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Should stage 1a patients with EFGR mutation take Targrisso (Osimertinib)?


Minh

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Happy Holidays to all,

I am stage 1a2 and had a lobectomy 4 weeks ago at MD Anderson. While there, surgeon did not recommend any additional adjuvant therapy for this stage. However when I got home and saw my local oncologist, he recommended me to take Targrisso (Osimertinib) if my biomarker comes back with EGFR driver mutant. He thinks this drug will help reduce the chance of recurrence or even eliminate it. The biomarker panel has been requested and result will come back in about 3 weeks. From googling, I found that only stage 1b or higher patients are recommended to take this drug and I am stage 1a. Below are the links for this drug which has been approved by FDA for stage 1b and higher and also is in phase 3 clinical trial for stage 1a use.


https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-osimertinib-adjuvant-therapy-non-small-cell-lung-cancer-egfr-mutations

https://clinicaltrials.gov/ct2/show/NCT05120349?term=osimertinib&recrs=ab&cond=Stage+1+lung+cancer&draw=4&rank=1

So my question is SHOULD I take this drug even though it only has been approved for stage 1b>? What are the risks and benefits? Will it reduce my future options? Will it cause future drug resistance? All comments and suggestions are welcome.

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Ask your oncologist if you can take one of the earlier generation drugs like Iressa or Tarceva. By starting a TKI after surgery, they are going for a cure. You could keep Tagrisso in your back pocket for later on. I don't know if those earlier generation drugs have been FDA-approved for your particular stage. 

Tagrisso is exceptionally expensive ($13,000 per month) and is only partly covered by insurance. However, the manufacturer offers financial assistance through its AZandMe program, which your oncologist's office should help you with. 

I do know that people take drugs like Tarceva and Iressa for years and then move to Tagrisso. I suggest you seek a second opinion with an oncologist who specializes in EGFR lung cancer. Some will do virtual consultations. 

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I do not think I would take ANY drug that was not FDA approved for my condition, unless of course I was part of a clinical trail.   To be honest, I'm not sure you will even be able to obtain this drug if you do not be the medical requirements.   This is a rather expensive med and I believe it runs well over $10K a month (even higher).  If you were to take it "off label" and outside of FDA approval you likely would not have insurance coverage either.  

While I realize it's a very commonly used medication for those with EGFR, I've never heard of anyone using it this way and I agree with the others on saving this for a time down the road when you may benefit from it even more.  

And I would absolutely get a second opinion on this too!  Best of luck!

 

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FWIW, I recently heard an oncology physician/researcher speak. He said he would never prescribe a TKI or other cancer drug off-label, and he didn't know any who would. 

I know I was eager to proceed right to the hardest line treatment approach I thought could be taken, but my oncologist said that, with my staging and situation, I was not eligible for those treatments. As I come to understand lung cancer more, I see the wisdom in this. 

Although I have been living with lung cancer for a little less than a year, I am starting to see that I wanted to control the outcomes of the initial treatment. I wonder if you are in a similar place. Perhaps the best course of action right now is the second opinion others have mentioned. 

Are you familiar with the NCCN treatment guidelines for practitioners? It's a great resource. Go to www.nccn.org and create an account. Then look for the NCCN guidelines for NSCLC. 

 

Hang in, 

 

Karen

 

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Thank you all for your inputs and suggestions. I read all your links and will get second opinion. And your inputs are very important to me.

I just received my biomarker today and it indicates “…exon 19 of EGFR gene that is consistent with a 15 base pair in frame deletion.”. I don’t know what this means yet. I can wait and ask my local oncologist in 3 week appointment. But my curiosity is running high and I want to know if this biomarker has any targeted therapy, any approved drugs for it? Could anyone help explain this biomarker. I am hoping that Targrisso (Osimertinib) can be used for this mutation. If it does, will it make sense for me to at least try the clinical trial below for the chance of reduction in recurrence?

https://clinicaltrials.gov/ct2/show/NCT05120349?term=osimertinib&recrs=ab&cond=Stage+1+lung+cancer&draw=4&rank=1

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If what you have is an Exon 19 deletion, then yes it can be treated with Tagrisso. However, at your stage (1a), it's not FDA approved yet, and I suppose that is why Astra Zeneca is running the clinical trial you've referenced. 

Whether to participate in the clinical trial is a matter to discuss with your oncologist. He already has suggested you take Tagrisso, so maybe the clinical trial is what he was thinking of. You have time to consider since you're only a few weeks out from surgery. In fact, you would not want to start Tagrisso too soon in any event to allow for healing.

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