Questions about TDM1

[jml]

Hi Friends~

So, this bumpy journey goes on...
Can those of you on TDM1 offer any info and wisdom about how you're doing on the TDM1 regimen?
Which trial are you on?
Is it a hard regimen and are there lots of SE's?
Did you lose your hair?
I can't find much info about DM1, so would much appreciate your help.

After an intial partial response to Tykerb/Xeloda, shrinking sternal nodes & knocking down the SUV,
things have done a 180, in the wrong direction:(
My scans on Tuesday show that not only has the T/X combo stopped working for me-after only 16 weeks- but
my disease has progressed further than it has in years.

2 new spots in my liver- the L lobe this time. I had a R hepatectomy in Dec 05, and I'm strangely relieved that it's not on the "new" side. Regardless, it's disheartening to learn that my poor liver's been hit again, especially since I've been NED in my liver ever since the resection 4 years ago.

I have been battling recurrent mets in my supraclav & sternal nodes, and since the Herceptin + Gemzar didn't clean things up completely, and the sternal nodes recurred pretty quickly after finishing - or so I thought - H+G, we decided to try something completely new.
That's when I switched to Tykerb/Xeloda.
I guess that wasn't such a wise move, but how were we to know?

The added complication is that there are also nodes throughout my belly, causing all kinds of problems, including stricturing my kidneys/ureters and colon-causing everything to slow down in there.
This is the 1st time I've had discomfort directly due to this stupid disease. I hate stupid cancer.

So, clearly, Herceptin is still the right drug for me and I've already started back on Herceptin and had the loading dose on Friday. We just need to find the right combo to help knock everything back again.

Now we seach for a new regimen for me.
I'm really hoping to find a TDM1 trial that I will qualify for, so in the meantime I'm looking for more info.
And if I'm going to lose my hair again - for the 3rd time - I need a moment to wrap my brain around it.

Thanks in advance for your help.

Keeping the Faith~

Jessica

[Rich66]

There is some suggestion that changing the Xeloda dose to a metronomic (http://her2support.org/vbulletin/showthread.php?p=214879&highlight=capecitabine#post214879) (without break week)approach may maintain the efficacy. A lower dose may make that possible, as strange as that sounds. The Tykerb might not be the problem.

[Carolyns]

Hi Jessica,

I am sorry to hear your news. It sounds like you have your dukes up and you are ready to get this turned around and headed back in the right direction.

T-DM1 - I am on it now since the end of August. It worked well so far for me according to the first set of scans. The trial that I am in is T-DM1 and it allows for Pertuzimab to be added by the 6th treatment if there is progression. This trial is Phase I / Phase II and I started at Karmanos in Detroit and have since transfered back home to South Florida.

I have not lost my hair and the treatment allows me to continue my normal life. I had a bumpy start and did have a reation to the first treatment but I am one of very few that had this type of issue. Most do very well on the first dose and following doses.

Good luck to you!

Carolyn

[kk1]

check out this TDM-1 trial in Hollywood FL
http://www.clinicaltrials.gov/ct2/show/NCT00943670?term=TDM1&rank=6

[Kathy T]

Hi Jessica,
I am also on TDM-1--the same trial as Carolyn but not the same location. It has not been a difficult drug so far--no hair loss, some problems with chilling and nausea after the infusion, but very tolerable. My bone scan was confusing indicating either disease progression or tumor flare so i'm not sure if it is working but I hope so. I hope the best for you.
Kathy T

[chrisy]

Hi Jessica,
I've been on TDM1 since Feb 08, open label single agent study which is not currently recruiting. I think they may be reporting out more results from this trial at San Antonio in the next couple of weeks.

The main SE's for most people on TDM1 is low platelets (which generally recover quickly) and elevated LFT's. I've also experienced mild flu-like symptoms a couple days post-infusion, and minor neuropathy. I had a stronger reaction to the first infusion also.

It's not a hair-challenging therapy by itself; although some of the current trials combine it with chemos that may cause hair loss.

I've had great success with this agent, as have many. It seems to be very effective for those who have done well on Herceptin in the past so if you can get in a trial, it's definitely worth a try!

By the way, last year at San Antonio I saw some data looking at which factors predict response to Tykerb and to Herceptin - and there were some differences. So if Tykerb did not hold you that long, that's not an indicator that TDM1 would not work. In fact, I came directly off a Tykerb/Avastin trial (with fast progression) into the TDM1 trial and it worked great.

Good luck, hang in there!

[Sheila]

Jessica
Just wondering if you have tried Herceptin with Tykerb....and no Xeloda, they are reporting on that in San Antonio too.....I dont want to jinx myself, but when I didnt get into the clinical T-DM1 trial, I did finally get the approval for the Tykerb with my Herceptin....I just started my 3rd week, 5 pills a day and Herceptin every 2 weeks, the nodes in my neck, axilla and chest are already half the size they were! This might be an option....many of the current T-DM1 trials exclude you if you have had Tykerb or Xeloda. This might work if you cant get in.

[StephN]

Great suggestion, Sheila. And wonderful news that the combo is attacking those nodes. YAY!

Jessica, you have been in this fight for a long time, too. Can you run Sheila's idea with her results past your doctor?

Maybe your doc could even have a chat with Sheila's doctor.

I make this suggestion if T-DM1 is not an available option right now.

