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Evero;imus clinical trial

sunlover_56's picture
sunlover_56
Posts: 110
Joined: Apr 2012

Hi Everyone. I had my left kidney removed. I was told it was RCC clear stage 2 grade 1. I am a month out of surgery and finally feeling like maybe I may beat this awful disease. THEN I had my first visit with my oncologist and I am back to doing nothing but worry.. Not so much for the cancer that I am assuming I will beat but because they have given me another decision to make... grrrrrrrrr... They would like me to take part in a blind clinical trial fr the drug everolimus. They are alrady using it on advance RCC but I am not sure of with what sucess. Now they would like to try it on stage 1 and 2 to see if it may stop reaccurances. I am scared to try it because of some of the MANY side effects that sound really horrible. But the one that scares me the worse it the fact that it works on the immune system (killing bad and good cells)It states that it could INCREASE your chances of lymphoma and or skin cancer. Has anyone eles with my similar type and grade of cancer tried this drug yet.. Do you think it is worth the risks> I would either get the drug or a placebo and they are not sure how or if it will even work. Please someone help me. I am so agonizing over this after just starting to feel like I could have a normal life finally.. Thank you.... Judy

Texas_wedge's picture
Texas_wedge
Posts: 2807
Joined: Nov 2011

Have you had a good appraisal of what's in it for you? It sounds as if your prognosis is so good that you're on a hiding to nothing going in for it. If no-one has given you a well-reasoned justification for being a guinea pig I think you should demand such a justification and unless it's very compelling, turn down the offer of the trial.

It's very worthy to help in the advance of knowledge but there's a limit to what makes sense in the cause of altruism and charity begins at home. If i were in your shoes I'd turn it down flat unless and until I were given a totally convincing argument for participating.

DMike's picture
DMike
Posts: 238
Joined: Nov 2011

I know exactly what you are going through. I am stage 1, grade 4 (5% sarcomatoid) clear cell and I was presented this same scenario at my first office visit in January. Just when you think things are okay they throw this at you! My oncologist made the appointment for me (I didn't know about it until I showed up for my appointment with him) and I went to the appointment with the other doctor out of respect/politeness..

I looked at everything and turned them down. They were so eager to get someone in the trial (with a placebo) until I felt like they were just looking for a guinea pig like TW said.

This is all fresh in my mind because I just got a bill for $400+ for the office visit where they promoted the trial to me. I was shocked that I was charged and I'm fighting that bill.
--David

Texas_wedge's picture
Texas_wedge
Posts: 2807
Joined: Nov 2011

I'd be shocked too, David and I'd be furious - I hope you're successful in contesting that bill.

My tumours were mostly sarcomatoid so no surprise to be grade 4 but I'm a little surprised that you were too. Was this on the basis of being 5% sarcomatoid, or were there other factors?

Texas_wedge's picture
Texas_wedge
Posts: 2807
Joined: Nov 2011

I'd be shocked too, David and I'd be furious - I hope you're successful in contesting that bill.

My tumours were mostly sarcomatoid (chromophobe) so no surprise to be grade 4 but I'm a little surprised that you were too. Was this on the basis of being 5% sarcomatoid, or were there other factors?

DMike's picture
DMike
Posts: 238
Joined: Nov 2011

The pathologist's comments for my 5cm tumor with 5% sarcomatoid:
"The tumor is predominantly clear cell with a Fuhrman nuclear grade 3/4. However there is a focal area with tumor cells exhibiting rhabdoid features in a myxochondroid background, thus warrant a Fuhrman nuclear grade 4/4. This case was reviewed in the Consultant's Conference on 12/9/11, with consensus as to the diagnosis."

So, I'm not really sure if it's a grade 3 or 4. I did not have this report when I met with him after surgery. I'm much more prepared to ask questions at my next appointment and first followup scan in June.
--David

icemantoo's picture
icemantoo
Posts: 1529
Joined: Jan 2010

Sunlover_56,

Based upon your pathology I agree with Tex and his reasoning.

Icemantoo

sunlover_56's picture
sunlover_56
Posts: 110
Joined: Apr 2012

Thanks everyone. I pretty much decided not to take it.. I am thinking if the cancer should come back (20% to 30% chance) then I will deal with it then. I need to start thinking on the lines that I am cancer free. If I do this trial it will be another year of having to deal with and think about my cancer and treatments. I am going by the old phrase. Ifs its not broke dont fix it.. lol by the way. If it would change any of you're advice to me, it actually was approved by the FDA, bu for advanced RCC.. they now want to see what it does for patience who have not had any reaccurances to see if it will stop them.

sunlover_56's picture
sunlover_56
Posts: 110
Joined: Apr 2012

Was the drug they were promoting Everolimus?

DMike's picture
DMike
Posts: 238
Joined: Nov 2011

sunlover_56,

Yes, they were promoting an Everolimus trial. I checked the paperwork and the trial title is "S0931 - EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, a Phase III Study". It's sponsored by the National Cancer Institute and Southwest Oncology Group.

