Reply to Lani's HERA post is rejected??

[dlaxague]

Hi, I tried to reply in usual way to Lani's HERA news and got this message: Your submission could not be processed because a security token was invalid.

If this occurred unexpectedly, please inform the administrator and describe the action you performed before you received this error.

Weird. Is anyone else having trouble?

So here's another try:

Lani, this is amazing to just log on and get these late-breaking reports. Thank you so much for providing them to us, and for the vigilance that involves on your part.

Okay, I admit to skimming (fish soup on the stove requires attention, thank you Louise!) but where is the data about 1 year vs. 2? Did I miss it? Isn't that what we're waiting for?

And why does the benefit seem to be decreasing, the longer out these studies go?

Always the questioning one,
Debbie Laxague

[Debbie L.]

I see the problem, I think. I was allowed to log in with my old username (which my computer seems to have taken upon itself to do - I didn't notice it), but the post was rejected. As Debbie L., let's see if I can reply ...

[Becky]

I believe the bottom of Hera results article says the full analysis (including 1 yr vs 2 yrs of Herceptin) will be available in 2011.

[Debbie L.]

Becky said: I believe the bottom of Hera results article says the full analysis (including 1 yr vs 2 yrs of Herceptin) will be available in 2011.

Thanks, Becky. I did see that. For some reason I thought we were going to hear preliminary information about 1 vs. 2 this year, though. I'm also wondering if allowing cross-over (other studies did not, did they?) will dilute the stats to where they can't tell if there's a significant difference.

Still, there were tidbits of interest. We'll be interested to see, for instance, the stats on those who received Herceptin late. How late, and how large was their benefit compared to those who received it initially? Although I guess that's largely a moot point because everyone now is getting Herceptin initially - but still it's interesting and might provide clues. And what about those subset analyses so we can look at recurrence r/t hormone status, etc. Lani, do you know if there will be a more detailed report available or is that it for now?

Debbie Laxague

[Becky]

It is also interesting as there are waning results as time goes on 51% to 36% to 25%.

Perhaps Jean is right in thinking that we should get tuned up with some Herceptin on a quarterly basis (or something like that). For example, highly hormone positive women who take Taxoxifen tended to recur about 2 years post Tamoxifen therapy but now those women would then take 5 yrs of Femara (or take any anti hormonal longer). Perhaps Herceptin is kind of like "tamoxifen" for Her2+ and that something should continue to be taken for a longer period of time? Who knows? The 2 yr results will be interesting in dealing with part of the "over time" question as these women will have gotten Herceptin for a longer period. Perhaps the initial results aren't any better for 1 vs 2 yrs but maybe there will be a difference in the 4 yr or 6 yr results of 1 vs 2 yrs.

I guess we will just have to wait and see.

[Debbie L.]

Like StephN said in another post, it's hard tell from just the abstract. I think that HERA's best report was 34-36% maybe? So now it's 25% but is that including the cross-over people? I couldn't really tell from the abstract but if they're now doing stats that include the cross-over people in the no-Herceptin group that could account for the apparent decrease in benefit.

I don't say this to in any way deny that there is an amazing number of dedicated and brilliant scientists working on the cancer puzzles. But there is also a lot of corporate mentality ($$$) driving the train. My cynical voice says that IF 2 years of Herceptin were even hinting (trending) in a better-than-one-year direction, Genentech/Roche would be shouting that from the rooftops (it would double their profits, right?). This lack of shouting says to me that it's probably not better. And if that's the case, it takes us back to the only study I know of that did less - FinHER, with only 9 weeks treatment (small study, other issues)and reporting apparently equal-ish benefit. It seems to me that we need a good study looking at 1 year vs. less. But there's no incentive ($$) for doing it. No drug company is going to help with a study to find that we need less of their drug. Although it would be refreshing if they would.

Debbie Laxague, off today and supposed to be cleaning house, not playing on the computer all morning long!

[Mary Jo]

In reply to Becky's post.....

I've always wondered that Becky.....why in tarnation we DON'T receive herceptin as maintenance. It has always seemed logical to me and still does. I always ask myself...... "self, why did your cells over produce the her2 protein in the first place and why in the world won't it again?" Ya, I've changed things in my life....alot of things BUT "ain't perfect yet" Sometimes I wish I could demand herceptin as maintenacne - but of course, my insurance company would just say "oh, sure Mary Jo...anything for you!"

Oh well...just wanted to say that.....

Mary Jo

[Patb]

I agree with you Mary Jo, I think we need a boost every
six months or so. I was at a confence and Dr. Brufsky
with the Magee-Womens Cancer Program gave a talk.
I asked him how they arrived at a year of Herceptin to
start with. His answer was that it was based on a colon
cancer study and his opinion was it surely could be tweaked. Of course now they are doing studies and that
might change, in the meantime, how about boosters.
patb

[Debbie L.]

