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-   -   early Christmas present--10 yr overall & bc specific survival results just published! (https://her2support.org/vbulletin/showthread.php?t=62385)

Lani 12-16-2014 01:33 AM

early Christmas present--10 yr overall & bc specific survival results just published!
 
from the two key trials which led to approval of herceptin for adjuvant use.

And cardiac problems now estimated only at 3% with majority of these reversible

RELEASE DATE: 15-Dec-2014
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Contact: John Wallace
wallacej@vcu.edu
804-628-1550
Virginia Commonwealth University
@vcunews
Herceptin found to improve long-term survival of HER2-positive breast cancer patients

VCU Massey Cancer Center physician-researcher Charles E. Geyer, Jr., M.D., was the National Protocol Officer for one component of a large national study involving two National Cancer Institute (NCI)-supported clinical trials that demonstrated that trastuzumab significantly improves the long-term survival of HER-2 positive breast cancer patients. The combined study was designed to determine the long-term safety and efficacy of the drug trastuzumab, which is commonly known as Herceptin and is primarily used alongside chemotherapy to treat HER2-positive breast cancer. The combined study focused on both the overall survival rates of patients up to ten years post-treatment as well as the known and potentially harmful side effects to the cardiac system.

Published in the Journal of Clinical Oncology, the study found that Herceptin, when added to chemotherapy, improved 10-year survival from 75 percent with chemotherapy alone to 84 percent with the addition of trastuzumab. Additionally, results also demonstrated continued improvement of survival without cancer recurrence--the 10-year disease-free survival rate increased from 62 percent to 74 percent with the addition of trastuzumab. Although heart problems are recognized side effects of Herceptin, the incidence rate of such events was found to be about 3 percent and the majority of those patients recovered from the initial effects.

"We have found that when Herceptin is used in combination with chemotherapy, a patient's survival is significantly improved," said Geyer, who serves as a senior scientific advisor to the NSABP and at Massey is the Harrigan, Haw, Luck Families Chair in Cancer Research, associate director for clinical research and member of the Developmental Therapeutics research program, as well as professor in the Division of Hematology, Oncology and Palliative Care at the VCU School of Medicine. "There are minimal long-term side effects, and the likelihood of the cancer recurring is greatly reduced."

The study was designed to provide much needed long-term efficacy data on Herceptin--a proven effective treatment, but one without much information on the role it plays in patients' long-term survival. The study combines data from two trials: NSABP B-31, led by the National Surgical Adjuvant Breast and Bowel Project (NSABP), and NCCTG N9831, led by the North Central Cancer Treatment Group (NCCTG). Each trial was designed independently to analyze overall survival rates of patients with early-stage HER2-positive breast cancer. The study specifically addressed whether or not the patient experienced a cancer recurrence and if there were any harmful side effects that would diminish favorable treatment results.

The local principal investigator leading the NSABP B-31 trial at Massey was Harry Bear, M.D., Ph.D. Bear, who is the Dr. Walter Lawrence, Jr. Chair in Surgical Oncology, director of the Breast Health Center and medical director of the Clinical Trials Office at Massey, also serves on the Board of Directors of the NSABP Foundation, Inc.

Herceptin was approved by the Food and Drug Administration in 2006, based on the initial results of these two studies, as an adjuvant treatment for HER2-positive breast cancers, which test positive for the HER2 mutation and are often more aggressive than other types of breast cancers. HER2 - human epidermal growth factor receptor 2 - is a protein that plays a significant role in breast cancer. HER2 proteins are products of the HER2 gene and work to control the growth of healthy cells. If the proteins are overexpressed, or if the HER2 gene is amplified, the cells can grow uncontrollably and become cancerous. Approximately 15 to 20 percent of invasive breast cancers result from HER2 gene amplification or overexpression of the HER2 protein.

Additional trials are currently underway to try to improve patient outcomes by using Herceptin in combination with various other drugs that also specifically target breast cancers with overexpressed HER2 proteins. Other trials are investigating applications of Herceptin for different cancers. For example, one study is presently investigating whether or not patients with breast cancers with lower amounts of HER2 protein might also benefit from Herceptin's promising results.

