Tykerb-only arm "fails" in ALTTO trial. What to do?

krcll

I have always been worried about the Lapatinb (Tykerb)-only arm that I was randomized to on the ALTTO trial and indeed they are stopping it early. It is comparing badly to the Herceptin-only arm, which means that we haven't even received the normal standard of care. There have been ethical questions from the start about this arm (they refused to have the trial in Sweden because of this) and I guess the "ethisists" were right.

Does anyone know how bad the Lapatinib-only results are compared to the Herceptin-only results? I know that many had to reduce the dose or stop the Lapatinib early because of the harsh SE's and I'm wondering if this could be part of the reason for the bad results. Has anyone heard what the results are for the people that did take the full dose for the year? 

In one press release, it says that we should contact our onc to determine what we should do. But on the ASCO website (they made a "statement" at the conference), they said that Herceptin would be available to all of us, even if we had finished our year of Lapatinib. I finished in December 2010. I will be talking to my onc  on Wednesday, but I am trying to gather as much information already now.

Has anyone talked to their onc already? What has he/she recommended? Would we get Herceptin for a year? Is Herceptin just as effective without chemo and some months after all other therapy is done? 

I will be cross-posting on the clinical trial and stage III forums. I don't know if that is against some rule, but there aren't so many of us lapatinib-only ALTTO trialers and I would like to get in touch with the ones I can. I'm really upset by all of this....

krcll

Is there no-one else from the ALTTO trial that got Tykerb only?? There were 8,000 on the trial and 2,000 of them got Tykerb (Lapatanib) only so some of those people must be on these boards...... Survivorwoman answered me on another thread, so we are 2 in the club, so far ;-)

krcll

I have posted about the same thing in 3 different forums to try to reach as many other ALTTO trial Lapatinib-only arm women (and men?) as possible. I thought I would update all of the threads.

So I had an appointment with my onc today and he recommended a year of Herceptin. I had already talked to the people at the ALTTO patients telephone number and knew that their official recommendation was a year of Herceptin. They said that less then a year might be enough, but without any data they recommend the standard one year. I am 8 months post Lapatinib and 18 months post chemo, but the results from the HERA trial show that even after a pause in treatment, Herceptin is effective. After freaking out at first when I heard the ALLTO results, I am now feeling lucky. As long as I had been randomized to the Lapatinib-only arm, this is the only way for me to get the protection of both drugs.

An interesting thing my onc said was that Lapatinib did pass the first Interim Review and it was only the 2nd review that it didn't pass. If I understand my research, the interim reviews were to come at 400, 600 and 800 "events" (recurrances, I assume). That means that out of 8,000 women on the trial there have only been 600 recurrances so far, divided between the 4 arms- so these are not big numbers they are talking about. The trial started in May 2007. The ALTTO trials hotline woman also said that since they were testing Lapatinib against a proven therapy (Herceptin) the standards Lapatinib had to fulfill were especially high.

All in all I feel great about it. I now will get the fantastic protection of both drugs and that is the best treatment available to me right now.

By the way, I asked the trial nurse the day before if I might be able to get Herceptin right after the onc and I decided what we would do. They were nice enough to set up things tentatively for me, so I came right out of the appointment and got started with Herceptin. Yeah!

kellysblevins

I did!!! I got the Tykerb only for a year also. I finished the Tykerb in May 2010 and just got the call last week from my onco about it. I had my first Herceptin dose last Tuesday and will get it every three weeks for the next year. I have been so sick with this first dose. From what I understood from my oncologist at Vanderbilt, the Tykerb did provide some covereage, but just not equal to or more than the Herceptin did. I was a stage 3 at original diagnosis so she recommended me take the herceptin now since i am at peak time of recurrence.

krcll

kellysblevins- I'm so sorry to hear that you've had a hard time! I've heard that we get a loading dose the first time and that the succeeding times are easier. I felt under the weather for about 6 hours but by the morning was pretty much good to go. Just like so much of this BC experience, things are so very individual. I hope that you have an easier time of it next time. Keep in touch!

AlaskaAngel

Hi Krcll,

You and I both are triple pos, and both of us had a less common tx (I had FACx6, you had FECx?). I was 51 at time of dx and not yet menopausal. (I'd had a hyst 3 years before dx but had left my ovaries in... which they still are....)

I qualified for the trial for "late" Lapatinib in 2006, but opted not to participate. My onc was willing to provide me with "late" trastuzumab when I was just about 3 years out from treatment, but I also turned it down.

I am posting because from what I have seen over time in various breast cancer forums, triple positives who do not recur  within the first two years, have not recurred whether or not they do trastuzumab or lapatinib. Please don't take that as gospel, but look into the numbers as best you can, and see what a really honest onc has to say about it.

