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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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.”


Chemotherapy After Radium-223 Safe in Metastatic Castration-Resistant Prostate Cancer

“The explosion of new drugs for the treatment of castration-resistant prostate cancer (CRPC) is a welcome advance, but raises questions about how best to sequence these drugs with standard docetaxel chemotherapy. A subanalysis of the ALSYMPCA trial suggests that chemotherapy can be safely administered after treatment with radium-223—one of the newer agents approved in this setting—in patients with metastatic CRPC and bone metastasis.

“The study, presented at the 18th ESMO-40th ECCO 2015 European Cancer Congress, was a post-hoc analysis of patients enrolled in ALSYMPCA who received chemotherapy post treatment with radium-223 and post treatment with placebo. Follow-up was 3 years.

“ ‘This study has some limitations, including the fact that it represents a subset of patients based on post-randomization factors, including study drug treatment with radium-223 or placebo, and randomization of the original study does not ensure comparability of the treatment arms,’ said lead author Oliver Sartor, MD, Tulane Cancer Center, New Orleans, LA.”


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-223 Chloride: Extending Life in Prostate Cancer Patients by Treating Bone Metastases

“The treatment scope for patients with metastatic castrate-resistant prostate cancer (mCRPC) is rapidly expanding. On May 15, 2013, the FDA approved radium-223 chloride for the treatment of mCRPC patients whose metastases are limited to the bones. Radium-223 is an alpha-emitting alkaline earth metal ion, which, similar to calcium-ions, accumulates in the bone. In a phase 3 study (ALSYMPCA), mCRPC patients with bone metastases received best standard-of-care with placebo or radium-223 chloride. At a prespecified interim analysis, the primary endpoint of median overall survival was significantly extended by 3.6 months in patients treated with radium-223 compared to placebo (p < 0.001). The radioisotope was well tolerated and gave limited bone marrow suppression. Radium-223 chloride is the first bone targeting antitumor therapy which received FDA approval based on a significant extended median overall survival. Further studies are required to optimize its dosing and to confirm its efficacy and safety in cancer patients.”