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mCRPC: Implications of the ALSYMPCA Trial

Insights From: Evan Yu, MD, University of Washington; Ulka Vaishampayan, MD, Barbara Ann Karmanos Cancer Institute ; Neeraj Agarwal, MD, Huntsman Cancer Institute
Published: Thursday, Dec 20, 2018



Transcript: 

Evan Yu, MD:
The ALSYMPCA trial looked at patients who had bone metastases, castration-resistant prostate cancer, and symptoms. It randomized patients to either 6 cycles or doses of radium-223, given approximately once every 4 weeks, or placebo. This study was interesting in the fact that they allowed patients on the trial who had received prior docetaxel chemotherapy, who were intolerant to docetaxel, or who refused docetaxel chemotherapy. I think it was quite fortuitous that they had this eligibility criteria, because what ended up happening is about half the patients were in the predocetaxel setting and half were in the postdocetaxel setting. There was enough statistical power to show a survival benefit in both settings.

The key thing you have to think about is obviously that a patient has to have bone metastases and some symptoms, although over 40% of patients had mild symptoms that required only analgesics with Tylenol [acetaminophen] or ibuprofen. They didn’t really require narcotic pain medications. But those patients who fit those criteria had a dramatic survival benefit when given those 6 cycles of radium-233. They had many other benefits—secondary benefits—as well, such as delayed time to pain and decreases in skeletal morbidity. That is an agent that is approved and leads to clear benefit for our patients.

Neeraj Agarwal, MD: The ALSYMPCA trial was a large phase III trial that led to approval of radium-223 for patients with metastatic castrate-resistant prostate cancer. In this trial, patients were randomized to  androgen deprivation therapy with AR [androgen receptor] inhibitors, which were standard therapies at that time, or standard androgen deprivation therapy with radium-223. The primary endpoint was overall survival, which was met. There was a 30% reduction in risk of death in patients who got radium-223.

But on top of that, many other benefits were noted, such as an almost 6-month delay in the onset of fractures or skeletal-related events with the use of radium, which was very significant. Other benefits that were noted were delay in the bone pain, or an improvement in the bone pain. I think based on these data, radium-223 is one of the very good options for our patients who have progressive metastatic castrate-resistant prostate cancer, who are experiencing bone pain, and who were symptomatic, regardless of whether they have received chemotherapy in the past. The only exclusion I can think of is in a minority of patients who have visceral metastasis. Those patients are not considered eligible for treatment with radium. But other than that, I would consider radium-223 as a very well-tolerated treatment option for my patients.


Transcript Edited for Clarity
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Transcript: 

Evan Yu, MD:
The ALSYMPCA trial looked at patients who had bone metastases, castration-resistant prostate cancer, and symptoms. It randomized patients to either 6 cycles or doses of radium-223, given approximately once every 4 weeks, or placebo. This study was interesting in the fact that they allowed patients on the trial who had received prior docetaxel chemotherapy, who were intolerant to docetaxel, or who refused docetaxel chemotherapy. I think it was quite fortuitous that they had this eligibility criteria, because what ended up happening is about half the patients were in the predocetaxel setting and half were in the postdocetaxel setting. There was enough statistical power to show a survival benefit in both settings.

The key thing you have to think about is obviously that a patient has to have bone metastases and some symptoms, although over 40% of patients had mild symptoms that required only analgesics with Tylenol [acetaminophen] or ibuprofen. They didn’t really require narcotic pain medications. But those patients who fit those criteria had a dramatic survival benefit when given those 6 cycles of radium-233. They had many other benefits—secondary benefits—as well, such as delayed time to pain and decreases in skeletal morbidity. That is an agent that is approved and leads to clear benefit for our patients.

Neeraj Agarwal, MD: The ALSYMPCA trial was a large phase III trial that led to approval of radium-223 for patients with metastatic castrate-resistant prostate cancer. In this trial, patients were randomized to  androgen deprivation therapy with AR [androgen receptor] inhibitors, which were standard therapies at that time, or standard androgen deprivation therapy with radium-223. The primary endpoint was overall survival, which was met. There was a 30% reduction in risk of death in patients who got radium-223.

But on top of that, many other benefits were noted, such as an almost 6-month delay in the onset of fractures or skeletal-related events with the use of radium, which was very significant. Other benefits that were noted were delay in the bone pain, or an improvement in the bone pain. I think based on these data, radium-223 is one of the very good options for our patients who have progressive metastatic castrate-resistant prostate cancer, who are experiencing bone pain, and who were symptomatic, regardless of whether they have received chemotherapy in the past. The only exclusion I can think of is in a minority of patients who have visceral metastasis. Those patients are not considered eligible for treatment with radium. But other than that, I would consider radium-223 as a very well-tolerated treatment option for my patients.


Transcript Edited for Clarity
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