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Great News For HER2 Positive Breast Cancer Patients

Ritzy's picture
Ritzy
Posts: 4384
Joined: Aug 2009

The US Food and Drug Administration (FDA) approved ado-trastuzumab emtansine (Kadcyla) for the treatment of patients with metastatic HER2-positive breast cancer earlier today. HER2-positive disease accounts for nearly 20% of all breast cancers.

The new drug, known as T-DM1 during clinical research, is intended for patients whose disease has progressed following treatment with trastuzumab (Herceptin) and a taxane.

“Kadcyla is trastuzumab connected to a drug called DM1 that interferes with cancer cell growth,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a press release. “Kadcyla delivers the drug to the cancer site to shrink the tumor, slow disease progression, and prolong survival. It is the fourth approved drug that targets the HER2 protein.”

Most recently the FDA approved pertuzumab (2012) for HER2-positive breast cancer—trastuzumab (1998) and lapatinib (2007) are also FDA-approved for this indication.

The trial that led to the approval of ado-trastuzumab emtansine, the phase III EMILIA trial, was an open-label trial that included 991 patients. Patients were randomized to receive ado-trastuzumab emtansine at a dose of 3.6 mg/kg every 3 weeks or lapatinib (Tykerb) plus capecitabine. Primary endpoints of the trial were progression-free and overall survival.

http://www.cancernetwork.com/her2-positive-breast-cancer/content/article/10165/2129615

jnl's picture
jnl
Posts: 3873
Joined: May 2009

This is great news and very encouraging!  Thanks Ritzy!

camul's picture
camul
Posts: 2256
Joined: Dec 2010

article on T-DM1 and the research.  It said that some of the early recipients who had continued tumor growth were let go from the trial.  It still gave some good hope for longer survival, but again, it is not a miracle drug that will stop the cancer, once again only will give more time. 

I just wish they could find an actual cure!  I got really excited at first and started reading more articles and it is promising to have alternatives when one stops working.  I guess I am just so discouraged that there is still so little monies going towards research for advanced bc or a cure.  Most of the research is coming from drug companies that will prosper from the drugs gettng approved. 

SIROD's picture
SIROD
Posts: 2204
Joined: Jun 2010

Hi Carol,

Anyone in a trial who has progression are immediately eliminate. 

I never become excited anymore, over the last 18 1/2 years, I read so many hopeful article but they never seem to pan out long term.   I really don't believe that there will be a cure in our time though I do want to very much.   I wish the METAvivor had the money that Komen receives with all it's races.   I wish for you my friend, there was something to help you.   Would your oncologist allow your tumors to go those labs with those mice.  Perhaps they can figure out what would actually work on your tumor now.  

They give us a biopsy at the beginning but as time moves on, the tumors change, so why don't they do a second biopsy to see how much they have change and allow a mouse to be the "guinea pig" to figure out what would work as far as a drug?  

I'm posting what I've been reading all week on an article on Afinitor and Torisel.   I'm not pasting the whole article which I found on one site and found it again on another.  

Fatal AEs Higher with mTOR Drugs in Cancer 

By Charles Bankhead, Staff Writer, MedPage Today 
Published: February 17, 2013 
Action Points

This study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

Fatal adverse events occurred more than twice as often in cancer patients treated with mammalian target of rapamycin (mTOR) inhibitors compared with control therapies.

Point out that the most commonly identified cause of death was sepsis/infection.

ORLANDO -- Fatal adverse events occurred more than twice as often in cancer patients treated with mTOR inhibitors compared with control therapies, a review of multiple clinical trials showed.

Altogether, the trials showed a 3.4% incidence of treatment-emergent deaths among patients randomized to everolimus (Afinitor) or temsirolimus (Torisel). Control groups had a cumulative fatal event rate of about 1%, which is consistent with results from other types of clinical trials, Toni Choueiri, MD, said here at the Genitourinary Cancers Symposium.

"Use of mTOR inhibitors is associated with a small, but significant increased risk of developing a fatal adverse event," said Choueiri, of Dana-Farber Cancer Institute in Boston. "I do want to emphasize that both study drugs, everolimus and temsirolimus, benefit the overall patient population with their approved indications, including renal-cell carcinoma (RCC)."

"The risks associated with these drugs may be greater once they are introduced [more widely] to the real-world oncology population." he added.

conitnued at: 
http://www.medpagetoday.com/MeetingCoverage/MGUCS/37404

A reply was posted to this about the math.  I'm not a math person but it makes you wonder.

Their math is off.  If the control group experienced 1% fatalities and the mTOR group over 3%, then the risk increases threefold with Afinitor, not twofold.

I'm glad that I decided not to go on Afinitor and Aromasin at this time.  Lots of kinks need to be worked out on this drug. For me it wasn't Afinitor that caused paused but it was to soon for another AI.

Best to you Carol,

Doris

 

Gabe N Abby Mom's picture
Gabe N Abby Mom
Posts: 2415
Joined: Sep 2010

Being triple neg, and being the selfish person I am...I would like to see more testing and hopefully more development for us triple neg gals. I'm just saying....(don't want to stir anything up here)

Hugs,

Linda

camul's picture
camul
Posts: 2256
Joined: Dec 2010

I wish there was the funding for all mets research!  I wasn't knocking that they had a new one, I was just stating that the doctor who was quoted in another article was pointing out that he read and followed this study, and in the results there were so many that it did nothing to stop the progression!  I am happy that they are looking at new meds, but at the same time when you read deeper you see that it is not exactly as the initial article stated.

