Prescribing Tagrisso Off-label for EGFR+ - 1272649

chidog
Posts:3

Hello friends,

I am seeking advice on behalf of my mother. She has been on Gilotrif for 21 months. This is her first and only line treatment for stage IV NSCLC adenocarcinoma (EGFR+ Exon 19)/never-smoker. Her response initially was very positive but recently, the medication seems to be less effective and the disease has shown progression.

Given her advance age (will be 84 this January), we opted for a liquid biopsy to test for the T790M genetic marker using the GeneStrat test. The test unfortunately came back negative. I realize that only tissue biopsies can conclusively determine the mutation but depending on the site sampled, false-negatives are still possible using this method.

With greater than 50/50 chance of developing drug resistance due to the T790M mutation, it is possible that she is positive but there is not enough circulating tumor to be detected by the current sampling methods. Finding the T790M mutation can be an Easter egg hunt that can leave out candidates that could potentially benefit.

My questions are:

1. Even though the results of the T790M mutation may be negative, the new medication, Tagrisso, still works against the germline EGFR genetic marker. It would not be going too far off label to treat with Tagrisso despite an inclusive result for T790M. What are the possible drawbacks for prescribing for EGFR with the chance that she is T790M+?

2. What steps would be needed to prescribe Tagrisso as second-line treatment for off-label use in treating EGFR+ patients?

Given her condition, traditional chemotherapy would be too overwhelming.

Sincerely, Chi

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Reply # - January 20, 2016, 01:11 PM

catdander
Posts:

Hi Chi,

I'm very sorry about your mother's diagnosis. I know it must be devastating for all. The problem might not come from having an oncologist prescribing as much as it would be having an insurance company pay for it. Since it's a very expensive treatment they are more likely than not going to be set on a standard line of prescribing on this.

It may be possible to get a second blood sample to test just as a second biopsy is often needed. For both types of testing false negatives are common but false positives are not.

It seems you've read quite a bit about egfr mutations. I wonder if you've read what is available on Grace about acquired resistance. The following is a link to videos from a live patient forum held a few months ago and still relevant. A couple of questions are, is your mother's cancer growing in just one or 2 spots or is it several. If in just a couple then stereotactic body radiation therapy may be in order and she can stay on Gilotrif for possibly quite a while longer.
http://cancergrace.org/lung/2015-acquired-resistance-in-lung-cancer-pat…

All best,
Janine

Reply # - January 20, 2016, 09:13 PM

chidog
Posts: 3

Janine,

Thank you for your response. I appreciate the knowledge and expertise that this forum brings to address this awful illness. Unfortunately, this disease hits people of all ages and everyone's experience is different but I find it helpful to hear other people's stories. Maybe the experience I share about my mother can help those in similar situations.

Through this forum and others, I've learned a lot about the course of this disease and the diagnosis and treatments often undertaken by patients much younger than my mother. The difference I see between the testing and treatment regimens pursued comes down to the goals involved. Given my mother's advance age and frailty, my family's decision making process is driven primarily by the goal of maintaining or improving her quality of life followed by the goal of extending time. For younger patients who are able to tolerate more, I think the reverse is usually true.

With these goals in mind, comes the question of off-label use in the last line setting. Often times, especially in cases of cancers, doctors have been able to prescribe off-label treatment and insurance has picked up the tab--which depends on the argument presented. I feel that there is too much uncertainty with the testing for the T790M which could leave out a large population that can benefit from Tagrisso. I'm interested in hearing opinions about the circumstances and conditions it would be considered for off-label prescription as a last line treatment for inconclusive T790M test results.

By seeking off-label use of Tagrisso, it is in keeping with the goals we have for the treatment of my mother's illness. We will continue monitoring her condition through monthly liquid biopsies and chose treatments that pay the greatest dividends and corresponds with our goals. Hopefully, one of these tests will come back positive and this will not be an issue for my family.

Chi

Reply # - January 21, 2016, 10:48 PM

gilbertofarthing
Posts: 6

So sorry to hear about your mother. If there is anything that I can add to the huge support that I am sure you already have. I and my family will pray for your mother. Hoping for good results. Keep us updated.
God bless your mother for her healthy future..

Reply # - January 23, 2016, 11:24 AM

carrigallen
Posts: 194

I see a focus on the off-label promotion, but this thread seems unusually vague about her case:
1. Where in her body is she progressing?
2. Was EGFR exon 19 detected on the GeneStrat, or was no DNA detected?
3. Why can't she get a regular biopsy?

Tagrisso is not holy water. It has side effects. I would be reluctant to use it without a solid justification. Our motto is, "first do no harm".

I suggest sending pleural fluid, or tumor tissue for EGFR. It does not require much tissue to do this test. As Janine points out, SBXRT is a reasonable option for single sites of progression. Chemotherapy or immunotherapy are still proven options for patients who are older age. Hope this helps.

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