###

This study was supported by NIH grants U10-CA25224 and CA129949; NSABP grants U10-CA12027, U10-CA69651, U10-CA37377 and U10-CA69974; by the Breast Cancer Research Foundation; and by grants 35-03 from Genentech. P.A.K. received research funding from Cancer and Leukemia Group B.

The full study is available online at: http://jco.ascopubs.org/content/earl....5730.full.pdf

suzan w 12-16-2014 02:38 AM

Re: early Christmas present--10 yr overall & bc specific survival results just publis
 
Good news indeed...I feel so lucky to have benefited from this protocol as I meander toward my 10 year Mark!

PinkGirl 12-16-2014 09:14 AM

Re: early Christmas present--10 yr overall & bc specific survival results just publis
 
thank you Herceptin.

Becky 12-16-2014 10:32 AM

Re: early Christmas present--10 yr overall & bc specific survival results just publis
 
I am beyond 10 years and had Herceptin after chemo was completed and not with chemo. It must have helped too.

'lizbeth 12-16-2014 10:47 AM

Re: early Christmas present--10 yr overall & bc specific survival results just publis
 
I am so happy that Genentech and others continued the research beyond Herceptin.

These numbers are a bit shocking. I suppose because everyone is lumped in together.
I am truly looking forward to seeing long range data for the Herceptin/Perjeta combination.

The Disease Free Survival and Overall Survival numbers for the current generation of Her2 breast cancer patients will be even better. What a difference a decade makes!

lkc Gumby 12-17-2014 10:13 AM

Re: early Christmas present--10 yr overall & bc specific survival results just publis
 
I am celebrating my 10th Christmas thanks to God and Herceptin

Rolepaul 12-17-2014 10:38 AM

Re: early Christmas present--10 yr overall & bc specific survival results just publis
 
We are celebrating Christmas 2014 after being told that Nina had 3 to 6 months to live at Christmas 2011. She had Intrathecal Herceptin starting January 2012, with IV Herceptin in February 2012. We switched to TDM-1 for the systemic in August 2014. October 2014 MRI scans showed disease in full remission. Confirmed this week with followup MRI and CT scans. There is hope out there for even the worst situations. It takes a site like this to help people out. And then it takes the patient and support group to get the correct treatment done. Fight to get what you need and deserve.
I hate to lose (Wrath of Khan). Never give up (The untouchables).
Paul the Herceptive Positive Equalizer

sassy 12-17-2014 11:02 AM

Re: early Christmas present--10 yr overall & bc specific survival results just publis
 
We need you as an Equalizer Paul! Wonderful news on Nina! Your tireless efforts are beyond laudable.

I have no doubt Herceptin has given me the life I would have missed! My Onc was celebrating with me last month my near 10 year survival---he grinned, shook his head, and said, "You had one nasty cancer."

For me: Herceptin 1
Nasty Cancer 0

PinkGirl 12-17-2014 01:13 PM

Re: early Christmas present--10 yr overall & bc specific survival results just publis
 
my oncologist didn't say "nasty" he said "really ugly." In 2005 I knew nothing about Dr. Slamon and Herceptin . My oncologist explained it to me - he ended by saying "you are very lucky."

Rolepaul 12-17-2014 01:47 PM

Re: early Christmas present--10 yr overall & bc specific survival results just publis
 
In 2005, I knew of Slamon, but the team at Genentech working on this are past co-workers in some cases. I knew about Herceptin in 1992 (prior to most others) and worked on a diagnostic in 1985 (which makes me old). It took my mother at Christmas 2000 and will not take any more of the people I know.
I am a pharmaceutical consultant on making drugs, but also helped Nina pass her RN and Clinical trial exams. I guess you could call me as close to an expert on certain issues as there is. I had someone ask about autoimmune disease work, but it has not hit home for me in a while. I understand physiology, drug metabology, regulatory, and manufacturing in detail. It is my goal to help as many people as I can, because I can. HER+ just makes me mad as it got personal. It is up to each of you to get angry that you were chosen, for no special reason, to get this disease. The why's are not understood at this point, only the pain and suffering. It is up to everyone on this site to change the why's into "Why nots?"

tricia keegan 12-17-2014 03:51 PM

Re: early Christmas present--10 yr overall & bc specific survival results just publis
 
Pink, my Onc used similar words and said I was very lucky indeed, as I head to the ten year mark next summer I remember his words and feel very thankful.

