My Update on 09-093 Trial

[KDR]

Dear Friends,

Here's my update for the 09-093 trial:

The 09-093 trial I have been on for one year has concluded and I remain NED. It was a hard won NED, but no regimen is easy. This trial started with Taxol, T-DM1 and Perjeta. I tolerated it quite well, but the infusions were five hours long when the three drugs were given together, and ultimately, during month three, Taxol had to be dropped due to severe side effects: 1) an SMA, which is an intestinal aneurysm (and it contained a blood clot), 2) near total loss of vision in my right eye which was neuropathy of the optical nerve and, 3) general neuropathy of hands and feet. After the Taxol was dropped, we continued on with the T-DM1 and Perjeta for the next nine months. I needed to use blood thinners for a time and learned my blood was too thin when a nosebleed landed me in the hospital with my face packed for for four days. We stopped the blood thinners. My vision returned and to everyone's amazement, the SMA was gone as well. This is nothing short of a miracle. Arteries just don't dilate and un-dilate.

This trial also required weekly bloodwork and CT scans, sometimes combined with PETs every six weeks. The hardest part has been the hit blood platelets take with T-DM1. Also, I take a dose of 2.4 mg/kg weekly. Part of the study was to determine whether there's more efficacy in weekly or tri-weekly doses.

So, on Wednesday, I had a CT, brain MRI, bone scan and echo done, as you have to repeat the inclusion criteria to continue on the extended study. I had such jitters waiting for the results--we all know how that feels. But, all is clear and I must forge on. The hardest part is the neuropathy, which I have at Grade 2. T-DM1 contains agents that can cause taxane-like side effects. I'm just happy to have my sight back.

Now, I will have bloods done every three weeks and scans every four months. A welcome change indeed. By participating in this trial, I hope I laid some groundwork and have given scientists and doctors and co-patients much-needed information.

I, for one, have been overwhelmed in recent months by the friends I have lost, with special mention to those on our list. I remember Jackie's father's words (no rest for a soldier's daughter) and my own father's words (you are going to be good) in their honor. None of us should have to endure the pain, the interruption of our lives, the terror of scan and test results.

Sent with love for the holiday season and beyond,
Happy 2013,

Karen

[Becky]

Oh Karen, how joyous news to hear. You have endured much to get such wonderful results. But NED is worth it. You are so brave to do such a trial and I am so happy you were rewarded so gloriously. And, you are helping all those who come after you by participating in this trial too. I am so happy for you. Thank you.

['lizbeth]

Karen,

Amen! NED, Forever, please.

Grateful to hear about your experience with the trial. Your progress sounds like another Christmas miracle.

I applaud you for helping advance the treatment of cancer. The more of us that join a clinical trial, the sooner treatments will be available. You are a pioneer and an awesome person. So happy you are NED and I am excitedly anticipating the trial results.

[StephN]

Dear Karen -
WOW - NED, NED and NED again. Love to see that.
I seem to not understand which drugs, if any, you are taking now. Anything?

That clot experience sounds very worrying! It is indeed a miracle that it unknotted itself and normalized.

At SABCS there were a couple of forums on clinical trials. Not any trial in particular, but things like design, how to coordinate end points, how to trial new agents, etc. I recall either in those talks or somewhere else a startling statistic.
ONLY 3 - 4% of all cancer patients enter clinical trials.
I was stunned - really thought it would be more like 10%, including the vaccines and everything else.

No wonder some trials take forever to accrue enough patients, and SOME have to be abandoned for lack of accrual! There was major appeal to the doctors in attendance to do a better job of participating and enrolling patients in trials.

So, you get a gold star for participating and doing the hard work. And I KNOW the work is hard, but the end result can be many years of NED. Happy New Year dear friend.

[michka]

Dear Karen. Thank you so much for sharing. First let me tell you how happy I am you are Ned. I remember being so worried when you were trying to enter the trial and then so amazed it worked so well and so fast but you never really told us how difficult it had been. I understood that bad neuropathy led you to drop Taxol but I did not know it even hit your eye! And that SMA!
You are so courageous. I am asking myself how the oncs determine what side effects come from what product? The second question is about that TDM1 dosage. It is so high if you multiply by 3. It is the double of a 3 week dosage. Am I right to calculate that way? How do they know if it is not that dosage that brought you Ned and not the combo?
Thank you for the info about neuropathy. I have residual neuropathy from my first treatment with Taxol and it is getting worse in my feet. I hope it will stabilize because I am now on a lower TDM1 dosage.
What is the "extended study"? Perjeta + weekly TDM1? For how long?
Karen, your post gives hope to many! Hugs. Michka

[KDR]

Friends,
Here how the trial started:
December 2011: Taxol (weekly), Perjeta (every three weeks), T-DM1 (weekly).
February 2012: Drop Taxol. Continue both T-DM1 and Perjeta.
December 2012: Enter extended phase of trial. Continue T-DM1 and Perjeta.
Hope this clears up any confusion!
M-the Taxol is the usual culprit for neuropathy.
S-the doses continue weekly, until further notice. The ultimate goal would be to drop T-DM1 and be on Herceptin and Perjeta, but I'd be off trial for that.
Trials are hard work. I felt like I had a full time job and offered by body up for science. I don't know how we calculate what had "done the job," I just hope it keeps going, like everyone else. It's frightening to think beyond where I am now, but I am banking on vaccines and things of that nature. I have always said I believe in The Cure and I do.
One thing I worry about is the head. There's no coverage on that. With trials, you can't add, change, or otherwise alter the criteria set forth.
It is true, recruiting people to join trials is difficult, but so is tissue donation.
We keep asking for better drugs, and a way out, but we all have do our part to make that happen.

