Alisertib with Fulvestrant

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Anne45
Anne45 Member Posts: 1,037

Hi all I have just stared this phase II trial of Alisertib with Fulvestrant. I was wondering if anyone else is also on this drug. I am 11 days in and so far so good. Just feeling a little tired. Hope to hear from someone soon. Hugs to all

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Comments

  • Daniel86
    Daniel86 Member Posts: 271
    edited March 2019

    Hey Anne!

    Convos about this drug have popped up here and there but I dont recall there being a thread entirely dedicated to it just yet. I definitely recall someone else on the same drug, so they will probably chime in at some point. Cur-ious is a big fan so I am sure she will make an appearance 😉

    I will start by congratulating you on the almost ten year mark and by asking if you have only been on anti-hormonal so far.

  • ann273
    ann273 Member Posts: 209
    edited March 2019

    Hey Anne,

    I've read about Alisertib on here also and am super interested in it. I believe ann1999 has been on it for a while.

    Good luck and hope you have a run on it!

    Ann


  • Daniel86
    Daniel86 Member Posts: 271
    edited March 2019

    seems like the name Ann(e) is a requisite to enter the study hehe (sorry, stupid humor)

  • Anne45
    Anne45 Member Posts: 1,037
    edited March 2019

    Daniel86 I have been on taxol twice. Once in 2009 when first dx with Mets and again in 2018 to treat a tiny bit of progression in the liver. I have done very well with hormonals.

  • Anne45
    Anne45 Member Posts: 1,037
    edited March 2019

    I love hearing the name Anne (Ann). Going through school I was always the only one with the name

  • ann1999
    ann1999 Member Posts: 104
    edited March 2019

    Hi all! I’ve been on this trial for seven months. Very tolerable drug for me. SE included hair loss, fatigue, neutropenia. Was initially randomized to Alisertib alone but just had progression so added Faslodex. Getting six months or so of stable disease was huge for me as no other treatments worked at all. Mayo Rochester was the only site initially that had the trial from what I know but within the last month or two several other sites opened so thinking they are seeing good results!!

    Best to all

  • Cure-ious
    Cure-ious Member Posts: 2,626
    edited March 2019

    Good to hear you are continuing to do well, Anne, its great that it works as monotherapy but hopefully you get a lot longer with Faslodex added on.

    Below is a link they posted of phase 1 results, a small study with just nine MBC patients, but one went 25 months and another was still in treatment at 31 months!

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC58422...

    PS Alisertib works even better if you get rid of an oncogene called Yap1, and statins can do this, so if you take a statin you may be getting a better than average response to this drug..

  • ann1999
    ann1999 Member Posts: 104
    edited March 2019

    Cure-ious- thanks for sharing the link. Very interesting about the role of statins. Keeping my fingers crossed the dual therapy works.

    Anne45 - Hoping great success for you on the trial. Are you on the 3 days/week for three weeks with the fourth week off pill schedule - with the Fulvestrant shots?

  • Anne45
    Anne45 Member Posts: 1,037
    edited March 2019

    Hi Cure-ious thank you for the information/link. I am not to savy with finding research so I appreciate your help. I am feeling very positive hearing long time results on this drug. I am not on a statin but will definitely ask at my next visit.

    Ann1999 Yes I am on the 3 days a week for 3 weeks and the 4th week off, however just yesterday I have neutropenia so I didn’t get to finish the 3 week on. It was a shock to hear but dr assured me I will be checked next week and should be ok to resume treatment. I was randomly selected to receive the Fulvestrant along with Alisertib. I am currently receiving 50 mg twice a day but due to the neutropenia I amwondering if it would be reduced.

  • ann1999
    ann1999 Member Posts: 104
    edited March 2019

    Hi Anne- the second time I had low neutrophils the dose was decreased to 40mgs. I was told the trial allows for neulasta or neupogen which helps to keep the counts up so you wont be kicked off the trial. I was told can only be low 2x. So it’s almost guaranteed I will get neulasta - unless progression kicks me off first. I have had two shots of the fulvestrant and have noticed more fatigue and nausea but keepin going.

