Thread by @VPrasadMDMPH

Led by UCLA chief resident @uclaimchiefs Jack Sharp & with my friend @arkhaki our NEW paper is now OUT in @JAMANetworkOpen!! @vkprasadlab

Check it out 👇👇🧵

We analyze second line therapies in trials that seek to replace sunitinib as front line RCC Rx
jamanetwork.com/journals/jaman…

These are the 6 studies we focus on
They will be no surprise to RCC folks

Our question is simple:

Did pts assigned to the control arm get appropriate post protocol care?

I pray the answer is yes!

Here is the key figure 👇👇👇

Let me walk you through it...

The top color is acceptable
Obviously if you are still on TKI front line, that's fine

The bottom bar is also good
Post protocol IO is the standard of care second line treatment

This color is not ideal
Come on, we all know the other post protocol options lack the desirable feature of durability & we have some head to head trials.
Come on... you know it is not ideal...

And this color is very problematic
These trial patients should largely be getting second line therapy

And PLEASE do not reply to me with real world data on subsequent lines, as this is not all comers, but TRIAL pts, it should be higher than RWD

What is the point?

If companies want to move their costly combos to the front line, they should prove that routine front-line administration of the combo is superior to sequencing--

that is literally the Q facing doctors & patients...

BUT...

... it is much easier to show that when you provide inappropriately poor post-protocol care in the control arm... and the easiest way to achieve that is...

recruit in countries where post protocol therapy is beneath the US standard.

It is shocking US FDA accepts this!

This is our take home message

Billions of dollars on the line
Loads of patient toxicity and we still don't have a trial that seeks the honest scientific answer

Read the full paper here:
jamanetwork.com/journals/jaman…
SAD!