I just didn't see any point in participating.
--David

sunlover_56's picture
sunlover_56
Posts: 110
Joined: Apr 2012

That is exactly the same trial offered to me.. I have decided not to participate either. To many side effects and not enough proof it will do me any good. Hope I am doing the right thing. I am usually a pretty strong minded person but this DX has me like a noodle brain. lol. I AM coming back though.

garym's picture
garym
Posts: 1651
Joined: Nov 2009

Sunlover & David,

For what its worth I think you made the right decision. I don't understand how a trial to prevent recurrence proves anything unless the test group has very high odds of recurrence in the first place, something just seems off to me.

foxhd's picture
foxhd
Posts: 1901
Joined: Oct 2011

My thoughts exactly. And also my response last May when they wanted me to trial votrient. I've been realy glad I made my decision. Good luck to you too.

sunlover_56's picture
sunlover_56
Posts: 110
Joined: Apr 2012

Thank you Fox, Gary, Tex, Ice, and Mike.. and everyone.. I am feeling better and better now about my decision after hearing from you all. I think I will fire up my BBQ and cook some steak.. Its time I try to forget about cancer for a while and start to enjoy all the things I love to do!!

sunlover_56's picture
sunlover_56
Posts: 110
Joined: Apr 2012

I just learned how to do my profile.. lol.. now I need to figure out how to add all of you wonderful people to my friends list :-)

cww71964's picture
cww71964
Posts: 95
Joined: Dec 2011

Hi all,
Been awhile since l have posted although I do drop in to check on everybody. I have been really busy with work and with the weather being nice, spending a lot of time outdoors. I just started my second cycle on the Everest trial. Other than a little insomnia, I haven't experienced side effects. It is quite possible I am getting the placebo but my research nurse tells me most are tolerating it well. I take 2 pills every morning so nothing to it. I get a physical and blood work every 6 weeks and ct scans at 18 weeks. I am not sure if this trial will benefit me in anyway but if the research from this can help someone in the future, it will be worth me being a guinea pig. At the very least, I am being monitored closely which does comfort me somewhat.

Health and happiness to all,

Wayne

Texas_wedge's picture
Texas_wedge
Posts: 2807
Joined: Nov 2011

Good to see Wayne back, even just as an occasional visitor - it's cheering to see people have good outcomes and go off and get on with their lives, just as it's good to see others with good stories who can find the time to stick around, like iceman and GaryM to help the endless stream of newcomers.

I feel the need to comment now because I nailed my colours to the mast here, against the trial (for sunlover) but had supported Wayne in going for it a couple of months ago. This is not inconsistent. The two cases are different and it's always a matter of 'horses for courses' with RCC. Wayne is young, very fit and psychologically robust, so well able to endure the possible side-effects (and you'll see he hasn't been bothered by them, assuming he's not on the placebo!) The key fact is that his prognosis is a little poorer than sunlover's, being stage 3 with some renal vein invasion. Consequently, he has a higher risk of recurrence and so being in the trial is better indicated in his case.

Aside from this, Wayne made a very compelling argument for it in his situation (on the "Need advice" thread started by Raj)

"It is a blind trial as well, but the way I see it is that whether or not I get the drug, I have established a relationship with an oncologist, and I am going to be closely monitored. If it does come back, it will be caught early. In Gerald White's book he says that " if you don't take charge of your own healthcare somebody else will and you won't like the results". I am doing everything in my power to increase my chances of staying cancer free. Exercise, dietary changes and most of all, a positive attitude."

I think that was excellent reasoning on Wayne's part. For sunlover, I feel she has the exercise, diet and attitude angles well covered and also has youth and tough-mindedness on her side but doesn't have the reasons Wayne had for entering the trial.

So, I believe both arrived at the best decisions for themselves and both have also benefited from being very active participants in managing their own health.

sunlover_56's picture
sunlover_56
Posts: 110
Joined: Apr 2012

Arent you being monitored more closely due to the side effect? If you're not on it then you dont need to worry about side effect.. I will still get a scan to see if the cancer comes back the same amount of times as if I was on the trial. I would love to do the trial to help the next person who gets RCC, but for me, my emotional state is very important to my healing and if I was on this pill for the next year, I would be worried about every little pain or ache or cough.. etc...Also about the fact that it can increase your risk of getting a different type of cancer. (I read that if you accidentally crushed it or broke it open in your hand, you need to wash your hands asap.. now that scares me to put something like that in my body.. I am trying to keep positve and stop thinking about the big "C" word. I am concidering myself cancer free since they told me they got it all (That may be foolish cause I know it can come back) but I have to believe it wont. Should it come back in the future, I will deal with it then. If I was on this trial for the next year or several years it will keep cancer in the forfront of my life when I dont want it there anymore. Perhaps my reasoning is a little bit of hopeful thinking but thats how I feel. I do, though, respect anyone eles's choice to participate in this trial.

cww71964's picture
cww71964
Posts: 95
Joined: Dec 2011

Sunlover,

I completely understand your reasoning as well. I must say however, that in all the paperwork, disclosures, possible side effects, etc. I did not see anything about the possibility of the drug causing any other cancers. Believe me, I read through all the paperwork numerous times and there was nothing of the sort. Also,the pills are small and hard, not capsules, so you would have to intentionally crush them but again there was nothing in the documentation discussing that either. Not that any of that should sway your decision. As Tex wrote, you and I were in different situations, different percentage chances for recurrence. I didn't want to be in a position down the road where I asked myself why didn't I go on the trial.

