Abiraterone successes before chemo in metastatic castrate resistant PCa with no/mild symptoms

[JimJimJimJim]

Abiraterone successes before chemo in metastatic castrate resistant PCa with no/mild symptoms

Jim Marshall (not a doctor) said ...

Earlier studies have shown that Abiraterone is effective for a significant number of men after chemotherapy fails. It is already approved in the USA and Australia for this use, but in Australia at a patient's considerable personal expense (though supplying it through the PBS is being considered).

The study used 1088 men in 151 cancer centres in 12 countries, including USA, UK, the Netherlands, Spain and Australia with prostate cancer who:

• were castrate resistant;
  
• were metastatic;
  
• with no symptoms or few symptoms of metastases (except being visible on bone scans); and
  
• had not had chemotherapy (with drugs like Taxotere/Docetaxel).
  

Half the men got Abiraterone tablets, half got an apparently identical placebo (fake) tablet.

All the men were given prednisone, because prednisone has to be given with Abiraterone, and nobody in the study (doctors, patients or researchers) knew who was getting the real tablets or the placebo while the trial was running.

The progress of the men on either treatment was also secret to all participants but was known to an outside Independent Data Monitoring Committee.

This Independent Committee looked at the results at certain points in the study. When they saw that the men with Abiraterone were clearly ahead on all measures, they called a halt to the study, to be fair to the men who did not get the real pill.

The study was unblinded letting patients, doctors and researchers know which men got the real Abiraterone, and which the placebo. Men who had been getting the placebo were then offered Abiraterone, and all men will have this as long as they need it.

The results:

Men who got Abiraterone during the study:

• clearly (with statistical significance) showed less progression on the regular scans all men had;
  
• had fewer deaths (not statistically significant, but a strong trend);
  
• In this report 27.2 months after the study started:
  
  • half the placebo men showed progression on scans at 8.3 months;
    
  • more than half the Abiraterone men had not yet showed progression on scans;
    
  • half the placebo men had died at 27.2 months;
    
  • more than half the Abiraterone men had not yet died;
    
  • half the placebo men had started using opiates for pain at 23.7 months;
    
  • more than half the Abiraterone men had not yet used opiates for pain;
    
  • after treatment started it was reported to affect the daily living abilities of the patient:
    
    • after 10.9 months for the placebo men;
      
    • after 12.3 months for the Abiraterone men;
      

    [*]PSA progressed started going up:

    • after 5.6 months for the placebo men;
      
    • after 11.1 months for the Abiraterone men.
      

Does this mean Abiraterone pre-chemotherapy is coming soon?

It might mean that it is closer to coming, but:

• This is only a report to the ASCO annual meeting, rather than a paper to a peer-reviewed journal, so it has not yet been widely appraised by doctors and researchers world wide; and
  
• While I am not a doctor or researcher, I think that approval by the FDA only happens when a very clear, significant survival benefit is shown. Because this study was stopped and Abiraterone then given to all men, demonstrating that survival benefit is no longer possible.
  

... end Jim

A link to the abstract that was released a few hours ago:

http://abstract.asco..._114_95300.html

[Admin]

About Abiraterone before chemotherapy, Charles J. Ryan, MD says it better:

So, in summary these results show that patients:

• can live longer without disease progression
  
• can live longer without symptoms
  
• can live longer until performance status deteriorates
  
• and live longer until receiving chemotherapy
  
• and probably live longer overall.
  

Reminder - pre-chemotherapy use not yet approved by the FDA in the USA or the TGA in Australia (Aug 2012).

Source

UroToday

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