AlaskaAngel 12-22-2014 09:34 AM

Re: early Christmas present--10 yr overall & bc specific survival results just publis
 
I'm thankful for everyone who genuinely benefitted from treatment.

At the same time, the blanket application of the drug for early stage HER2 positive bc limits our ability as individuals to evaluate with accuracy which of us actually benefitted and which did not, or why.

Today, after 12 years, the truth is that not receiving the drug made zero difference for me, AND we have not learned anything at all about which of us are not likely to benefit from receiving such an expensive drug, and at the same time we are encouraging some to rely upon it while they are progressing. We have not determined which patients would benefit from the use of this drug without chemotherapy, such as possibly many or most early stage patients.

The cup is both half full AND half empty; better than 10 years ago (and that IS good news), but with a long way to go to be as effective as we like to believe it is on an individual basis.

Rolepaul 12-22-2014 09:58 AM

Re: early Christmas present--10 yr overall & bc specific survival results just publis
 
Maybe Herceptin is like a seatbelt in a car: You never know if it benefited a particular case, and it will not save everyone. It is clear that those populations that are not able to get Herceptin, now or in the past, may provide a potential comparison group. Without Herceptin, the death rate is quite high, where it drops significantly with Herceptin. Whether you believe the drug helped a specific individual may not be a good reason to say it is great for all. I know my wife Nina is alive due to the drug as all other treatments have not shown the ability to help Brain/spine HER+ involvement. I am glad for success in your case without the drug, but hope that you do not feel that there is no benefit in the drug.

AlaskaAngel 12-22-2014 10:17 AM

Re: early Christmas present--10 yr overall & bc specific survival results just publis
 
I am genuinely grateful for those who benefitted from the drugs, because they do improve the picture for a meaningful number of people -- including a fair number who only receive brief or intermittent benefit.

But because the blanket use of the therapies still does delay the pursuit of better treatment for others while encouraging false hope, and

Because overall there is such a huge cost in continuing to support the blanket use of drug(s) that provide no benefit for some, there are good reasons for stubbornly pointing out those realities, even though it means going against the tide. That cost would be better spent finding other solutions.

I'm glad I refused the drug personally, because it forces a somewhat more realistic viewpoint. Otherwise I too would have been counted as one of those who was "rescued" by the drug.

BonnieR 12-22-2014 11:27 AM

Re: early Christmas present--10 yr overall & bc specific survival results just publis
 
these study results are a real world response to people who are cynical about "big pharma" only interested in making money Where would we be with out Dr Slamon and the developers of this drug.
I recall my surgeon saying "your Cancer might be small but it's very aggressive" and she proceeded to tell me my good fortune about Herceptin being available for me
It has been 7 years
Keep the faith

Jean 02-19-2015 06:54 PM

Re: early Christmas present--10 yr overall & bc specific survival results just publis
 
Medicine is called the "Art and Sciences" for a very strong reason.
Give consideration to the fact that we as human beings are so different, DNA, genetics, etc. A slight chemical difference can make all the difference in a patient response to a drug.
We all have our belief system. I think it is safe to say that early dx. is a plus and can make a huge difference (again to some )
but for the majority it is an advantage for early detection.
We also need to educate our daughters and young women to be aware and take the necessary health precautions to assist them to have a healthy life. It is so upsetting to hear, a women who is well past the age of 50 say she never had a mamo. Often hearing they are afraid. That is very sad to hear. Fear of the unknown can and does cripple some. That makes a profound statement to women to take the best care possible of themselves.
There is no doubt that Herceptin was the break thru drug of the decade. Many had to fight to have it (early stagers) that for me was far more upsetting. A person should have the right to be treated as they make the adult choice for themselves. The FDA took way to long to establish a standard of practice for early stagers. I will never forget Dr. Salmon frustration when we met. He was point on that ALL her2 patience should have herceptin. This coming from a man with his credentials speaks volumes. He is cutting edge and way ahead of the pack. But, as any great leader he moved forward. For those who may have not needed herceptin (and may not ever know) God Bless them. For those who did not have Herceptin and did not progress, God Bless them. For the most part this is what we did know. Her2 was a dead sentence for most. We are now seeing for the first time in a decade that tide has changed.....and it is due to herceptin.
We are not seeing the progression of this ugly nasty life sucking disease taking many of us who were dx. early and had treatment and those who were dx. later, living 12 years and more during herceptin treatment.

