What about the Herceptin Control Arm?

Will we get a crack at herceptin finally?

..........or are we stuck with our unlucky draw?

6 months ago I did everything humanly possible to get herceptin. And I was refused no matter what I did. In fact the only reason I joined the trial was to try and get on a receiving arm.

I am completely furious. It appears that we controls will not be reaping any benefit from this discovery at all. My clinic is not planning on offering the control guinea pigs anything other than platitudes. According to them it is too late for us...

Unfortunately, they needed a control group to demonstrate that it made a difference and that this difference wasn't offset by the increase in heart problems. Could you have gotten herceptin-based chemo (not herceptin after chemo) at the time you entered the trial? If not, you didn't lose anything by participating.

To their credit, the researchers did keep the control group to the minimum needed to make their point, which is why they were able to get the results out years earlier than expected.

It will be nearly impossible for U.S. insurers to deny patients early herceptin-based chemo now, and you played an important part in this.

I know how you feel. When I heard last June that M.D. Anderson found that herceptin doubled the response rate in the chemo that I had just finished, I was really sickened by the whole thing. Unfortunately, the only advance that will benefit all Her2 patients is the cure for secondary cancer and there is no sign of it yet. In a perfect world, it would also be cheap and readily available so that people in poor countries could get it as well. Given the unpleasant and unpredictable nature of cancer treatments, I think that we can all understand the importance of vaccines to prevent HER2 cancer and early BC treatments that mean that fewer women will get secondary HER2 BC, even if those discoveries are too late for us.

I would focus on getting on to a vaccine trial, if you can.

[Rozebud]

Meredith - find someone who will give it to you and drop the trial. It's great that there was a control group, but you need to look out for yourself. I know a woman who was in the control arm, and finished chemo in July. She dropped the trial last January and found an onc that is giving her 12 months of herceptin stand alone. If it were me, seeing this now, and I was not on it....that is what I would do. SURELY there are oncologists in your city that will give it to you after this announcement.

I agree with Rose. You MUST pursue getting Herceptin now. Find another Oncologist if you have to, and with the news this week you will surely find one who will give you at least 1 year of Herceptin.

Cindi.

[michele u]

Meridith,
What stage are you? Just wondering. Yes, I would drop the study and give your onc. a copy of the news coming out. They will be giving this to everyone now with the study results, but that could be months, and you need to act now. First i would call your insurance co. and tell them whats going on with the news, then tell your onc. you want the Herceptin now. Then hopefully the insurance company will go back and pay for it once it gets approved for everyone. I'll cross my fingers for you!

Merridith,
I am sorry from your frustration. FDA rules are v. strict about clinical trials, but if you can't get Herceptin, you can try for a vaccine trial like the one in Winber or Seattle. Atleast you will be getting a little more insurance against a recurrence.
Take care,
Anne

Thanks for allowing me to vent.

There is nowhere in Canada that I can get Herceptin at my stage right now (stage 1, 1 year after chemo). I am not eligable for the vaccine trials out of Seattle, and Philidelphia is geographically to far/expensive to go to.

I've emailed Genentech to see if they are going to offer anything to the control guinea pigs, but so far no answer. Am not hopeful of hearing from them either because I emailed them a question last year and received no response.

My biggest fear is that according to the stats, a person in my condition has about a 70 - 75% chance of acquiring mets over 20 years, so clearly there is a very high probability of the cancer circulating even though there is no sign of it currently.

The latest breakthrough - and I am basically 1 year too late to make use of it. Not only that, but no doubt because of the horrific expense, I highly doubt whether we will be offered "catch up" herceptin because they "don't know how or if it will benefit people so long after finishing chemo".

Merridith

Hi Merredith,

Unfortunately, we're still a while away from early results on the HERA trial (the herceptin trial here in Canada). I was told when I entered the trial that if early results were overwhelmingly positive, that the 'controls' WOULD get herceptin. You may have to wait a bit longer, but I'm pretty sure you should get hercetpin eventually.

