Confused first line second line third etc.

dancingdiva

I don't understand the first line second line treatment

If before stage IV I was on tamoxifen was that first line? Now that it wasn't working , graduated to IV and just started Femera this is second line?

Or is this in reference to disease? Now that it is met BC, Femera is the first line?

Having issues with drug approvals

Thanks DD

cive

Hormone reduction treatment is considered a first line treatment which includes Tamoxifen, Femara, Aromasin, and Arimidex. Second line treatment would be a targeted therapy such as Ibrance. Meaning if your response to hormone reduction is insufficient, they may try a targeted therapy in addition to hormone reduction. You were probably switched to Femara which works slightly differently than Tamoxifen because the Tamoxifen was no longer working to reduce your estrogen levels.

JFL

I have always wondered that myself. I don't know if they look at what you took for early stage or not.

What drug are you having trouble getting approved? Is it Ibrance? I don't know about Canada as I know you have universal healthcare but in the US, approval issues are usually with the more expensive drugs (insurance companies then find any reason to deny). The indurance companies never question things such as first line v second line on inexpensive drugs. I had a lot of trouble getting Ibrance approved because it hadn't been specifically approved with one of the drugs I was taking it with when it was prescribed. However, in the US, there are laws about what insurance companies need to cover based on how many credible journal write-ups with clinical trial results, even before express FDA approval. After fighting, I and many others gots it covered on this basis.

The whole first line, second line, third line, etc is simply recommendations (or, in some cases, based on what the clinical trial resulting in approval happened to be was testing for). My doctor put me on Aromasin and Faslodex together upon Stage 4 dx (and added Ibrance to that cocktail once it showed a benefit with Faslodex in clinical trials), even though I have never had Arimidex or Femara. He had reasons as I was a unique case diagnosed while pregnant, with soaring estrogen levels and growth heir mines swirling my body. My point is that these categories are not fixed and drugs can be given a in different order.

Keep pushing to get it aporoved! It is a hassle but you should be covered for your treatments! I know everyone had trouble getting Ibrance approved when it first came out in the US.

LindaE54

Dancingdiva - It is mind boggling. I don't really have an answer for you. Since Ibrance was approved by Health Canada in May, there seems to be different methods of obtaining it, but not always easy. Respective provinces have not approved it yet and do not fund it. It was approved for first line tx for stage IV only. I saw my MO last week who told me Ibrance can be obtained on an exception basis for first line only stage IV. MO's office would make the application to get approval. But if you have personal/employer insurance, that could change the deal. I checked my ex-employer's medical plan yesterday. They listed Ibrance, but my ex-employer will not cover because of the cost. I was told it differs from one ins co to the next and of course from one province to the next. MO said she was confident Ibrance would be approved for second line tx, but it may take a while. Just to confuse you a bit more LOL, my MO is trying to get me on the Palestra trial that Dee/GG27 has been talking about on other threads (protocol is 2 different dosages of Ibrance with a hormone therapy for second line stage IV patients). We may be hitting a hurdle because I was on Tamoxifen for 5 months and Femara since I was dx'd stage IV de novo, and thus can be considered 3rd line. I don't really understand because the literature Dee showed us it is not specific about how many HTs we had. I guess MO is being cautious and doesn't want to waste time if that can be a deal breaker. All this to say, I am so confused! It would be so much simpler if provinces approved it. Hmm, provinces have not even approved Faslodex yet. Although, it doesn't seem to be an issue to get the latter.

GG27

I'm just going to jump in here too. Linda & DD, I was on tamoxifen for 6 years, anastrozole for 2+, I'm still considered first line until Tuesday (fingers crossed) when I will start the Palestra Trial, taking Ibrance/Letrozole.

My new MO says also that if I have too many SE's on Letrozole, I took it before & it was horrible, then I can go back to Tamoxifen or Anastrozole or try one of the others on the list or none at all. This is why I asked about it being part of the trial as Deanna suggested & MO said no, this trial was only looking at the efficacy of Ibrance at different dosages over a 28 day period.

But I have noticed that different MO's have very different ideas about these things, so while our situations may seem similar you may have very different conversations with your insurance companies & MO's. If you are having problems getting Ibrance covered can you talk to your MO about getting in the Palestra trial?

LindaE54

Dee, what I don't understand is if the protocol is only looking at tx since stage IV dx only? Does that make sense?

dancingdiva

I guess that's what I wanted to put into words Linda ....tx since stage IV.

