4.7 • 789 Ratings
🗓️ 21 April 2022
⏱️ 20 minutes
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0:00.0 | Just out today in the New England Journal of Medicine, Ivocydenib and Azoidine and IDI-H-1 mutant AML. |
0:06.1 | This is the paper you've been waiting for. |
0:08.5 | It's the Agile Study, and it's the study that aims to move Ivo-Sidinib into the front line in AML in older, |
0:16.2 | frailer people who cannot tolerate intensive induction therapy. |
0:19.4 | Now, I have not had that much time to read this paper. |
0:22.6 | I've had about an hour to read the paper, get into the supplement, get into some of the history, |
0:25.6 | but I've already found so many things, so many things. |
0:27.6 | This is my prelim read. I've got to get it out there. |
0:29.6 | I have to get it out there because this is really one of the worst papers I've ever seen. |
0:34.6 | You'll already see why. I've got at least six problems in this paper, |
0:37.8 | and you will see why. And I'm going to show you with the series of illustrations. Number one, |
0:42.5 | a little bit of a timeline. Let's run through the timeline. The timeline is key. This randomized |
0:47.0 | control trial of azocidine and ibocidin versus placebo azicidine occurred and started enrolling in March of 2018. |
0:56.7 | That's when the accrual starts. |
0:58.0 | And the accrual was meant to accrue 392 people for a primary endpoint of overall survival |
1:03.8 | and it needed 278 events. |
1:06.0 | And at the time it launched, I think that sounds to me quite good. |
1:09.1 | Proved to me in somebody who's ineligible for |
1:11.2 | intensive chemotherapy up front that if you add Ivo Citadem and IDH1 mutant AML, that you will have |
1:17.2 | a survival benefit over just A's alone, which is the standard of care at the time it started |
1:21.1 | enrolling. They needed 278 events. They were going to wait for 90-some events for the first |
1:26.8 | interim analysis. Then, |
... |
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