Has anyone been on TDM-1 for more than 2 years?

waterdreamer · 08-31-2013, 11:58 PM

Hi beautiful brave ladies,

I want to know if anyone has been on TDM-1 for 2 years or more, and if so how is your body tolerating it? Have you experienced an increase in side effects?

I have been on TDM-1 since the beginning of June 2011, and my cancer has remained stable. Sadly I have permanent damage to two of my bones from previous mets, and so I will never be NED.

I am thinking of stopping the trial I am on, and just switching back to Herceptin, until scans show progression.
The side affect that is hardest for me, is the shortness of breath and the fibrosis that has occurred in my lungs. Other side affects are dryness of all the mucosal surfaces of my body, eyes, mouth and vaginally. I am also having pain in my feet and neuropathy. Lastly there is a rash on my chest, which comes and goes with the stage of treatment I am at. I will be making this decision on Thursday with my doctor.
Also, has anyone had a hard time getting their insurance to pay for Kadcyla (TDM-1)?

Thanks
Fern

michka · 09-01-2013, 01:06 AM

Hi Fern. What is your TDM1 dosage now? Michka

Kathy T · 09-01-2013, 05:50 AM

I've been on TDM 1 for 4 years. I have problems with low platelets and liver issues. I am not NED, but stable.
Kathy T

waterdreamer · 09-02-2013, 12:20 AM

Hi Michka,
My current dosage is 3.0 and I do not think I will be able to get a lower dose on trial. What dosage are you on?
Fern

michka · 09-02-2013, 08:09 AM

My dosage is now 2.4. I am in the Theresa trial. TDM1 is not announced yet in France. I first was on 3.6 for 10 rounds then on 3.0 for 8 rounds and since April I am on 2.4 It is the minimal dosage allowed for this trial.
I already wrote about my SEs. The doctors decided to lower the dosage because of the breathing problems but also the fatigue.
The 10 first rounds were really tough for me. The first dosage reduction made me feel better. I could get up but I was still very tired and handicapped by my breathing. The second dosage reduction made a big difference. I still feel TDM1 is very toxic for me since I have pain fatigue neuropathy nausea and dryness. (and other minor problems) but I can live much better.
I do not know how much time the doctors will recommend us to take TDM1 and I figure they do not even now. I do not want to stay on Herceptin alone since I know it doesn't work for me and I am afraid to stop TDM1.
I however understand your question so well. I dream I could stop but I know I cannot. I also know how lucky I am TDM1 is working for me.
Fern you can ask for a dosage reduction first before stopping and see if you feel better. The last dosage reduction improved my dryness problems for example. Before it was horrible for my eyes,nose, mouth. Now I can manage.
Kathy you give me hope with your 4 years on TDM1. What does stable mean in your case?
Phil, do you have an opinion? You are our TDM1 "specialist".
Love to all. Michka

SoCalGal · 09-02-2013, 09:14 AM

Another idea - space out the infusions to monthly and see how you do. I think that we all can get by with every 4 weeks instead of every 3 weeks. That is strictly an opinion :-) Something I am now doing with my regime. Last cycle, due to s/e's I waited 7 weeks and my markers went down. This is just not an exact science.

Del · 09-02-2013, 02:40 PM

I've been on T-DM1 for 3 years now on the Emilia trial. Great to hear Kathy that you've been on it for 4 years! I'm the longest running patient at my hospital, so it's great to hear others have been on it for longer! I'm questioning if my side effects have been increasing lately. Usually I just have dry mouth and occasional tingling in 1 finger, but lately I've been having slight nausea for 2 days, and loose bowel movements for several days after. I am on the first dose reduction, as I had really high liver enzymes with the max dose. I'd be nervous to go off of T-DM1, as Herceptin alone stopped working for me (although it did work by itself initially for 2.5 years).

Kathy T · 09-02-2013, 03:23 PM

Michka, by stable, I mean my bone mets have not improved, buts have not worsened either.
Kathy T

phil · 09-02-2013, 06:20 PM

fern and I have talked regularly, and I left her a message w/ our thoughts. its nice to hear from so many that are doing so well, 4 yrs !! I don't know how " expert " I am , so many on the boards are more scientific, more adept at finding , reading trials. I am an " expert ' in how This FDA since 2009 has slow-tracked life saving drugs , cost thousands of lives. you all are " Living Proof " of how their System is too slow, and ignores Stage IV Rights.
OK , speech over for now . Fern, our trial lets you reduce to 2.4. maybe try that . we have good ins., so we may get off trial to get more flexibility - every 4 weeks for ex., but our doc made a face and said 4 weeks is "not standard " , and made it sound like she'd need her superiors ' approval. so check w/ your doc. each hospital is different. check ins. co. rules. we have strong rules here re ins .coverage. we are a universal health care state.
so far we have gotten exceptions a no. of different times to get tx' ed every 4 weeks , sometimes 5 weeks. based on low plats. and we welcome them , want more breaks in tx. so we stay on the trial ( extension study ) for now. Lorraine has few s/e - plats in 60's to 70's, fatigue, neuropathy in feet.
we are afraid to reduce , fear cancer may come back, for L. Herceptin alone was never enough .but..maybe cancer is truly gone ? so we go on, cts last week were again ned, next ctts in Nov. 2 full yrs ned will come in Nov., 3 yrs overall great response will also come in nov.
I might try herc/perjeta. 2 pathways shut off. herc/tykerb involves tykerb , w/ its diarrhea , not pleasant qol . Good luck , happy to talk more anytime !

