Gene Mutation Test

Some people on here have not had the gene mutation test and are or have been on Tarceva. Is the gene mutation mandatory only by the insurance companies to approve it for first or second line? I thought .. Tarceva was approved now for a first line treatment. My mothers Oncologist is still saying second line. Or the insurance won't pay. But.. I read first line now.

If you refuse gene mutation test.. does that mean they won't put the patient on Tarceva?

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The FDA approval of Tarceva does not require the patient have any mutation of lung cancer. (In contrast, Xalkori requires the ALK mutation, and trials of it for other mutations require those specific mutations.)

Some patients who do not have the EGFR mutation do get some benefit from Tarceva (not as strong or as long, though).

Studies have started to show that in late-stage (e.g., inoperable) lung cancer, there is a benefit to using EGFR inhibitors like Tarceva as a first line treatment instead of as a 2nd line treatment, so doctors are beginning to adopt that approach. I don't know in what way it was better, but my oncologist mentioned there have been 5 studies on it.

Maybe some insurance companies are slow to catch up with the latest research?

Keep in mind that inhibitor drugs (they're actually called tyrosine kinase inhibitors, TKI's) inhibit cancer, so they aren't thought of as a way to try to cure cancer. They manage it, they can kill some of it (sometimes all the way to NED -- no evidence of disease visible), but surgery and chemo may have a better chance of cure. So for early stage lung cancer that has some chance of cure, something like Tarceva might not be the best option to try first (... unless maybe it can be used to scale back the disease before whacking it with surgery and chemo????).

Best hopes

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In January of 2008, I had a PET scan while being sick with bronchitis. My Oncologist said my cancer was back in 4 different places and he was putting me on Tarceva.

At that time, I asked him if they sent a piece of the biopsy for testing to see if I was EGFR positive. My oncologist said, No, we don't do that here. If you break out, then you have the mutation.

Something in my gut told me that my cancer did not come back. After spending 2 years and 4 months on this Very difficult medicine, I finally got fed up with my Oncologist and decided to go to another Oncologist. (The full story is in my profile if you would like to read it.)

The New oncologist said that he would send a piece of my biopsy and send it off for testing. Three weeks later, the results were back. I did not have any of the mutations that Tarceva would help. My New Onc said "stop taking it" you were sick and the Pet scan showed the congestion and you simply got better. Your cancer did not come back.

The reason I am mentioning this is that Tarceva is a very difficult medicine to take. There are more side effects to it than I had with Chemo. In fact, Chemo was a breeze compared to Tarceva.

I have been off of Tarceva since May of 2010, and my last CT scan was in August, 2011. I am perfectly fine. If you ever run into an obnoxious that tells you it's his way or the highway, take the high way.

If your mom is weak or small, please reconsider pushing for Tarceva unless she is proven to have the mutation. It will sometimes help people without the mutation, but it is a very low percentage.

Wishing you and your mom the best possible outcome.
Marylou ♥

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Pat-M on the board, is a perfect example that Tarceva can work for first-line therapy. She had stage IV NSCLC and had a tumor specimen assay-tested. Her report out confirmed that Tarceva was "sensitive" to her cancer cells.

She was in the Functional profiling in stage IV NSCLC: A phase II trial of individualized therapy at Rational Therapeutics/Malcolm Todd Cancer Institute (Long Beach, CA).

Make a Friendship Request to Pat. She is great at transforming medical geek that she personally learned into layman's terms. She had her Cigna insurance cover the entire $3500 for the test.


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My oncologist put me on tarceva as a 1st line in 3/08 - not yet recommended for 1st line and before widespread EGFR testing. His reasoning was quality of life; I was stage iv, inoperable but asymptomatic and still working full etc, I responded for about 8mos without progression. no doubt some insurance companies wuold now hold out for a positive EGFR but there is enough evidence that patients respond even if egfr negative so we should always appeal such a decision. So far I have not heard of any insurance company refusing to pay for Tarceva based on EGFR result...based on cost yes. And now we have the issue of Avastin and metastatic breast cancer with a number of women who have achieved stability and/or improved quality of life but because the FDA has withdrawn approval, insurance companies are now refusing to pay for it. Consideration for quality of life is regretfully not included in FDA decisions. You have my very best wishes for a great response to whatever treatment you proceed with.