Dakini52 02-20-2015 08:02 AM

Re: early Christmas present--10 yr overall & bc specific survival results just publis
 
My oncologist referred to Herceptin as the "silver bullet" for treating my cancer. At the time I had no idea how fortunate I was to have access to this drug. I am grateful for all the research that continues to be done and feel blessed to know that should Herceptin stop working for me, I have other options available and more becoming available.

Mtngrl 03-12-2015 08:47 AM

Re: early Christmas present--10 yr overall & bc specific survival results just publis
 
This is an interesting and informative discussion. Thanks to all.

I'd like to point out that early detection of breast cancer does not actually improve overall survival. I know that goes against common sense, but it's a fact. The small drop in death rates from breast cancer in recent years is from better treatments, not from "catching it early." In less-developed countries, breast cancer is a leading cause of death. I suspect that the disparity is not so much due to the lack of mammograms as to the weakness in the health care systems in general (not to mention misogyny/undervaluing girls and women.)

Alaska Angel rightly questions the reflexive, blanket use of a drug that is never effective for some patients (for example, our beloved, dear departed Mandamoo) and becomes ineffective for many others. She says the money spent on that one-size-fits-all approach might be better spent otherwise. That goes double (at least!) for routine mammography. Billions are spent on it, yet there is no demonstrable benefit. There is also no evidence that routine breast self exams save lives.

Mammography, ultrasound, and MRI are necessary and essential for diagnosis of symptoms that might indicate that a person has breast cancer. That is a very different proposition from "let's screen everyone whether they're symptomatic or not." The main outcome of early detection is the opportunity to boast of five-year survival rates that look pretty great. Yet overall survival hasn't budged much. If you find it early you just have more years of knowing you have cancer, and being a cancer patient (and, hopefully, getting to NED and staying there.)

We are, indeed, lucky to have Herceptin and other targeted treatments for HER-2+ breast cancer. But don't fall too far down the "early detection" hole. After all, finding it "early" still means you have cancer. Chrissy was first diagnosed and treated at Stage 0. Yet her cancer metastasized, and she died. It happens.

Alaska Angel makes a great point about Herceptin that can be applied to all current cancer treatment protocols. There is no way to know if a particular person was "saved" by her specific cancer treatment. If she's alive, it's not unreasonable to assume the slash/burn/poison worked. But some cancers are slow-growing and indolent, and never become deadly. A good example is prostate cancer. Virtually all men who live into their 90s have prostate cancer, yet most of them die "with" it and not "of" it. That's true of some breast cancers. (Not HER-2+, but some other types.) Some are deadly no matter what, some are curable, and some never become deadly. We don't have a great way to tell which is which.

Substantially more research and attention should be going into preventing or curing metastatic cancer. That's what kills, and there's no known cure. All our expensive new treatments do appear to prolong survival for some people, but there's still no cure and, as the recent results published for Kadcyla, some brutally expensive new drugs are really no better than the old ones.

With cancer, an ounce of prevention is worth about a ton of cure. Lung cancer is virtually incurable. But lung cancer rates dropped substantially as smoking rates declined. Stomach cancer used to be widespread. With the advent of refrigeration and food preservatives, it's now very rare in developed countries. I'm very happy about the HPV vaccine, and hope it becomes ubiquitous.

Breast cancer doesn't seem to be caused by a specific virus. My money is on environmental pollutants and endocrine disruptors. The "vaccines" that are being studied train the body's immune system to go after the cancer cells in some way.

