T-DMI information

[Ellie F]

Hi
I have read a number of posts about members on trials of T-DMI. This is not currently available in England and my onc does not seem to have much information about it though I noticed they are opening more trials in America.

I would be really grateful for any information such as how often it's given, what the side effects are and do you loose your hair!

Many thanks
Ellie

[Kim in DC]

Hi Ellie
I have been on TDM1 since Dec. The trial that I am on doses every 3 weeks. I believe Barbara's trial is a weekly dose. Some of the side effects are elevated liver enzymes, fever/flu symptoms, back aches but no hair loss.

Based on the results so far there is about a 40% response rate. For the ladies on this list it has been feast or famine for the most part. Either the response was excellent or none at all.

[Missyw]

Hi Everyone,

Does anyone know if the trials accepting new patients? Kim, I am in the DC area also and would love more info. about your trial experience. Thank you so much.

Missy

[Barbara H.]

There is a new TDM1 trial opening up in the next few weeks. One site is the Dana Farber in Boston. Perhaps you could call Dana Farber or Genentech to see where the other trials will be held.
Best wishes,
Barbara H.

[schoonder]

Here's link to a number of t-dm1 trials that might be of help.

http://www.clinicaltrials.gov/ct2/results?term=t-dm1

[chrisy]

Ellie,

Back to your original questions, Kim was correct

In the Phase I/II trials, there were 2 dosing schedules. Either weekly or every 3 weeks. In either protocol adjustments were needed (skip a week on the weekly trial, or go to every 4 weeks instead of 3) for some people due to side effects (low platelets or high liver function tests, etc.). I have not seen any efficacy comparisons on if one was "better" than the other - too soon for that.

The most common problematic side effects include low platelets (which recover quickly for most people) and elevated liver enzymes. I also have a mild "flu like" reaction (fever, headache) and mild neuropathy. Overall it's much more easily tolerated than chemo, but tougher than plain Herceptin. You do not lose your hair on this therapy.

Efficacy has been good statistically - in the trial results that have been reported, many of the people had been "heavily pretreated" meaning multiple chemos, herceptin and tykerb. So 40% response rate in this population is really good.

[Jean]

Hi Chrisy,
I am so glad that you are having good results (and everyone else also) on the T-DM1...I have been following the information and I am so pleased to hear that 40% are having response - that is promising indeed.

I have a question. Do you have any idea how many trials...before it is released as standard treatment?

Wondering since it is going so well how fast will it be
tracked.

Best Wishes,
Jean

[runtolive]

kim/ congrats on your doing so well on tdm1..


jean, roche/genentech has made public that they expect to file for approval for tdm1 in q1 / 2010 with an expected approval around q3-4 / 2010.

based upon results of the phase 2 tdm1 for patients who have progressed on tykerb. that study is considered as a 3rd line treatment, but once approved, docs will be lining up to prescribe it for those who need it, or whose insurance will cover.

[Carolyns]

Hi Ellie,

I am also interested in TDM1 and hoping for a trial to open for me soon. I just stopped treatment today and will need to make a move in the next couple of weeks due to progression. I noticed that they have trials listed in both Italy and France.

I hope you get the information that you need and that TDM1 comes near to you soon.

Carolyn

[Joe]

Ellie,
There is one in England:

http://clinicaltrials.gov/ct2/show/NCT00934856?term=t-DM1&rcv_s=07%2F01%2F2009&rcv_e=07%2F23%2F2009&rank=2

Regards
Joe

[Ellie F]

Thanks Joe, probably not eligible for this one but will keep looking. Still find it hard that we are so conservative in England about trials. There was an earlier one that was advertised as being available in England but when I rang they told me that the oncologists had changed their mind!
So I have not yet given up on a visit to your side of the pond!
Cheers and thanks again for thinking of me
Ellie