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Old 03-27-2012, 12:30 PM   #17
phil
Senior Member
 
Join Date: Nov 2010
Posts: 393
Re: TDM1 EAP - Good news for those in TDM1 EAP study who need to travel

My wife, Lorraine, is doing great on it, just started her 17th month. You can see her on youtube ' FDA Blocks Life -Saving Cancer Drug ", Part 4. ( google the petition by the same title, sign and pass on ). While there , take a look at peter in Part 3. hes doing great on the pertuzumab/t dm-1/taxol trial. Where evryone gets t dm-1 . The next best trial is Theresa, becuase 2 out of 3 get t dm-1. The other trials are 50/50 .
If your cancer strongly overexpresses her 2, t dm-1 seems to work better. My wifes FISH Scale measurement of her2 was a 6.0, anything over 3.0 is considered significant.
There is a s/e of platelet drops. my wifes did, and she took a dose reduction from 3.6 to 3.0. Probably should have done it sooner . Her plats barely stabilized in time to stay in the Study. She got 7 doses at 3.6, now has had 11 at 3.0. Hinsight , maybe 4 -5 doses at 3.6 then dropping to 3.0.
We have not been afraid to speak up, to both Gen. top brass, our Partners Health care Insurers, FDA, Congress. pressure put on us to drop to the lowest dose , 2.4 , by Gen. top brass, even by our own doc, who we love, she had never used it, was nervous , . We refused , its Lorraines life, and we want the strongest dose , until its approved, becuase of the rules. We wrer right ! with 3.0 every 3 weeks, plats slowly stabilized at 65,000 -80,000, slowly rising . And most importantly , the cancer shrunk away. No sign of it on CT's since November !
Another consequence of This FDAs' bureaucratic, political , denial of approval , is that pts continue to be forced into trials with rigid dosing rules ( once you reduce you cant go back up ), and timing ( more than 6 weeks betw. doses, and you may get dropped ). So the s/e of platelet drop is made worse by This FDA ! I know this may sound scary, but want people to be informed. It is a great , breakthrough Drug for metastatic her2 . !! QOL is awesome ! Good luck !
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