Re: Evidence Mounts on Heart Failure After Trastuzumab in Breast Cancer Survivors
 

Ok - there is a financial benefit which always seems to win but
what about the large study that looked at tykerb vs in the adjuvant setting which found herceptin was more effective than tykerb? I'm sorry I can't remember the name of the study?
I for one seem to respond better to tykerb and hope to keep it in my kit for sometime.

You bring up a perfect point about average population studies. Average population studies point to Herceptin being more effective than Tykerb, while in your case Tykerb seems to respond better. The reason so many patients suffer from chemotherapy is that treatment (based on those average population studies) usually follows a standard protocol and many patients have to try two or three kinds before one works (if any work), making them sicker in the process. Anti-cancer drugs should work best for you as an individual, not average patients from average population studies.

As increasing numbers and types of anti-cancer drugs are developed, oncologists become increasingly likely to misuse them in their practice. There is seldom a "standard" therapy which has been proven to be superior to any other therapy. When all studies are compared by meta-analysis, there is no difference. What may work for one cancer patient, may not work for another.

In a TheScientist.com article, "Crowdsourcing Drug Discovery," it was commented that for the last 50 years, randomized controlled trials have been the unquestioned gold standard, when in fact they have become a fiercely defended relic of our ignorance in 1962 when (US) Congress empowered the FDA to begin regulating efficacy.

At that time, it was a "best we could do" solution - but now? They take too long, cost too much, are fraught with unsolveable ethical problems that patients and many physicians dislike, and cannot ask the patient-specific molecular questions we now know need to be asked and answered.

Yet, most clinical trialists and the FDA cling to these crude, simplistic tools like an irrational safety blanket. If we can't reach agreement that clinical methodologies must adapt to new knowledge of the biology of disease, and that the way drug development is regulated must rapidly adapt in much the same way, then our ability to accelerate advances in medicine will remain stagnant.

A key point in this article is that the new system should be patient-centric. It has to be something patients will not only tolerate, or enter under duress, but rather a system that makes sense to them personally - even when they are not yet facing a serious or terminal condition. If real patients are left out of the process of change, we will likely end up in the wrong place again.

http://www.f1000scientist.com/article/display/57646/

I heard women who were bumped from the T-DM1 clinical trial because of disease progression, which meant that their cancer was growing despite the drug. Bumped off the trial because of disease progression? Wonder how many patients there were?

Response rates (how much a tumor decreased in size) can be inflated when excluding patients during clinical trials (evaluable patients). Patients not considered "evaluable" are often those who do not get the benefit of an entire treatment plan. The response rate is calculated after removing patients, who die or have been excluded, from the calculation. This inflates the response rate.

But clinical oncologists want to publish their papers. They need to report on the outcomes of their experiments, but if they had to wait for survival data, it could take years until all the data was aggregated. That wouldn't bode well for them to participate in pharma-sponsored trials in the future.

Response rates give clinical oncologists the opportunity to take a more optimistic look at therapies that have limited success. They can describe results as being complete remission, partial remission or simply clinical improvement.

If they treat all patients for three weeks, they can fairly evaluate the efficacy of a compound, which takes that lone (on average) before it can be regarded as effective. If they disregard all patients who die or were excluded after onset of therapy, and include only those treated three weeks or more, they can improve their data.

To justify their existence, they have to publish papers. That's what they do.

Re: Evidence Mounts on Heart Failure After Trastuzumab in Breast Cancer Survivors
 

It is definitely food for thought. Thanks for the information. I wish I had got this disease 20 years down the track - please keep fighting for personalised medicine - it has to be that way.
I have to say that my appointment with the Principal Investigator for the Theresa trial this week was interesting as for the first time I saw genuine interest in the tumour specific profiling I have had partially done and wishes for more genetic information. I have to hope that just maybe, there is something out there that may work for me.

Re: Evidence Mounts on Heart Failure After Trastuzumab in Breast Cancer Survivors
 

I havent heard a $ issue w/ tyk in my discussions w/ several top docs; but more that they dislike its common , nasty se/. and that it doesnt work long for many. There are exceptions, some get long response . they find more broad + response w/ herc, and fewer s/e.
Mandamoo, i think it's a lousy system in many ways. here in US genentech is re-opening exp access, and comp use. yet theparent co, Roche , can deny thiese programs in other countries. they expnad world-wide to reap profits, but that expansion doesnt cover merciful tx. Not thier priority. Early in our battle i usd to say , " Do you think some accountant at Roche Holding AG in Zurich gives two hoots about Lorraine ? " ; they just want a return on thier investment as soon as possible. I hope we continue to publicize this. over the past yr, Severin Schwan, Roche CEO has repaetedly said his co. is all about " Personalized Health Care " We called him on it at our BIO protest, and will continue to !

Re: Evidence Mounts on Heart Failure After Trastuzumab in Breast Cancer Survivors
 

Just FYI, Tykerb (with first Xeloda and then Herceptin) works long term for some... 3 years for me. Avoided WBR because of Tykerb, was able to do 'wack-a-mole' instead. For me, and several others, my oncs have loved it. For others, it hasn't worked as well. Same as other treatments. Not bad SEs either. Just one girls opinion.

Also, the folks who have heart congestion/failure with Herceptin over time, be sure at first that you are taking exceptional care of your teeth. There is a known connection to less cared for teeth (brush 2x a day, for 2 min each time, and floss once a day.... all this is minimum). We are not immune to normal folks problems and we know that tooth health is directly connected to heart failure. We are probably even more affected by regular issues, + Herceptin issues added on top. Just one girls opinion.

