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

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krcll
krcll Member Posts: 343
edited June 2014 in Stage III Breast Cancer

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 HER2 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....

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  • Survivorwoman
    Survivorwoman Member Posts: 620
    edited September 2011

    Hi krcll -- keep me posted about what your onc says. I am going to see mine on Thursday.

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  • krcll
    krcll Member Posts: 343
    edited September 2011

    Survivorwoman- there is also a number for ALTTO patients to call: 888-313-5689. I have only gotten an answering machine. I've left a couple messages but they haven't called me back yet.

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  • Survivorwoman
    Survivorwoman Member Posts: 620
    edited September 2011

    Thanks krcll- I sent you a PM.

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  • krcll
    krcll Member Posts: 343
    edited September 2011

    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!

    Survivorwoman- we are good to go! I assume you will be offered Hercetin as well, after a "wash-out" period to get the Lapatinib out of your system. I feel just fine 6 hours after I got it so we will see tonight. They say the first time has the most SE's then they get less. Hey, we made it through Lapatinib. We can make it through anything!

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