AlaskaAngel

Lydia1

Hi.  I am Her2+ on the ALTTO trial, Tykerb only arm.  Just wanted to tell you there is someone else out here, someone who is just finding out about all of this - yesterday, in fact.  I learned of lapatinib failing in the trial and called my oncologist's office yesterday.  Within a day we're talking about a year of Herceptin.  It will start in less than a week as long as the blood work checks out and the ECHO comes back ok.  Like you, I am long done with chemo and even Lapatinib.  My last dose of Lapatinib was end of April, so over 6 months ago.  Last chemo was in July 2010.  In 2010 I did AC x 4 followed by T x 12 with lapatinib.  So now it looks like I'll be starting Herceptin too.  I have lots of questions and can't really seem to get answers.  I'm meeting my doc and then having tx right after on 10/10.  You mentioned an ALTTO hotline?  Maybe I could find out about this number to get some of my questions answered?  How are you doing by the way?  You are a little ahead of me at all this.  I only wish my doctors would have contacted me sooner.  It seems like they waited until I called them.  Maybe, maybe not.  Anyway, I would love to hear your experience or anyone else's experience on this issue.. And sorry if I sound a little down about the whole thing.  You are probably right that it's a good thing.  I just thought I was done - that's all. 

Rubyluby

Hi again, You and I had a few chats (by PM) when we had both just been allocated to the Lapatinib only arm of the ALTTO trial and we were both weighing up our options.

The news of the Tykerb arm failing is indeed galling, and I so understand how upset you must feel. What does your onc say you should do now?  

 I stuck to the Lapatinib for 3 months, but the more I researched, the more uneasy I became about it. While Lapatinib had produced good results for metastatic BC, its results were unknown in the adjuvant setting. What freaked me out was that I discovered that there have been drugs that work well for metastatic bowel cancer but do very little for early bowel cancer. Another thought I had was that for a trial to be ethically sound it has to give you what is already the standard of care PLUS something extra, at best, or nothing extra, at worst. It shouldnt compromise whatever is the existing standard of care. I had a row with the trial team about it as I felt it was unethical to have an arm that excludes Herceptin in the first place. I also felt vaguely like I myself was being unethical to have embarked on the trial only to pull out, but its my health after all! Also I found the SEs horrific. I had an itchy rash that started, of all places, around my bottom, and it spread down my legs. (I have never completely got rid of this itchy rash, btw, as it set up an itch/scratch cycle which has become self perpetuating). Anyway, I threw my toys at my onc who was very understanding. She put my interests first, not the interests of the trial. I stopped the Lapatinib after 3 months and was started immediately on the Herceptin, which I had for a full year. I asked my onc if my Herceptin treatment was compromised by the delay but she said it wasnt.  My breast surgeon had another perspective which is that there is a growing school of thought that its actually better to stagger or spread out adjuvant treatments than give them all in one hit early on. If this is true, then you might still benefit from having a year of Herceptin now.

Take heart that you have done incredibly well and got yourself through the first two years after diagnosis in one piece, which is the most critical period after all. 

Let us know what you decide to do.

Big hugs to you,

Lucy from London (Rubyluby) 

orange1

Herceptin given "late" still provides significant benefit.  This was demonstrated in the HERA trial.  Those were were not originally randomized to the Herceptin arm were allowed to cross over (receive Herceptin) as soon as the benefits of Herceptin were proven in the trial.  There was an analysis done a few years after the cross over was allowed.  Those who crossed over (received herceptin late) fared MUCH better than those who did not receive Herceptin - and this good result was despite the fact that the patients who crossed over had over all larger tumors/more positive nodes, than patients that elected not to cross over.

I don't blame you for being upset; I would be too.  But data from the HERA trial argue strongly for significant benefit from late Herceptin.

Linda100

Hi...just wondering if you have found anything out. I was in the ALTTO trial Tykerb only arm. I finished in December 2009 .... read in the fall of 2011 that they were saying anyone in the Tykerb only arm should talk to their oncologist. My oncologist acted like tykerb was a very good drug ... only slightly less good than herceptin and basically said she was glad I wasn't insisting on doing the herceptin.  By my next appointment in 2-3 months she said it was highly recommended that anyone in the tykerb only arm do a year of herception. So it has taken from early December until now for me to get to start the herceptin ... I will have my first treatment on January 27 ... they wanted to make sure my insurance would cover, although they said if it didn't that the trial would cover it. So, it's been maybe 5 months since the drug was pulled from the trial and over 2 years since I finished the lapatinib. That's part of my story .... frustrating..... how is it going with you?