I don't know the answer to the question about booster doses of Herceptin (and probably no one does).

But my guess is that boosters would not fit into the theory about how adjuvant treatment "works". At primary diagnosis, it is hoped that surgery cures everyone and no viable cancer cells remain. But since we can't know who those cured-by-surgery people are, adjuvant treatment is done in case there are stray cells out in the body that could be capable of setting up a metastatic site. The purpose of adjuvant treatment is to kill those cells and prevent metastisis.

So adjuvant treatment is done with curative intent. We can argue (and many do) about whether at least some adjuvant treatment merely delays the onset of metastatic disease. But as we know/understand it right now - its intent is curative (whether or not the result is cure).

So I think that the response to the booster question would be that after adjuvant treatment, one is either cured, or they are not. If one is cured, there's no point in further treatment. If one is not cured, treatment can be started when the recurrence becomes evident. So I hear you asking - but what about those who were not cured - wouldn't it keep it at bay longer to give the booster doses of Herceptin? Maybe it could keep it at bay forever! I think that's a reasonable question and who knows (no one) maybe the answer is "yes". But say we use HERA's most recent stats - we'd be giving booster doses to 74% of women who had no need of them, and we have no evidence at all to even suggest that booster doses would offer any advantage to the 36% who do recur (and that's only in the first 4 years). This stat discussion is assuming that at an average of 4 years out, HERA has seen most of the recurrences they are going to see (HER2 typically recurs early). But we don't really know that for sure, either. Maybe Herceptin-treated HER2 has a different timeline and we're not far enough out to know it yet. SO many questions.

It is truly a mystery to me - the difference between adjuvant treatment and its ability to achieve cure with no cancer ever seen again - and metastatic treatment where even if it's just one small site of mets that appears to be treated until it's gone, still it's extremely unusual for it to stay gone. What is different about primary vs. small-and-isolated mets? Is it that only the primaries that are incabable of spreading are the ones that respond to primary treatment and are cured? It doesn't seem so at this point - some of us with pretty dismal primary diagnoses do seem to be cured, and others with reasonably good (relatively) pathology details go on to metastasis.

No answers, just more questions ...

Debbie Laxague

[Mary Jo]

Wow Debbie......my simple question seems so small in light of your "speculative" answer! But then again I should know better than to use the word "simple" when referring to anything cancer related. "Simple" and "cancer" definitely do NOT walk hand in hand.

[sarah]

This is very much on my mind since my onc has said this is my last year for Herceptin when I'm sure I heard him originally say for life. He tried to explain to me that Cancer needs to keep growing and doubling, etc and that the Herceptin stops that and the effect is to stifle the cancer and kill it because if it can't grow, it dies.
He used a plant analogy but I think seeds can lie dormant for a long, long time.
I like the idea of a booster periodically but protocols aren't there yet.
I'm glad I have a year to get used to the idea of being without it.

[Becky]

What will be interesting in 2011 will be the long term results of 1 yr of Herceptin versus 2 yrs. Those results, if favorable, may begin trials (such as the Tamoxifen trials from decades ago) on the true length of Herceptin.

I agree that the short term 1 yr vs 2 yr results could not have been dramatically different. I heard Eric Winer speak once and he alluded to this fact. However, I have a friend from a local support group who is a 26 yr bc survivor who was in the very first Tamoxifen trial. She got the one year arm so she received it for only one year. In the beginning years, there was very little difference between who got Tamoxifen 1, 2, 3 yrs etc. It was over time that that difference became dramatic (and it was the trial that concluded 5 yrs was optimal. In the 10 yrs of Tamoxifen trial it seemed 7 yrs was the best but not that much better vs 5 and the associated side effects of Tamoxifen). So, all I am saying is over time, more may be better. How much more, I don't know. Also, it may be better but associated with side effects or future detriments that none of us really know about yet. Prior to recently, the only long term Herceptin users had metastatic disease and many weren't around for years and years of follow up.

Time will tell and we'll see. I did get 16 months of Herceptin (long story - had to do with getting ooph so I could be on Arimidex and then convincing my onc to give me extra Herceptin so I could be on the Herceptin/Arimidex combo a full year. Did my research based on metastatic disease and the combo results for mets was great so I figured why not?)

I too was disappointed about the 2 yr results not being published.

Lastly, I do want to comment that Tamox and the AIs are also considered adjuvant therapies and they are given over years. Chemo is short term but Herceptin is immunotherapy. Perhaps Tykerb could be tested differently (a Tykerb a day keeps the cancer away). Pills are easier for the patient and the whole medical community if just one pill a day (much like Tamox or an AI) could help the Her2+s out long term (just thinking out loud here).

Have a great weekend

[sarah]

a pill a day! sounds like a good idea.