If we're going to spend billions of dollars on breast cancer, cleaning up toxic waste, developing clean energy, and finding safe alternatives to pesticides, herbicides, plastics, and other industrial chemicals (and ways to neutralize the ones we have dumped into the environment) appear to be better uses of the money. Increasing the budget of the NCI would be a fabulous place to start.

Jean 03-12-2015 05:17 PM

Re: early Christmas present--10 yr overall & bc specific survival results just publis
 
Very Interesting indeed....I do believe that early detection is a true benefit and does save lives. What patient dx want to hear they are stage 4? The horse is out of the barn and running at stage 4 and it is a different course of fighting the disease. That is fact.

Please see below link from Jama.

http://jama.jamanetwork.com/article....icleid=1883018

Chrisy: She was dx. in 2002 and did not have chemo or Herceptin. I don't believe that the test for Her2 was being done at that time as standard of care. I stand corrected if it was. Trials were still being performed.
Case in point: So many women were dx. early back then and NOT treated for HER2 as they are now. Chrisy was one.
She had mastectomy and was told she had a clean sentinal node. Again, back then the thought was if the node was negative you were home free. The cancer cells did not invade into the system. Well, we know now that is not true. Had Chrisy be dx. with Her2 and treated with Herceptin maybe (a strong maybe) as she was early stage she might have had a totally different outcome. Yes, we will never know for sure. But we do know that many women after Chrisy were dx. as she was and Her2 dx. and treated and they have NOT recurred. So are we saying that early detection holds little or no value?
Are we saying that because Herceptin is not 100% perfect, we should not have treatment since it doesn't serve all we should think about not having treatment?
That when a women is dx. with Stage 1 we just say, "well I don't know if Herceptin and the treatment will 100% work for me, so therefore, I am taking a pass and not electing to have that treatment, which is now standard of care. Okay, if that is your individual choice then I respect it. But to also blanket and say that early detection earns no merit is a heavy statement. I also have to say that most if not all oncologist wish that every patient they administer care to were stage 1 and not stage 4.

Back to Chrisy, she was dx. stage IV in 2004 with extensive liver mets. Fair to say that was the history of Her2 to return and most often in a 2 year time line. Chrisy Began treatment with TCH and gained a complete response. In 2007 she had recurrence. The dr's. certainly don't know why the treatment stopped benefiting her. Yet many others remained NED. We do know this - that thousands of lives were saved due to early treatment of Herceptin. Chrisy is case in point. Here she is in 2007 another 5 years of NED I think it is safe to say that the treatment did work for the five years.

For our new members who are dx. and have been encouraged by their oncologist that having an early dx. is a great advantage, it is certainly without merit to say that is not an accurate statement. I believe it to be an extremely discouraging statement to say that early detection does hold strong value to the life and quality of the patient.

Most important, each year new drugs, new procedures, new trails are being presented. If our good dr. had the attitude that early detection did not hold strong value it would be a sad state of affairs to the cancer patients.

In the United States:

  • Breast cancer is the most common cancer among American women after skin cancer.
  • 231,840 new cases of invasive breast cancer will be diagnosed in women in 2015.
  • 62,570 new cases of breast carcinoma in situ (non-invasive, has not invaded nearby tissue), including ductal carcinoma in situ and lobular carcinoma in situ.
  • 40,290 women will die from breast cancer.
  • 2,350 new cases of breast cancer will be diagnosed in men.
  • 440 men will die from breast cancer.
  • The five-year relative survival rate for female invasive breast cancer patients has improved from 75 percent in the mid-1970s to 90 percent today.
  • The five-year relative survival rate for women diagnosed with localized breast cancer (cancer that hasn’t spread to lymph nodes or outside the breast) is 98.5 percent. In cancer that has spread to nearby lymph nodes (regional stage) or to distant lymph nodes or organs (distant stage), the survival rate falls to 84 percent or 24 percent, respectively.
  • There are more than 2.8 million breast cancer survivors in the U.S., including women still being treated and those who have completed treatment.
    According to the American Cancer Society, Cancer Facts & Figures 2015
Cancer of any kind is best detected early - and we have an oblation to ourselves and family to maintain a yearly care system of our health. People who wait until systematic to see their doctors is not wise. Be it breast or your teeth.



