It's Getting Closer

[IRENE FROM TAMPA]

Well, I had a visit with the oncs office that will be supplying me the Tykerb.
The co-ordinator had her "telephone interview" last week with the Glaxo people and I went in on Thursday and signed my consent form - Yippeeeee

I had everything explained to me in depth, had my blood work done and had an Ecocardiogram on Friday and am scheduled for a CT on Monday. I will meet with them again on Wednesday and hopefully they will have the drug by Thursday.

I can't believe I can be so anxious to actully begin on Chemo AGAIN but of course after 6 weeks off of chemo and progressing tumors, I see why.

I do not forsee any reason at this time that the Glaxo people will not allow me to have the compassionate use for this but until I actually receive the drug, I am still keeping my fingers crossed.

I am sure that those of you out there that are working with an office that is trying to obtain qualification for the EAP, will be seeing results soon.

Will let everyone know when I start.

Good luck to everyone.

[Becky]

Irene


I am so excited and happy for you. Keep us in the loop (and let us know when your vacation starts so we don't worry about you). I am interested in how Tykerb works in general and how it will make you NED!

You are in my thoughts.

Kindest regards

Becky

[chrislmelb]

it is great that something is finally happening.
Good luck
Christine

[Jean]

Dearest Irene,

Will keep you in my prayers and wishing you all the best!

Jean

[chrisy]

Dear Irene,
I'm so glad to see that you finally have some forward movement on this. I hope and pray that this will be one perfect treatment for you - one that will set you back on track for a long time.

Best of luck to you, thanks for keeping us updated.
chris

[Chelee]

Irene, It must be a relief to finally get the ok. I am so happy for you. Please keep us updated as I know we are all excited to see how fast this tykerb takes to kick your tumors behind. I have a good feeling about this drug. Many prayers that this one will do it for you. Hang in there...it won't be long till your on the road to NED again.

Chelee

[karenann]

I am so happy for you.

Hugs.

Karen

[Bev]

Best of luck to you. BB

[tousled1]

Irene,

I'm glad that you have gotten the go ahead to receive tylkerb. Please keep us informed on your progress as I'm sure there are many of us on this board who may one day be going down the same path. My thoughts and prayers are with you.

[Cathya]

Irene;

So glad to hear your good news.... I can well understand your relief at finally getting some action on this.

Best regards,

Cathy

[RhondaH]

Will keep the prayers coming. Take care and God bless.

Rhonda

[lexigirl]

Oh, I can feel your excitement reading your post. I have nothing but positive thoughts and prayers for you as you begin the new tx. The tykerb sounds so promising. They are coming out with new txs all the time it seems. This may be the tx for you to keep this disease at bay.

Love and Prayers,
Lexi

[mamacze]

Irene,
I am curious, did they analyze your tumor to see if you had overexpression of HER1?
You truly are a trailblazer and how fortunate the rest of us are to have the benefit of your experience. Thank you for sharing your experiences with us.
Love Kim from CT

[Lisa]

Irene,

My onc says that GSK keeps sending him forms to sign. I don't know whether anyone has had a telephone interview yet. Do you remember when your onc started the process with GSK?

Love and light,

Lisa

[Steph]

I too have signed my consent forms, had all my tests and go back next monday. Are you getting just Tykerb? I am getting mine on the EAP(?) I believe but not sure. I will be in the Tykerb/herceptin or Tykerb alone study so I find out which arm I'll be on next monday also.

I pray that this works for you and I!

Steph

[fitztwins]

I remember when I found out that I could get herceptin, I felt like I had won the lottery!

May Tykerb be your lottery.

[vickie h]

Hi Irene, I am so happy for you. I just had a PET scan that came back with new signs of possible metastesis to nodes on my right hilar region and paratreacheal region. I have been on Herceptin for 2 1/2 years and Avastin for 1 year. I have asked my Onc for options including Tykerb and am awaiting news from him. He has a call into UCLA to see where to go from here. It is quite scary after I thought I was doing so well. I have IBC and have been through chemo twice, radiation twice and will see what happens next. I have heard great things about Tykerb. I wish you the best, Vickie H

[IRENE FROM TAMPA]

Thank you all for your constant support through all of this. I am almost afraid to get too confident since I am not on it yet....but

I did have the encocardiogram last Friday (all was good) and I am having a CT scan tomorrow and that should be all for now. My oncs office has not received the drug yet but hoping to this week (I call and check with them every day)

I was not checked specifically for Her1 although I know that Tykerb is suppose to target those also.