Re: Evidence Mounts on Heart Failure After Trastuzumab in Breast Cancer Survivors
 

I will be watching this site and thread closely now. My fiance' is to receive t-dm1 therapy as part of expanded access program, I believe.

Tomorrow 9/14 she will receive multiple baseline tests, and if there are no issues uncovered, proceed with infusion tomorrow afternoon of this t-dm1 treatment.

The heart damage debate has my attention. She had Herceptin only, about a month ago. Unlike the prior times she received it, for the first 24 hours she had nausea, chills, fever around 100, and 'chest pressure'; she also felt pretty rotten for about a week. I believe it was a mild infusion reaction.

The doctors will discuss this tomorrow with her. Jen is aware of the conversation about heart damage; however at present wants to move forward.

It is really scary to be in this place; so many unknowns and it seems like such a dart-throwing approach to medicine; I still want to believe the underlying cause needs discovered; that all these chemos are not only just bandaids; they might possibly be aggravating some cancers. There is not enough focus on the whole body!

I believe a rigorous exercise program and super-organic diet should be mandatory for anyone who fights a cancer, of any kind. There are too many variables out there to rely on a single treatment or small variety of treatments as a cure.

I pray those involved are making decisions based on a cure; not on making their mortgage and car payments.

Bob

Re: Evidence Mounts on Heart Failure After Trastuzumab in Breast Cancer Survivors
 

Wow! great discussion! yes we all hope for more directed, personalized treatment.
Just wanted to point out that I had a heart problem, heart attack (didn't know I'd had one!!), 100% blocked artery, had to have an angioplasty and stent put in.
I saw 3 different cardiologists at 2 different hospitals and of course asked the obvious question, particularly since I'd been on Herceptin for 6 years but had now been off it for nearly 2 - "is it the Herceptin?" and all 3 immediately said "No! it's the radiation" 2 of them showed me my radiation tatoos. I had heart sonograms (echographie du coeur) every 3 months during Herceptin and it was always good and constant.
Brenda thanks for the reminder about the teeth, I am pretty good about it.
So I think anyone who had radiation, particularly outside the breast area, should be followed by a cardiologist and be aware of chest pains and breathing.
While I'm sorry my heart and lungs were damaged, I'm just grateful that after the recurrence and the very scary news it came with, that I got Herceptin for so long and radiation despite radiation's side effects, which by the way the New York Times (and I'm sure other papers) are talking a lot about.
I'll make sure that everyone in our support group, particularly those who take Herceptin and have radiation, know the importance of seeing a cardiologist and not just for the Muga or echo.
Love this site and appreciate your info, great that you keep us so informed.
I am so terribly sorry Greg and Phil for your losses and send you a cyber hug. You are exceptional people to keep so involved and it's so appreciated.
health and happiness
Sarah
sarah

Re: Evidence Mounts on Heart Failure After Trastuzumab in Breast Cancer Survivors
 

Bob, please keep us posted on your wifes t dm-1 tx. Good luck, God Bless . It is a great drug for her2, . Recent NY Times article ( peter canellos , (sp ?), June article ) quoted researchers as saying it has the BEST survival rates so far for ANY her2 drug ! , and in EMILIA decisively outperformed tykerb/xeloda . L. has been doing great on it for nearly 2 yrs. Some are at 4 yrs and counting. It is very common to have a fever, chills w/in several days of taking t dm-1. That s/e often goes away after several doses as body adjusts to it. We did go to er once or twice w/ fever over 100.5 . no ongoing problem. The one time we ignored the fever , it turned out to be sepsis related to stents L. had , nearly killed her, so follow protocol for fevers !
cardiac risks have to be weighed against risks of a very aggressive cancer. Lorraine was in good physical strength prior to cancer , not a smoker, not much of a drinker, regular exerciser. She has passed every echo w/ flying colors . 6 yrs of near continous herc ., last 2 herc w/in t dm-1. My mantra for aggressive cancers is aggressive tx first, w/ as much wholistic living as possible w/in that tx., adding more and more wholistic tx as sxs subside. Conventional tx first, alternative as secondary , for the early part of Stage IV fight. I feel that many cancers will turn out to be related to pervasive chemical pollution in environment, coupled w/ genetic susceptibility , that we cannot avoid simply by diet, exercise , etc. Nothing wrong w/ healthy living, and it can strengthen us greatly for the battle, and future healthier living.

Re: Evidence Mounts on Heart Failure After Trastuzumab in Breast Cancer Survivors
 

This is a thread that is appropriate for me.

I was on Herceptin for almost 8 years. My MUGA dropped a little once and I took a short Herceptin holiday, then resumed, remaining NED during that time.

I had been taking CoEnzyme Q10 for a couple of years prior to my diagnosis, on the basis that heart problem run in my father's side. Continued to take the supplement most of my 2-year active/chemo/rads treatment time. Still take it.

Also ate heart healthy, low fat diet, which became more organic upon diagnosis.

My curious side has to wonder if factors like family history, diet, exercise level, lifestyle were incorporated into this "evidence," which could combine with the affects of Herceptin for heart failure.

I also had Adriamycin, Taxotere and Taxol, which are also cardiotoxic. In my case there are a number of ways my heart could be affected besides taking Herceptin.

Bob, let us know how it went with the T-DM1.