Ok, pembrolizumab first line for mCRC has taken up too much of my time on twitter, so I won’t be engaging on that debate anymore. I can see why some might think it’s immediately practice changing. The PFS graphs are impressive, yes. But the general principle is that... 1/ thread
We have nothing beyond a presentation for this data. When dexamethasone for COVID-19 results were released despite full protocol and details, we said “where’s the paper?” during a pandemic. How are we now happy not seeing the paper but changing practice? @VPrasadMDMPH
And, we are now claiming - without reading the paper- that this drug cures and not giving this drug means losing lives. Ok, what do you think, “cure” and “lose lives” mean? They mean the effect on OS, right? OS data are not available yet.
If the drug is really wonderful, why are we not confident that this will definitely and quickly improve OS? If it doesn’t improve OS, shouldn’t we reevaluate our appraisal of the drug?
Why is the onus not on the industry to publish the full paper before applying for approval but the onus seems to be on oncologists to use the drug even without a chance to read the paper?
If a meeting presentation was enough for oncologists to change practice, why do we even feign we practice medicine based on critical appraisal of evidence? We simply practice based on what we are told to do.
This thread is not about one particular drug/disease. This is about the culture of medicine and regulatory affairs. We are on a very critical juncture of medicine. https://twitter.com/oncology_bg/status/1298407684161572865
I’ve nothing else to say on this matter, and won’t be responding to tweets about this. To clarify, I’m not against pembro 1L in CRC and I’d hypothesize that it will translate to OS but In God We Trust, All Others Must Bring Data.
You can follow @oncology_bg.
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