Any Tykerb Questions?

[Joe]

Christine and I have been invited to participate in a teleconference with GSK on March 16th (Friday 2-3:00 EST). Please post any questions that you might have as replies to this post. We will forward the entire thread to GSK at 1:00 EST.

Regards
Joe

[Sheila]

Joe and Christine

Do they know of any cardiac toxicity with Tykerb or Tykerb/Herceptin or Tykerb/Xeloda?
Sheila

[Lani]

have any of the studies shown a difference in efficacy between her2+er+ and her2+er- patients? Were any of the patients treated with tykerb who were ER+ not on antihormonals at the time?

Thanks

[Margerie]

And do they have any information about Tykerb in an adjuvant setting, concurrent with herceptin? (Thinking specifically of "advanced" local bc, preventing mets)

What is the incidence of side effects -%'s.

Thanks Joe and Christine. Progress rules!

[Celeste]

My question:

I have been on Tyberb since December of 2006. My recent scans(CT and Bone) show stable disease with no progression since starting the Tyberb/Xeloda, although my CA15-3 tumor marker is rising. What information does GSK have about tumor markers and Tykerb? Is there any evidence that Tyberb may contribute to rising marker levels.

Thanks so much.

Celeste

[caya]

Is Tykerb going to be available in Canada, and if so, when?


Thanks
Caya

[chrisy]

What data is there on the "great debate" over adding Tykerb to Herceptin? In the adjuvant setting I think there are ongoing trials, but what about the stage iv gals on "indefinte" Herceptin?

[anne2]

Hi Joe,

Is Christine going to go on Tykerb after her Gamma Knife? Could you ask please what the major side effects are from Tykerb. Does it affect cardiac function, or the blood vessels in any way. My mom had a stroke last year in addition to the b.c and I wonder if it's worth the risk. How long have they studied Tykerb for the side effects anyway?
Thanks,
Anne

[Sherryg683]

My question is pretty much the same as Chrisy's. Should I get on it now with Herceptin to prevent the cancer from coming back (I'm stage IV in remission). Or should I wait and keep it for later. I really am leaning towards trying to keep this beast from coming back for as long as possible. I figure if I can keep it away for years, maybe something better will be available then. I meet with my Oncologist on Thursday and he's willing to put me on it with Herceptin right away. Will there be any problems with insurance not covering this drug unless you have active disease..do you know?...sherryg683

[Lolly]

Is GSK planning any trials of Tykerb with Avastin?

Lolly

[michele u]

If one is take Tykerb "off label" do they think there will be a problem with getting "immune" to the med. And if they have any adjuvant trials yet, and how long do they think one should stay of Tykerb adjuvantly

[Joe]

GSK can only answer questions which are included in the "Boxed Label Instructions" as approved by the FDA. This is true of all drugs manufactured by all pharmaceutical companies. This is a strict FDA policy which carries major penalties if violated.

But that does not preclude your oncologist's opinions.

Warmest Regards
Joe

[AlaskaAngel]

If you receive TCH (the regimen that showed better results than the regimen with an anthracycline) and your cancer progresses, before you could get Tykerb you would have to continue to progress on an anthracycline, and then progress on trastuzumab, and then you would have to get the Tykerb with capecitabine?

[janet/FL]

I have a friend who is stage IV, Her2 postive but did not respond to Herceptin. Was taken off Herceptin and other chemos were tried. She has progressed on all. She is in Hospice but she is a fighter. Would she be eligible for Tykerb? Could it be given alone at first to see if she could tolerate it and maybe see if the progression could be slowed or halted and adding more chemo later if necessary?

[Robyn]

Same question, but we need to know if this is going to be available in Canada, or how can we get access to it. I failed herceptin and omnitarg and they won't continue me on even herceptin alone here, even if it actually slows down the cancer. I was hoping to get a kick at the can with tykerb. Thank you for this posting.


Robyn

[Marcel]

I took a year of "Late" Herceptin, beginning 18 months after completing chemo. As the efficacy of Herceptin as a single agent post-chemo has not been definitively proven, I am very much inclined to try a course of Tykerb to throw at my stage 3A HER2+ BC, diagnosed in the fall of 03 as I try to make it to year 5 +. However, the Mass General trials rule out those who have previously taken Herceptin. I would hate to wait for disease progression, before the drug is available to me, and would much prefer to try to head this off. if possible, or at least as long as possible. Any hope that "early" bc patients will be able to access Tykerb in the near future?

Many thanks for your wonderfully informative postings and advocacy on our behalf!

[heblaj01]

Joe/Christine,

Based on the lab study below does GSK believe that adding Tykerb to Herceptin after resistance to Herceptin has set in is likely to be more effective than Tykerb alone in advanced cancer?
Would the answer also apply to early cancer?
Is the Tykerb+Herceptin combo likely to delay resistance in any situation?

http://mct.aacrjournals.org/cgi/con...bstract/6/2/667
Lapatinib induces apoptosis in trastuzumab-resistant breast cancer cells: effects on insulin-like growth factor I signaling

P.S.
Tykerb is approved but is GSK ready to mass produce the pills or when will it be ready to supply any demand?

[rinaina]

Is there a place for Tykerb in early stagers such as Stage I, no metastasis or recurrence to date but her2 positive?

[heblaj01]

Joe and Christine,
Other than allergic reaction are there situations (previous treatments, vaccines...) which would preclude Tykerb even off label?

[DonnaD]

When will Tykerb be available for early stage breast cancers,
Stage l and ll, Her2nu positive patients who are on or finished Herceptin?