Health and happiness to all,
Wayne

sunlover_56's picture
sunlover_56
Posts: 110
Joined: Apr 2012

The articles that I read said that if the pill was crushed or boken for some reason and you got it on your hands you ahould wash right away. I have the link to that. I also have a link from Drug.com stating that it increases your risk for lymphoma and skin cancers.I I know you didnt mean to but your post upset me just a little. I was quite convinced I had made the right decision. I think your last statement is what worried me a little... Quote: "I didn't want to be in a position down the road where I asked myself why didn't I go on the trial."

Here is one of the links where I found info

http://www.drugs.com/cons/everolimus.html

If you scroll down to "Proper use of Everolimus" you will read about the crushed or broken pill.

Even if I have some misinformation, I still dont feel 100% comfortable taking this drug.. it mentions Hepititis B also can flare back up if you have had it before and I did when I was a small child. I hope and pray that I am making the right decision.

Texas_wedge's picture
Texas_wedge
Posts: 2807
Joined: Nov 2011

I think what you were remembering, sunlover, was on MedlinePlus, under the ominous heading "Important Notice"

http://www.nlm.nih.gov/medlineplus/druginfo/meds/a609032.html#special-dietary

There's no doubt it's powerful stuff and I've read elsewhere about washing it off your skin in the event of exposure as a result of a broken or crushed tablet or in laboratories etc. or if involved in fire-fighting when there might be a risk of inhalation etc.

On a hobby horse of mine about interactions, I note the warning not to have grapefruit or grapefruit juice, or St. John's Wort, if on everolimus.

I'm still convinced that you made the right decision and also that Wayne's analysis was sensible on the data he had available.

I'm just a little disquieted that some aspects evidently weren't made clear to him and wonder whether the information supplied was edited down. Usually the accompanying warnings with medications err on the side of alarmism (doubtless due to the advice of my brethren in the legal profession) but maybe it's different with powerful toxic agents that someone wants you not to be put off taking!

Fortunately Wayne is doing fine and I must confess that if I were in his shoes I wouldn't mind if I found I'd been on the placebo! He will have the satisfaction, whether on the drug or the placebo, of knowing he's helped further research and he's getting the expert close monitoring he wanted with the guarantee of an early alert if it becomes appropriate, which we all hope it won't.

garym's picture
garym
Posts: 1651
Joined: Nov 2009

I believe that the decision to do this or that is completely individual and governed by personal make up, experience, and circumstance, there are no wrong answers. I marvel at how different we all are and yet how alike. I find myself self sharing more with my "extended family" here because you understand, I think that's a common feeling among us. This "sharing" of emotions, experiences, research, and decisions is a powerful thing and it keeps us coming back for more.

Just my $0.02,

Gary

sunlover_56's picture
sunlover_56
Posts: 110
Joined: Apr 2012

You are so right Gary. And thank you Tex. I am back to being quite comfortable with my decision.. I do have a bone scan scheduled for this morning but before I go I am going to go out for breakfast and enjoy some bacon and eggs and hashbrowns!! You all have a wonderful day because that is what I plan on doing :-)

PK_Chicago
Posts: 29
Joined: Mar 2012

I was offered the same trial - but then my second pathology report showed my mass was not clear cell - but chromophobic! My second opinion oncologist told me that I shouldn't do the clinical trial seeing that the sub type chromophobic is less aggressive and ha a better prognosis.

I was also surprised by the side effects -

I had my surgery in January and am going for my first set of post surgery scans tomorrow.

We'll see what happens - my advise is a seconf opinion or consultation with another oncologist...

Good Luck!

PK

sunlover_56's picture
sunlover_56
Posts: 110
Joined: Apr 2012

Good luck with your first set of scans. My first scan is in August. My oncologist scheduled them for 6 months but my urologist wanted it in 3 months. I like his plan better lol

todd121
Posts: 575
Joined: Dec 2012

I'm confused. I had thought the classification of these was very objective. Are you saying you had another pathologist look at the same samples and came up with non-clear cell?

How can that happen? Did you ask for another opinion, or do they automatically do a follow-up pathology report using a second pathologist?

What was your original Fuhrman grade, if you don't mind my asking?

Thanks,

Todd

Texas_wedge's picture
Texas_wedge
Posts: 2807
Joined: Nov 2011

The classification isn't that objective Todd.  Opinions not infrequently differ and there can be different pathologies in different parts of the same tumour. 

I have the impression that clear cell is re-classified as non-clear more often than vice versa.

Incidentally, Fuhrman grading may well be phased out in due course and it isn't valid for chromophobe pathology or, if I remember correctly, for pRCC either.

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