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January 30, 2014 at 8:28 pm #21776
Hi, I am a participant in the Roche BRAF/MEK trial and recently had a pesky adrenal gland tumor removed. It turned out to be fibrotic tissue, no cancer cells left what so ever! When I started the trial this tumor lit up on PET scan with a SUV of 9. The only other tumor in my body are a few very small lung nodules that are non-reactive on PET. My oncologist is considering me NED, the first time in over six years as a Stage IV patient I have had this designation.
My question is, for those of you complete responders to targeted therapy, what have you done next? Do you stay on the drugs? Go off of them? I am still in the trial, which means that I am getting scanned every six to eight weeks, per their protocol. One option I am considering is leaving the trial and going on the the other BRAF/MEK combo that is now FDA approved, since there is no clinical reason for me to be scanned so often anymore.
Thanks for your input.
Stage IV for over six years and still thriving!!!!!!January 30, 2014 at 10:13 pm #63451MathewRParticipant
Eileen, thanks for posting such wonderful news! As a patient on the GSK combo, I love hearing about folks getting to NED on targeted therapy. Gives the rest of us hope.January 31, 2014 at 2:24 pm #63452LesliParticipant Eileen, I second Matt in expressing my gratitude for stories such as yours. In response to your question in the subject line, I suppose I would get back to thinking about more interesting things than Melanoma. We will be cheering you on and hoping for a similar experience! Congratulations to you. Were you taking Zelboraf and Mekinist?
LeslieJanuary 31, 2014 at 2:55 pm #63453Catherine PooleKeymaster
I am curious as to your combo therapy, it was Zelboraf (Roche) and then a Roche MEK? Where was the trial? What does your doctor suggest? These drugs are different (Roche vs. GSK)
Thanks for the happy news!January 31, 2014 at 5:00 pm #63454
Thanks to all who responded. As to which trial I am on, I am on the Phase 1B Roche trial of the combo therapy, Vemurafenib and an experimental MEK inhibitor. My understanding is that this combo has now gone into Phase 3 trials, but the few of us on the Phase 1 protocol continue! I have been on the drugs since May, 2012. When I first went on the trial, I had a few small hot lung nodules and a large adrenal gland tumor, measured over 6 cm with an SUV of 9. The lung nodules are now undetectable on PET, and before the surgery the adrenal gland tumor had shrunk to 1.7 cm and was also “cold” on the PET. We decided to remove it because I was having some flank discomfort and since PETs are known to have false negatives, we weren’t sure if the drugs had totally knocked the melanoma out! Well, we now have our answer, the drugs are working very well for me.
The conundrum now seems to be whether or not to continue the therapy. Since the drugs are so new there isn’t much of a history of folks like me who seem to be total responders and whether we need to continue the therapy or should we go off the drugs and take a wait and see attitude. Quite frankly, I am managing the side effects having adjusted to the extreme sun sensitivity, fatigue, foot pain, etc.For now,my doctor and I have decided I should stay on the trial but I worry because the protocol demands I have PET/CT scans from head to toe every six weeks! I use to be cavalier about this, thinking I should be lucky enough to live so long to get a secondary cancer from the radiation exposure. I am now not as certain that I won’t have some longevity to my life. This is a good problem to have, and I am very grateful that I am one of those people who have responded to targeted therapy so well!
BTW, I get my care, including study participation, at the University of California at San Francisco, from Dr. Daud at the Melanoma Treatment Center there. I love Dr. Daud and got wonderful inpatient care when I had my surgery there. Again, I feel very fortunate that I live just a few miles down the road from the center.
Eileen LJanuary 31, 2014 at 7:26 pm #63455Dick_KParticipant
Great news and thanks for sharing. I have a similar problem that I wrestle with.
In four weeks I will reach the four year mark as part of the Roche phase 2 trial for Zelboraf. My PET scans stopped lighting up in December 2010. Tumors shrunk by about 96% and have been that size since February 2012; my doctor thinks what is left could be scar tissue. My trial protocol also called for scans every six weeks but that was changed to every twelve weeks in September 2012.
Very shortly I will transition out of the phase 2 trial to a rollover study. The hope is that scan frequency will then change to six month intervals. I too am managing the side effects well and have decided I will continue with the medication largely because of the unknown of what will happen if I stop. There is also the feeling that I am providing information that will be helpful to others.
Anyway, that’s my brief story, congratulations and continued good luck to you.January 31, 2014 at 11:39 pm #63456
Thanks Dick for your response. It is good to hear from other folks who have some longevity on the targeted therapies! I did ask about rolling over into the Phase 3 study, but was told that wasn’t being done. I think I will make the inquiry again. Not only am I getting a bit concerned about the frequency of my scans, it is also getting a bit tiresome to have to be seen every four weeks by the study team, etc. I assume on a Phase 3 protocol all of that would be less frequent.
EileenFebruary 4, 2014 at 10:58 pm #63457zephyr66Participant
first off, congrats!! my partner was also on the braf/mek trial for 12 months before progressing. our oncologist said basically, that if you get off the treatment, the cancer will undoubtedly grow again – but, that is something for you to speak to your onc about. also, i may be wrong, but are you bound in some way to continue the study unless you experience adverse side effects or progress on the drug? i believe all that paperwork you signed before the trial indicates some sort of agreement, so i would inquire about any possible consequences if you decide to stop. i may be wrong, but it’s good to check.February 7, 2014 at 6:29 am #63458
Thx for your response. In all the studies I am aware of you can opt out at anytime. Take care!
EileenFebruary 7, 2014 at 12:22 pm #63459BNP68Participant
What a wonderful problem to have! Congrats on being a complete responder. It is definitely a tough question to answer because no one really knows what the answer is. You are a pioneer! I know what you mean about the scan radiation and along with that I often wonder about the long term cumulative effects of some of these new treatments. I’m not sure what I would do in your shoes. One thing I might consider is staying on the drug a little while longer until PD-1 was approved. I think your Braf/Mek combo was just approved wasn’t it? That might be another one I’d wait for before coming off the treatment if it hasn’t been approved yet. Like I said it’s a tough question and one I hope to be facing sometime in my future
BrianFebruary 7, 2014 at 6:00 pm #63460Catherine PooleKeymaster
Well if the PD1 is approved soon, I would go with that for maintenance because of the low side effect profile. As for leaving the trial, yes, you can do so at anytime. Going from one BRAf/Mek to another is an interesting idea. There is also the Novartis Braf/Mek which is showing less side effect, no fevers, etc. It is in trial only for the time being.February 10, 2014 at 5:19 pm #63461 Thx Brian. I am currently on the Roche drugs, the MEK inhibitor is not yet approved. Moving over to the approved drug combo is something I am going to discuss with my oncologist when I see him next week. I just heard Dr Weber give a talk about the three combo drugs and he indicated the major difference is the side effect profiles. So it seems I should respond to the GSK combo if the Roche drugs work for me.
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