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Enasidenib and Cholangiocarcinoma

Researchers
#1

Do any of the partner sites have patients who have Intrahepatic Cholangiocarcinoma (icd10=C22.1, icd9=155.1, Concept IDs 4166154, 4321680, 4208660), had an IDH2 mutation, and were treated with Enasidenib (RXCUI = 1940370)?

Just knowing the counts of patients with Intrahepatic Cholangiocarcinoma, who had an IDH2 mutation, or who had Intrahepatic Cholangiocarcinoma and were treated with Enasidenib would also be highly useful. @hripcsa, @pbiondich, @Patrick_Ryan

#2

Do you have a cohort def in the public Atlas we can copy and paste?

#4

No. Because Enasidenib isn’t in the vocabulary. The IDH2 mutation is a text search. So that’s why posted on forum.

#5

No? Enasidenib has been there since February. Or do you mean IDH2? But that, too, is there.

#6

Hi @nigam:

I created a cohort definition to explore the question you posed, and put it out onto the public ATLAS instance: http://www.ohdsi.org/web/atlas/#/cohortdefinition/1769438

Briefly, I looked for persons with a condition occurrence of ‘intrahepatic cholangiocarcinoma’ (and our standard concepts cover the ICD9/10 codes you mention), a drug exposure of ‘enasidenib’ (which has a standard concept in the vocab at ingredient level and various clinical drug concepts), and a IDH observation (which could include procedure to perform genetic panel or observation of a mutation).

I ran this cohort across my databases to assess feasibility for you. I do see a fair number of ‘intrahepatic cholangiocarcinoma’ cases (ranging from the hundreds to thousands across various databases), but I don’t see any of these patients with exposure to enasidenib.

I created a separate cohort to look at new users of enasidenib: http://www.ohdsi.org/web/atlas/#/cohortdefinition/1769439

there I saw that there are very few number of exposures to this drug in general: <30 persons in all databases that I have access to.

I see this drug was only approved in Aug2017, for the indication of AML. Given the recency of the drug and the off-label use you are looking for, I suppose it makes sense why I don’t see cases. But perhaps others in the community could run these same cohorts to see if they have been lucky in helping than I do.

1 Like
#7

So seems like I need some basic tools training. I was searching ATLAS … and the public version would not even let me search. So I used our Stanford internal instance, and concept search in ATLAS didn’t return Enasidenib. So blame it on user error!

#8

Thanks Patrick. For some reason, I can’t use the public instance anymore. Searching concepts, http://www.ohdsi.org/web/atlas/#/search, works (that’s how I got the concept IDs) … but accessing a cohort gets me “This feature is protected. Please, log in.” So I can’t see cohort: 1769438; and can’t create them either.

In our internal searches, same results as you report. Reasonable number with the condition. None on condition+drug. There are exposures, but mostly for the approved use for AML.

This is for a real patient as you can imagine. So thank you for taking the time!

#9

@nigam:

Almost no cases either, with a total of 120k Cholangiocarcinoma patients in 3 US databases, covering half the country. Only 553 patients who got the drug. Practically all of them have leukemia. I don’t think you have a case for this off-label use.

#10

Thanks for looking into this @Christian_Reich. Well, very soon there might be one case. I was hoping someone, somewhere had tried Enasidenib for a cholangiocarcinoma (esp. one that harbored an IDH2 mutation) and that experience might inform the next case. There is a trial that finished recruiting in 2016. So there have to be cases. We aren’t able to reach them yet!.

#11

@nigam: Oh. That’s a very different question. We have 12 such patients in our Open Claims database (but without the IDH measurement, at least not in the claims). However, we must not re-identify them.

What do you want to do?

#12

Just trying to get a sense of “what happened” when Enasidenib is to treat Cholangiocarcinoma (esp. one with an IDH2 mutation). 12 patients (sans the IDH2) is the max we have heard so far. We don’t need to reach them as in recontact. Just need to see the de-identified summary data to understand if the treatment did any good, was there harm, was there benefit. A descriptive summary of what happened to similar cases is what I am trying to get (to share with the treating physician of the case that triggered this question).

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