TDM1 dosage

[michka]

Hello all. Does anyone know to what dosage TDM1 can be reduced before being kicked out of a Theresa trial? Michka

[phil]

In the expanded access there are 2 dose reductions, to 3.0 from 3.6 then to 2.4 . Lorraine is hanging in at 3.0 for well over a yr, 2 yrs on drug total. we resist reducing becuase we dont know if cancer is still there. she has been ned for over ayr. plats are the issue , and liver irritation from drug. plats are in 60-s to 70's . L. is now in a rollover or extension study , beyond eap. rules have been flexed for her to have option to delay tx a week ( to 1x every 4 weeks ) , if plats are below 75,000, and hopefully to also liver counts down below 100. lately they have been in 70-s to just over 100.

[michka]

Thanks Phil. My counts are still OK but I am fatigued and have limitation in my chest. The traces they see on the top of my lungs worry me although they say that they do not what it is exactly. They lowered my dose to 3.0 and I hope I will be able to stay on that level. Michka

[phil]

I can't emphasize enough that we must speak up for ourselves w/ these large entities , whether it be Pharma , FDA , etc. More flexiblity in tx , if we are getting a response , even mixed response. extra time for counts to recover. we had to fight down in Va. to stay in eap after Lorraines palt counts crashed w/ sepsis. sepsis from stents put in prior to t dm-1 . nothing to do w/ t dm-1 . we got an exception that took 9 weeks for plats to get to about 50,000. that decisionwas apparently controversial w/ some of the higher ups in eap , but it WORKED ! we have since taken extra time beyond 3 weeks many times. we now can wait a week or so beyond 3 weeks . we had to fight for it , we shouldn't have to , if its working . These are Stage IV Rights issues that we will continue to fight for.
T DM-1 will soon be approved , which should give more flexiblity , it would be nice to pair it up w/ perjeta, or estrogen blockers , but I fear that This FDA will continue to be rigid . Right now Stage IV's can't get perjeta except of -protocol