Could This Breast Cancer Vaccine Be a Game Changer?

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  • leggo
    leggo Member Posts: 3,293
    edited August 2013

    This article is confusing me. It states the vaccine is for Her2 negative, but then goes on to say it could be used in conjunction with Herceptin for Her2 positive women. I'm obviously reading this wrong. Gonna check into it a little more.

  • cp418
    cp418 Member Posts: 7,079
    edited August 2013

    leggo - it sounds like they are running multiple trials for both patient populations as Her2 negative and Her2 positive.  The Her2 Positive group would receive this vaccine in conjuction with Herceptin treatments.  Sounds like a booster.

  • toomuch
    toomuch Member Posts: 901
    edited August 2013

    cp- As always, thanks for posting. I tried to get into this trial early on but was too far out from treatment. The initial results seem really promising!

  • mary625
    mary625 Member Posts: 1,056
    edited August 2013

    Does anyone know how much longer the Stage III trial is expected to last?

  • cp418
    cp418 Member Posts: 7,079
    edited August 2013

    Mary625 - check this vaccine site.  Maybe there is a number you could call or contact information.

    http://www.neuvax.com/

  • Colt45
    Colt45 Member Posts: 771
    edited September 2013

    My wife had the FISH test for Her2 and the pathogy report said she had a 1.4 to 1 ratio and that Her2 was not amplified---and that she was "Her2 negative".



    I keep seeing the IHC test results (+2, +1) for Her2 used to determine candidacy for the trial------ but we don't have an IHC score. We have a FISH score. How does one translate a FISH score of 1.4 to an IHC score? Would my wife be IHC +1 or 0? Anybody?

  • SpecialK
    SpecialK Member Posts: 16,486
    edited September 2013

    colt - FISH and IHC are two different tests, you can't convert one into the other - here is some info on the difference (2nd link). If your FISH is equivocal they usually move on to do the IHC because the method is different.  If your wife tested negative, or unequivocal, on FISH there would be no reason to do the IHC.  I looked at the trial enrollment criteria for Neuvax and it states a FISH of less than 2.2.  I linked the page for you:

    http://www.neuvax.com/about-the-trial/

    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2706184/

    leggo - I am in the vaccine trial linked below.  It is for Her2+, but they just started enrolling lower expressing Her2 (essentially Her2- patients) into one of the arms - the AE37 arm, which are sorted by histological tissue types (like for transplants).  They have found that this particular vaccine, which was developed for recurrence prevention for Her2+, also helps low-expressing Her2-.  I think there is a lot that is not well understood about treatment for Her2, partly because of the non-homogeneity of tumors, and Her2 response to treatment.

    http://clinicaltrials.gov/show/NCT00524277

  • Colt45
    Colt45 Member Posts: 771
    edited September 2013

    SpecialK:


    "We are currently enrolling breast cancer patients for the NeuVax™ Phase 3 PRESENT (Prevention of Recurrence in Early-Stage Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax™ Treatment) study, an investigational drug trial to evaluate the effectiveness of the NeuVax™ (nelipepimut-S) vaccine to prevent or delay breast cancer recurrence after standard of care treatment (chemotherapy, hormone therapy, radiation therapy)."


    It looks like one would have to be finished with Tamoxifen before doing this drug. Am I reading it right?

  • Colt45
    Colt45 Member Posts: 771
    edited September 2013

    "NeuVax targets approximately 50-60% of HER2-positive patients (IHC 1+/2+ or FISH


    This part confuses me.



    The claim here says the drug is for HER2 POSITIVE patients with FISH < 2.2.



    But many patients with FISH < 2.2 are actually HER2 NEGATIVE, as anything < FISH 1.8 is HER2 NEGATIVE.



    Are they just unclearly saying they want those with FISH 1.8 to FISH 2.19999999999999?



    Does a person with FISH 1.4 qualify? On 1 hand it's < FISH 2.2, but on the other hand, it's NOT HER2 positive.



    What am I missing?

  • SpecialK
    SpecialK Member Posts: 16,486
    edited September 2013

    colt - I believe that are targeting patients who are "clinically" Her2- because they don't express Her2 positivity strongly enough to receive Herceptin, but still express Her2 amplification strongly enough to register on the test, as your wife does.  Think of it in terms of 1.4 being more "positive" than zero.  I believe that you can be on hormonal therapy and enroll in the trial, but it seems as if you need to enroll 30 days after active treatment of chemo or rads.  For the trial I am in, which is a similar type of vaccine, I can be on hormonal therapy and the enrollment window was 6 months from active treatment.  Here is a link discussing both this Neuvax trial and the AE37/GP2 peptide trial I am in ((I am in the GP2 arm since I am A2+ histologically).  If the enrollment cutoff for Neuvax is indeed 30 days from active treatment you would have missed that window, but might fall into the AE37 window of 6 months in the other trial. Your wife would have to be histologically negative to enroll in the AE37 arm as it is the only one being offered to low expressing HEr2 patients, and of course, in any trial you run the risk of being in the control group and not receiving the vaccine.  The AE37/GP2 trial is offered at a limited number of locations - see the link in my post above to check out where.

    http://www2.mdanderson.org/depts/oncolog/articles/13/1-jan/1-13-1.html

  • Colt45
    Colt45 Member Posts: 771
    edited September 2013

    SpecialK, thanks for your explanation.


    Edited to remove my griping about all this crap.



  • SpecialK
    SpecialK Member Posts: 16,486
    edited September 2013
  • Colt45
    Colt45 Member Posts: 771
    edited September 2013

    I was looking at different sites and articles trying to find info on FISH ratios of 1.4 and came across an explanation that makes sense to me.



    SpecialK, you may likely be already aware of this, but I will share in case it helps anyone else understand FISH ratios better.



    The HER2 gene/ chromosome 17 ratio should be 1.0 to 1 in a normal NON-DIVIDING cell.



    With FISH testing, they supposedly look at 60 cells on a slide and come up with an average number of HER2 genes/ chromosome 17.



    In normal cell division, the ratio can go up to 2.0 to 1 in certain stages.



    This could account for why a ratio could be 1.4 to 1------and still be deemed 'non amplified'.... because the 1.4 is within the range of the normal cell division process.



    This point had been escaping me and I was struggling to understand how 1.4 could still be 'normal', as I thought it HAD to be 1.0 to 1.



    Darned normal cell division at the point of tissue preparation!



    Kind of like catching people with their eyes closed during a group photo. They were just blinking right at the time you took the shot----and were not necessarily sleeping, dead or unconscious.



    Scoring problems can occur when the HER2 gene/ chromosome 17 ratios are in the 1.8 to 2.2 range, as the ratio couldn't be above 2.0 and still be explained away as 'normal cell division'. (I guess 1.8 is where it starts to get 'too close' to just attribute to normal cell division----but I'm just guessing).



    Anyway, the neuvax vaccine MAY benefit some people with a FISH ratio of 1.4----and I guess an arm of that trial is trying to shed further light on this... BUT I think I'm through with thinking there HAS TO BE something amiss because my wife's FISH ratio wasn't exactly 1.0 to 1. A study I read about had a sample of patients with non-amplification whose FISH ratios ranged from 1.05 (to one) up to something like 1.7 (to one). In other words, NOBODY had precisely 1.0 to 1... because EVERYBODY had normal cell division going on at the point of tissue preparation.



    One of the links that SpecialK shared surprised me with how relatively FEW initial tests for HER2 are done by FISH. Those links were very informative, SpecialK!



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