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.
Significance:
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 ...
[<a href="http://storify.com/pipet2pen/prostate-cancer" target="_blank">View the story "Prostate Cancer @ #ACSO12" on Storify</a>]<h1>Prostate Cancer @ #ACSO12</h1><h2>Some of the action on Sunday, Jun 3, 2012 in the Windy City by Lake Michigan</h2><p>Storified by Pipet2Pen · Sun, Jun 03 2012 20:50:55</p><div><b><u>Abiraterone Delays Progression in Patients with Chemotherapy-Naïve CRPC.</u></b> <div>From ASCO Daily News: (http://chicago2012.asco.org/ASCODailyNews/LBA4518.aspx)<br><br><div>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.<br></div></div></div><div>undefinedAsco</div><div>undefinedAsco</div><div>Fox discussing FDHT PET for imaging the AR in CRPC #asco12Pieter Droppert</div><div>Fox: one future imaging direction is prostate specific membrane antigen tracers as markers of downstream AR signalling #asco12Pieter Droppert</div><div><b>Cautions, cautions, cautions (about the simplest of technologies).  The human factor will not go away.</b></div><div>Ryan: bone scans used to determine progressive disease in COU-AA-302 trial #asco12Pieter Droppert</div><div>Ryan: many radiologists miss bone flare in mCRPC bone scans #asco12Pieter Droppert</div><div>Ryan: brighter bone scan images don't automatically mean PCa progression - need to confirm new lesions #asco12Pieter Droppert</div><div><b>Prostate Brawl (!) sounds like an English Rugby Match between MDs wearing suits.  Just what's needed before people head out to the bar to have a drink.</b></div><div>Upcoming: Post-Plenary Discussion on Prostate Cancer: Abstract #4. Expect yelling and interuptions out of room S100a #ASCO12Steven Tucker, MD</div><div>This is a pilot session for ASCO, a recap of the plenary, then open mike night! #ASCO12 #ProstateBrawlSteven Tucker, MD</div><div>Less arguing than expected, but crowd really does not seem to buy what they are selling. #ASCO12 #ProstateBrawlSteven Tucker, MD</div><div>Gleave: Also the issue of post-study interventions is critical. #ASCO12 #ProstateBrawlSteven Tucker, MD</div><div>Gleave: Retreatment triggers may be an issue when comparing studies. Hussain: No you misunderstand... #ASCO12 #ProstateBrawlSteven Tucker, MD</div><div>It is so imp in these PC men to individualize against competitive mortality, imaging, CTC's, QOL #ASCO12 #ProstateBrawlSteven Tucker, MD</div><div>Is the PC result a factor of retreatment triggers? This is very important, in studies it is standardized, in practice individualize #ASCO12Steven Tucker, MD</div><div>We will forget the past ands repeat all of this with our new toys (MDV and Abiraterone) See concurrent breast cancer/Dickens talk- #ASCO12Steven Tucker, MD</div><div>The longest survival is not always the best outcome - anonymous speaker #ASCO12 #ProstateBrawlSteven Tucker, MD</div><div>Why are prostate cancer trials so often muddled, unclear, and thus controversial? #ASCO12 #ProstateBrawl #dobetterSteven Tucker, MD</div><div>Oh: We are trying to cure metastatic disease. Beer: scoff. This is not how to cure met PC (my comment not Beer) #ASCO12 #ProstateBrawlSteven Tucker, MD</div><div>Taka NY: Underlines what Tannock said, we r not confident it is inferior. Suggest review both Type 1 and 2 errors #ASCO12 #ProstateBrawlSteven Tucker, MD</div><div>Tannock - Intermittent is perfectly acceptable option. Applause follows. #ASCO12 #ProstateBrawlSteven Tucker, MD</div><div>Tannock: This should have been, no significant difference in outcome. The presentation was dangerous. #ASCO12 #ProstateBrawlSteven Tucker, MD</div><div>Not non-inferior is not the same as not not-inferior, right? Or only on Tuesdays? #ASCO12 #ProstateBrawlSteven Tucker, MD</div><div>Is the outcome, the decision to call intermittent inferior being driven by a subset? Probably. #ASCO12 #ProstateBrawlSteven Tucker, MD</div><div>It would be nice if we had audience voting tools. 1. do you think intermittent is better? 2. Are you med onc or uro? #ASCO12 #ProstateBrawlSteven Tucker, MD</div><div>【#ASCO12 101】 Abiraterone inhibits 17α-hydroxylase/C17,20 lyase (CYP17A1) in adrenal gland/testis. It reduces male-related hormone. Naoto T. Ueno 上野直人</div><div>Abiraterone and enzalutamide: the next steps in prostate cancer #ASCO12Martín Lázaro</div><div><b>Stopping early is a very difficult call.  Patients who offer themselves as guinea pigs deserve some empathy.  This issue of early stoppage will always be there as long as there will be clinical trials.  There will never be one-size-fits-all decision.  The key will be how much data is enough.  Continuing with Phase IV trial is the best answer in support of early stoppage and continuing to monitor efficacy and safety.</b></div><div>J&J Prostate Cancer Trial Shouldn’t Have Been Stopped Early. Guest post by @3NT http://www.xconomy.com/national/2012/06/03/jj-prostate-cancer-trial-shouldnt-have-been-stopped-early/ #ASCO12Luke Timmerman</div><div>Cardoso: More research needed in mechanisms of resistance (eg, for AIs) #ASCO12Robert S. Miller, MD</div><div>Certain Men With Prostate Cancer Get Marked Boost in Survival With Continuous Hormonal Therapy http://ow.ly/bkiws #ASCO12OncLive</div><div>@JNCI_Now W.Oh: Q: So why recommend intermittent ADT inferior therapy in non-metastatic prostate cancer? #ASCO2012PDara MD, FACP</div>
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