Were you able to get your chemo Friday?

Hugs,

Carol

SIROD's picture
SIROD
Posts: 2204
Joined: Jun 2010

Linda,

I believe that triple negative people should have other alternatives other than chemotherapy.  It isn't right.

Still wish that METAvivor could have the funds that Komen receives for research.

Best,

Doris

 

 

SIROD's picture
SIROD
Posts: 2204
Joined: Jun 2010

I believe it is always good to know what is approved by the FDA.  It is wonderful for those with the Her2 oncogene to have another drug to prolong their life.

Thank you again for posting.

 

Doris

Margeaux
Posts: 80
Joined: Dec 2011

To say I am disappointed with the news is putting it mildly.  On Jan. 27 there was this upbeat article in the Houston Chronicle under the heading "Smart bomb gives patients new hope".  It sounded like the Holy Grail for us HERB+ patients.  The premise of that article was that eventually Kadcyla would replace regular chemotherapy and give us a greater survival chance.  Dr. Jenny Chang the director of this study at Methodist Cancer Center at the Medical Center in Houston.  Words uch as "groundbreaking, creating lots of excitement", etc. were used.  The article described a 66 yr. old patient whose tumor was roughly the size of a lemon.  Five months later it had disappeared.  The only thought I had was - well, I had 2 tumors and 2 lymph nodes, one tumor 3.5 cm, the other .9 cm and they were no longer visible after 12 treatments with Taxol.  Doris, I will eventually learn not to get too excited about wonderful new treatments.  Like you I believe that, unfortunately, there will not be a cure for cancer, no matter how many pink T-shirts we wear or how many "Runs for the Cure" take place, but I always hope there will be less harsh treatments just around the corner.  Look how much has been accomplished with heart disease, maybe one day in the not too distant future this will hold true for cancer.  What disappointment.  I'll see the oncologist on March 20, and I am going to ask his opinion.

Margeaux

 

SIROD's picture
SIROD
Posts: 2204
Joined: Jun 2010

Dear Margeaux,

I guess it's the media's job to hype up any new approach to cancer.  We were suppose to find a cure before landing a man on the moon.  We've done a lot better in space than here on the ground in understanding what makes a cell loose it's programming and how can we kill them who have.  Since the time I read about Dr Judah Folkman and his angiogenesis only to learn a few days later that he could cure mice but not people, I stopped and now really read between the lines.  

I believe in hope and one day, they will find something not as harsh as chemothrapy to help rein in those cancer cells.  It might not be in my time but I sure hope it will be there to help others after me.

Heart disease is a different because the heart is a motor and can be understood.   Cells have different functions and there are so many of them, each with their own blue print.  I do believe there is hope in that concept of using our own tumor and figuring what makes it go amok and how it can be stopped.

Do ask your oncologist and I am interested in what he says.  Please report back to us.

Best,

Doris

SIROD's picture
SIROD
Posts: 2204
Joined: Jun 2010

Back in October 2011, one of the ladies on this discussion board posted about a "new breast cancer treatment breakthrough" .  I posted a reply but it is "only in mice".  I was nearly run over by posters who want to believe one thing instead of the reality.  I then foolishly posted myself on a hopeful vaccine a few months later.  I was then treated with a lot of abuse that I asked CSN to pull my post which they kindly did.

 

Following will take you to the articl put out by Hershey and the post of the "New bc treatment breakthrough" should anyone want to read the article.  I do believe the you will have to copy & paste as I have yet to learn about how to put it on so you won't.

 

http://www.abc27.com/story/15631198/penn-state-hershey-may-have-found-cancer-eating-virus

 

or the one posted here:

 

http://csn.cancer.org/node/228747

 

 

It was a virus that was developed by Dr. Craig Myer's that kills 100% breast cancer cells albeit in mice.   I also knew that from my years of reading about the "next miracle" where it probably was going.   There are about 10,000 new hopes which are found and only one of them will be funded to go to human trial.  That is cost somewhere about a billions dollars to make a "new hope" from development to usage for the general public.  My figures might be wrong but there as close as I remember them to be.  A good read is "Dr. Folkman’s War: Angiogenesis and the struggle to defeat cancer” by Robert Cooke" on how persistent with his research paid off, not for him but for those who can use this drug.

 

I was curious on what happened to Dr. Craig Meyer's breakthrough so a year after the lady who posted the news article I found the following one year after the other one came out in October 2012.  You will probably have to cut and paste the website and not expect it to work by a click.  Or just Google Dr. Craig Meyer 2012.

 

http://articles.mcall.com/2012-10-06/health/mc-virus-kills-breast-cancer-20121006_1_cancer-cells-breast-cancer-awareness-healthy-cells

 

Dr. Meyer's has been unsuccessful in finding the funding needed for his virus. 

 

I think there is promise there though the concept was an old idea he used.  In the cancer world the reality is not what media hype portrays it be no matter how we wish it wasn't so. 

 

Doris

 

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