Yours,
Karen

[StephN]

Dear K -
Thanks for the further explanation. At least staying on the trial gets you the drugs paid for by the companies who make the drugs.
OH! You do remind me the amount of time it took at the infusion suite each week to get three drugs. But they each worked a little differently, and I would give them their instructions as they were entering the IV line. Had just enough energy afterwards to make a run into the organic foods store on my way home, get the groceries put away and collapse onto my bed.
Month after month after month. But the good scans kept me going. Trying to outrun the cancer cells is a hard race!

As in your case, we never knew exactly which of the three drugs I took was most effective, just that there was an established synergy. On a two drug regimin it is a little easier to tell. And most of us know that for mets a single agent is not the most effective.

[StephN]

P.S. Re your head. They must give you a brain MRI every so many months?

If your body is NED the chance for brain mets is quite small. I never spent much energy on my brain getting mets, just my chemobrain!

[karen z]

Karen,
Very good news indeed.
It sounds like you have been quite an ordeal but, as others have pointed out, so worth it for NED and to help the cause.
Have a good holiday season and get some rest and peace.

[NEDenise]

Karen,
Sending love and prayers that you will remain NED for many, many years to come! Your courage, and determination have made a lasting difference in our HER2 world....and in my little corner of the world particularly.
Happy, Healthy 2013. my friend!

[Bunty]

Thank you Karen for being on this trial, and I hope your reward is continued NED. It means a lot to us all....
Best wishes
Marie

[Laurel]

Karen,

I echo the words of Marie and others with a resounding THANK YOU for your tenacity and courage. Your news is so welcomed. I cannot think of a nicer Christmas present!

['lizbeth]

Ladies,

3-4% enroll in clinical trials - now you see why I get so excited when someone on the board enrolls in a clinical trial. A big thank you again to Karen for enrolling!

I have heard many stage IV folks upset about the amount of money for MBC research. Yet if enrollment was filled quickly many clinical trials would have been completed years earlier. Successful trial treatments would have been available to many, many cancer patients.

When a newly diagnosed patient goes for treatment - the majority are only offered standard of care. It is difficult to convince a traumatized newly diagnosed stranger on the board to consider a trial.

I asked if I could be in a clinical trial for primary treatment and my oncologist told me she didn't want to do the paperwork, and she used scare tactics about what could happen.

I don't want to minimize the risks, some patients have died from participating in clinical trials. More patients have had positive results from participating. Some have been miraculously cured, others have gained months and years of precious time.

and yes, if more research needs to be in a certain area - that needs to be addressed as well.

If we work together - to get the word out. Most Cancer patients are not doing their part to advance the standard of care. It is up to us to ensure the millions and millions of dollars going into research are not wasted due to inadequate enrollment. It is up to us to push the advancement of standard of care.

So my wish for the new year is to get more ladies involved with me to encourage the newly diagnosed to consider a clinical trial for primary treatment. And to help those with recurrence to find an appropriate trial. Better yet - for those completing primary treatment to enroll in one of the Vaccine trials within 3 to 6 months. The numbers are already showing effectiveness from the phase 2 data.

In 2013, we ladies need to become cancer pioneers and not victims. Even if you are NED, there are studies to be in: Vaccine, breast reconstruction, exercise, cognitive studies. Look, consider and please enroll.

Thanks again Karen, and may you be NED, forever please!

[jacqueline1102]

Hello Karen,

Thank you so much for your information and narrative of what you have experienced with the trial. I want to add that I so respect you and have looked at your previous posts when I have felt despondent. May you continue to have no evidence of disease and 2013 brings much peace and happiness. Merry Christmas to you and your family.

Take good care,

Jackie

[Mandamoo]

You are my hero Karen!

[phil]

Congratulations Karen ! You are one tough cookie !! That was one rough tx schedule, Lorraines was just t dm-1 every 3 weeks. Lorraines now in a rollover trial too, passed the one yr ned mark in Nov. soon comes t dm-1 approval , then we can get away from these company rules. we have good ins., so should cover. others may stay in trial , so costs are covered by co.
We want flexibility, as ned continues, becuase of s/e like plats, and neuropathy. Lorraines ' neuropathy was already there before t dm-1, from nav. ,xeloda, but we now feel t dm-1 has increased it, for both reasons we asked for an exception, which the co. just gave, if plats are below 75,000, but above 60,000 , we can delay tx to monthly, maybe more time. When appr comes , we may go with 3.0 monthly, and prayerfully , later next yr go to 2.4, trying to balance ned w/ health in the long-term. so , think about building in breaks. God Bless, have a great Holiday. we are very grateful for t dm-1 , our best Holiday in 6 yrs.

[mamacze]

Karen - please add "December 2012 NED Forever" to your signature.

:>)

[KDR]

Thank you all so much for your kind words, really...
I am still in the boat, you know, still doing weekly treatments, but to look at me--no one would know. I sometimes feel off balance and definitely have those side effects (neuropathy and low blood platelets), but look at the trade off! When T-DM1 comes on the market, and that day will be soon, I hope you all experience the same.
Happy 2013 to all,
With love,
Karen


Mamacze-Hey, Angel! I wish I could add it but I can't usurp the BB markup code limitation. Wonder how Sheila did it...

[StephN]

Hi Karen -
I am not sure how to get more into your siggie except by condensing what is there. Such as June - Nov - NED, instead of listing each month. I had to condense mine and if anything else happens, I will just have to shorten the thing some more!

(I was not an editor for nothing!)

Stay in the NED boat - that is the most important one ...