  • Anne45
    Anne45 Member Posts: 1,037
    edited March 2019

    Thank you so much for this information. I was so worried about being kicked off. The nausea came for me the first week and a half but has subsided. The fatigue remains. I am hoping to have the dose reduced. I wonder which is better.....the neulasta. Or the neupogen

  • ann1999
    ann1999 Member Posts: 104
    edited March 2019

    Not sure which one would be better or if one is better than the other. I had neulasta in 2013 and it worked very well with no SE for me however I’ve read on the boards many have had a lot of bone pain but not sure which drug they had. I didn’t get a choice back then.

  • Anne45
    Anne45 Member Posts: 1,037
    edited March 2019

    Ann1999 thank you for the information. I will find out Wednesday when I have my dr appointment and get my blood checked to see if I can resume the treatment.

  • likestobike
    likestobike Member Posts: 16
    edited March 2019

    Hi all, This is my first post.

    I have been reading and following several threads ever since my mom progressed on Ibrance / Faslodex in Feb. She then had a liquid biopsy sent to Foundation One with ESR1 and PIK3ca markers

    I am so thankful for everyone who posts about their experiences and especially the research posts and links from Cure-ious. Based on this research we are looking into 2 trials:

    Alisertib clinicicaltrial: NCT02860000 or Alpelisib: clinical trial NCT03056755

    We are soliciting a 2nd opinion and are hoping to make a decision very soon. Alpelisib seems like it may have more potential SE than Alisertib? Definitely interested in hearing what others would recommend or other's experience.

    thanks!

    Andrea

  • likestobike
    likestobike Member Posts: 16
    edited March 2019

    Hi all, Just posted this on the Alisertib topic, but thought I would crosspost here as well:

    I have been reading and following several threads ever since my mom progressed on Ibrance / Faslodex in Feb. She then had a liquid biopsy sent to Foundation One with ESR1 and PIK3ca markers

    I am so thankful for everyone who posts about their experiences and especially the research posts and links from Cure-ious. Based on this research we are looking into 2 trials:

    Alisertib clinical trial: NCT02860000 or Alpelisib: clinical trial NCT03056755

    We are soliciting a 2nd opinion and are hoping to make a decision very soon. Alpelisib seems like it may have more potential SE than Alisertib? Definitely interested in hearing what others would recommend or other's experience.

    thanks!

    Andrea

  • Anne45
    Anne45 Member Posts: 1,037
    edited March 2019

    Hi Likestobike welcome. Unfortunately I have no experience with Alpelisib but I know I have the PIK3. My white cell count has not come up enough yet to resume treatment but I will be tested again on Monday and will have second biopsy on Tuesday per the trials request. I wish I could help you more with choosing the right treatment for your mom. For me with the exception of the low white blood cells (which my trial nurse said they will reduce my dose).this treatment is very doable.

  • Cure-ious
    Cure-ious Member Posts: 2,626
    edited March 2019

    kattysmith, I keep forgetting to ask you- did the testing they did on your cancer reveal anything about PD1/PDL1 expression or high tumor mutation burden? Anything on there that would indicate that you should respond well to immunotherapy?

    PS Also, do you have the PI3K mutation or amplification? thanks!

  • Bornfighter
    Bornfighter Member Posts: 19
    edited March 2019

    Hello everyone, we(my fiancé) are starting alisertib trial in 10 days time. Hoping for the best.

  • ann273
    ann273 Member Posts: 209
    edited March 2019

    Good luck, Bornfighter! Hope it yields good results and is an easy treatment for y'all!

  • ann1999
    ann1999 Member Posts: 104
    edited March 2019

    Welcome Bornfighter

  • Cure-ious
    Cure-ious Member Posts: 2,626
    edited March 2019

    Great that you got a date, Bornfighter!! You can have a countdown clock now! Hope your wife has an OUTSTANDING response, and would like to hear from others how long (or quickly) Alisertib takes to kick in...

  • Anne45
    Anne45 Member Posts: 1,037
    edited April 2019

    Welcome Bornfighter! I have just started my second month. I did have low white blood cells so I had to skip the last dose but they lowered the dose so I will see how my counts react to this new dose. I wish us great results on this drug.

  • Bornfighter
    Bornfighter Member Posts: 19
    edited April 2019

    Alisertib was not meant to be for us. We passed all the requirements in the pre-screening. On Day 1, we failed total bilirubin requirement and not eligible for the trial. Total bilirubin went up quite a bit within a week. We are going to platinum based therapy due to the urgency. Good luck to those on alisertib.