I am not quite sure when this office applied for the EAP program but am assuming it was as soon as it was opened up for compassionate use which I think was a couple of months ago. I can find out when I go this Thursday. and yes Lisa, they have had paperwork going back and forth for a while (this is why I am so anxious since it seems to go on forever) Everytime I call the co-ordinator there is another piece of paper she has to send. I will meet with the co-ordinator in the office on Thursday and if they have all of my test results back, they have to fax over to GSK and have me documented with tumor size, then and only then can I start on the chemos. This week is 7 weeks without chemo for me so you can just imagine how I am bouncing off the walls (and I am a pretty patient person) . I can only imagine how big my tumors must be by now.

I think that if you are approved for the EAP program you will be taking Tykerb with Xeloda. You will bet both on this program. The Tykerb with or without Herceptin I believe is a trial being conducted.

I will certainly let everyone know the outcome of this week and wish those of you waiting the best of luck and speedy acceptance.

Take Care

[Joe]

Heres the latest from GSK:


Hi Joe,
The latest US update is that we have 9 sites active and 10 patients enrolled.
As you know sometimes site approval is longer than 2 weeks as it takes a while for contract negotiations, reg doc submissions and IRB approvals.
For patients who are being screened for the study, it could take up to 2 weeks, depending on what testing needs to be done for the patient and the time frame in which these tests can be scheduled.
All patients must have progressive disease with scans done within 2 weeks of study entry to confirm this progression, as well as an ECHO or MUGA scan to confirm that the subject has adequate cardiac function. If these can be done, and results gotten back rather quickly at an institution, the patient could probably be treated in less than 2 weeks. If not, then it could be up to 2 weeks from consent to dosing.
Hope this answers your questions.
Thanks and take care.
Cathy

[StephN]

Dear Irene -
I have been following your posts on trying to get Tykerb. And you always mention that with no chemo those tumors must be taking off. This is an absolutely normal and reasonable fear. (Most of us think that with every little new ache and pain anyway ...)

Think of the half life of those drugs you are just off of and know that they have been there attacking cells. We know they were not reversing the progress, but you may be somewhat stable right now. That is my hope and prayer for you.
Can't remember if you do tumor markers or not, but my message is that I am thinking good thoughts that your scans will only show the progression necessary to get you on the new drug.

Make sure you have lots of "comfort food" since you can't eat before the scans!

[al from Canada]

Joe, correct me if I am wrong however, a lot of the patients seeking Tykerb are looking for a "salvage" regime so isn't 2 weeks pushing the elvelope just a little?Al

[Sherry in WV]

Good LUck!!!! I go today to start the process.
sherry

[IRENE FROM TAMPA]

Yipeee for you Sherry and much good luck. Let me know when you get started.
I am still waiting but getting closer.

[vickie h]

Good luck, Sherry. I will be goping to The City Of Hope next week and will try to get Tykerb also. Please keep us all posted. Love, Vickie H

[Sandy H]

I am so happy for you Irene. I sure hope it comes through. I am frustrated thinking of those that need it and it is taking so long to get it. My doctor applied June 12th and the IRB is working on it. I need it but not as bad as some on this board. That is almost two months now and it doesn't look like it is coming in the next couple of weeks. It may not be until Sept. Now, I can see why some people don't live long enough to get these drugs. Sorry, if I sound negative but never realized how long these drugs really take to come through. The last I was told last week is that the IRB is sitting up protocal on how it is to be given. I have had a muga but no cat scan or signed any forms. Mine are skin mets and therefore do not show on any scans or markers. It is still very active disease. I know my oncologist is doing all he can and he will start screaming pretty soon if need be. For those that don't have an agressive doctor I feel bad. We have to be our own advocate. Wishing you well Irene and keep us updated as I know you have. hugs, Sandy