T-DMI = Who is on this? How is it doing?

[julierene]

http://www.kintera.org/TR.asp?a=hiJP...=ojK0K4PJLgL1G

from the LLBC website at www.lbbc.org

[hutchibk]

It got RAVE reviews in all trial results at SABCS. It is one of the next in line options for me should we need to switch to something else.

Chrisy and Irene are on it, I know for sure. They should probably be piping in soon...

[Kim in DC]

I've been on it since Dec. 8. So far so good. I get scans on Friday. I'll keep you posted.

[chrisy]

I am in the trial that was reported at San Antonio. I started Feb 11, 2008 and am due to "roll off" this trial into the follow up trial next month.

This has been a great drug for me overall. I've had, and continue to fight, elevated liver enzymes since starting the DM1. This almost got me DQ'd from continuing the trial back in June, but I fought to stay in because it was working on the cancer. Since October I've been NED or nearly so - the CT still shows some indistinct stuff which is not lit up on the Pet scan, I think it's necrosis or scar tissue.

As noted, my main issue with side effects has been elevated liver enzymes. It also hits my platelets but they rebound quickly, and the week of my treatment I get a little achy/fevery but not severe.

[julierene]

My doc said he has the trial, but that I am not eligible because I have had too many prior treatments. I notice some of you have too, what am I missing?

[Kim in DC]

There are different arms of this trial. Some arms said you couldn't have more than 3 regimines for mets. You need to check for yourself. Go to www.clinicaltrials.gov. Just type in T-DM1. If you think there is a trial you qualify for, contact the study nurse from Genentech and as her if you qualify.

Kim

[julierene]

I only see 2, and I don't qualify for either one because I have had Tykerb and Herceptin and so many other treatments. I still feel like I am missing something.

[runtolive]

they have closed the phase 2 third line study.. which was much more open..

genentech is on the homestretch to approval.. so now they are tightening the requirements to get into further studies..

they have the pivotal phase 3 head to head with tykerb / xeloda vs tdm1 280 pts in each arm.. should be enrolled within 9-12 months

also have first line trial in phase 2 100 pts vs taxotere for newly diagnosed MBC pts..

soon to begin will be a phase 1 trial with tdm1 + pertuz..this will start by june.. supposed to be farely nonrestrictive.

[donalddonald]

HI julierene:

I am from Macao and I am here because of my wife, and I follow the links of this T-Dmi and it led me to this forum.....
I also want to know more about this T-Dmi , but it seems only have 2 trials also not suitable for my wife too .....
but I am glad I am here to share with you all !

[julierene]

Have they released anything about what TDM1 is?

[runtolive]

julie/ tdm1 is herceptin + a toxin... a maytansine derivative attached via a linker to the herceptin..

HERceptin is an antibody which directly targets HER2+++ CANCERS. once herceptin locates the tumors / mets/ etc and attaches to them. the toxin enters/internalizes into the tumor.. and releases its potent poison into the tumor and kills the tumor. IN ABOUT HALF THE PATIENTS, hopefully preventing recurrences. eventually tdm1 will be the gold standard/ replacing herceptin entirely

run

[julierene]

I guess I just have to wonder why Herceptin becomes ineffective and something that is like a hyjacker to Herceptin doesn't? I always assumed that Herceptin stopped working because the cancer had become mutated to a point where all the HER2 receptors were gone. Does that make sense why I am not understanding why this new method is working?

I'm excited to try it. I wonder when it will be out for the rest of us? Sometimes they open things up sooner when the results are so promising. I am keeping my fingers crossed.

[runtolive]

depending on who you talk to.. the absolute soonest that tdm1 could be approved is q-1 to q-2.. 2010. based on the data from the just completed phase 2 third line study that just completed enrollment..

[donalddonald]

i hope it will be on the market a.s.a.p. !

[schoonder]

Maybe Hope Rugo is able to get T-DM1 approved for compassionate use.


“There is just a whole explosion of drugs out there,” Hope Rugo, MD, of the University of California at San Francisco, said in an interview with CURE.
One of those drugs is trastuzumab-DM1 (T-DM1). According to data from a phase II trial presented by Svetislava Vukelja, MD, of Tyler Cancer Center, T-DM1 has anti-tumor activity in patients with previously treated HER2-positive metastatic breast cancer, including activity in patients who have been pretreated with trastuzumab or lapatinib.
Rugo was one of the investigators in the trial, and she explained, in an interview with CURE, that T-DM1 is Herceptin linked to a chemotherapy drug that acts as a toxin. It works by taking advantage of the fact that the HER2 receptor binds to Herceptin and brings it into the cell. “So if the Herceptin has a toxin attached to it, you are delivering the toxic payload straight to the cancer cell. It’s called a smart-bomb approach.” Rugo said T-DM1 has been so effective in treating patients whose disease has progressed despite treatment, her team is looking into the possibility of petitioning the Food and Drug Administration to allow compassionate use of the drug after it enters phase III trials.
Rugo added that oncologists are exploring whether existing drugs could be used in new ways. “Maybe in the future, when we’re combining biologic agents, we can combine oral agents with an antibody. That’s very encouraging, because these are drugs that are already out there,” she concluded.
Read more of CURE's coverage of the 31st annual San Antonio Breast Cancer Symposium at http://media.curetoday.com/htmlemail/sabcs.
http://www.curetoday.com/index.cfm/fuseaction/article.show/id/2/article_id/904

[donalddonald]

compassionate use? could be a good news !

but would it possible for international patient like my wife?