Definition of locally advanced in the indication for IBRANCE?

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Chang1
Chang1 Member Posts: 5
edited July 2018 in Stage III Breast Cancer

Hi,

I was classified when diagnostic as locally advanced breast cancer.

In surgery after neoadjuvant chemotherapy (AC-T) , I had 2 lymph nodes affected with Extracapsular Extension and skin involvement.

I was a candidate for the Pallas trial but I was randomized to the Standard adjuvant endocrine therapy.

I would like to take IBRANCE.

I looked at the indication for IBRANCE (Palbociclib) in "EMA" and in "NICE" "Technology appraisal guidance" and as far as I understand it is indicated for locally advance breast cancer. (Please look at the attached quotes and links below)

My questions:

1. Is IBRANCE indicated for locally advanced breast cancer based on the indication from NICE or EMA?

2. What is the definition of locally advanced in the indication for IBRANCE in NICE or EMA?

3. Is the indication for IBRANCE from NICE and EMA, also valid for locally advanced breast cancer that is amenable to resection or radiation therapy with curative intent?

4. Are you aware of specific countries in the world or other recommendation that will indicate IBRANCE for locally advanced breast cancer that is amenable to resection or radiation therapy with curative intent?


The "Marketing authorisation" from NICE website (Technology appraisal guidance [TA495]):

Palbociclib is indicated for treating 'hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative "locally advanced" or metastatic breast cancer:

in combination with an aromatase inhibitor"

The "Therapeutic indications" from EMA :

"Therapeutic indications

IBRANCE is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative "locally advanced" or metastatic breast cancer:

• - in combination with an aromatase inhibitor;"

Thank you.

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  • buttonsmachine
    buttonsmachine Member Posts: 930
    edited July 2018

    Hopefully more people will chime in soon. I also have locally advanced disease with skin involvement, so I can only offer my experience on this, but here it goes:

    It's good that you did AC+T chemo. What kind of surgery did you have? I had a mastectomy, but then got "upgraded" to a chest wall resection with a skin graft. A lot depends on whether your cancer is still resectable. It's true that Ibrance can be indicated for locally advanced disease, but there are other treatment options to consider besides just Ibrance. Will you have radiation? What about Xeloda for residual disease? In my case, my MO said we would consider adding Ibrance to ovarian suppression and an AI, but only AFTER finishing radiation and Xeloda.

    Of course everyone has a unique situation, and I only raise these other treatment possibilities because you may want to get a second opinion from a major cancer hospital, if you haven't already. I learned the hard way that skin involvement is dangerous and difficult to treat, and not all doctors/facilities are able to deal with it adequately. A second opinion will help you know that you are proceeding in the best possible way for your situation, and that you are not missing out on any life-saving treatments! I hope that helps, please keep us posted.

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  • Chang1
    Chang1 Member Posts: 5
    edited July 2018

    Hi buttonsmachine,

    I had a mastectomy and ALND.

    I had radiation to the chest wall supra and IM.


    I also asked MO about Xeloda for residual disease, MO said to me that they don't give Xeloda and hormonal therapy in the same time.

    MO suggested that I will start hormonal therapy.

    Did you take Xeloda and hormonal therapy in the same time?


    Thank you for bringing up these other treatment possibilities, it is very important to share data and I think I will ask again MO about adding Xeloda.

    I saw another Oncologist for a second opinion.


    I think Ibrance is indicated in the UK for locally advance amenable to surgery, I am not sure.(As I wrote in the original post)

    Do you know if it is indicated for locally advance amenable to surgery in somewhere else in the world?


    Thank you very much for your help.

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  • buttonsmachine
    buttonsmachine Member Posts: 930
    edited July 2018

    You are correct that they don't do hormone therapy and Xeloda (or chemo in general) at the same time. My understanding is that because chemo only kills rapidly dividing cells, and the hormone medicine will make the cancer cells less active, taking both simultaneously would be counterproductive. I will start hormone therapy after finishing approximately 6 months of Xeloda, although I know some people take Xeloda for longer.

    As for Ibrance and locally advanced disease that is amenable to surgery, I am not sure of the specific guidelines. To be honest, locally advanced breast cancer seems like a frontier area in oncology. That is why I always advocate for people like us to get opinions from top cancer centers; we are in complicated situations and there is no room for error.

    My MO said that she would "consider" me for Ibrance after I finish Xeloda. If I were to do Ibrance, it would be for approximately one year, and taken with ovarian suppression and an AI. So there are two rough scenarios:

    1. Chemo - surgery - radiation - Xeloda - OS+AI for 5+ years

    2. Chemo - surgery - radiation - Xeloda - OS+AI for 5+ years, with Ibrance for 1 year.

    As for me, I'm not sure whether I even want Ibrance after Xeloda, but I will cross that bridge after Xeloda. :-) A lot could change between now and then, and I trust my MO's judgement on this one.

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  • buttonsmachine
    buttonsmachine Member Posts: 930
    edited July 2018

    PS - my cancer did not respond much to TC or AC chemo, and that might be why I'm doing Xeloda too. If your cancer responded well to ACT, maybe Xeloda isn't necessary for you, but I'm just speculating. Hope that helps and please keep us posted!

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  • Chang1
    Chang1 Member Posts: 5
    edited July 2018

    My cancer also didn't respond to much to AC-T.

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