Wow....my mind is on a roller coaster so I bought ice cream sandwiches to feel better😊

I just saw the letter from the insurance company's pharmacy on Friday. So emailed MO but won't hear from him till Monday. This denial is all new. I'm hoping Pfizer lady calls me back and we will try with husbands ins. Or trials. MO mentioned trials BUT I need radiation too he didn't seem to want to go that route first.

This is such bs. ANd I feel like u have to do it all urself. Thank God for these website, I get the most information from here.

D

Bestbird

dancingdiva, indeed the terms can be quite confusing!

For early stage cancer, your Tamoxifen was considered "adjuvant" treatment, which is meant to lessen the risk of recurrence. I am sorry it didn't quite work out for you, as it doesn't work for some. I was on adjuvant Tamoxifen for 5 years and recurred years later with mbc.

Once one is diagnosed with metastasis, the very first treatment given to them irrespective of whether if is hormonal, chemo, and/or targeted is called "first line treatment." If and when that treatment no longer works, the next treatment prescribed is called "second line" treatment. And so on.

Doctors generally will not prescribe a treatment that a patient has already taken unless: 1) it had initially been successful for a satisfactory length of time, and 2) sufficient time - usually several years - have elapsed since the patient took it.

With best wishes.

GG27

Ok, I see now what you're saying.... my understanding is that I can try several different AI's and still be first line, stage iv? But as BB says, each different type of therapy is a another line? Perhaps this is why new MO says we could go back to tamoxifen when I recurred on it. So it would seem that would be why you are having trouble getting Ibrance covered because you started Femera? But that doesn't make sense because you can take Femera with Ibrance.... oh man, I just don't know, sorry.

DD, you do have to be an advocate for yourself I'm afraid. As both Linda & I and many others have discovered, there seems to be too many of us here & our Dr's are overwhelmed. I have brought a number of things up to my Dr's.

pajim

As Bestbird says, once you are diagnosed with mets, first line therapy is whatever your doctor wishes to give you first. Not all doctors agree on what that should be. Some women get tamoxifen, some get letrozole, some get letrozole plus Ibrance, some get Letrozole plus Faslodex.

The reason the term "first-line" matters, at least in the Untied States, has to do with insurance coverage and drug labels. Insurance companies like to start with cheap treatments if they can -- saves money :-) Clinical trials and the FDA (not sure the regulatory agency in Canada) determine what is on the drug label, and whether the drug is approved for "first-line", i.e. first treatment when diagnosed, therapy.

On to Pfizer. They did Paloma 1 and Paloma 2 (Femara +- Ibrance) in women newly diagnosed with MBC, so that they could get Ibrance approved as first-line therapy. In the United States, at least, insurance companies are paying for it in conjunction with Femara. Paloma 3 was the trial with Faslodex so that they could also get Ibrance approved as second line combination therapy. (Faslodex is usually given once letrozole fails)

I'm not knocking the drug, nor Pfizer. Ibrance works. Whether it will show a overall survival advantage is yet to be seen, but it's probable. However, from Pfizer's point of view, the more women who are eligible to take the drug, the happier their shareholders are.

If you've just been diagnosed with mets, even if you've been on tamoxifen, the current standard of care is one of the last three items above. Increasingly it's Femara plus Ibrance, though not everyone agrees. You should have a good appeal to the Canadian healthcare system.

Lynnwood1960

Bestbird, you always seem to have a knack for explaining things in a way that is easy to understand! Thanks

dancingdiva

Even in this thread there r so many diff perspectives. Best bird, the way I explained it I get it. so since I just started Femera with my Pfizer free month of Ibrance yay, this is my first line. I don't understand the denial from my ins.. My ins co must have a diff definition of first line.

Dd

ShetlandPony

I was mulling this over and I had a thought: Maybe the insurance company does not understand that Ibrance is being prescribed to you as first line for metastatic disease. Your record will show that cancer was found in axillary and mammary lymph nodes only. That is more common as a local/regional recurrence (i.e. not metastatic) on the same side as a breast tumor. Yours, however, is on the opposite side, and no tumor was found on the same side as these nodes, so it is considered metastatic. If they didn't read carefully or the doctor didn't explain it well, they might think this is an earlier stage diagnosis and thus not eligible for Ibrance.

Bestbird

Dancingdiva, once you start taking letrozole (generic Femara) with Ibrance, that will be considered your first line treatment.

Many patients in the US are experiencing difficulty obtaining insurance coverage for Ibrance, which is probably due to the fact that there's no generic form of the drug yet available, and it is expensive. Your medical team, a social worker, and/or a patient advocate at your place of care should be able to assist you with obtaining it.

dancingdiva

that makes sense. Thanks ladies.

Tomorrow's Monday...we'll see what happens

LindaE54

Good luck DD!