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new member- stage 3a grade 4 considering clinical drug trial of Everolimus

stacy1111
Posts: 3
Joined: Mar 2014

Hi! My name is Stacy and Im 39 years old, very healthy and no risk factors. I'm married with 2 young daughters. I went to the ER 1/5/14 for Abdominal pain that turned out to be an 8.5 cm tumor on my right kidney. It was also hemorrhagic. Had total right open nephrectomy on 1/15/14. Pathology. stage 3 grade 4. No renal vein involvement or lymph node involvement. My urologist said I was cancer free and for me to live my life and he would scan me every 6 months. I didnt really like that answer so I got a second opinion from a local oncologist and he wants to enroll me in a clinical study in Chicago at Northwestern about 3 hours away from me. The study is for adjuvant therapy and is Everolimus. Anyone elso doing this or done one in the past? I'm worried about SE and getting resistant to the drug shall I need it in the future and its a phase 4 trial and I think ther is a 50% change ill get placebo anyway. Also, its a ways to travel to Chicago but I could do it depending on how often they would want me to. Northwestern is suppose to call me within the next couple of days to set up an appt with the md. any suggestions on doing a clinical trial for this drug?  Thanks for your time! Stacy

todd121
Posts: 568
Joined: Dec 2012

I was also stage 3 but grade 3. Due to the very high chance of recurrence (I was told about 50% chance by two RCC experts) I decided to do this. I just finished the 1 year period last month. I believe I was on the drug. Side effects weren't very bad. Some fatigue. Some nausea. Neither were constant or extreme. I had just a very few mouth sores (by that I mean I had one now and then in the beginning, but it was really very mild, and it happened only a few times). The first 3-4 months were worse with the fatigue and nausea, then the nausea mostly went away. There was one period where the nausea got especially bad in the first 3 months where I considered going off it, but I stuck with it and it got better. Blood wise, I had no symptoms to speak of. My blood work came back normal (I already had increased creatinine, but it stayed constant at 1.6 or so).

All in all, I don't regret doing it. To date, I have had no more tumors.

They will want you in every 6 weeks for blood work and a checkup. They did mine in the same day. Every 4 months or so (it's a multiple of the 6 weeks) you'll get a CT of chest/abdomen and pelvis with contrast if you can tolerate the contrast (I could not, my creatinine was too high).

I just wanted to do something to hopefully bring down my chance of my cancer coming back, or push it out.

I thought I was in a phase 3 trial...Are you sure it's phase 4? Because as far as I know there are no results yet on whether this is effective.

There's a time limit on when you have to start. The clock starts ticking when you had your kidney removed. I want to say it's 12 weeks, but I might be wrong. You should ask. They will do scans to make sure you're currently cancer free.

One of the upsides for me was getting followed a bit more closely by an oncologist that was very familiar with RCC and getting to know him.

I wouldn't recommend you one way or the other on the study. I'd say do what you think is right. However, I would strongly suggest you get followed by a medical oncologist that is familiar with RCC and not by a urologist (or urologic oncologist). I don't think they have the expertise to follow *possible* or actual metastatic RCC.

Best of luck,

Todd

todd121
Posts: 568
Joined: Dec 2012

There's a very small risk is of pneumonitis (I think that's what it's called), so you need to have your lungs listened to at each check up and your lung scans need to be looked at for this (I believe the risk was about 3%, but it can be very serious if it happens). It's an inflammation of the lungs. My doctor said he hadn't seen it very often, but this was the major point of the 6 week checkups. The other risks were related to blood chemistry. As I remember, there were small risks of increased lipids, blood sugar changes, and maybe anemia. There may have been a small risk of increased creatinine/kidney problems. This is the reason for 6-week blood work. I didn't have any of these problems.

I was offered two different studies to take part in. The first was a one year on votrient adjuvant trial. The second was one year on everolimus (the study was called EVEREST). I chose the second.

Not sure I summarized my reasons for doing the study. First, I have a high risk of recurrence and I was hoping to do something that would reduce or delay that possibility. Second, I wanted to be followed more closely the first year after my nephrectomy. Third, I wanted to get to know one of the groups in my area that are very knowledgeable about RCC (the doctor I saw is considered to be an RCC specialist). Finally, I wanted to help advance science in this area, hoping that what I would do might help others down the road. (I have an uncle who is a retired oncologist and he recommended I do something.)

