Progression: Out of the Paloma3 trial. What next?

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IrishTwin
IrishTwin Member Posts: 50
edited January 2016 in Just Diagnosed With a Recurrence or Metastasis

Hi, I am posting on behalf of my sister who had progressed to Stage IV in Sept 2013. She has been in the Paloma3 trial since April 2014. However, Friday they told us she has an aggressive new lesion in her neck (4cm x 6cm) and she is out of the trial. Her bone mets had disappeared and she was feeling otherwise great so she was really sad and disappointed.

They won't tell us if she got palbociclib or placebo in the trial but she thinks maybe placebo because her counts were always normal. But because she has been in the Paloma3 trial she's not eligible for other palbociclib trials :-(

Has anyone else figured out a way to get palbociclib in Canada outside of a trial? Is it possible to get a prescription in the US and be followed here?

If not, what happens after you've progressed on tamoxifen, arimidex and faslodex? Did you keep doing aromatase inhibitors? My sister's appointment isn't for 3 weeks and she doesn't know what to think.

Any thoughts or shared experiences would be greatly appreciated.

IrishTwin

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  • LindaE54
    LindaE54 Member Posts: 2,054
    edited November 2015

    Irishtwin - So sorry for your sister. We are all anxiously waiting for palbo (Ibrance) to be approved in Canada, but we don't know when. I asked my Onc if is there was any way to get Ibrance other than in clinical trials and she asked me if I could afford it. So I imagine there would probably be a way but the cost is over US$100,000 a year which ruled out that possibility pretty quickly for me. I don't have an MD beside my name so take this with a grain of salt. If she has used up the hormone blockers, I assume she has had Tamoxifen, Arimidex and Faslodex, the next move could be Afinitor + Aromasin. Aromasin is a AI and Afinitor is a targeted therapy. You can do a quick search of the site and find a few threads for this combo. If this combo is ruled out, then Xeloda which is a chemo in pill form can be considered. Another idea is to see if the met can be biopsied to see if pathology is the same but bone biopsies are not always easy or possible and does not always give accurate answers. Wishing your sister the best in her next tx plan.

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  • IrishTwin
    IrishTwin Member Posts: 50
    edited November 2015

    Linda, Thank you so much for your reply. If the doctor asked if you could pay for it, I am hoping that means it is possible for someone to get access before it is approved. I found on-line that an expert panel reviewing Ibrance approval in Canada is supposed to meet in mid-March 2016. I don't know how long it would take after that for it to be approved but too long for us :(

    Thank you for the info about Afinitor and Aromasin. I will read up on it. I saw on your signature that you have been on letrozole, which my sister hasn't. I don't know if the progression on tamoxifen, arimidex and faslodex means that letrozole would not be an option.

    She is having a biopsy soon because the neck tumour is growing so fast they want to check if it is something else. We are not sure what to hope for.

    my beloved sister's Irish Twin

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  • LindaE54
    LindaE54 Member Posts: 2,054
    edited November 2015

    Irish - Thank you for the info on March 2016 - I did not know that. Another problem is once Health Canada approves, then it's up to the provinces to approve. They are not all synchronized in the approval process unfortunately. Letrozole is pretty much the equivalent of Arimidex. If Arimidex failed, letrozole may not be an option. Oncs interchange them mostly because of SEs. A biopsy is an excellent move and will guide the next tx. Wishing you both the best. I'd like to know the outcome - keep me posted if you feel like it.

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  • ShetlandPony
    ShetlandPony Member Posts: 4,924
    edited November 2015

    Irish, aromasin works a bit differently than letrozole and arimidex, even though all three are aromatase inhibitors. So that makes it seem a more likely choice than letrozole (alone) for your sister. Plus that's the one you can add afinitor to. A/A was my onc's choice before Ibrance was approved just in time for me, and she said A/A is what we will turn to if Ibrance + letrozole stop working. (Although I will ask about more chemo first.) Obviously, treatment has to be individualized for your sister, but it sounds like you want to read ahead about what might be suggested. I'm the same way.

    I can't imagine anyone getting Ibrance rather than a placebo and not having lowered blood counts. If your sister got the placebo, that means Ibrance didn't fail her, so it will be a future option when it is approved in your country. In the meantime, thankfully, there are other options.

    Good wishes to you both.

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  • IrishTwin
    IrishTwin Member Posts: 50
    edited November 2015

    Linda and Shetland Pony,

    Thank you so much for your replies!

    Linda: Here is a link to the panCanadian Oncology review timetable. A person in the access office at Pfizer told me this group makes recommendations about which drugs to fund to all provinces except Quebec.

    https://www.cadth.ca/ibrance-advanced-breast-cance...