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Let me try to summarize the debate.

1. Response Rates for Mutation Positive and Negative

Tarceva is an unusually effective drug for EGFR positive patients, those with the mutation. A number of studies have shown a response rate of about 60%, more than double that of standard chemotherapy. In contast, response rates for EGFR negative patients are no more than about 10%, less than conventional chemotherapy.

The approvals for Tarceva and Iressa occurred before the differentiation between EGFR positive and negative was known. The approval was conservative, recommending that the drug for third-line treatments after other treatments were no longer effective. Today, as an indication of success, Tarceva is increasingly used as first-line treatment for EGFR positive patients.

2. Use of Tarceva for EGFR Negative Patients

Should Tarceva be used for EGFR negative patients; there are not clear answers and one can just outline the debate. Some European government health plans no longer pay for Tarceva for EGFR negative patients. Others argue that while the drug is not as good for negative as positive patients, it still has its benefits. They argue that response rate may be an inaccurate criterion. Disease stabilization and symptom relief are fair markers, and note that many who have used say the drug has relieved symptoms or stabilizated the disease. Opponents says such soft data can be manipulated, at least misinterpreted, and that anecedotal reports cannot form the basis for medical use.

Finally, at least one study identified a subgroup of EGFR negative patients with a particular mutation profile who did have a higher response rate. At the least, the drug should be permitted for this group, and supporters suggest there are likely to be others.

Skepticism and suspicion provides few answers for who should we be skeptical about. Tarceva supporters suggest that governments and insurers have made a sad and callous decision to deny a drug to those who need it to save money. Skeptics of drug manufacturers suggest that the drug companies cast their net out wide, and even once they knew of the studies showing little impact upon the large EGFR negative population, continued to market the drug to all instead of those who would really benefit, because sales to 100,000 patients are better than 10,000 (only about 10% of patients are EGFR positive). While alternatives are limited, giving patients an expensive drug which provides little real help and is not as effective as alternatives helps no one.

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Very interesting. Do you recall the genetic subgroup that was identified in that study of EGFR-negative responders to Tarceva?

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My problem-My onc sent my sample from Oct 2006 in Aug 2010.
6 months later I received a bill for $2047.00. My insurance did not cover the cost. After 2 appeals I was able to put about $1200.00 on my suppliment insurance. My onc did tell me after I asked repeatedly for help, that he learned his lesson.
I finally reached a woman in the same office who contacted the lab and I received a refund for the balance from the lab last month.
I'm negative and am on no cancer meds. Doing well.
You should call and find out if the test is covered.

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The FDA approved indication for Tarceva does not limit prescribing specifically to EGFR positive patients. In the registration trial only one third of the patients were tested for EGFR and determining response based on EGFR was not a major end point of the study. You're right, response rate may be an inaccurate criterion. Disease stablization are fairer markers for targeted drugs.

Regardless of whether you are EGFR positive or negative, your individual cancer cells may be "resistant" or "sensitive" to Tarceva. Just because a patient tested EGFR positive, it doesn't mean Tarceva "will" work for the "individual" cancer cells. Tumor cells have such an uniqueness that not much is known of their respective reaction to targeted therapies.

Rather than only give Tarceva to all patients with EGFR+ NSCLC, it could be given selectively to patients with all types of cancer, if it otherwise indicated and if a functional assay is positive for it. It could be vastly more beneficial to measure the net effect of all processes (systems) instead of just individual molecular targets.


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Negative for EGFR? What about ALK (and maybe ROS1, if current research supports it)? Xalkori is available for those either by Rx (or a trial if you have the right mutation). Or does your doctor assume you have KRAS instead (it's common in smokers, but not all smokers have that)?

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