate cancer represents 21% of all new cancer cases in men and is the second most common cause of cancer death among American men after lung cancer, reported Shore.”

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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.”


Abituzumab Improves Bone Lesion Progression, not PFS in CRPC

“Abituzumab did not extend progression-free survival (PFS) compared with placebo in a phase II study of patients with metastatic castration-resistant prostate cancer. The agent did, however, offer a lower incidence of bone lesion progression, and researchers say it still warrants further investigation.

“Previous research has suggested that integrins play a role in the progression of metastatic prostate cancer and associated bone lesions, wrote researchers led by Maha Hussain, MB, ChB, of the University of Michigan in Ann Arbor. Abituzumab is a pan-αv integrin inhibitor; a phase I trial previously showed that the agent has activity in patients with castration-resistant prostate cancer and bone metastases.

“The new phase II trial randomized 180 patients between three arms: a 750-mg abituzumab group, a 1,500-mg abituzumab group, or placebo. All groups also received standard of care. The results were published in Clinical Cancer Research.”


Early Chemotherapy Improves Survival for Men with Prostate Cancer

“Two papers from UCL show that having early chemotherapy improves survival for men with prostate cancer. The papers, published in the Lancet and Lancet Oncology, report the results from the STAMPEDE clinical trial and a meta-analysis.

“Both papers looked at the use of a chemotherapy drug called docetaxel. Docetaxel is already used for men with prostate cancer once hormone therapy has stopped working. In STAMPEDE and the meta-analysis, the researchers looked at using it earlier, when men are starting long-term hormone therapy. Both studies found that adding docetaxel improved survival for these men.

“The studies also looked at whether the drug zoledronic acid improves survival. Zoledronic acid is used to reduce the risk of bone problems in men whose cancer has spread to their bones, and whose hormone therapy has stopped working. The new studies looked at using it earlier, when men are starting long-term hormone therapy. Both studies found that adding zoledronic acid did not improve survival for these men.”


The Potential of Radium-223 as a Treatment in mCRPC

“From its approval in May 2013 to recently being considered as a combination treatment with other drugs, radium-223 dichloride (Xofigo) shows great potential in positively impacting treatment for metastatic castration-resistant prostate cancer (mCRPC), according to Michael Morris, MD, medical oncologist, Memorial Sloan Kettering Cancer Center.

‘This drug has been shown to prolong survival and improve quality of life in men with mCRPC. It improves overall survival; therefore, it helps patients live longer. It also delays complications related to bone metastases, known as SSE. These include bone fracture, bone pain, spinal cord compression, and others. Nevertheless, the drug is not only helping patients live longer, but it is helping them live better, as well,’ said Morris in an interview with Targeted Oncology.”