    The submission only went in November 11 :-(

    Quebec's review group is called INESSS. I couldn't find any record of a submission for Ibrance or palbociclib on the Quebec website.

    https://www.inesss.qc.ca/activites/evaluation-des-...

    Shetland: Thank you so much for sharing your experience with these tx options! I have been reading up on Aromasin and Afinitor vs. Ibrance and letrozole for my sister. My brother offered to pay for the Ibrance if that was the better route (he is awesome and has more $ than us). If it were covered we would do it for sure, but found an Ontario article that said it is $250k first month, 10-15K/month after that (!!) and after reading I still don't know if one option is clearly better than the other. It seems like there is more excitement about Ibrance+AI than Aromasin+Afinitor but I am not sure if it is because it is a brand new class of effective drug or if it's because Ibrance+AI is better than the pre-existing options.

    I know I am going around in circles. My sister's real onc won't be at the Dec 9 meeting, so we are worried that if we don't have a plan on Dec 9, the replacement will delay the decision and it will likely be mid-January or later before my sister gets started on any treatment (her last tx was in October).

    Thank you for putting up with these anxiety-infused posts.

    IrishTwin

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  • LindaE54
    LindaE54 Member Posts: 2,054
    edited November 2015

    Irish - Wow you're awesome! Let's keep our fingers crossed! I know Quebec has an entirely different process for drug approval and unfortunately, we are usually among the last ones. There are so many budget cuts in the medical system and lots of cancer drugs (not only for MBC) don't get approved here. The cost of Ibrance you indicate is totally outrageous! I simply cannot understand why the first month would be so indecently expensive. Last time I saw my Onc in Oct, I mentioned to her that I probably won't live long enough to see Ibrance in Quebec, to which she replied, oh you will. Now the question is what is my life expectancy and nobody knows that. That would be the ideal next tx for me, but there are other options.

    I understand your anxiety and it's a shame that her Onc can't be there, but perhaps another pair of eyes of other opinion will be good. You are wise to do your "homework", that way you will be prepared to ask questions and probably have a better understanding of their next tx plan. Furthermore, the biopsy will give answers. I suppose they will have the pathology on 9 Dec? Will you or somebody accompany her to the appt? Always better to have another pair of ears for important appts like that. Don't worry about your anxiety-infused posts, we've been there and this is one of the best places to share and gain knowledge and support. You and your sister are in my thoughts and prayers.

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  • ShetlandPony
    ShetlandPony Member Posts: 4,924
    edited November 2015

    Good question, Irish. I don't know how A/A compares to Ibrance/Letrozole as far as effectiveness, and they can't yet have done any trial comparing them directly. In both cases they are adding something to enhance the effectiveness of the aromatase inhibitor alone. It is possible the main difference is in the side effect profile. It seems there is the idea that Ibrance is easier, but I think it really can vary from one person to another. I remember my onc saying two things about afinitor. She said it seemed like you either got the side effects or you didn't (rather than degrees), and that there was choice in the dose so she would put me on the lower dose since I seemed to react to things. So hopefully your sister could be one of the people without bad side effects, if A/A is the recommended treatment.

    I actually started aromasin right after chemo, and in those few weeks I developed depression, so that played into my onc's decision to go with letrozole plus Ibrance instead. (I really don't know how much aromasin was at fault for the depression, and how much it was the post-crisis realization that I would be on treatment forever, along with some other sad and mad situations I was dealing with. I switched drugs, fixed those situations, and found support with a therapist, BCO, and an in-person group. I'm doing well now.)

    I totally get wanting to make sure your sister has the best. With stage iv not even the oncs always know what will be best for a particular person, and there is trial and error involved. (Awful, isn't it?) Consider that the stress of trying to pay for Ibrance may be a quality-of-life issue for your sister, and it is not the only option.

    I see no reason why the onc you see on December 9 couldn't start your sister on something, depending on the biopsy results. Will they give you a copy of the report to study before the appointment?

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  • carpe_diem
    carpe_diem Member Posts: 1,256
    edited November 2015

    I've been on Arimadex (45 months), Faslodex (4 months - progression at first scan), and now on Xeloda for 8 months. It seems to be keeping the cancer under control - my tumor markers are in the normal range for the first time since all this started - but the side effects are a nuisance. I've already discussed the next treatment with my onc, either Ibrance or Afinitor with letrozole. She favors Ibrance because the side effects are generally easier, but I'd like to try Afinitor first. My husband's company was bought by Novartis shortly before he retires and I get their drugs free. Mostly I'm hoping to continue on Xeloda and get the Hand Foot Syndrome under control. If you check the Xeloda thread you'll see that some women have been on it for three or four years! It's chemotherapy, but in pill form. I don't know if this is an option for your sister, but it's worth looking into.

