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 (http://mct.aacrjournals.org/cgi/content/abstract/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?

[Andi]

My questions have been asked by some of the above, but I am assuming you will be posting the answers you receive.

[natalia rae]

I know there is an Tykerb/Avastin trial open at UCSF under the direction of Dr. Hope Rugo. It just opened last week or so. I imagine there are others around.

You can call the study coordinator:
> Jacqueline Lyandres, MS
> Clinical Research Coordinator
> University of California, San Francisco
> 1600 Divisadero Street
> 6th Floor, Room B612
> San Francisco, CA 94115
> tel: 415.353.7857
> fax: 415.353.9651

Your doctor can also give this combo to you directly.

[Roz HUNTER]

Hi, Just joined the recurrence on a recurrence group this week!! (Damn!!).

I have a small pleural effusion, and wanted to go on Tykerb, however, the EAP states that I must have progressed whilst on Herceptin and Taxol. I don't tolerate Taxol well at all (from adjuvant experience). Is there any other chemo drug (preferrably one where my hair doesn't fall out) that I can go on. Will there be a cut off either of patient numbers or a time limit for the EAP in Australia?
Cheers
Roz

[Rupali]

what is the best protocol in adjuvant setting for non metastatisc BC :

Tykerb/Xeloda after Herceptin OR Tykerb/Xeloda with Herceptin

[Belinda]

Hi Joe - like Caya - would like to know how to get access to Tykerb for EBC outside the US - ie in Australia (stage 11B) - can I get access if I travel to the US? Otherwise I gather it will take several more years for the drug to be listed. thanks for taking on our questions -cheers - B

[Rupali]

When will Tykerb be approved for sale in India and Canada?

[Linda]

Thanks, Joe. I think this may be Chrissy question, but:
For women who had positive node (s) but no mets, have finished a year of herceptin and are currently NED -- any trials to test returning to treatment on Tykerb for prevention of future recurrance?
THANK YOU
Linda

[Val Pfeiffer]

Thanks for doing this, Joe. My questions concern off-label usage, but I will still be watching this thread for the answers they are able to provide.

Val

[SuesSister]

First, I want to thank you for taking these questions. My sister's oncologist at Memorial Sloan Kettering told us she would not be eligible for Tykerb because she was on Xeloda before ( or Zometa before ). She has advanced liver mets that have stopped responding to any other drugs ( Herceptin, Avastin) and we are out of options. They cannot operate either because of the location of the tumor. She has fought so hard to make it to the Tykerb approval date so we were devastated to hear that she would not be eligible. Tykerb is really our last hope. I am hoping that either her oncologist is mistaken or we misunderstood.

Does anyone know of any eligiblity restrictions?

THANKS SO MUCH!!

[Val Pfeiffer]

Joe--
I thought of a couple things to ask--maybe they're repetitive, so my apologies (I only have a moment this monring).

1. Please comment on the preventative properties of Tykerb with respect to brain mets. Do they feel there is value in taking the drug in situations where there is a high probability of brain mets?

2. Please comment on the value of Tykerb when taken by iteself. What do you feel that the difference in Tykerb's efficacy when (1) taken by itself, and (2) combined with other drugs (which ones)?

thanks!
Val

[heblaj01]

Joe,
Since in an other post you say that GSK is not going to answer many of the questions in this thread which go beyond the FDA appoval criteria, could you get some responses from oncs not tied to GSK?