[chrisy]

Sweet, Sheila! Flori's had great success on the Tykerb/Herceptin too. I'm looking forward to the update at San Antonio!

[Barbara H.]

Hi Jessica,
I was on the T-DM1 trial for two years. I just went off of it this past September because it was causing inflammation in my lungs as a side effect. However, it was still doing its job and I would consider trying it again with careful monitoring once it becomes approved.

I have written a few posts about it. You can check out my old posts.

Best wishes,
Barbara H.

[jml]

It's like the clouds have parted with the weight of your wisdom, advice, compassion and encouragement showering down!
Thank you so much, everyone, for everything.

Yesterday I had the procedure to place the stents in my kidneys/ureters to keep everything open and flowing, in spite of the met/nodes down there that are clogging everything up, and I'm READY TO START SWINGING!
I had not thought about adding the Tykerb to Herceptin, and since I've been approved by the Pt. Asst. program & am getting it for free, this sounds like a great and reasonable option. I'll send a note to my doc. In the meantime, I'll continue to research the TDM1 trials that might be accessible to me. Hopefully, TDM1 will be available to all of us soon enough.

Thank you again everyone. I can give my brain and anxiety a rest and confidently turn to you guys for guidance and wisdom.
So much to be thankful for this year, and every year~

Keeping the Faith~

Jessica

[Kim in DC]

Hey Jessica,
I am at the end of one year on TDM-1. I have a sternum met and a soft tissue met right behind the sternum. The soft tissue has shrunk and the bone met has remained stable. Like Chrissy, I get flu like symptoms 3 of 4 days after treatment. Other than that I feel fine.

[Ellie F]

Hi all
Can I ask a related question from all my knowledgeable her 2 t-dm1 sisters.
If you are on the trial and t-dm1 gets you either back to NED or there for the first time do you continue getting it or do you have a break?

Hope this isn't a silly question but I have been pondering it!

Ellie

[Chelee]

Ellie, Great question...I wanted to know the same thing for a while now. Sure would be nice if it would keep one stable long enough, or in remission to have a break here and there.

Chelee

[Barbara H.]

Hi Jessica,
Generally you can not take a break on this trial just because you reach NED. Of course, you can elect to discontinue the trial. I was on the weekly trial and was able to skip a week to visit my parents or to take a week off for a trip, but I only did it a few times. I also missed a few treatments when I had a lung biopsy last year.

I am doing very well on Herceptin and Tykerb, but still regret having to go off this trial. It was very effective for me.

Best wishes,
Barbara H.

[chrisy]

Barbara is right, you do not discontinue within the trial - although I saw in one data abstract that at least one patient left the trial after becoming NED.

If TDM1 were available outside a trial I would consider dropping it or better yet trying to combine/alternate it with some other stuff. But as it is NOT available, I so far am choosing to stay in the trial. Long term I'd love to try and partially wean myself from it, so as to "save it" for later if necessary.

[Ellie F]

Thanks for your posts.I understand your point about staying on it as it's in a trial.Hopefully the data will be so good that it will soon be available, which will as you say allow oncs more freedom about how to use it.

I would like to send thanks to you all for your part in these trials which will ultimately improve things for so us all
Ellie

[Ellie F]

Thanks Kim
You look the picture of health in your photo which is really encouraging.
Did you base your thoughts about remaining on T-DM1 for 5 years on some research?
Are the liver side effects thought due to the chemo component rather than the herceptin part?
Many thanks for your advice. As T-DM1 has only just arrived in trials here in England I am so glad I have my friends in the States to turn to for information.

Ellie

[Kim in DC]

I was on Herceptin for 3 years straight without any liver problems. I had elevated liver function test after the first treatment of TDM1 so I figure it's the DM1 portion of the drug.

As a drug rep and cancer survivor, 5 years is usually the point where they start to evaluate the possibility of a drug holiday.

I was wondering if any of you ladies are having any GYN problems (if you are premenopausal). I get a cyst almost every other month on my ovary. It always freaks the radiologist out because I am a cancer survivor. I would never have known this if it were'nt for the frequent scans. I also have 2 large fibroids. I will probably have a hysterectamy within the next month. Its funny, but if its not cancer, I'm not freaked out about it.

[chrisy]

Hey Kim,
nice to hear you're so well-connected!

Re the liver SE, I'm also a bit concerned about that; in my case it eventually got quite a bit better - my ALT has actually been within normal limits lately and my AST and some of the others are still elevated, but not as much. So I'm less concerned about long term effects for now.

I hear you on the other stuff - I also have large fibroids and somehow I just really don't care about that!!!

[jml]

I ran your suggestions about adding Tykerb back to my Herceptin & my doc says "yes". I'm feeling more proactive again and hoping this extra punch will help, even though the Tykerb/Xeloda combo didn't.

I've been searching TDM1 trials, but the only ones that are still recruiting are for MBC patients that are newly metastatic with no prior treatment. That's definitely not me:(
I'm still optimisitc that we'll find a fit for me somewhere, and in the meantime keeping fingers crossed that Herceptin + Tykerb will make some headway.

Kim~my sister works for Genentech in So.San Fran - she's a senior MD recruiter for BioOnc, so she's able to ask the brilliant minds at the top of the heap for guidance. AND one of my clients at my Pilates studio is a Genentech rep here in Atl.
Genentech is such a great company & hope that everyone stays positive in spite of the merge...

Thanks again for everyone for your support & suggestions!

Jml