I saw two different specialists (both medical oncologists specializing in kidney cancer). One recommended the votrient study (this doctor is one of the developers of votrient, so I took his advice with a grain of salt. To be fair, he was neutral on me doing a study at all). The second recommended the everolimus one. The second specialist recommended I do a study. On my own, I decided to go with the everolimus study. It seemed to me to be the one most likely to work in an adjuvant setting. The doctor that recommended everolimus said in his experience the side effects are very mild and everolimus is much better tolerated than votrient and that I was more likely to stay on the drug an entire year.

One of the funny things about everolimus is that nobody has been able to explain to me how it works. Votrient and the other TKI's I can sort of understand (they inhibit the tumors ability to build a blood supply for itself). All I got about everolimus is that it somehow interferes with the cancer cells ability to reproduce itself. One of the reasons I thought everolimus might work, is that everolimus works at an inter-cellular level, whereas the TKI's work more on an inter-cellular (or extra-cellular) level. My hope is that if I had/have cancer cells floating around, this will reduce the numbers to 0 or to so few that my immune system can take care of them. Who know if it will work. I'm no microbiologist for sure! Nano has given me links to papers on some of this stuff, and they are filled with words that I don't understand. Sometimes when I read those papers, I think the people that wrote them don't understand what they are talking about either...I'm digressing. :)

I achieved most of my goals. I probably will never know if I was on the drug or not for sure and it will be years before the result of the study are available/published. Even when they are available, if it's statistically helpful I probably will never know if it helped me in particular or not unless it turns out to be very beneficial.

Wishing you well,

Todd

P.S. My uncle, a retired oncologist, explained adjuvant therapy this way: the idea is that a drug that might not be very effective when there is a huge tumor load/huge cellular load, sometimes has been found in other cancers to be quite effective if the cancer cells are attacked early when there are very small numbers in the body, before they've had a chance to form tumors. Of course they don't know if this approach will work with kidney cancer, hence the adjuvant therapy studies.

stacy1111
Posts: 3
Joined: Mar 2014

Thank you Todd! Im just trying to weigh all the options. so much to consider. Its very overwhelming.

 

todd121
Posts: 568
Joined: Dec 2012

Hi Stacy,

We had another poster here in the study who finished several months ago. I think he thought he was on the placebo. If you do a search you might find the posts where we were discussing it. A few pretty knowledgable people on this site advised against me doing the study (actually any study for adjuvant therapy), but I decided to go for it. If you search, you might find those discussions so you can read their point of view. Maybe search on everolimus, affinitor, everest, adjuvant.

Wish you the best,

Todd

todd121
Posts: 568
Joined: Dec 2012

I hope you'll share with us what you decided and how you are doing either way.

Wishing you well,

Todd

angec's picture
angec
Posts: 621
Joined: Mar 2012

Hello Stacy.  Hope you are recovering nicely from surgery.. I would like to give my opinion.  Since you had a rather large tumor and were grade four, I would not waste any time on a trial that is extremely inconvenient and you have no idea if the you will be getting the drug.  I would spend my time getting my body as healthy as can be, resting up and being very studious about getting scanned at the very least, every three months.  I would also suggest, if you haven't done so already, to get full body pet/ct scans to rule out any mets.  I dont' blame you worring about side affects because you know there will be some for sure. I think you also have it right saying to wait to use a drug in case you need it in the future. Did you want to share your path report? What type of rcc do you have?  I would get in touch with an experienced RCC specialists.. I am sure some here can offer you one in your area.  You definitely want to stay on top of this and that doctor that said to scan every six months, i am not feeling positive with that answer.  Glad you got a second opinion.  Be well, live your life, but be sure to keep on top of your scans and be involved in your treatment. Votrient is a very good drug for most, and there are many other options if needed.  If it were me, i would nix the trial at this point.  All the best to you.. 

dhs1963's picture
dhs1963
Posts: 373
Joined: May 2012

There are potential down-sides to adjuvant protocals for RCC -- which is why they are still trials.  The issue is that the protocal may delay the onset of recurrance, but if it recurs then you have lost one potential drug to use.  I do not have references, but in some studies from UCLA, they found that there was a delay in recurrance, but when it came back, it was more agressive.  The unlimate number, time till death was at best neutral, and possibly sooner with the protocols they looked at. 

Couple that with the risk of side effects, and you can see why no adjuvant theropy is FDA approved.  With that said, if it is going to be approved, people have to go through the tests. 

Personally, I am lucky.  So far, my disease has presented as isolated tumors, which are removed in a whack-a-mole style.  Surgery sucks, but it beats the alternative.

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