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Adjuvant Treatment Questions

lobbyist0724's picture
lobbyist0724
Posts: 427
Joined: Sep 2016

Hi everyone,

Some of the members of Kidney Cancer Forum will be joining in some discussions at an upcoming conference about the latest "hot" topic in kidney cancer treatment. It's about "Adjuvant" treatment, meaning treatment post-nephrectomy in the absence of visible metastasis, but for patients who are deemed to be at high risk of recurrence. I am trying to help to gather more information for them so they can share our thought to the doctors attending the conference. THANK YOU!

Would you mind weighing in on this so that we can represent as many different patient/caregiver views as possible? There are just three main questions below. Please feel free to add your comments as a Reply so that others can read what you think. If you really want to keep your views private, please send me a Private Reply. (Patients/Caregivers of all stages welcomed to weigh in.)

Please note: Adjuvant therapy is not yet available (anywhere) for high-risk patients outside of a clinical trial setting, so if this "hypothetical situation" applies to you directly, the current standard of care is "active surveillance" unless there are visible signs of recurrence.

The 3 Questions:

As a patient or caregiver who has been personally affected by kidney cancer (renal cell carcinoma):

 

1. If after surgery for kidney cancer (local disease, not metastatic), your doctor told that you are at High Risk of recurrence, would you consider taking sunitinib (Sutent) for one year to delay the onset of recurrence even if your overall survival was not improved?

(Yes/No)

 

2. If YES, how much delay in recurrence would make the one year on sunitinib of value to you?

a) 6 months

b) 1 year

c) 2 years

d) Others:

 

3. If NO, why not?

 

NewDay's picture
NewDay
Posts: 273
Joined: May 2012

1)NO

3) For 2 reasons:

      - Because taking the Sutent could potentially make me ineligible for future trials if it does recur.

      - Most importantly, because, knowing the common side effects of Sutent, I would not have been able to work and would have had to take disability, as I had to do after starting Votrient and then Inlyta.

 

 

lobbyist0724's picture
lobbyist0724
Posts: 427
Joined: Sep 2016

Those are very good points, we haven't thought about the ineligibility to participate in future trials after taking Sutent.

So far, most of the concerns are related to the side effects since it affects the ability to have a normal life. Some suggested to bring it to the doctor to see will a lowered dose achieve the same benefits but without the annoying side effects. Also, perhaps the doctors can also replace Sutent with new agents/meds that will be more effective and cause less side effects.

Please continue to share your thoughts. The meeting is Feb 16th, Would you or wouldn't you take a drug for a year right after surgery if the prospects were that it could delay (probably not prevent) a recurrence from happening.

todd121's picture
todd121
Posts: 1427
Joined: Dec 2012

This study was already done and proved to have little/no value. So I'm not sure why this would be an interesting question.

todd121's picture
todd121
Posts: 1427
Joined: Dec 2012
todd121's picture
todd121
Posts: 1427
Joined: Dec 2012

I was offered a trial using votrient I think after my second tumor was removed. I declined.

A quote from the above article, "Furthermore, the time gained from adjuvant sunitinib therapy in disease-free survival is equivalent to time spent on treatment, implying a net zero gain".

The studies so far have not shown clear benefit. I wouldn't want to take a poison like sutent unless I really had to do it. If I had no evidence of disease, and a "decent" chance it wouldn't come back, I'd prefer to wait and use close surveillance. That's exactly what I decided to do. Caught early, another tumor might well be resectable or treatable via radiation. I've known several people to get years and years out of this strategy.

After my first tumor, I did go into the EVEREST study. However, the side effects of everolimus are substantially less than sutent/votrient. The study I was in was a 50/50 placebo/everolimus study. I had many health problems that year and a lot of anxiety, and I chalk much of it up to thinking I was on everolimus. After my metastasis, I discovered through being unblinded from the study that I had been on the placebo that year. I was really pretty shocked. I decided I wouldn't do a study like that again unless I really had to.

Best wishes,

Todd

foxhd's picture
foxhd
Posts: 3183
Joined: Oct 2011

What Todd said about zero gain is dead correct. ?pun?..Consider this: Any drug whose job is to inhibit tumor growth and vascularization after nephrectomy is the wrong direction to persue as  therapy. In my opinion joining this study is for some stastistical purpose for data collection for someones research. It has zero benefit for the patient. Don't fall for the trap.

Now if anyone was to begin taking a drug, post nephrectomy, shouldn't that drug be a drug that will assist in killing any residual cancer? These are the immunologics. Like low dose nivolumab. Or low dose injectible il-2.  Something that will assist toward a cure. Not palliative care.

Dutch1's picture
Dutch1
Posts: 152
Joined: Mar 2014

I had originally responded positively to the question about the test trial.  That was before learning via Todd that the test trial results are in and the conclusion is that Sutent is ineffective in this test trial.  Obviously, there'd be no point in participating in this particular trial any more.

I am in favor of participating in other test trials if there is legitimate potential to benefit both me and others in the future.  Without test trials, we wouldn't have the drugs we have right now. 

