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

todd121 said:

I did this study

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

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 said:

Thank you Todd! Im just

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

 

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

stacy1111 said:

Thank you Todd! Im just

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

 

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

Wishing you well,

Todd