Take care,

/Christine (also in Vancouver)

Hi again,

Forgot to mention that it is Roche (Genentech's parent company) that is actually running the HERA trial. They are the people you should contact regarding when and if the controls will receive herceptin.

www.roche.com

Regards,

/Christine

The announcement wasn't for herceptin on its own. Personally, I doubt that HERA will have results that are nearly as dramatic, since they had to increase the numbers involved in the trial, which I would guess means that they are looking for the subset of patients who benefit. The 50% reduction has only been shown when herceptin is given at the same time as standard chemo, not for herceptin after chemo on its own. So, by all means try to get herceptin, but keep in mind that the benefit of taking it after chemo by itself is not at all clear.

Hello Christine
You write:
>> The 50% reduction has only been shown when herceptin is given at the same time as standard chemo, not for herceptin after chemo on its own.

I was diagnosed Nov. 2004 and assumed that I would get Herceptin after reading all about it. As a stage 1, the two doctors I consulted all said, NO. I turned down A/C feeling that Herceptin was the key.

I know none of you are surprised to find that I was right! Now I wonder if I could still get Herceptin with chemo. The doctor was willing for me to start chemo after completion of radiation which was March 4th so a month later shouldn't be a problem. But Herceptin still hasn't been approved for stage one and it doesn't seem that it will be in time for me to get full benifit from it.

I am not sure what to do but try to figure out what is going on. Hopefully more information wll be out before my June appointment. But by then it may be too late to begin it without mets?-and would Blue Cross even think of paying for it if the FDA hasn't approved of it.

I feel this is somewhat akin to the problem of getting air bags into cars. They knew it would save lives, but it cost too much money. Now we have air bags--but a lot of people aren't alive to benifit by them. Soon we will get Herceptin. I wonder if I will then be able to benifit???

Hi Christine:

Thanks for your info. I actually thought that it WAS the HERA trial reporting. They have been expecting an early report any month now and I thought that the big announcement was it.

I thought that it was a 52% improvement for herceptin alone, not in the chemo combo. That makes it a different situation and definately lowers my fuse. I thought that I was missing out on a really significant survival improvement.

By the way, where in Canada are you located? I'm in Vancouver.

Regards,
Merridith

[Rozebud]

Janet/Merredith: Again, we know that for some people (stage IV) herceptin by itself keeps things at bay. We also know that herceptin plus chemo seems to work better for some people. There was not a group to study that did herceptin after chemo - so there is no data. No one can say whether it works or not. All I know is that 75% of my herceptin treatments were after chemo. They give it to you for a year and only 3 months is while on taxol/taxotere during the main studies. I would say....go for it. I have to believe that even if the numbers aren't 50% decrease, there has to be a benefit.

What a confusing time! I'm learning so much from all these posts and of course coming up with more questions than answers...

The one thing that seems clear to me is that there is no evidence yet of note from the huge international HERA trial. While I know it is true that they upped the number of women enrolled, it is not clear what motivated that: there has not been any interim analysis done (I know this because I emailed Brian Leyland-Jones, a lead investigator in Candada)--only safety monitoring.

So to my mind it remains unclear what was going on with the HERA trial when they expanded. I know that the larger a trial the more "power" it has in terms of statistics. But if they had not yet done an interim evaluation (and presumably been worried about demonstrating statistical significance) why would they have made this change?

Just wondering...

Jeff

Hi Christine MH

Just a thought... you say "The 50% reduction has only been shown when herceptin is given at the same time as standard chemo, not for herceptin after chemo on its own. " We cannot know at this time whether the people in the U.S. trials benefitted from the combination or if it was, perhaps, the year of herceptin following that did the trick. Only the HERA results will shed light on this question (and demonstrate if there is any further benefit to 2 years of the drug). I, personally (because I have a vested interest) am still hopeful for equally dramatic findings.

Cheers,

/Christine (in Vancouver)