phil · 09-03-2013, 08:14 AM

More thoughts , info - Lorraine reduced dose to 3.0 back in 2011, after 7 doses at 3.6. low plats . still worked well. we get regular breaks , usually due to low plats. last week we delayed tx due to bilrubin of 1.6, over level of 1.5 in study rules . its liver irritation from the drug . but we like to take weeks off. we are in it for the long run, preserving bone marrow, liver . this week MGH infusion is full due to holiday , so we will go to next week. that will be a 5 week break . Loraine has had 38 doses total , starting in Nov. , 2010. To give you an idea - last dose was 8/8/13. previous dose was 4 weeks back , 7/11. dose before that was also 4 weeks - 6/14. 3 weeks before that .
we plan on staying on strong a dose as possible , watching physical s/e, for as long as possible . until something better comes along. we stay on the study for now , becuase they work w/ us, and Lorraine likes the security of the familiar. even she is now thinking more and more about leaving the study , if our hospital will give us more flexibility . we will check that out very carefully before we go. we want to keep a safety net level, hoping to prevent any mets, any brain mets in particular.
Genentech monitors these boards , so here's a message to them " Love your drug , and appreciate the flexiblity , personalized tx., but we want more flexiblity , based on these great responses " . Thanks . So , God continue to Bless you all - ALWAYS be the " Squeaky Wheel ! "

Redwolf8812 · 09-03-2013, 08:38 AM

Thanks for all your info, Phil. I have a question. How are Lorraine's AST and ALT's? I also have mets to the liver and mine are creeping up, although the bilirubin is fine. Thanks.

- Penny

schoonder · 09-03-2013, 09:39 AM

Phil, since t-dm1 doesn't cross bb barrier and drug's effectiveness prolonging life, and thus increasing possibility of disease metastisizing into brain, I'm somewhat surprised that Genentech which is conducting so many clinical trials with this product isn't conducting one in intrathecal setting. Understand that a number of patients with their oncologists on this Board are conducting some tests which require huge doses of herceptin, not sure why t-dm1 which has a proven trackrecord to help fight mBC at other loci, wouldn't be effective in brain. Do you know if Genentech is contemplating such evaluation?

phil · 09-03-2013, 10:10 AM

Lorraines' lfts are alwys a little elevated , due to drug irritation , so we are not really concerned , at least in terms of cancer . Similar to how we feel about bili. We like breaks in tx as lfts, bili drop.
I don't have her exact no's here, but Lorraines' lfts are often 55 + in one , into 80's - 90 in the other , even over 100 . we take 1 -2 week break , and they drop .
as far as brain tx, i dont know, but the emtansine is a toxic chemo , un-like the biologics like herc and avastin. so that may be a factor.
I wish they would get Marianne finished up so we can compare t dm-1 to taxanes in first line tx. the small trial just completed says t dm-1 outperforms herc/taxotere. and I wish This FDA would open up full approval for perjeta to stage ivs's . They are SO SLOWWWW, they are " killing " us , ( not intentionally , but...) and no advocacy grp speaks up.

yanyan · 09-03-2013, 01:32 PM

Hi Fern I have been on Kadcyla since May and have had 5 infusions. My major side effects are low platelets and very heavy menstruation since cycle 4. I haven't had any problem getting Kadcyla approved from my insurance company as this is already an approved treatment for Her2+ who have progressed on herceptin and tykerb. Genetech does have a patient copay assistance program if you have PPO. Your doctor's office can apply it for you or you can call them directly. The standard dosage is 3g/kilogram if your plateles are 75,000+. I am in Southern CA also.

waterdreamer · 09-04-2013, 11:58 PM

For the present time, my doctor is holding the chemo. After we have the results from the CT scan of my lungs, then she will go ahead and advise me of my options. I will keep you updated. Thank you all so much, for sharing. Hopefully it will help others that travel the same path we are on.

Best wishes
Fern

waterdreamer · 10-03-2013, 10:49 PM

So, the results are in:
Bone scan, small area of tracer uptake on 1st left anterior rib.
Brain MRI - Clear (Happy dance)
Chest, Lungs Abdomen CT - Chest shows hilar lymph node or lung nodule enlargement, liver shows 2 small hypodensities and 3 other quesionable subtle hypodensities. I wonder if this is a side affect of Kadcyla - since it irritates the liver so much, or the start of liver metastasis?
Also interesting to note that there is partial fusion of the left SI joint.