Thought: What if Dr. Dennis Slamon felt that why bother researching Herceptin unless it worked for all? or any thought other than researching a drug for Her2 breast cancer. Or he felt, well - it only saves some not all, so why take it at all since we just don't know who will have the positive results. Let's not offer herceptin until the trials show every patient is 100% NED.

While I do agree that money should be spent on prevention tell it to the greedy corporations who pollute our world and do not want to take accountability for their actions. Why, because it is all about their profit center.
Governments and environmental agencies have to track them down, take them to court and spend millions of additional dollars in court fees. While you are spending years in court, thousands upon thousands of people are dying from cancer related disease from the environment. While the thought is accurate that our environment needs to be addressed, in the meantime we are being attacked by companies who continue to pollute our earth. It is a double whammy, we have to address the patients who are dx. and fighting for their lives.

I can't jam my head and heart with that those big corporations who damage our earth when I was dx. with breast cancer. My first thought was to survive and find out what my choices were.

This is a individual choice of treatment. I venture to bet that if we could take a poll among the women who are dx. with Her2 breast cancer how many have made the choice to pass on the standard of care? How many of our members who back in the day were told they were Her2 stage 1, and herceptin was not available since it was not approved by FDA and then within 2 years recurred as a stage 4. Would they have chosen to have treatment with herceptin if offered? How many of those treated would have become NED?

This is a compelling and truly interesting discussion.
But I cannot believe that a blanket overall statement that early detection does not improve the dx and treatment of a women with early stage cancer is something to take the bank.
I am not seeing it that way.

We have so many new members coming to the site who are terrified with their dx. I think we all remember the day our doctor told us we have breast cancer. The fear and terror that runs down your spine. To think that their is no advantage to early detection and treatment (if the patient has chosen to have treatment) is a dismal give up attitude. You have cancer be it stage 1 or 4 - it is the same thing.
I have to repute and say not so. We have way too many sisters stage 4 on this site surviving for years
and doing so NED. What are the possibles to those who are dx. stage 1?

We do know that the landscape of a Her2 dx. was changed forever with herceptin. Dr. Salmon I am sure wanted to know who is guaranteed to have positive results. Hopefully his next gift to us will be the ability to determine who herceptin works for and who doesn't.


jean
__________________
Stage 1, Grade 1, 3/30/05
Lumpectomy 4/15/05 - 6MM IDC
Node Neg. (Sentinel node)
ER+ 90% / PR-, Her2+++ by FISH
Ki-67 40%
Arimidex 5/05
Radiation 32 trt, 5/30/05
Oncotype DX test 4/17/06, 31% high risk
TOPO 11 neg. 4/06
Stopped Arimidex 5/06
TCH 5/06, 6 treatments
Herceptin 5/06 - for 1 yr.
9/06 Completed chemo
Started Femara Sept. 2006

Mtngrl 03-12-2015 06:15 PM

Re: early Christmas present--10 yr overall & bc specific survival results just publis
 
Dear Jean,

I had no intention of starting a fight. You make some good points. However, there are studies to back up what I said, and I'm not being defeatist. Please re-read what I said. You're putting words in my mouth.

The study that started this thread said Herceptin improves ten-year survival to 84% from 75%. That's a big improvement, and it is right to celebrate it. But it's not a cure. In that ten-year period, 16% still died. And the article doesn't give figures for overall survival.

Symptoms can arise at any stage, and if they do then we have great tools for diagnosing and treating. You make it sound like you think not getting annual mammograms means you won't know you have breast cancer until it metastasizes. That's not the case. On the other hand, many women with HER-2+ bc are metastatic at diagnosis, even with annual mammograms. A friend of mine turned up at Stage IV one month after a "clean" mammogram.

I'm advocating for prevention and cure, and for a rational allocation of resources. That's all.

Love and peace to all,
Amy


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