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  • IrishTwin
    IrishTwin Member Posts: 50
    edited December 2015

    Linda, Shetland and Carpe,

    Sorry I dropped off the map. My uncle died of cancer the week after I started this thread, and then we were absorbed in trying to get treatment for my sister. Linda, Shetland and Carpe, thank you all so much for your advice. We used it in our meeting with the oncologist.

    The biopsy came back same as the original. The substitute onc realized we wanted some action right away, and started her on radiation for the rapidly growing tumour which is pressing on her nerves. She also submitted the application for Special Access to Ibrance (I hope; she read us the application on Friday but I don't know when it went in). However, she also read us emails from high-ups at Pfizer (i.e. above the person I had been dealing with in the Special Access office) who said special access from their point of view was reserved for people who had failed five treatment lines already (this must mean -- in addition to tamoxifen, anastrozole and fulvestrant -- Afinitor&Aromasin, and Xeloda). I said they might be saying that because they don't want to pay, but the doctor insisted they don't care about money (!), and did not put that we would pay into the email :-( We have not heard back from Health Canada yet, but even if they said yes, Pfizer can say no. In the meantime, the onc started my sister on letrozole in the hopes we might get palbociclib to go with it. If that doesn't work out, she will continue on letrozole to see if it helps, and if there is evidence of progression will switch to Afinitor&Aromasin.

    Linda, thank you for your compliment! Regarding the cost of Ibrance, the price I quoted was from a Toronto Sun article, but when I went back to reread it, I realized the price wasn't all for the drug:

    http://www.torontosun.com/2015/08/23/cancer-patien...

    The $250K start-up cost is probably for the medical work up or hospitalization or something in addition to the drug because she was trying to get treated in the US. The price of the drug in the U.S., according to a pharmacy report, is ~$10K U.S./month wholesale ($15K Canadian, but I don't know what it would retail at…)

    http://www.prnewswire.com/news-releases/prime-find…

    Shetland, thank you for the additional info about AA vs. Let/palbo. What you said was also what the doctor seemed to say, regarding balancing side effects. She was more reserved about let/palbo in my sister's case, saying that she was worried about the expense given that so far that combination had only been studied in first line and my sister is fourth line, so she was afraid it might be a lot of money and stress for naught. However, she said it is less intrusive than AA, and if we really wanted to do it and could get it, it could be worth trying, because we we would still have AA to go to, and except for the fast growing tumour which is being radiated, my sister's lesions are in bone and have been fairly stable, so we have time to see what works.

    Carpe Diem, thank you for the info about Xeloda. I will look up Hand and Foot syndrome. My sister is afraid of getting to chemo again, but the doctor told her Xeloda would be less intense. It is really encouraging to hear you can be on it a long time! (We don't know what to think about time anymore. I guess it doesn't matter what we think anyway. My sister was diagnosed in 2008 and in many ways is doing great. My uncle was diagnosed on Sept 28th of this year :-(

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  • LindaE54
    LindaE54 Member Posts: 2,054
    edited December 2015

    Irish, first let me offer you my deepest condolences for the loss of your uncle.

    Sounds like you have an excellent plan in place with rads and Letrozole. Having only one new met which is being radiated and trying Letrozole would have been my preferred option. I hope you get approval for Ibrance from Health Canada and Pfizer for later use if necessary. That would be awesome.

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  • IrishTwin
    IrishTwin Member Posts: 50
    edited December 2015

    Thank you Linda!

    Just to let you know what happened with Ibrance, Health Canada contacted our oncologist saying they would not review the application without a letter from Pfizer agreeing to provide the drug, and Pfizer wouldn't provide it, saying they would only do it if you had already failed five lines of treatment. This was disappointing, given that the Special Access office at Pfizer had said the important thing was that your medical oncologist thought it was the right choice. Also frustrating because the rejection email was couched in conciliatory double-speak (e.g. No we will not provide the medication but we will continue to "reach out" to your institution. ???) We have an appt at Dana Farber in January to see if it may be possible to get it through a doctor we have seen there.

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  • LindaE54
    LindaE54 Member Posts: 2,054
    edited December 2015

    Irish - how disappointing but not very surprised. I hope Dana Farber will provide it. Happy Holidays to you and stay in touch!

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  • ShetlandPony
    ShetlandPony Member Posts: 4,924
    edited January 2016

    Irish, my condolences on the loss of your uncle. I'm sorry to hear Ibrance wasn't approved. Really frustrating! I hope DF can help. But it's good your sister has started on something. I think your sister is lucky to have you help navigate.

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