💡A few thoughts about the recently published PROfound trial “Olaparib for Metastatic Castration-Resistant Prostate Cancer” @ NEJM.
I decided to give a shot at critical lecture.
The first thing that draw my attention was the inclusion criteria.
#UroSoMe @VPrasadMDMPH
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I decided to give a shot at critical lecture.
The first thing that draw my attention was the inclusion criteria.
#UroSoMe @VPrasadMDMPH
1/8
"men with confirmed M1 castration-resistant prostate cancer (CRPC) whose disease had progressed during treatment with enza or abi, administered for M1 or M0 CRPC or M1 hormone-sensitive prostate cancer. Previous taxane chemotherapy was allowed.”
Now look at control arm 👀
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Now look at control arm 👀
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So.. to be included u had to progress to the control arm, that way, chances of doing well, correct me if I’m wrong but are pretty low.
One may argue that you can give it either way, but to the best of my knowledge this is NOT standard of care.
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One may argue that you can give it either way, but to the best of my knowledge this is NOT standard of care.
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Others may say, Hey previous taxane was allowed! so it's not that far from SoC.
Well, only about 20% in each arm had received both docetaxel and cabazitaxel & about 40% in each arm had received none of them!
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Well, only about 20% in each arm had received both docetaxel and cabazitaxel & about 40% in each arm had received none of them!
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And that's not all, look at this beauty.
About 20% in each arm had ALREADY RECEIVED BOTH, abi AND enza. So these patients received a treatment they already progressed to… (is this ethical?)...
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About 20% in each arm had ALREADY RECEIVED BOTH, abi AND enza. So these patients received a treatment they already progressed to… (is this ethical?)...
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Everyone's talking about the overall survival benefit, so how much benefit (in the interim analysis, as a secondary end-point) they found? median of 3.4months
Considering aprox. 1/5 patients had to discontinue the treatment due to adverse events…(yes data may be immature)
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Considering aprox. 1/5 patients had to discontinue the treatment due to adverse events…(yes data may be immature)
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And what about the crossover? Was crossover desired in this study (spoiler: NO)
In the supplement you can find this nice table about treament after progression, were pts in control arm mostly got olaparib while those in olaparib arm got mostly, well, the standard of care.
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In the supplement you can find this nice table about treament after progression, were pts in control arm mostly got olaparib while those in olaparib arm got mostly, well, the standard of care.
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So... are the OS benefits due to olaparib or due to olaparib arm receiving better subsequent therapies after progression and a control arm receiving a "not good enough" treatment?
I don't really know…
What are your thoughts about this trial?
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I don't really know…
What are your thoughts about this trial?
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