Dutch

lobbyist0724's picture
lobbyist0724
Posts: 427
Joined: Sep 2016

Thanks again for the feedback, and I completely agree with Todd that the "zero gain" is a show stopper :(

The S-Trac study is the first one to show benefit in adjuvant setting, but it is disappointing to see that there is no OS benefit. But in the ASSURE study, Sutent didn't even improve the DFS of the patients. It is possible that it is related to the inclusion criterias of the studies (i.e. Assure included pT1b patients and lower grade tumor patients). At the same time, the sub-study analysis of the S-Trac study shows that patients at higher risk than the overall population of the study (tumor stage 3, grade 2 or higher, ECOG 1 or higher, or tumor stage 4), the difference in DFS was significant up to 2.2 years. So there are patients belong to this group urging that they do want to receive Sutent after nephrectomy. There is also another patient points out that perhaps we should have a trial testing a reduced dose of Sutent (to minize side effects) and hopefully it will achieve the same endpoint.

I shared exactly the same view as Fox, the new adjuvant therapy should target the residual tumor cell, cancer stem cell and improve the OS. I personally don't think Sutent is suitable in this setting. So I look forward to see new studies testing immunotherapy (nivolumab?) in adjuvant setting.

The purpose for this question is to bring the cancer researchers with what we want as a patient. Hopefully we can help the researchers to design new trial to developer new adjuvant therapy that we want.

Thank you!

Hd67xlch's picture
Hd67xlch
Posts: 149
Joined: Apr 2016

Today was my 1st visit with my oncologist after my rcc wedge resections in my left lung Jan 3rd. 1st thing he says is that there is a new study out saying Sutent could/should be taken after a patient like me (high risk) has had rcc spread to both lungs and has been sucessfully surgically removed, even though at this moment in time he feels I have no visible cancer. He then tells me he would like me to give it a try, I then told him I will not give it a try at this time, that my quality of life is more important to me than anything else. To humor him I told him Id consider it after my April scans if anything has shown up, seemed to make him feel better.

todd121's picture
todd121
Posts: 1427
Joined: Dec 2012

I think the link above is regarding the study your oncologist is talking about. It doesn't look too promising.

I personally don't think any of the anti-angiogenisis drugs are going to pan out for adjuvant therapy. Votrient. Sutent, etc. If you think about it, it sort of makes sense. Micro-tumors don't really need much of a blood supply to get started growing. It only becomes more important as the tumor grows. These drugs inhibit the tumor's ability to build its own blood supply.

Also, most (maybe all...) patients tumors seem to develop resistance over time as they take the drug.

Of course I'm not doctor or scientist and I don't even play one on TV, but it would seem to me I'd be worried that tumors that did appear while taking this drug would already be resistant to it by the time it would become effective.

Like Fox, I think the immune system drugs are more likely to be found to be helpful in an adjuvant therapy situation. I'm not sure if they are doing any studies yet, but if I was a newcomer to this situation and there's an adjuvant therapy study using one of these immunologic approaches, I'd definitely try it. Plus the side effects aren't so bad and when they've been effective, they seem to have long lasting effects even after the drug is stopped (while the anti-angiogenisis drugs seem to stop working as soon as they are withdrawn if there's still active growth going on).

But, don't listen to me. I am not an expert.

Go ask your RCC expert oncologists.

Todd

lobbyist0724's picture
lobbyist0724
Posts: 427
Joined: Sep 2016

I am just reposting the response from the a member of the International Kidney Cancer Coalition who asked me the Adjuvant Treatment Question. Her response also mentioned a couple new study with immunotheraphy as the testing agent. Thank you all for your input.

---------------------------------------------------------------------------------------------------------------------------

Thanks for all the input so far. Actually this topic came up at the Canadian Kidney Cancer Forum (medical/research meeting) this past weekend. One of the kidney cancer specialists from Ottawa came to the microphone and specifically Asked what patients thought about this question -- so it was great to mention that we've had your input, and some of the key themes that have come up. Thank you. (And separately there was a Canadian Guidelines meeting on this topic which will, for now anyway, recommend against any kind of recommendation to treat with sunitinib/Sutent in the Adjuvant setting (for high-risk patients, who have no evidence of recurrent disease). My interpretation: This will be based upon 1st principles of "do no harm" -- that a significant percentage of patients who would not recur anyway would experience potential harm from 1 year of therapy. Of course it's different in the metastatic setting where the data is significantly different and there is a very different risk vs benefit equation.

If you're still reading this, there's another clinical trial that has caused a bit of a stir...  it's in the same Adjuvant (high risk, post-surgery, no metastasis) setting, but this one is with one of the newer immuno-oncology drugs called atezolizumab. 

Here's the trial description in lay language with a picture of who gets what:

http://iokidney.com/clinical-trials/immotion010

So half the patients will get an intravenous infusion of atezolizumab every 3 weeks (for 16 cycles)... and the other half will get... an Intravenous PLACEBO every 3 weeks (for 16 cycles) -- essentially saline solution.

Personally I can't believe that this has gone through... Clearly it has been approved by ethics boards, but I'm not sure if anyone consulted a real patient.

Would you sign up for this trial? (There is another trial coming soon, with nivolumab instead, that will NOT include an IV placebo arm because those trial designers thought that an IV placebo was unethical...).

Thoughts?

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