Sunday, June 3, 2012

Notes on Prostate Cancer From ASCO 2012

Phase 3 date on abiraterone trial in asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer (mCRPC) was profiled in the ASCO daily news.  These results have the potential of changing the standard of care in mCRPC.

"In patients with asymptomatic or mildly symptomatic chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC), abiraterone acetate (AA) plus prednisone produced a statistically significant benefit in radiographic progression-free survival (rPFS) over placebo plus prednisone, according to a planned interim analysis of a phase III study.
Trial: COUAA-302 Phase 3 multicenter, randomized, placebo-controlled study.
Compared abiraterone acetate (AA) with prednisone against placebo (PL).
Patients: with mCRPC who did not had symptoms or mild symptoms, and were not previously treated with chemotherapy (chemotherapy naive). 

Primary Endpoints: 
  • Overall survival (OS): abiraterone trend towards increased OS compared to PL.
  • Radiographic progression-free survival (rPFS) which was determined by bone scan. Patients on abiraterone had significant advantage.  Also CT-Scan was done to study soft tissue lesions.
Secondary endpoints:  
*These are more meaningful to the patients and their quality of life. Abiraterone patients fared better in all.
  • Time to opiate use (ie how long before the patients start using opiate to deal with bone pain, for instance)
  • Time to chemotherapy initiation.
  • ECOG performance status deterioration (a scale reflective of quality of life).
  • Time to PSA progression (a surrogate of failure, or relapse, or disease progression).

The interim analysis of the data done in December 2011 concluded that there was significant advantage in rPFS with abiraterone.  That's when early termination and unblinding was recommended so that those patients on placebo may be offered the real drug.


This was the first phase 3 study to test abiraterone in chemotherapy naive patients.
Thus, it has the potential to elevate abiraterone as the first-in-line therapy and a new standard of care in mCRPC patients.  

Below the the sampling of tweets related to prostate cancer results from the meeting -- there is lot more going on ...

Abiraterone Delays Progression in Patients with Chemotherapy-Naïve CRPC.  ASCO Daily News.

Also worth reading from across the web:

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