  • theresa45
    theresa45 Member Posts: 314
    edited April 2019

    Bornfighter, I'm so very sorry that your fiancé is no longer eligible for the Alisertib trial! I was turned down for both of the Alpelisib trials (Solar1 and ByLieve), but may still have access to Alpelsib when it's approved later this year. Hopefully the Alisertib trial will be positive and it will become available outside of trials. In the meantime, I'll be praying that the platinum-based chemo will be very effective against her cancer. She is very fortunate to have you as her advocate! Very best wishes! Theresa

  • Anne45
    Anne45 Member Posts: 1,037
    edited April 2019

    Bornfighter I am so sorry that your fiancé is not eligible for this trial. I was supposed to go on another trial but it was closed so this is how I ended up here. I am praying for all of us that what we are currently on will be very effective and will last a long time. Hugs to everyone

  • M3llon
    M3llon Member Posts: 26
    edited May 2019

    I’m in my first cycle for this trial; getting the alisertib/fluvestrent combo. The first week was rough with a lot of digestion problems and a wee bit of nausea. SE have mellowed quite a bit, but my hair has started falling out. My first blood work was today, not sure about my counts yet. Ibrance/letrozole worked for about a year on me. Hoping thus will have a long run as well. Glad I found this thread. It’s hard to find any practical info about alisertib.

    FYI I went through initial bc treatment in 2012 with taxotere and cytoxin, radiation, lumpectomy. The usual.

  • Cure-ious
    Cure-ious Member Posts: 2,626
    edited May 2019

    Hi M3,

    I didn't realize the hair loss was so fast on this drug! But am interested in what you find, its a very powerful inhibitor of a kinase that is super-common in MBC. Some women were on this drug for 2-3 years right out of the gate in phase 1! Please keep posting, and it would be helpful to know what other treatments you have tried thus far..

  • M3llon
    M3llon Member Posts: 26
    edited June 2019

    Hi Cure-ious. Thanks for the well wishes. I was surprised how quickly it fell out too and that it was so much, but maybe it means it is working. First year of mbc diagnosis I was on iBrance, zoladex, and letrozol. (Sorry about misspelling meds, there’s only so much I can retain.) I never tolerated iBrance. My neutrophils were always low. Ibrance cleared up mets in the lungs and slowed down the liver. Once it stopped working I was on ibrance and faslodex for about three months. That didn’t work at all. Moved my care to MD Anderson and they put me on this phase II trial of alisertib. I was randomized to the arm with faslodex. To qualify for the trial I had to get an oophorectomy. I’ve had a lot of testing done on the liver mets. So far nothing unusual, just very aggressive. My MO is looking at HER3.

  • Cure-ious
    Cure-ious Member Posts: 2,626
    edited June 2019

    M3,

    I hope that means you are getting Alisertib and Faslodex (since Faslodex alone won't do anything)?

    It's interesting they put you on this trial, and I hope it means they are seeing good results- the clinical trials have been really good, however it had just been used in only 10-15 patients the last time they reported.

    What do you know from the biopsy and sequencing? Do the cancer have a PI3K mutation? BRCA1 mutation? Good luck with Alisertib!!

    PS Well, duh, of course you are getting Alisertib- Faslodex won't cause your hair to fall out!! And yes it is definitely working, which is great- different from chemo, it is hitting Aurora K kinase activity, which is a great thing!

  • Cure-ious
    Cure-ious Member Posts: 2,626
    edited June 2019

    M3,

    Aurora A kinase, like a PI3K mutation, turns on the PI3K/mTORC1 pathway. So, if you respond to Alisertib (and Aurora A kinase inhibitor), the cancer likely has high PI3K kinase activity.

    If so, it would help to add in an NSAID. This idea came from a study of head and neck cancers, where they showed that people who have PI3K mutant cancers (therefore high PI3K kinase activity) had a much higher five-year disease-free survival if they took daily NSAIDs (72%) than those who did not (25%). So the recommendation came out that people with cancers of any type that have PI3K mutations or high PI3K activity should be treated with some kind of aspirin/ibuprofen/Celebrex.

    The PI3K mutation causes the cells to increase prostaglandin and inflammation, and the NSAIDs counteract that- plus they help the immune response. The question is how much- would a baby aspirin do it? Or you need the higher levels of Ibuprofen that they use to reduce swelling and inflammation. If it hasn't already come up, its something worth discussing with your onc...









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