a new study - In HER2 positive breast cancer...

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nixie
nixie Member Posts: 35
a new study - In HER2 positive breast cancer...

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  • nixie
    nixie Member Posts: 35
    edited September 2014

    hi everyone. wife has er+ pr+ her2- breast cancer therefore my knowledge of her2+ is pitiful but im your man if you have er+ bc :). i have a blog where there are hundreds of links to studies re er+ pr+ her2- bc. a few days ago a regular poster posted the following. looks really good. just wanted to share this with all of you. dont know if this was posted before.

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    In HER2 positive breast cancer, novel immunotherapy vaccine decreases recurrence

    A new breast cancer vaccine candidate, (GP2), provides further evidence of the potential of immunotherapy in preventing disease recurrence. This is especially the case for high-risk patients when it is combined with a powerful immunotherapy drug. These findings were presented by The University of Texas MD Anderson Cancer Center at the 2014 American Society of Clinical Oncology's Breast Cancer Symposium in San Francisco.

    One of only a few vaccines of its kind in development, GP2 has been shown to be safe and effective for breast cancer patients, reducing recurrence rates by 57%. Further, women with the highest overexpression of HER2 (known as HER2 +3) had no cancer recurrences when they were administered the vaccine after completing trastuzumab (Herceptin), a type of immunotherapy drug known as a monoclonal antibody. HER2 is an oncoprotein that promotes tumor growth and is expressed to some extent in 75-80% of breast cancers.

    "This is an important and different avenue in immunotherapy research, in that we are investigating ways to prevent cancer recurrence by stimulating the immune system to treat cancer," says principal investigator Elizabeth Mittendorf, M.D., Ph.D., associate professor of Surgical Oncology. "The ultimate goal is to develop a preventative tool that will minimize the risk of recurrence in women who have already had breast cancer and for whom standard therapies have failed."

    The findings are the result of a phase II randomized trial that paired the GP2 vaccine, designed to stimulate the CD8+ cells, commonly known as "killer" or "toxic" T cells, with an immune stimulant known as granulocyte/macrophage colony stimulating factor (GM-CSF). The trial included 190 patients with varying levels of HER2; 89 women received the GP2 vaccine with a GM-CSF adjuvant and a control group of 91 patients received GM-CSF alone. Eight patients experienced early recurrence or developed a second malignancy and did not complete the vaccine trial. The vaccine is injected subcutaneously and the initial series consisted of monthly inoculations for six months, followed by four cycles of booster shots administered every six months thereafter. The patients were monitored for nearly three years.

    For all 190 patients, including those who did not complete the trial, the disease-free survival (DFS) rate was 88% among those who received the vaccine and 81% in the control group - representing a 37% reduction in recurrence. Excluding the patients who did not complete the vaccine series, the results are higher - 94% DFS rate versus 85% who did not get GP2 - a 57% risk reduction.

    Women with HER2 +3 who were administered trastuzumab as part of the standard of care prior to receiving the vaccine experienced no cases of cancer recurrence. According to Mittendorf, trastuzumab may act like a primer for the vaccine. Trastuzumab stimulates CD4+ T cells to release substances that fight cancer cells and initiates an antibody response. Thus, it may prepare the immune system, making the vaccine even more effective. MD Anderson is now testing this combination of immunotherapies in other clinical trials.

    Personalized Immunotherapy

    The GP2 study supports previous MD Anderson research on similar breast cancer vaccines, such as AE37, which showed a significant immune response and improved recurrence rates in triple-negative breast cancer patients. Another candidate, E75, known as NeuVax or nelipepimut-S, showed a 50% recurrence decrease in high-risk patients. Currently, NeuVax is being tested internationally in a phase III clinical trial.

    "We believe many more patients will benefit in some way from immunotherapy," says Mittendorf. "The challenge will be identifying the right immunotherapeutic approach for each individual patient. When doctors are able to do that, cancer therapy, and immunotherapy specifically, will follow a more personalized approach."

    http://www.medicalnewstoday.com/releases/282160.php
    http://en.wikipedia.org/wiki/NeuVax
    http://www.neuvax.com/how-neuvax-works/
    http://galenabiopharma.com/pipeline/neuvax/present/

  • Girlstrong
    Girlstrong Member Posts: 438
    edited September 2014

    thank you for caring about us HER 2 folks....hope your wife is doing well. She's lucky to have you on her "team" 

  • The1toC
    The1toC Member Posts: 126
    edited September 2014

    Nixie thank you so much for that valuable info! This gives me something to bring to my medonc to discuss.

  • SpecialK
    SpecialK Member Posts: 16,486
    edited September 2014

    I am actually in this trial - I had to enroll within six months of finishing Herceptin. The trial is only in Phase II, to my knowledge Phase III has not begun to recruit, so it will be quite some time before this vaccine comes to the market. Here is a link to the study:

    http://clinicaltrials.gov/show/NCT00524277

  • Skoolgirljen
    Skoolgirljen Member Posts: 28
    edited September 2014

    Special K, how did you get in the study? I will finish my Herceptin in February, so I wonder if phase III will begin within my 6 month window. I'm very close to both MD Anderson and Brook Army Medical Center in TX.  Thanks!

    Jennifer

  • Moderators
    Moderators Member Posts: 25,912
    edited October 2014

    Perjeta Boosts Overall Survival in HER2-Positive Metastatic Breast Cancer September 30, 2014

    Final results from the CLEOPATRA study showed that women diagnosed with HER2-positive metastatic breast cancer who got Perjeta, Herceptin, and Taxotere lived about 1.5 years longer than women who got only Herceptin and Taxotere. Read more...

    The Mods

  • SpecialK
    SpecialK Member Posts: 16,486
    edited October 2014

    skoolgirljen - sorry I missed that you posted a question for me!  I called the coordinator at the Sibley Hospital (Johns Hopkins) location in Washington D.C. to enroll.  I knew I met the eligibility criteria, but had to go up and see their surgeon for a physical exam, and forward a bunch of records to them from my MO.  I had blood work done, and was accepted after signing a contract with them.  I chose the Washington D.C. location because my husband was stationed at the Pentagon for an extended period, I still had a lot of friends there and my son is in college there.  I am familiar with the area so can get around with no problem.  I live in Tampa, so I had to fly up a lot, but used frequent flyer miles, and had limited costs since I stayed with friends.  I am not sure when Phase III will start, I asked last time I went for a booster in the early summer but there was no word.  Because of the good results I think they would like to move the approval along so I imagine it will be soon.  You have six months from last Herceptin to enroll and start.  They may expand the locations for Phase III, as Phase I was only at the U.S. Military Cancer Institute and used only military dependents, and Phase II was quite a bit wider with an assortment of locations.  To participate at the Brook you would need to probably be a military dependent - I could have gone to either Walter Reed/Bethesda or Sibley, but I have no regrets - the folks at Sibley have been awesome!

  • Jmo06
    Jmo06 Member Posts: 159
    edited October 2014

    wow good stuff!!

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