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Old 05-08-2012, 09:47 AM   #21
phil
Senior Member
 
Join Date: Nov 2010
Posts: 393
Re: TDM1 EAP - Good news for those in TDM1 EAP study who need to travel

The best trial in my opinion is at Sloan in NY, Farber in Boston, where t dm-1 is given in low doses , w/ taxol unfortunately at first. If you respond , they drop taxol. And 50/50 chance of getting pertuzumab too. We have seen quick responses in folks who highly overexpresss her2 ( FISH scale over 3.0 ), whether they get pert and taxol w t dm-1 , or no pert , just taxol/t dm-1 together . t dm-1 is the main factor, and in this trial everyone gets it !
The other trial that I know something about is Theresa, you have to have progressed on at least 2 previous her2 targeted therapies, herceptin, tykerb would count . In theresa 2 out of 3 get t dm-1, but the third gets " physicians best choice ". So, thats a gamble that you might not want to take if your cancer is rapidly progressing. Lorraines was, and she got into access before they closed it.
Have you had a taxane ? , like taxol ?or taxotere, abraxane ? Some docs might want you to try those first. Bad s/e, but effective , and t dm-1 should be out w/in a yr , or less.
Another option is compassionate use. Esp if youve progressed on a taxane and tykerb, definitely. Gen. top execs have been very rigid about it , denying it 100 %, but now that the main trial " Emilia " , that This FDA forced them to finish before approval would even be considered, is done, Gen. may ease up . Nothing to lose, be ready to go public if they give you the runaround.
Most docs are skittish about comp. use , so most go at it half -heartedly, dealing w/ Big Pharma isnt something they relish. So, you have to push docs . This FDA will stand on the sideline, let you bargain w the co., then ok it , if co. does. What a racket our govt is ! Start w/ calling Genentech, 888-662-6728, ask about trials , good luck !
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