I have really enjoyed my 5 - 6 week break from all treatment, but tomorrow I go in to see my doctor to discuss the various options and what our next game plan will be. I am so done with this cancer, I want to get on and live my life - I am regaining my teaching status as a scuba instructor and I don't want anything to interfere with that on the medical front...
I will update soon..
In the meantime, all of those on Kadcyla, make sure to drink a lot, and take potassium/magnesium for cramping.

Wishing you all a restful nights sleep
Fern

phil · 02-19-2014, 06:11 PM

just an fyi to those on t dm-1 one yr plus. Lorraine has developed some varices ( varicose veins) around liver, spleen . some blood not getting thru . had biopsy and preliminary report is its a smaller issue , Thank God. biopsy says no cirrhosis, and good outflow pressure from liver. from t dm-1's chronic liver irritation .so we reduced dose again , to 2.7. liver varices developed sometime in early yr 2. small, not spotted until a few months ago , at end of yr 3 . now 3 months into yr 4 . if u have been on drug long term and have high lfts, alt/ast counts up to 100 or so. lorraines' liver counts would go down when given extra time betw. doses so we didn't worry , until now. share this info w/ your doc.

michka · 02-20-2014, 02:29 AM

Hi Phil, thank you for sharing. I am sorry Lorraine has this new se. I hope the dose reduction will stabilize the situation. I am happy they told you it was not a big issue. Did they explain why this happens if there is no cirrhosis and a good outflow? Maybe they do not know.
I am on round 33 ( 22 months). My liver counts keep increasing and increasing. I asked several times about liver toxicity but got no answer from the oncologists in the clinical trial dept.
How were these varices found, With what kind of exam? How can I check that?

I have been wondering for months how long I will be able to stay on TDM1 without toxicity. My breathing is much better since I had a treatment with a powder cortisone inhaler. It seemed to have fixed a chronic inflammation of the small bronchi (is that the right word?). Now I do not need it anymore.
I have digestion problems that led me to take out all fat out of my diet. Liver?
I am still exhausted, but my last scan last month was still good so I cannot complain although I dream of stopping chemo.

Michka

phil · 02-20-2014, 10:45 AM

The varices were picked up on 4 month ct scan 2 scans ago - 6 months . splenetic varices ( spleen ) were mentioned , buried in body of report. noone noticed. i think because they are small and as our onc says now, " we all have been focused on looking for cancer " . then in next scan in Dec. i saw a mention now of esphoageal varices, and splenetic . again buried in the body of the report . radiology focus on an" opacity ' in a lung which turned out to be nothing. plus mention at length of no mets seen anywhere. which is great but...from my work as an addictions specialist i recognized esophageal varices , as they are common in late stage alcoholics , when they are extremely swollen and rupture you die. so, i asked , and the onc and nurse looked at it again , and sent us to a liver specialist . he checked all scans closely , knew what he was looking for , and told us they were there since late 2011, about a yr on drug. he ordered biopsy , but noone seems acutely alarmed, which is good.
so anyone w/ long term liver irritation, from t dm-1, plus a hx of a lot of liver mets, which is lorraine , should make sure liver scans are looked at closely. because of low plats , L. has taken many breaks from the usual 3 week cycle, 4 -5 weeks , and she has been on a reduced dose at 3.0 since near beginning ( 8th does on ) . that may have helped keep thse varices small. know your hx ., and check w/ your doc accordingly. i heard of a pt. who had a great response for 2 yrs from herc/perjeta , had a hx of bone mets, yet their doc stopped annual bone scans , for over a yr., now has significant bone mets back . now on t dm-1.

KeriK · 02-21-2014, 12:47 PM

Hi my kadcyla sisters
I've been on it for 14 months, 3.6 dose and have only missed one treatment when I had opherectomy I had that done due to my very heavy and never ending periods! Ugh so no more periods, now just menopause symptoms. I have gained 17 lbs since going into immediate menopause!! With no changes in diet or exercise!! Is it kadcyla or what???
My main s/e is dry mouth dry eyes, blurred vision. My last scan, 12/13, showed colitis too.
My newest s/e over the last 6 wks has been constant joint pain. I have always had it the first few days after infusion, but lately it's not going away!!
My liver counts have always been in the 20's. I do take milk thistle, drink dandelion tea and wheat grass shots twice daily. I read a lot about those helping to detox the liver
And to help my heart and breathing, I take coreg twice a day, diovan once a day for heart protection and make sure I walk, bike or swim at least 30 mins a day, 4 times a wk. I had major issues w ef decrease on herceptin but no problems w tdm1