Tykerb for early stage?

[CherylS]

I noticed mention on another thread of someone considering Tykerb when approved as preventative for early stage. I hadn't heard much about this before. Is there new news about this?

[Hopeful]

CherylS,

Really, the only mention I have seen for consideration of Tykerb for early stage disease is a suggestion at the end of the article posted in this thread by RhondaH in the "articles of interest" forum: http://her2support.org/vbulletin/sho...rid=1173<br />.

I spoke to my onc yesterday about he and I talking about adding Tykerb to my regimen of Herceptin and Arimidex should the FDA approve Tykerb as anticipated in the next few months. The use would be "off-label," as approval has only been sought to use the drug in metastatic patients. However, I, and alot of other people were receiving Herceptin for early stage disease on the same off-label basis, prior to the FDA's approval for its use with early stage disease. Technically, I am still receiving it off-label, because it is only approved for use in early stage bc in conjunction with standard chemotherapy regimens. I chose not to do chemotherapy, and receive Herceptin as monotherapy.

Dr. Slamon made some comments about Tykerb vs. Herceptin, that Tykerb would have good synergy with Herceptin, but not replace it. Because the two drugs together would attack two different ascpects of the cancer cells, this makes excellent sense to me. My interest in adding it even for a short time is that it supposedly crosses the blood brain barrier, which Herceptin does not. I would like just a little insurance against the potential for brain mets.

Anyway, when and if the time comes, it is no slam dunk that my onc would agree to it or that insurance would pay for it. It is just something I would like to go over in depth with him once the drug is available, to see if he feels that it would be worthwhile for me, given my diagnosis and treatment.

Hopeful

[bashmaz]

Hi - I'm planning to participate in a clinical trial (tykerb vs placebo) for a year to see if if would be a viable drug for early stagers to help prevent/delay a recurrance.

This is similar to the large trials that were done with Herceptin - first it was approved for stage 4, then after years of trials, it has become standard for early stagers.

This current trial is only for those who have not had Herceptin nor a recurrance. I started a thread a few days ago, voicing my concerns about what i would have to pay for in this trial, but after talking with the trial coordinator, she said all of the regular "required" tests (ekgs, etc) will be paid for by GSK, which is great news.

hope this info. helps
Marianne

[kat in the delta]

When you took the Trial of Tykerb, did you also take Xeloda(pill)? Looks like tykerb is almost ready to me...Did you have side effects ?Is it just a pill ?? Will the GSK company let You know the results first ?? I thought someone said that herceptin may work in 1 out of 6 people...I just finished it. What about Tykerb ?? I guess if it comes back(I was early stage, but poorly differ with macro lymph node invasion) then my Onc, will give Tykerb to me once approved. Let me know about it... thanks alot..............kat in the delta

[heblaj01]

An extensive piece of info on Tykerb published trial results & a list of current trials can be found in this ASCO document:
http://www.gsk.com/investors/present...able-paole.pdf
TYKERB at ASCO 2006

Of particular interest are these trials:
-Tykerg+ Xeloda
-Tykerb+ Herceptin
-Tykerb monotherapy for brain metastases

[mts]

When I went on Herceptin, it was still only FDA approved for Stage IV...
I was Stage I.

The way I understand what happened with me getting Herceptin before it was FDA approved was basically the onc providing it to me.

Anyone can call their insurance company and ask them to tell you if Tykerb is on their list of allowed drugs. If the insurance is paying for Tykerb for Stage IV; it will likely pay for any other stage as well. Call customer support to hear what your insurance can do and relay that info to your onc. I found that I got more out of it if I made the call and not the onc's billing clerk. When the onc's bill the insurance, they just enter the ICD-9 code for "breast cancer" without mention of stage. Herceptin and Tykerb are billed as chemo...

In the end, the 4th onc I consulted with gave Herceptin to me because I insisted... I was well into my Herceptin Tx when it was finally FDA approved for early stage.

Because of Herceptin's dramatic success, and Tykerbs early findings, one would think the onc's would be more apt to provide Tykerb when we ask for it -regardless of Stage. I know they want to make sure the drug is safe and all that stuff, but so far, the side effects are less traumatic than Herceptin!

Either way- it will be up to the onc!

Maria (MTS)