TDM1 Trials - Questions seeking answers

phil · 02-24-2014, 09:13 AM

my wife has done very well on t dm-1 for over 3 yrs. she is ned. she was on a trial until last month. we left voluntarily to get more flexibiblity . didn't want to to be pushed by trial rules to get tx every 3 weeks. we want more breaks. it would help if u were specific about the hurdle. is it a s/e affecting trial rules ? or a re-ocurence of the cancer . that would be trickier in a trial, altho the fact that u in England are behind us w/ this drug is an issue. the trails for this very effective drug have dragged on for yrs and yrs. ridiculous. we stage ivs' should have more flexibility - to add perjeta to t dm-1 and see if re-occ. is halted . or tykerb.
we have had to fight to stay on the drug since early on, learned to be a " squeaky wheel ". always using the ' response card ", we are getting good response , in our case ned , or in other pts stability , so we pushed to stay on . first it was low platelets , aggravated by sepsis related to old stents put in from previous cancer that t dm-1 wiped out. so we argued for extra time, arguing that sepsis aggravated plat. issue. and they gave it . we reduced dose to 3.0, but fought lowering it any further , based on response. we argued to get drug when plats went below 50,000 even tho trial rules said 75, 000. and we were part of change in rules that allow tx below 50,000. we went to the Press and our pols early on as we had to travel to Wash. DC from Boston to get the drug. see my wife Lorraines ' story at www.stageivsurvivor.webs.com Speak Up for Stage IV Rights !

mcjr4djxXx · 02-24-2014, 09:36 AM

Hello Phil,

Great to speak to you I have read a lot of your posts and I am so happy for you and your wife Lorraine.

I do apologise I should have made myself a lot clearer, the hurdle we face is an increase in the size of one of the nodules in her lungs, its seems incomprehensible that someone should conclude that TDM1 is no longer working based on this and this alone when just 3 weeks things ago things were as good as they could be. Her bloods have been brilliant, we have seen decreases in the sizes of various other nodules and hardly any adverse side affects, this is a strong as I have seen her in 2 years!!!

We want to fight this, but I am new to this. I have never had to face cancer up until now and I want to give this everything I have got because I can't accept that this is the end of the road! We have looked into the harmful effects of radiation giving off during CT scans, could this be a potential reason for the increase in size seeing as she is having to have them every 3rd course...I don't know!

Thank you so much your response!

michka · 02-24-2014, 10:41 AM

Hello Mandy. I read that Kadcyla (TDM1) was announced in the UK this month. This should allow you more flexibility to discuss with the oncologists. Maybe you can ask for a re-scan in 2 weeks? Just to check and have time to think.
How big is the nodule and how much did they say it grew?
Michka

mcjr4djxXx · 02-24-2014, 12:38 PM

Hello Michka,

Thank you for your response.

Yes you are correct TDM1 will be funded by the National Cancer Drugs Fund, so we will definitely ask the question with the oncologist.

It is just so sudden to have gone from everything being as good as they can be to being withdrawn from the trial! I believe there has been a 6mm increase. There has been no mention of observation, no discussion of further investigation basically that this is the end of the road!

I would like to find if anyone on the trial had to declare that they had exhausted all other forms of treatment in order to be accepted?

Once again thank you for your responses and getting back to me so quickly

Mandy